Exhibit 10.1
  Confidential Materials omitted and filed separately with the
 Securities and Exchange Commission. Asterisks denote omissions.
 


 


SUPPLY AGREEMENT


by and among


PLC SYSTEMS INC.,


PLC MEDICAL SYSTEMS, INC.


and


EDWARDS LIFESCIENCES LLC


dated


March 9, 2006



   
 














 


TABLE OF CONTENTS


	
  

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE I Definitions

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE II Appointment

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Section 2.1.

  	
   

  	
  Appointment

  	
   

  	
   

  	
   

  
	
  Section 2.2.

  	
   

  	
  Future Laser Power Sources

  	
   

  	
   

  	
   

  
	
  Section 2.3.

  	
   

  	
  Product Accessories.

  	
   

  	
   

  	
   

  
	
  Section 2.4.

  	
   

  	
  Endo Handpiece Inventory.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE III
  Obligations of PLC

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Section 3.1.

  	
   

  	
  Labeling of
  Laser Power Sources

  	
   

  	
   

  	
   

  
	
  Section 3.2.

  	
   

  	
  Manufacturer’s Warranty

  	
   

  	
   

  	
   

  
	
  Section 3.3.

  	
   

  	
  Insurance

  	
   

  	
   

  	
   

  
	
  Section 3.4.

  	
   

  	
  Production of
  User Manuals

  	
   

  	
   

  	
   

  
	
  Section 3.5.

  	
   

  	
  Costs and
  Expenses

  	
   

  	
   

  	
   

  
	
  Section 3.6.

  	
   

  	
  Legal Requirements

  	
   

  	
   

  	
   

  
	
  Section 3.7.

  	
   

  	
  Facilities

  	
   

  	
   

  	
   

  
	
  Section 3.8.

  	
   

  	
  Inspection

  	
   

  	
   

  	
   

  
	
  Section 3.9.

  	
   

  	
  Adverse
  Experience Reporting

  	
   

  	
   

  	
   

  
	
  Section 3.10.

  	
   

  	
  Records

  	
   

  	
   

  	
   

  
	
  Section 3.11.

  	
   

  	
  Recall

  	
   

  	
   

  	
   

  
	
  Section 3.12.

  	
   

  	
  Transfer of
  Regulatory Approvals.

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE IV
  Purchase Arrangements

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Section 4.1.

  	
   

  	
  Purchaser
  Orders; Product Quantities

  	
   

  	
   

  	
   

  
	
  Section 4.2.

  	
   

  	
  Placement of Orders

  	
   

  	
   

  	
   

  
	
  Section 4.3.

  	
   

  	
  PLC License

  	
   

  	
   

  	
   

  
	
  Section 4.4.

  	
   

  	
  Failure to Supply

  	
   

  	
   

  	
   

  
	
  Section 4.5.

  	
   

  	
  Technology
  Escrow and Transfer

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE V
  Pricing, Shipping, Payment

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Section 5.1.

  	
   

  	
  Retrofitted
  Model 3 Laser Power Source.

  	
   

  	
   

  	
   

  
	
  Section 5.2.

  	
   

  	
  New Model 3
  Laser Power Source

  	
   

  	
   

  	
   

  
	
  Section 5.3.

  	
   

  	
  Shipping; Taxes

  	
   

  	
   

  	
   

  
	
  Section 5.4.

  	
   

  	
  Payment

  	
   

  	
   

  	
   

  



 



 i
 






 



 


	
  

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VI
  Termination;

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Section 6.1.

  	
   

  	
  Immediate Termination

  	
   

  	
   

  	
   

  
	
  Section 6.2.

  	
   

  	
  Effect of
  Termination

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VII
  Warranties and Indemnification

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Section 7.1.

  	
   

  	
  Warranties

  	
   

  	
   

  	
   

  
	
  Section 7.2.

  	
   

  	
  Indemnification
  by PLC

  	
   

  	
   

  	
   

  
	
  Section 7.3.

  	
   

  	
  Indemnification by Edwards

  	
   

  	
   

  	
   

  
	
  Section 7.4.

  	
   

  	
  Indemnification Procedures

  	
   

  	
   

  	
   

  
	
  Section 7.5.

  	
   

  	
  Limitations on
  Liability

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE VIII
  Trademarks and Confidentiality; Intellectual Property Rights

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Section 8.1.

  	
   

  	
  Trademarks.

  	
   

  	
   

  	
   

  
	
  Section 8.2.

  	
   

  	
  Confidential Information

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE IX
  MISCELLANEOUS

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Section 9.1.

  	
   

  	
  Relationship

  	
   

  	
   

  	
   

  
	
  Section 9.2.

  	
   

  	
  No Conflict

  	
   

  	
   

  	
   

  
	
  Section 9.3.

  	
   

  	
  Governing Law

  	
   

  	
   

  	
   

  
	
  Section 9.4.

  	
   

  	
  Escalation

  	
   

  	
   

  	
   

  
	
  Section 9.5.

  	
   

  	
  Jurisdiction and Consent to Service

  	
   

  	
   

  	
   

  
	
  Section 9.6.

  	
   

  	
  Notices

  	
   

  	
   

  	
   

  
	
  Section 9.7.

  	
   

  	
  Interpretation

  	
   

  	
   

  	
   

  
	
  Section 9.8.

  	
   

  	
  Severability

  	
   

  	
   

  	
   

  
	
  Section 9.9.

  	
   

  	
  Counterparts

  	
   

  	
   

  	
   

  
	
  Section 9.10.

  	
   

  	
  Entire
  Agreement; No Third Party Beneficiaries

  	
   

  	
   

  	
   

  
	
  Section 9.11.

  	
   

  	
  Amendments and
  Modifications; Waivers and Extensions.

  	
   

  	
   

  	
   

  
	
  Section 9.12.

  	
   

  	
  Assignment

  	
   

  	
   

  	
   

  
	
  Section 9.13.

  	
   

  	
  Schedules

  	
   

  	
   

  	
   

  
	
  Section 9.14.

  	
   

  	
  Expenses

  	
   

  	
   

  	
   

  
	
  Section 9.15.

  	
   

  	
  No Consequential or Punitive Damages

  	
   

  	
   

  	
   

  
	
  Section 9.16.

  	
   

  	
  Force Majeure

  	
   

  	
   

  	
   

  



 



 ii
 






 



 


	
  Exhibits

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Exhibit A

  	
   

  	
  Laser 3 Power Source Specifications

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Schedules

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Schedule 2.1(a)

  	
   

  	
  Universal
  Functionality Specifications

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Schedule 2.4

  	
   

  	
  Endo Handpiece
  Inventory

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Schedule 3.12

  	
   

  	
  Regulatory
  Approvals

  	
   

  	
   

  	
   

  



 



 iii














 


 


SUPPLY AGREEMENT


SUPPLY AGREEMENT, dated as of March 9, 2006 (this
“Agreement”), by and among Edwards Lifesciences LLC, a Delaware limited
liability company (“Edwards”), PLC Systems Inc., a Yukon Territory corporation
(“PLC Parent”), and PLC Medical Systems, Inc., a Delaware corporation (“PLC”),
which is a wholly owned subsidiary of PLC Parent.


WHEREAS, Edwards is a company in the medical devices
field with experience in the commercialization and distribution of medical
devices, including laser-based products relating to the surgical treatment of
atrial fibrillation and atrial flutter;


WHEREAS, PLC has experience in the development and manufacturing
of laser-based products for medical uses and desires to supply to Edwards, and
Edwards desires to purchase from PLC, such laser-based products.


NOW, THEREFORE, in consideration of the mutual
agreements and covenants contained herein and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
and intending to be legally bound hereby, the Parties hereto agree as follows:


ARTICLE I


Definitions


As used in this Agreement, the following terms shall
have the following meanings:


“Agreement” shall have the meaning set forth in the
recitals.


“Complaint” means any written, electronic, or oral
communication that alleges deficiencies related to the identity, quality,
durability, reliability, safety, effectiveness, or performance of a Laser Power
Source after it is released for distribution.


“Damages” shall have the meaning set forth in Section 7.2.


“Dispute” shall have the meaning set forth in Section 9.4.


“Edwards” shall have the meaning set forth in the
recitals.


“Effective Date” shall mean the date of this
Agreement.



 1
 






 



 


“Escalation Notice” shall have the meaning set forth
in Section 9.4.


“Escrow Release Event” shall have the meaning set
forth in Section 4.3.


“FDA” means the United States Food and Drug Administration
and any successor agency thereto.


“Field of Use” shall mean the surgical treatment of
atrial fibrillation and atrial flutter, including, without limitation,
minimally invasive surgical treatment of atrial fibrillation and atrial
flutter.


“Firm Forecast” shall have the meaning set forth in Section 4.1.


“Force Majeure Event” shall have the meaning set forth
in Section 9.16.


“Forecast” shall have the meaning set forth in Section 4.1.


“Indemnified Party” shall have the meaning set forth
in Section 7.4.


“Indemnifying Party” shall have the meaning set forth
in Section 7.4.


“Intellectual Property” shall mean all intellectual
property rights of any nature or form of protection of a similar nature or
having equivalent or similar effect to any of the foregoing, including, without
limitation:  (a) inventions,
discoveries, processes, designs, techniques, developments, technology, and
related improvements, whether or not patentable; (b) United States
patents, patent applications, divisionals, continuations, reissues, renewals,
registrations, confirmations, re-examinations, certificates of inventorship,
extensions, and the like, and any provisional applications of any such patents
or patent applications, and any foreign or international equivalent of any of
the foregoing; (c) any word, name, symbol, color, designation, or device
or any combination thereof, including, without limitation, any United States or
pending trademark, trade dress, service mark, service name, trade name, brand
name, logo, domain name, or business symbol, and any foreign or international
equivalent of any of the foregoing and all goodwill associated therewith; (d) any
work, whether or not registered in the United States or elsewhere, that
incorporates, is based upon, derived from, or otherwise uses any intellectual
property, including, without limitation, mechanical and electronic design
drawings (including, without limitation, computer-aided design files),
specification, software (including, without limitation, documentation and
object and source code listing), processes, technical or engineering data, test
procedures, schematics, writings, materials, products, artwork, packaging and
advertising materials; and (e) technical, scientific, and other know-how
and information, trade secrets,



 2
 






 



 


knowledge, technology,
means, methods, processed, practices, formulas, assembly procedures, computer
programs, apparatuses, specifications, books, records, production data,
publications, databases, reports, manuals, data and results, in written,
electronic, or any other form not known or hereafter developed.


“Invention(s)” as used herein shall include, without
restriction or limitation, any and all devices, processes (including without
limitation processes of using devices or of manufacturing such devices),
compositions of matter, computer software, chemical formulations or
compositions or products whether patentable or unpatentable, and any and all
written materials or other works which may be subject to copyright, which are
reduced to practice, conceived or written during the Term of this Agreement,
and which is developed as a result of work done by either or both Parties under
this Agreement.


“Laser Power Source” shall mean a medical laser power
source and the associated control system (including all necessary hardware and
software) for tissue ablation in the Field of Use.


“Legal Requirements” means all laws, statutes,
ordinances, codes, rules, regulations, published standards, permits, judgments,
decrees, writs, injunctions, rulings, orders and other requirements of all
Public Authorities and shall include, without limitation, all applicable
requirements of QSR/ISO.


“Model 3 Laser Power Source” shall mean the Laser
Power Source currently identified by PLC to Edwards as its Model 3 Laser Power
Source based on the specification set forth on Exhibit A attached
hereto, and shall include Retrofitted Model 3 Laser Power Sources and New Model
3 Laser Power Sources.


“New Model 3 Laser Transfer Price” shall have the
meaning set forth in Section 5.2.


“New Model 3 Laser Power Sources” shall have the
meaning set forth in Section 2.1(b).


“New Laser Warranty Period” shall have the meaning set
forth in Section 3.2(a).


“Next Generation Laser Power Source” shall have the
meaning set forth in Section 2.2(c).


“Person” means any individual, partnership,
corporation, limited liability company, joint venture, association, joint-stock
company, trust, incorporated organization, government or agency or political
subdivision thereof, or other entity.



 3
 






 



 


“PLC” shall have the meaning set forth in the
recitals.


“PLC Parent” shall have the meaning set forth in the
recitals.


“PLC License” shall have the meaning set forth in Section 4.3.


“PLC Laser Power Source Intellectual Property” shall
have the meaning set forth in Section 4.3.


“Public Authority” means any supranational, national,
regional, state or local government, court, governmental agency, authority,
board, bureau, instrumentality or regulatory body, and shall include, without
limitation, the FDA.


“QSR/ISO” means the Quality System Regulation, as such
term is defined by the FDA which is in force and effect or hereafter adopted by
the FDA, and the ISO 9001 requirements as established for the European
Community, or other applicable regulatory requirements and standards, as
amended or supplemented from time to time.


“Retrofitted Laser Warranty Period” shall have the
meaning set forth in Section 3.2(a).


“Retrofitted Model 3 Laser Power Source” shall have
the meaning set forth in Section 2.1(a)


“Supply Breach” shall have the meaning set forth in Section 4.4(a).


“Termination Letter” shall have the meaning set forth
in Section 2.2(b).


“Territory” shall mean the entire world.


ARTICLE II


Appointment


Section 2.1.   Appointment.   Subject to the terms and conditions
contained in this Agreement, Edwards hereby appoints PLC as
Edward’s exclusive manufacturer and supplier of Model 3 Laser Power Sources in
the Territory. Subject to the terms and conditions contained in this Agreement,
PLC agrees to provide Model 3 Laser Power Sources to Edwards on the following
basis:



 4
 






 



 


(a)   With respect to Model 3 Laser Power Sources
bearing serial numbers 26 through 43 and 45 through 118 (each, a “Retrofitted
Model 3 Laser Power Source”), PLC will retrofit each such Laser Power Source in
a timely manner in accordance with the Universal Functionality specifications
currently described on Schedule 2.1(a) hereto (the “Universal
Functionality Specifications”), if and when such Laser Power Sources are
delivered to PLC by Edwards for retrofitting.


(b)   PLC agrees to manufacture and sell additional
Model 3 Laser Power Sources (“New Model 3 Laser Power Sources”) for which  Edwards has placed and not cancelled orders
in accordance with this Agreement, up to such number of units (estimated by the
Parties at approximately [**]) which may reasonably be manufactured by PLC
based on the inventory of component parts that PLC has on hand from time to
time or can reasonably procure. Such New Model 3 Laser Power Sources shall be
manufactured by PLC in accordance with the Universal Functionality Specifications;
provided, however, that in the event that Edwards and PLC agree on a
modification of  such specifications, the
Universal Functionality Specifications shall be deemed so amended to the extent
that Edwards agrees in writing to accept any increased costs and other expenses
reasonably charged by PLC for such modification.


Section 2.2.   Future Laser Power Sources.   Edwards shall not
purchase, offer for sale or otherwise utilize in the Field of Use any
Laser Power Sources manufactured or engineered by any person other than PLC
without compliance with the provisions of this Section or as a result of
an uncured Supply Breach (as defined under Section 4.4). In the event that
Edwards desires to sell or otherwise utilize in the Field of Use a Laser Power
Source other than a Model 3 Laser Power Source (each, a “Future Laser Power
Source”),


(a)   it shall notify PLC of any need for
engineering services with respect to such Future Laser Power Source, which such
notice shall set forth the specifications and related material terms reasonably
desired by Edwards for such Future Laser Power Source. PLC shall have a period
of sixty days from the receipt of such notice to quote Edwards a price and
other terms for the engineering of such Future Laser Power Source. If Edwards
does not accept such quote it shall be free to obtain such engineering services
from another party (which such services Edwards may investigate during the
above referenced 60-day period) provided that neither Edwards nor any of
its Affiliates shall obtain such engineering services from any other party
unless it has, following receipt of a proposal from (or acceptance of Edwards’
proposal by) such other party, offered to PLC the right to provide such
engineering services on the terms offered by such other party in such proposal,
and PLC has not accepted such offer in writing within five days; and



 5
 






 



 


(b)   it shall notify PLC of its need for a
supplier of such Future Laser Power Source, which such notice shall set forth
the specifications and related material terms reasonably desired by Edwards for
the supply of such Future Laser Power Source to Edwards. PLC shall have a
period of sixty days from the receipt of such notice to quote Edwards a
transfer price and other material terms. If Edwards does not accept such quote
it shall be free to obtain such supply from another party (which such supply
Edwards may investigate during the above referenced 60-day period)
provided that neither Edwards nor any of its Affiliates shall obtain such
supply from any other party unless it has, following receipt of a proposal from
(or acceptance of Edwards’ proposal by) such other party, offered to PLC the
right to provide such supply on the terms offered by such other party in such
proposal, and PLC has not accepted such offer in writing within five days.  PLC shall have no obligation during the above
referenced sixty day period to assist or otherwise cooperate with any third
party from whom Edwards is seeking a quote under Section 2.1(a) or
this Section 2.1(b). Thereafter, such obligations shall be as set forth in
this Agreement and (if any) in the letter agreement dated as of the same date
of this Agreement among the parties to this Agreement (the “Termination Letter”)


(c)   The foregoing provisions shall apply with
respect to Future Laser Power Sources through and including the Next Generation
Laser Power Source. For purposes hereof, “Next Generation Laser Power Source”
shall mean the first to be sold of either (i) the first Laser Power Source
after the Model 3 Laser Power Source which Edwards in good faith believes will
be a successor product to the Model 3 Laser Power Source, and not just an
upgrade or enhancement of the Model 3 Laser Power Source (to which this Section 2.2
shall also apply), or (ii) the first Laser Power Source sold following the
exhaustion of the inventory of component parts referenced in Section 2.1(b) above.


Section 2.3.   Product Accessories.   PLC shall supply such customary
product accessories, including, without limitation cables
and an operation manual, for each Laser Power Source that it supplies to
Edwards. The price for the product accessories is included in the Laser Power
Source price set forth in Section 5.2 (or as otherwise provided pursuant
to Section 2.2).


Section 2.4.   Endo Handpiece Inventory.   To the extent needed by
Edwards, Edwards will purchase from PLC at the same invoice
price paid by PLC any parts inventory (provided such inventory is in good
working order) with respect to Endo Handpieces presently on hand at PLC prior
to purchasing any such parts (or equivalents thereof) from any other person. PLC’s
inventory of these parts is listed on Schedule 2.4 attached hereto.


 



 6














 


ARTICLE III


Obligations of PLC


Section 3.1.            Labeling of Laser Power
Sources.   PLC shall and PLC
Parent shall cause PLC to provide and to assume regulatory
responsibility for all finished Model 3 Laser Power Source-related labeling
such that it complies with all applicable laws and regulations in the United
States and the European Union during the term of this Agreement. All labeling
for Model 3 Laser Power Sources shall include the statement “Distributed by
Edwards Lifesciences LLC, Manufactured by PLC Medical Systems, Inc” or, if
applicable, a similar statement reflecting the appropriate Edwards entity in a
given jurisdisction (provided that upon reasonable notification from Edwards
following registration of the Model 3 Laser Power Source with Edwards’ notified
body, such label shall include the alternative statement “Manufactured for
Edwards Lifesciences LLC by PLC Medical Systems, Inc.”)  For all countries of the Territory excluding
the United States and the countries of the European Union, Edwards shall provide
to PLC camera-ready labels in compliance with all regulatory requirements
related to such labeling for Model 3 Laser Power Sources to be sold in such
countries, which shall be affixed to Model 3 Laser Power Sources by PLC. PLC
shall label, as appropriate and in accordance with applicable laws and
regulations, Model 3 Laser Power Sources to be sold in the United States or in
any country of the European Union.


Section 3.2.            Manufacturer’s
Warranty.


(a)   PLC shall, and PLC Parent shall cause PLC to,
provide the manufacturer’s warranty described in this Section 3.2 to
Edwards on all New Model 3 Laser Power Sources for a period (the “New Laser
Warranty Period”) consisting of the earlier of (i) [**] from the date of
delivery of the Laser Power Source by Edwards to its customer, or (ii) [**]
from the date of shipment from PLC to Edwards of such Laser Power Source. Such
Laser Power Sources must be delivered to PLC for repair or replacement for this
warranty to be valid and enforceable. PLC shall, and PLC Parent shall cause PLC
to, provide the manufacturer’s warranty described in this Section 3.2 to
Edwards with respect to the new functionality provided by the retrofit
activities described in Section 2.1(a) above on all Retrofitted Model
3 Laser Power Sources for a period (the “Retrofitted Laser Warranty Period”)
consisting of [**] from the date of shipment from PLC to Edwards of such
Retrofitted Laser Power Source.


(b)   Subject to the restrictions in (c) below,
PLC warrants to Edwards that all New Model 3 Laser Power Sources shall be free
from defects in materials 



 7
 






 



and workmanship under
normal use and service during the New Laser Warranty Period (other than
materials and workmanship provided by Edwards or its Affiliates). Subject to
the restrictions in (c) below, PLC warrants to Edwards that the new
functionality installed on Retrofitted Model 3 Laser Power Sources shall be
free from defects in materials and workmanship under normal use and service
during the Retrofitted Laser Warranty Period (other than materials and
workmanship provided by Edwards or its Affiliates). PLC shall repair or replace
such defective Laser Power Source at its reasonable option during the
applicable Laser Warranty Period, at its own cost and expense. PLC shall pay
all costs associated with shipping and transportation of the defective part or
Laser Power Source if said defect appears during the applicable Laser Warranty
Period. Notwithstanding the previous sentence PLC shall not be responsible for
any shipping and transportation costs for any parts or Laser Power Sources that
are not covered by the manufacturer’s warranty described in this Section 3.2,
and Edwards shall pay, or reimburse PLC for, all such shipping and
transportation costs. For any product failure that appears after the expiration
of the applicable Laser Warranty Period, Edwards shall pay PLC for all usual
and reasonable charges of PLC to repair or replace such product failure
including any shipping and transportation costs, if Edwards elects to have such
product failure repaired by PLC, in which case PLC shall in a timely manner
repair or replace such defective Laser Power Source.


(c)   The warranties described in Section 3.2(a)-(b) shall
not cover failure due to negligence, accident, deliberate abuse, misuse, nor
improper storage, installation and/or maintenance, nor components supplied by
Edwards. Any use of a Laser Power Source inconsistent with such Laser Power
Source’s operating instructions and any modifications made to such Laser Power
Source shall void such warranty in its entirety. Such warranty does not cover
any Laser Power Source which has been altered, serviced, repaired or changed in
any manner whatsoever by anyone other than PLC, or an authorized service
representative of PLC, provided, however, that such warranty shall not be
voided by proper installation of such Laser Power Source.


Section 3.3.            Insurance.


(a)   PLC shall and PLC Parent shall cause PLC to
obtain and keep in force during the term of this Agreement product liability
insurance coverage in an amount not less than $10,000,000, and from an insurer
rated A- or better by A.M. Best Company and in a form reasonably
acceptable to Edwards. During the term of this Agreement and for a period of
[**] following the
expiration or termination of this Agreement, such insurance coverage shall
evidence Edwards and all of its Affiliates that sell Laser Power Sources
manufactured by PLC as additional insured entities and shall provide for
written notification to Edwards by the insurer not less than 30 days prior to
cancellation, expiration or modification. PLC shall and PLC 



 8
 






 



Parent shall cause PLC to
provide a certificate of insurance evidencing compliance with this Section 3.3(a) to
Edwards within 30 days of the date hereof.


(b)   Edwards shall maintain product liability
insurance in an amount not less than $10,000,000 and from an insurer rated A-
or better by A.M. Best Company during the term of this Agreement. During
the term of this Agreement and for a period of [**] following expiration or
termination of this Agreement, such insurance coverage shall evidence PLC and
all of its Affiliates that manufacture Laser Power Sources as additional
insured entities and shall provide for written notification to PLC by the
insurer not less than 30 days prior to cancellation, expiration or modification.
Edwards shall provide PLC with a certificate of insurance evidencing compliance
with this Section 3.3(b) within 30 days of the date hereof.


Section 3.4.            Production of User Manuals.   PLC
shall produce all English language user manuals for the Model 3 Laser Power
Sources and such other language user manuals for the Model 3 Laser Power
Sources as Edwards directs PLC to produce for the European Union, provided,
however, that Edwards shall provide, at no cost to PLC, translation of all such
user manuals and all end user interface menus that are not in English.


Section 3.5.            Costs and Expenses.   PLC
shall and PLC Parent shall cause PLC to bear all the costs and expenses
associated with PLC’s obligations set forth in this Agreement.


Section 3.6.            Legal Requirements.   PLC and Edwards undertake to
comply with all applicable Legal
Requirements and all applicable regulations of any Public Authority having
jurisdiction over the manufacturing, storage, import, export, handling or sale
of Model 3 Laser Power Sources and materials or related to obtaining and
maintaining legal approval for the manufacture, storage, import, export,
handling, marketing and sale of Model 3 Laser Power Sources. PLC shall manufacture
each Model 3 Laser Power Source pursuant to the specifications agreed to with
Edwards and in accordance with all applicable Legal Requirements for the United
States and the European Union. Notwithstanding the foregoing, the parties agree
that PLC shall not be responsible for conducting any pre-clinical or clinical
studies or for obtaining any approvals in connection with the storage, import,
export, handling, marketing or sale of Laser Power Sources. PLC acknowledges
that it is familiar with and shall abide by QSR/ISO.


Section 3.7.            Facilities.   Model 3 Laser Power Sources shall be
manufactured by PLC at its facility
at Franklin, MA, or such other facility as may be reasonably determined by PLC
and communicated to Edwards in writing. PLC represents and warrants that Model
3 Laser Power Sources shall only be 



 9
 






 



manufactured at a
facility which has been qualified by all applicable Public Authorities for the
manufacture of such Laser Power Sources. Upon request by Edwards, PLC shall
provide to Edwards copies of the relevant licenses and permits with respect to
all such facilities.


Section 3.8.            Inspection.   Upon the reasonable request of Edwards,
PLC shall permit duly authorized
employees of Edwards and, with the consent of PLC (not to be unreasonably
withheld), other representatives of Edwards, to inspect the facilities or its
contract facilities, procedures and capabilities to insure continued compliance
with this Agreement and applicable Legal Requirements; provided that PLC may,
in its sole discretion, refuse to grant access to any areas of its facilities
or manufacturing records to the extent that such access would jeopardize the
confidentiality of any of PLC’s or any third party’s proprietary technology not
related to this Agreement.


Section 3.9.            Adverse Experience Reporting.   During and after the
Term of this Agreement, each Party
shall notify the other Parties in a reasonably timely fashion, or sooner if
required by law, of any information on any Complaint (howsoever obtained and
from whatever source) associated with the clinical uses, studies,
investigations, testing and marketing of Laser Power Sources. Each Party shall
provide the Other Party with reasonable assistance in investigating Complaints.
Each Party shall further notify the other Parties immediately of any information
received regarding any threatened or pending action by any Public Authority,
which may affect the safety and effectiveness claims of any Laser Power Source.
Nothing contained herein shall be construed as restricting any Party’s right to
make a timely report of such matter to any Public Authority or take other
action that it deems to be appropriate or required by applicable Legal
Requirements.


Section 3.10.          Records.    All technical records relating to the
manufacturing of any Laser Power Source
by or on behalf of PLC shall be retained (i) in accordance with PLC’s
internal policies, a copy of which has been provided to Edwards, or, if
greater,  (ii) for the period
required by any applicable Legal Requirements.


Section 3.11.          Recall.   The Parties hereto shall observe at all times
all Legal Requirements in order to maintain
an effective system for the recall from the market of Model 3 Laser Power
Sources. Notwithstanding anything herein to the contrary, if either PLC or
Edwards deems it necessary to effect a recall of any Model 3 Laser Power
Source, it shall give the other Party reasonable notice of the circumstances of
such intended recall and an appropriate time to discuss and agree on such
intended recall. All costs of the recall shall be borne by the party at fault,
e.g., PLC shall pay for a recall due to the Model 3 Laser Power Source not
being manufactured under the QSR or if the Model 3 Laser Power Source does not
meet 



 10
 






 



specifications upon
release from PLC, and Edwards shall pay for a recall due to the Model 3 Laser
Power Source not being stored or installed under the QSR or if Edwards provides
PLC with false or misleading labeling. Where a violation of the law occurs that
is not the fault of either PLC or Edwards, e.g., the Model 3 Laser Power Source
is mishandled in a shipment by a common carrier, then PLC and Edwards shall
share the cost of the recall equally. In the event that agreement cannot be
reached on effecting the recall within five (5) business days, the Party
who desires, in its reasonable judgment, to effect the recall may do so. The
other Party or Parties shall take no action contrary to the recall and shall
cooperate fully with the Party effecting the recall.


Section 3.12.          Transfer of Regulatory Approvals.   In connection with
this Agreement and the transactions
contemplated hereby, PLC shall, to the extent permitted by applicable Legal
Requirements, transfer to Edwards within thirty (30) days of the date hereof,
all regulatory approvals held by PLC for Laser Power Sources, including without
limitation, all approvals and supporting documentation for the sale of Laser
Powers Sources in the United States and, to the extent existing, Canada, Europe
and any other jurisdictions, including all of the following:  (i) all documentation in support of 510(k) Pre-Market
Notification regulatory clearance(s) under 21 C.F.R. 807, and (ii) all
documentation in support of CE Mark(s) for the Laser Power Sources,
including, without limitation, in the case of (i) and (ii): all (A) submissions
and related correspondence with the FDA or applicable notified body, (B) technical
files, (C) justifications to file, (D) documentation to file, (E) engineering
supporting documentation, (F) engineering change requests, (G) laser
product reports, laser supplemental reports, laser abbreviated reports and
laser annual reports, and (H) and any other relevant documentation in
support of these regulatory clearances. Except as set forth on Schedule 3.12
hereto, PLC hereby represents and warrants that the approvals and documentation
with respect to the 510(k) Pre-Market Notification are current with
respect to the Model 3 Laser Power Source through the specifications set forth
in Exhibit A. PLC hereby covenants to perform its obligations
described on Schedule 3.12 within thirty days after the date hereof.


ARTICLE IV


Purchase Arrangements


Section 4.1.            Purchaser Orders; Product
Quantities.   Edwards shall provide an updated twelve (12) month forecast (the “Forecast”)
for Laser Power Sources on or
before the first day of the month preceding each calendar quarter. The Forecast
is non-binding and will be used for planning purposes only, except for the
first two (2) quarters within each Forecast (the “Firm Forecast”). The
Forecast for the first quarter within the Firm Forecast cannot be changed and
the forecast for the second quarter within the Firm Forecast cannot be
decreased by more than [**] 



 11
 






 



percent ([**]%) when such
forecasted amount for the second quarter rolls forward and becomes the
forecasted amount for the first quarter. Edwards shall be obligated to
purchase, and shall submit a purchase order to purchase not less than [**]
percent ([**]%) of the quantities of Laser Power Sources as specified for the
first quarter of the most recent Firm Forecast. Subject to the foregoing,
Edwards shall determine in its sole discretion the quantity of Laser Power
Sources it shall forecast and purchase and there shall be no minimum purchase
requirements for any Laser Power Source. To the extent that the terms of any
purchase order and the terms of this Agreement conflict, the terms of this
Agreement shall control.


Section 4.2.            Placement of Orders.   All
orders for Laser Power Sources submitted by Edwards shall be initiated by written
purchase orders sent to PLC no later than the first day of the month preceding
each calendar quarter, which purchase orders shall specify the desired delivery
date (which shall not be later than 10 days before the end of a calendar
quarter) and the Edwards Facility as the location for delivery in accordance
with Section 5.3. Quarterly purchase orders submitted to PLC by Edwards
will indicate the quantity of Laser Power Sources to be delivered for each
month of the quarter, provided, however, the quantity for any individual month
shall in no case be less than [**]% of the total to be delivered for the entire
quarter. There shall be no upper limit on the quantity of Laser Power Sources
Edwards may order in a quarter, provided, however, PLC will have no liability
under this Agreement for failure to deliver, in a timely manner, any amount of
Product in excess of [**]% of the quantity most recently forecasted pursuant to
Section 4.1 for the quarter. PLC shall use commercially reasonable efforts
to deliver Laser Power Sources on the agreed upon delivery dates set forth in
accepted purchase orders, but, in any event, shall make all deliveries within
ten days of the agreed upon delivery dates set forth in accepted purchase
orders.


Section 4.3.            PLC License.   PLC hereby grants
to Edwards and its Affiliates a non-exclusive license (the “PLC License”), in the Territory,
to all intellectual property owned by or licensed to PLC, to the extent
sublicensable without cost to PLC, that PLC uses to develop, make or have made
Laser Power Sources for Edwards, including, without limitation, the right to
use PLC’s manufacturing methods to manufacture Laser Power Sources (including
all necessary trade secrets, technical know-how and other intellectual property
of PLC) (collectively, the “PLC Laser Power Source Intellectual Property”), to
make, have made, import, sell, market, or offer for sale, Laser Power Sources
in the Field of Use that but for the license granted in this Section 4.3
would infringe or misappropriate PLC Intellectual Property. Edwards covenants
not to exercise the license granted under this Section 4.3 unless (i) a
Supply Breach as described in Section 4.4 by PLC occurs, or (ii) PLC
is not selected to engineer or supply Laser Power Sources pursuant to Section 2.2
above (each, an “Escrow Release Event”); provided, however, that in the event
of an Escrow Release Event resulting from the failure of 



 12
 






 



PLC to be selected to
provide engineering services pursuant to Section 2.2(a), such license
shall be for the limited purpose of enabling the person so selected to provide
such engineering services. Edwards agrees to require any licensee or sublicense
of PLC Laser Power Source Intellectual Property to enter into a confidentiality
agreement that protects the PLC Laser Power Source Intellectual Property with
the same degree of care that Edwards uses to protect its own comparable
confidential information; provided that PLC shall be expressly named therein as
a third party beneficiary of such agreement.


Section 4.4.            Failure to Supply.


(a)   In the event PLC (in each case, a “Supply
Breach”):  (i) refuses (including a
failure to respond in a reasonably timely matter to a written inquiry,
excluding a purchase order) to timely supply the Laser Power Source in
accordance with a timely issued purchase order that conforms to all the
applicable requirements of this Agreement or (ii) subject to the limits
set forth in Section 4.1 and 4.2, fails twice in any twelve (12) month
period to timely supply Edwards with at least [**] percent ([**]%) of the
quantity of the Laser Power Sources forecasted for the first calendar quarter
of any rolling Forecast (provided that Edwards orders at least [**] percent
([**]%) of such forecasted quantity), Edwards shall have the right to use the
PLC License granted above under Section 4.3. Notwithstanding the
foregoing, any Supply Breach under Section 4.4(ii) above shall be
excused if such failure to supply is the direct result of (i) the failure
of Edwards to timely supply the necessary quantity of laser diodes, optics
blocks or any other required Edwards supplied material to PLC within the
specified lead times necessary for PLC to timely manufacture the quantity of
product requested on Edwards purchase order; or (ii) the failure of
another PLC supplier to supply an adequate quantity of materials for the Laser
Power Sources through no fault of PLC, and where PLC has exercised commercially
reasonable efforts to find an alternative source of supply for such materials.


(b)   In the event of an Escrow Release Event, the
escrow described in Section 4.5 shall be released and Edwards may exercise
the license granted pursuant to Section 4.3.


Section 4.5.            Technology Escrow and
Transfer.   PLC shall place the PLC Laser Power Source Intellectual Property in a
technology escrow arrangement with Iron Mountain. The information placed in
escrow by PLC shall include all trade secrets, know-how, and other intellectual
property to allow Edwards to manufacture the Laser Power Source (subject to Section 4.4(b))
in the manner manufactured by PLC immediately prior to Edwards exercise of the
rights under the license granted under Section 4.3. PLC shall refresh the
escrow in a prompt and timely manner with any new innovations or know-how
developed or acquired by 



 13
 






 



PLC that relate to the
Laser Power Sources. Edwards shall have the right to periodically assess PLC’s
compliance with PLC’s obligations under this section. All escrow fees shall be
paid by Edwards. In the event of an escrow release, (i) PLC shall provide
Edwards with training in the use of the know-how and such other assistance as
is reasonably required to enable Edwards to manufacture the Laser Power Source
in the manner manufactured by PLC immediately prior to the exercise of such
rights by Edwards, and (ii) PLC shall transfer to Edwards at no cost to
Edwards all movable assets used by PLC that are dedicated exclusively to
manufacture the Laser Power Source, in order to enable Edwards to manufacture
the Laser Power Source in the manner manufactured by PLC immediately prior to
the exercise of such rights by Edwards.


ARTICLE V


Pricing, Shipping,
Payment


Section 5.1.            Retrofitted Model 3 Laser
Power Source.   Edwards shall pay $[**] to retrofit each of the Retrofitted Model 3
Laser Power Sources in accordance with the Universal Functionality
Specifications currently attached hereto as Schedule 2.1(a), plus shipping and
insurance costs incurred in connection with the shipment of such Model 3 Laser
Power Source to PLC for retrofitting and the shipment of such Model 3 Laser
Power Source by PLC to Edwards upon completion of such retrofitting. Except as
set forth in Section 3.2 above, in the event that Retrofitted Model 3
Laser Power Sources require repair or other work beyond retrofitting in
accordance with the Universal Functionality Specifications currently attached
hereto as Schedule 2.1(a) (including as a result of damage during shipment
to PLC, provided that such damage is not caused by PLC), PLC shall charge
Edwards its then standard rates for such work, or as otherwise agreed to by PLC
and Edwards.


Section 5.2.            New Model 3 Laser Power
Source.   Edwards shall purchase the New Model 3 Laser Power Source from PLC for
$[**] (the “New Model 3 Laser Transfer Price”); provided, however, that Edwards
shall provide laser diodes and optics blocks to PLC for timely incorporation by
PLC into each Laser Power Source. These laser diodes and optics blocks shall be
provided by Edwards to PLC at no cost to PLC. The New Model 3 Laser Transfer
Price shall be for the purchase of a Laser Power Source meeting the Universal
Functionality Specifications currently attached hereto as Schedule 2.1(a) and
shall be subject to increase in accordance with the “proviso” clause of the
last sentence of Section 2.1(b). Except as set forth in Section 3.2
above, in the event that a New Model 3 Laser Transfer requires repair or other
work (including without limitation post-delivery retrofitting), PLC shall
charge Edwards its then standard rates for such work, or as otherwise agreed to
by PLC and Edwards.



 14
 






 



Section 5.3.            Shipping; Taxes.   PLC
shall deliver Products directly to Edwards. Except as set forth in Section 5.1, all prices for Laser Power
Sources shall be F.O.B. to a single facility of Edwards located in the United
States, as designated in writing by Edwards (“Edwards Facility”), which Edwards
Facility may be changed to another facility in the United States by Edwards
upon advance written notice to PLC. The prices will not include any federal,
state or local sales, use, excise or value added tax that may be applicable. If
PLC has the legal obligation to collect such taxes, the appropriate amount
shall be added to Edwards’ invoice and paid by Edwards unless Edwards provides
PLC with a valid tax exemption certificate authorized by the appropriate taxing
authority. PLC shall ship Laser Power Sources using the method of
transportation reasonably determined by PLC. Except as set forth in Section 5.1
above, in all cases, title, risk of loss and all responsibility for
transportation, insurance and storage shall pass from PLC to Edwards upon
transfer of finished Laser Power Sources from PLC to the Edwards Facility and
after such transfer PLC shall promptly issue an invoice related thereto to
Edwards.


Section 5.4.            Payment.   Full
payment shall be made by Edwards to PLC within sixty (60) days from the invoice date which shall be the shipping
date for Laser Power Sources to Edwards. In the event Edwards fails to timely
pay more than four (4) invoices in any twelve month period, then payment
shall be due to PLC under this Section 5.4 within thirty (30) days from
such invoice date.


ARTICLE VI


Termination;


Section 6.1.            Immediate Termination.   This
Agreement may be terminated by either Edwards or PLC immediately in the event (a) of any breach
by the other Party of Section 3.3; (b) of any material breach by the
other Party remaining uncured 60 days after written notice containing details
of the breach has been delivered to the other Party; or (c) that the other
Party shall file for protection from its creditors under any applicable
Bankruptcy or insolvency laws, shall make an assignment for the benefit of
creditors, or shall have a receiver appointed for its property.


Section 6.2.            Effect of Termination.   Within
thirty (30) days of  expiration or early
termination of this
Agreement, PLC and PLC Parent shall return all Confidential Information of
Edwards, and vice versa, in its possession or under its control unless
otherwise provided for in this Agreement.



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ARTICLE VII


Warranties and
Indemnification


Section   7.1.   Warranties.   PLC
warrants that (a) it possesses good and marketable title to all Laser Power Sources sold to Edwards under
this Agreement upon delivery to Edwards of such Laser Power Sources; and (b) at
the time of delivery, each Laser Power Source will conform to its
specifications and will operate according to the indications described in its
labeling; and (c) it complies and will continue to comply with all
applicable laws and regulations of the United States and the countries of the
European Union with respect to Model 3 Laser Power Sources. Edwards warrants
that it complies and will continue to comply with all applicable laws and
regulations of the Territory with respect to Laser Power Sources and the sale
thereof.


(a)   EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT
OR IN ANY OF THE TRANSACTION DOCUMENTS, PLC AND ITS THIRD PARTY LICENSORS AND
SUPPLIERS EXPRESSLY DISCLAIM ALL OTHER WARRANTIES, REPRESENTATIONS, CONDITIONS,
GUARANTEES OR UNDERTAKINGS OF ANY KIND, EXPRESS OR IMPLIED, STATUTORY OR
OTHERWISE INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE.


(b)   EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT
OR IN ANY OF THE TRANSACTION DOCUMENTS, EDWARDS AND ITS THIRD PARTY LICENSORS AND
SUPPLIERS EXPRESSLY DISCLAIM ALL OTHER WARRANTIES, REPRESENTATIONS, CONDITIONS,
GUARANTEES OR UNDERTAKINGS OF ANY KIND, EXPRESS OR IMPLIED, STATUTORY OR
OTHERWISE INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE.


Section 7.2.   Indemnification by PLC.   PLC and PLC
Parent shall indemnify and hold harmless Edwards, its officers, directors,
shareholders, employees, parents, successors, Affiliates, assigns, in each
case, from and against any and all costs or expenses (including, without
limitation, reasonable attorneys’ fees, and the reasonable out-of-pocket
expenses of testifying and preparing for testimony and responding to document
and other information requests, whether or not a party to such litigation),
judgments, fines, losses, claims (whether or not meritorious) and damages
(collectively, “Damages”), as incurred, to the extent they relate to, arise out
of or are the result of (i) the manufacture by PLC of any Laser Power
Sources (except to the extent attributable to components supplied by Edwards); (ii) the
design of any Laser Power Sources or component of Laser Power Sources not
developed exclusively by Edwards except to the extent designed and 



 16
 






 



built in
accordance with the specifications provided by Edwards or attributable to the
components supplied by Edwards; (iii) the failure of Laser Power Sources
to satisfy any warranty made by PLC; (iv) PLC failing to perform any of
its covenants and responsibilities under this Agreement or any breach by PLC of
any representation or warranty; and (v)  PLC’s gross negligence,
willful misconduct or fraud in the development, labeling, supply and
manufacture of Laser Power Sources by PLC.


Section 7.3.   Indemnification by Edwards.   Edwards shall
indemnify and hold harmless PLC, its officers, directors,
shareholders, employees, parents, successors, Affiliates and assigns, in each
case, from and against any and all Damages, as incurred, to the extent they
relate to, arise out of or are the result of (i) the specifications of the
Laser Power Sources provided by Edwards; (ii) the sale by Edwards of any
Laser Power Sources or any other product or service not provided by PLC
hereunder except to the extent Edwards is indemnified by PLC; (iii) Edwards
failing to perform any of its covenants and responsibilities under this
Agreement or any breach by Edwards of any representation or warranty; and (iv) Edwards’
gross negligence, willful misconduct or fraud in the promotion and sale of
Laser Power Sources or other product or service by Edwards.


Section 7.4.   Indemnification Procedures.   The Party
seeking indemnification (the “Indemnified Party”) pursuant
to this Article VII shall promptly notify the indemnifying party (the “Indemnifying
Party”), in writing, of such claim describing such claim in reasonable detail, provided that the failure to provide such
notice shall not affect the obligations of the Indemnifying Party unless and
only to the extent it is actually prejudiced thereby. In the event that such
claim involves a claim by a third party against an Indemnified Party, the
Indemnifying Party shall have 30 days after receipt of such notice to decide
whether it will undertake, conduct and control, through counsel of its own
choosing (but reasonably acceptable to the Indemnified Party) and at its own
expense, the settlement or defense thereof unless (i) the Indemnifying
Party is also a party to the proceeding and the Indemnified Party determines in
good faith that joint representation would be inappropriate or (ii) the
Indemnifying Party fails to provide reasonable assurance to the Indemnified
Party of its financial capacity to defend such proceeding, and provide
indemnification with respect thereto, and if it so decides, the Indemnified
Party shall cooperate with it in connection therewith, provided that the Indemnified Party may
participate in such settlement or defense through counsel chosen by it, and provided further that the fees and
expenses of such counsel shall be borne by the Indemnified Party. The
Indemnifying Party shall not, without the written consent of the Indemnified
Party (which consent shall not be unreasonably withheld, conditioned or
delayed), settle or compromise any action, unless such settlement or compromise
includes an unconditional release of the Indemnified Party. If the Indemnifying
Party does not notify the Indemnified Party within 30 days after the receipt of
notice of a claim of indemnity hereunder that it elects to undertake the
defense thereof, the Indemnified 



 17
 






 



Party shall have
the right to contest, settle or compromise the claim but shall not pay or
settle any such claim without the consent of the Indemnifying Party (which
consent shall not be unreasonably withheld, conditioned or delayed). The
Indemnifying Party and the Indemnified Party shall cooperate fully in all
aspects of any investigation, defense, pre-trial activities, trial, compromise,
settlement or discharge of any claim in respect of which indemnity is sought
pursuant to Article VII, including, but not limited to, providing the
other Party with reasonable access to employees and officers (including as
witnesses) and other information. The remedies provided in this Article VII
will not be exclusive of or limit any other remedies that may be available to
the Indemnified Parties.


Section 7.5.   Limitations on Liability.   NOTWITHSTANDING
ANYTHING TO THE CONTRARY IN THIS
AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR THE OTHER PARTY’S
AFFILIATES FOR ANY INCIDENTAL, PUNITIVE, SPECIAL, MULTIPLE OR INDIRECT OR
CONSEQUENTIAL DAMAGES, HOWEVER CHARACTERIZED, INCLUDING, WITHOUT LIMITATION,
LOSS OF PROFITS OR BUSINESS OPPORTUNITIES, ARISING OUT OF, RELATED TO, OR IN
CONNECTION WITH THIS AGREEMENT OR ITS EARLY TERMINATION. IRRESPECTIVE OF
WHETHER SUCH LIABILITY IS ASSERTED IN TORT OR CONTRACT AND IRRESPECTIVE OF
WHETHER THE PARTIES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ALL
REMEDIES OF THE PARTIES SHALL BE LIMITED TO ACTUAL DIRECT DAMAGES.


ARTICLE VIII


Trademarks and
Confidentiality; Intellectual Property Rights


Section 8.1.   Trademarks.   Subject to PLC’s consent, which consent
shall not be unreasonably, withheld, delayed
or conditioned, Edwards shall have the right to indicate to the public that it
is an authorized distributor of Laser Power Sources and, at Edwards’ election, to
market and sell Laser Power Sources under any trademarks, service marks and
trade names that PLC adopts from time to time. Edwards shall state and confirm
in all advertising and promotional literature that its use of PLC’s trademarks,
service marks and trade names is pursuant to a license from PLC and shall
identify PLC as the owner of such marks and names and any proprietary rights. Edwards
shall not alter, obscure or remove any trademarks, service marks or trade names
of PLC which are contained on or in or affixed to Laser Power Sources at the
time of shipment. Edwards shall not use any trademarks, service marks or trade
names of PLC in connection with any business conducted by Edwards other than
dealing with Laser Power Sources in accordance with the terms of this Agreement.
Edwards agrees that its use of the trademarks, service marks and 



 18
 






 



trade names of PLC
shall not create in its favor any right, title or interest therein and
acknowledges PLC’s exclusive right, title and interest thereto. Edwards agrees
that it will not use, without PLC’s prior written consent, any mark which is
similar to or is likely to be confused with any trademarks, service marks or
trade names of PLC. In order to comply with PLC’s quality control standards,
Edwards shall:  (i) not modify any
of PLC’s trademarks, service marks or trade names in any way; (ii) use PLC’s
trademarks, service marks or trade names in compliance with all applicable laws
and regulations; and (iii) upon 30 days written notice, accord PLC the
right to inspect during normal business hours, Edwards’ or its Affiliates
facilities used in connection with efforts to promote and sell the Laser Power
Sources in order to confirm that Edwards’ use of any of PLC’s trademarks,
service marks or trade names is in compliance with this Section 8.1. Edwards’
rights to use the trademarks, service marks and trade names of PLC as set forth
in this Section 8.1 shall terminate upon termination or expiration of this
Agreement.


Section 8.2.   Confidential Information.   In order to avoid
disclosure of confidential and proprietary information to any other person, firm
or corporation, the Parties agree that each will treat any such information
which is received from one another in writing and clearly marked as “Confidential”
or if disclosed orally, which is confirmed in writing as “Confidential” within
thirty (30) days of initial disclosure, with the same degree of care that each
employs with respect to its own information which it does not desire to have
published or disseminated. It is understood that each Party shall be liable for
any unauthorized disclosure should it fail to safeguard the disclosed
information with such care. This obligation shall survive the termination or
expiration of this Agreement. The Parties shall not have any obligation with
respect to such information which is:


(a)   independently developed by the receiving
Party without the benefit of the disclosure or is already known to the
receiving Party at the time of the disclosure;


(b)   publicly known or becomes publicly known
without the wrongful act or breach of this Agreement by the receiving Party;


(c)   rightfully received by the receiving Party
from a third-party who is not under any obligation of confidentiality or trade
secret obligation to the originating Party;


(d)    is already known to the receiving Party at
the time of the disclosure; or


(e)   is disclosed by the receiving Party with the
written approval of the originating Party.



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ARTICLE
IX


MISCELLANEOUS


Section 9.1.   Relationship.   The relationship of
Edwards and PLC established by this Agreement is of independent contractors and not
agents (except as set forth in Section 2.1), and nothing in this Agreement
shall be construed:


(a)   To give PLC or PLC Parent the power to direct
or control the daily activities of Edwards, or vice versa, beyond the
obligations imposed on Edwards and PLC, respectively, by this Agreement;


(b)   To constitute the Parties as partners, joint
venturers, co-owners or otherwise as participants in joint undertaking; or


(c)   To allow either PLC or PLC Parent to create
or assume any obligation on behalf of Edwards, or vice versa, for any purpose
whatsoever. The purchase, promotion, and resale of, or any other legal
transactions concerning Laser Power Sources hereunder shall be carried out in
the name of and for the account of Edwards as principal, and Edwards shall not
enter into any agreement with third persons binding in any way on PLC or PLC
Parent.


Section 9.2.   No Conflict.   Each Party represents and
warrants to the other Parties that it is not subject to any contractual obligation or
restraint which will materially interfere with its right and ability to perform
pursuant to the terms of this Agreement.


Section 9.3.   Governing Law.   This Agreement shall be
governed by, interpreted under, and construed in accordance with the internal laws of
the State of New York, including, without limitation, Sections 5-1401,
5-1402 of the New York General Obligations Law and New York Civil
Practice Laws and Rules 327(b).


Section 9.4.   Escalation.   Edwards and PLC (and/or
PLC Parent) will attempt in good faith to resolve expeditiously any dispute, claim or
controversy arising out of or relating to this Agreement (the “Dispute”)
promptly by negotiations between executives who have authority to settle the
controversy and who are at a higher level of management than the persons with
direct responsibility for the administration of this Agreement. Either Party
may give the other Party, written notice (the “Escalation Notice”) of any
Dispute not resolved in the normal course of business. Within 15 days after
delivery of the Escalation Notice, the Party in receipt of the Escalation
Notice shall submit to the other a written response. The Escalation 



 20
 






 



Notice and the
response thereto shall include (a) a statement of each Party’s position
and a summary of arguments supporting that position, and (b) the name and
title of the executive who will represent that Party and of any other person
who will accompany the executive. Within 30 days after delivery of the
Escalation Notice, the executives of both Parties shall meet at a mutually
acceptable time and place, and thereafter as often as they reasonably deem
necessary, to attempt to resolve the Dispute. All reasonable requests for
information made by one Party to the other will be honored. All negotiations
pursuant to this clause are confidential and shall be treated as compromise and
settlement negotiations for purposes of applicable rules of evidence. The
Parties shall attempt to resolve any Dispute pursuant to the procedure set
forth in this Section 9.4 for a period up to 60 days from the date of
delivery of the Escalation Notice before resorting to other available remedies;
provided, however, nothing
contained in this Section 9.4 shall prevent any Party from resorting to
judicial process if injunctive or other equitable relief from a court is
necessary to prevent serious and irreparable injury to it or to others. The use
of the procedure set forth in this Section 9.4 will not be construed under
the doctrine of laches, waiver or estoppel to affect adversely any Party’s
right to assert any claim or defense.


Section 9.5.   Jurisdiction and Consent to Service.   In
accordance with the laws of the State of New York, and
without limiting the jurisdiction or venue of any other court, the Parties (a) agree
that any suit, action or proceeding arising out of or relating to this Agreement
shall be brought solely in the state or federal courts of New York; (b) consent
to the exclusive jurisdiction of each such court in any suit, action or
proceeding relating to or arising out of this Agreement; (c) waive any
objection which any of them may have to the laying of venue in any such suit,
action or proceeding in any such court; and (d) agree that service of any
court paper in any such suit, action or proceeding may be made in any manner as
may be provided under the applicable laws or court rules governing service
of process in such court. The foregoing shall not apply to actions for
injunctive relief, as to which such jurisdiction shall be non-exclusive.


Section 9.6.   Notices.   All notices, demands, requests, consents, approvals
or other communications required or permitted
to be given hereunder or which are given with respect to this Agreement shall
be in writing and shall be delivered (charges prepaid, receipt confirmed or
return receipt requested (if available)) by hand, by nationally recognized air
courier service, by certified mail or facsimile, addressed as set forth below
or to such other address as such Party shall have specified most recently by
written notice. Notice shall be deemed given and effective (i) if
delivered by hand or by nationally recognized courier service, when delivered
at the address specified in this Section 9.6 (or in accordance with the
latest unrevoked written direction from such Party), (ii) if by certified
mail, four (4) business days after mailing or (iii) if given by
facsimile when such facsimile is transmitted to the fax number specified in
this Section 9.6 (or in accordance with the 



 21
 






 



latest unrevoked
written direction from such Party), provided the appropriate confirmation is
received.


To PLC:


PLC Systems Inc.

10 Forge Park

Franklin, MA  02038

Attention:  Chief Executive Officer

Fax:  (508) 541-7990


with a copy (which shall
not constitute notice) to:


Wilmer Cutler Pickering
Hale and Dorr LLP

60 State Street

Boston, MA  02109

Attention:  Jeffrey A. Stein, Esq.

Fax:  (617) 526-5000


To Edwards:


Edwards Lifesciences LLC

One Edwards Way

Irvine, California 92614

Attention:  General Counsel

Fax:  (949) 250-6850


with a copy (which shall
not constitute notice) to:


Skadden, Arps, Slate,
Meagher & Flom LLP

300 South Grand Avenue, Suite 3400

Los Angeles, California  90071-3144

Attention:  Joseph J. Giunta, Esq.

Fax:  (213) 687-5600


Section 9.7.   Interpretation.   When a reference is made
in this Agreement to a Section, Schedule or Exhibit, such reference shall be to
a Section, Schedule or Exhibit of this Agreement unless otherwise
indicated. When a reference is made in this Agreement to a specific Schedule,
such reference shall be deemed to include, to the extent applicable, all the
other Schedules. The table of contents, table of definitions, titles and
headings contained in this Agreement are for reference purposes only and shall
not affect in any way the meaning or interpretation of this Agreement. When the
words “includes” or “including” are used in this Agreement, they shall be
deemed to be followed by the words “without limitation.”  All 



 22
 






 



accounting terms
not defined in this Agreement shall have the meanings determined by generally
accepted accounting principles as of the date hereof. All capitalized terms
defined herein are equally applicable to both the singular and plural forms of
such terms.


Section 9.8.   Severability.   In the event that any one
or more of the provisions contained herein, or the application thereof in any
circumstances, is held invalid, illegal or unenforceable in any respect for any
reason, the Parties shall negotiate in good faith with a view to the
substitution therefore of a suitable and equitable solution in order to carry
out, so far as may be valid and enforceable, the intent and purpose of such
invalid provision; provided, however,
that the validity, legality and enforceability of any such provision in every
other respect and of the remaining provisions contained herein shall not be in
any way impaired thereby, it being intended that all of the rights and
privileges of the Parties hereto shall be enforceable to the fullest extent permitted
by law.


Section 9.9.   Counterparts.   This Agreement may be
executed in two or more counterparts, each of which shall be deemed an original and all
of which shall, taken together, be considered one and the same agreement, it
being understood that the Parties need not sign the same counterpart.


Section 9.10.   Entire Agreement; No Third Party Beneficiaries.   This
Agreement, including all schedules and exhibits hereto, by and
among the Parties hereto,


(a)   constitute the entire agreement of the
Parties with respect to the subject matter hereof and supersede all prior and
contemporaneous agreements, representations, understandings, negotiations and
discussions between the Parties, whether oral or written, with respect to the
subject matter hereof, other than the Termination Letter; and


(b)   shall be binding upon and shall inure to the
benefit of each of the Parties hereto and thereto and their respective
successors and permitted assigns and is not intended to confer any rights,
remedies or benefits on any Persons other than as expressly set forth in this Section 9.10.


Section 9.11.   Amendments and
Modifications; Waivers and Extensions.


(a)   No amendment, modification or termination of
this Agreement shall be binding upon any other Party unless executed in writing
by the Parties hereto intending to be bound thereby.



 23
 






 



(b)   Any Party to this Agreement may waive any
right, breach or default which such Party has the right to waive; provided that
such waiver will not be effective against the waiving Party unless it is in writing,
is signed by such Party, and specifically refers to this Agreement. Waivers may
be made in advance or after the right waived has arisen or the breach or
default waived has occurred. Any waiver may be conditional. No waiver of any
breach of any agreement or provision herein contained shall be deemed a waiver
of any preceding or succeeding breach thereof nor of any other agreement or
provision herein contained. No failure or delay in exercising any right, power
or privilege hereunder shall be deemed a waiver or extension of the time for
performance of any other obligations or acts nor shall any single or partial
exercise thereof preclude any other or further exercise thereof or the exercise
of any other right, power or privilege.


Section 9.12.   Assignment.   Neither this Agreement nor
any of the rights, duties or obligations hereunder may be assigned or delegated by any
of the Parties hereto without the prior written consent of PLC or Edwards, as
the case may be, which may be withheld in its sole discretion except that
Edwards may assign all its rights and obligations to any direct or indirect
wholly-owned or consolidated subsidiary of Edwards Lifesciences Corporation,
provided, however, any Party may assign this Agreement and all rights, duties or
obligations hereunder in connection with the sale of more than 51% of the
outstanding capital stock of such Party in one or more related transactions, a
merger or the transfer of all or substantially all the assets to which this
Agreement relates. Any attempted assignment or delegation of rights, duties or
obligations hereunder in contravention hereof shall be void and of no effect.


Section 9.13.   Schedules.   Each of the schedules
referred to herein and attached hereto is an integral part of this Agreement and is incorporated
herein by reference.


Section 9.14.   Expenses.   Except as otherwise
provided in this Agreement, each Party to this Agreement shall bear its respective expenses incurred in
connection with the preparation, execution, and performance of this Agreement
and the transactions contemplated hereby, including all fees and expenses of
agents, representations, counsel and accountants.


Section 9.15.   No Consequential or Punitive Damages.   If
any Party claims any breach of this Agreement by
the other Party or otherwise becomes dissatisfied with any matter relating
hereto or arising herefrom, it shall have no right to seek consequential or
punitive damages and each Party hereby waives any right it may have to seek
such punitive or consequential damages.



 24
 






 



Section 9.16.   Force Majeure.   Notwithstanding anything
to the contrary contained in this Agreement, no liability or loss of rights
hereunder shall result to any Party from delay or failure in performance (other
than payment) caused by governmental restrictions (excluding any regulatory
actions taken by the FDA or similar bodies), war, acts of terrorism,
commotions, riots, strikes, lockouts and acts of God such as fire, flood or
other similar causes that are beyond the control of the parties (each a “Force
Majeure Event”). Except to the extent caused by the foregoing, Force Majeure
Events shall not include shortage of labor, lack of or inability to obtain
materials, fuel or supplies (unless caused solely by priorities, restrictions
or allocations imposed by governmental authority), or any other industrial
disturbance.



 25














 


IN WITNESS WHEREOF, the Parties hereto have executed
this Agreement as of the date first above written.


	
   

  	
  PLC SYSTEMS INC.

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ James G. Thomasch

  
	
   

  	
  Name:

  	
  James G. Thomasch

  
	
   

  	
  Title:

  	
  Senior Vice President and Chief Financial Officer

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  PLC MEDICAL SYSTEMS, INC.

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ James G. Thomasch

  
	
   

  	
  Name:

  	
  James G. Thomasch

  
	
   

  	
  Title:

  	
  Senior Vice President and Chief Financial Officer

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  EDWARDS LIFESCIENCES LLC

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ John H. Kehl, Jr.

  
	
   

  	
  Name:

  	
  John H. Kehl, Jr.

  
	
   

  	
  Title:

  	
  Corporate Vice President, Strategy and Business
  Development

  



 

















 


Exhibit A


Laser
3 Power Source Specifications


Optiwave
980TM Laser Console


System Requirements


(based upon Minnetronix # DP-0001-45-1 Rev 002-a)


	
  Mike Adams

  	
   

  	
  /s/ Michael Adams

  	
   

  	
  6/3/05

  
	
  New Ventures (Print)

  	
   

  	
  New Ventures (Signature)

  	
   

  	
  Date

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ken Luppi

  	
   

  	
  /s/ Ken Luppi

  	
   

  	
  6/3/05

  
	
  Operations (Print)

  	
   

  	
  Operations (Signature)

  	
   

  	
  Date

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Debbie Quigley

  	
   

  	
  /s/ Debbie Quigley

  	
   

  	
  6/7/05

  
	
  Clinical (Print)

  	
   

  	
  Clinical (Signature)

  	
   

  	
  Date

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dori Boermeester

  	
   

  	
  /s/ Dori Boermeester

  	
   

  	
  6/6/05

  
	
  Quality Assurance/Regulatory (Print)

  	
   

  	
  Quality Assurance/Regulatory (Signature)

  	
   

  	
  Date

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Mark Tauscher

  	
   

  	
  /s/ Mark Tauscher

  	
   

  	
  6/7/05

  
	
  Marketing/Sales (Print)

  	
   

  	
  Marketing/Sales (Signature)

  	
   

  	
  Date

  



 









 



 


1 
Introduction                                                                                                                      
Section Heading                                  Version: 1.4              (SYSREQ35557)


1.1  Scope                                                                                                                         
Section Heading                                  Version:
5.0              (SYSREQ35558)


This specification describes the functional and
performance requirements of the Optiwave 980TM Laser Console (console). The
console is intended for use with a fiber delivery device to deliver 980 nm
laser energy for surgical treatment. This document comprises the full set of
requirements for the console and is intended for internal use only, for review
and reference by development and product support teams.


This document contains both system requirements and
development guidelines. System requirements are denoted as such in section
headings and will be tested against during verification testing. Development guidelines
in this document include all sections denoted as guidelines, references,
targets, or overviews and will not specifically be addressed by system
verification testing.


1.2 
Glossary                                                                                                                   

Background Info                                  Version:
10.0              (SYSREQ35562)


Delivery Device:
[**]


Laser Console (console):
[**]


Laser System
(system): [**]


Wavelength:
[**]


Laser product:
[**]


Low OH: [**]


Numerical Aperture
(NA): [**]


UI: [**].


Thermal Safety System
(TSS): [**].


Optical Path:
[**]


Endocardial:  [**]


Epicardial:  [**]


Surgical:  [**]


Optic Block and Optic Module both refer to [**].


2 
System Overview                                                                                                               
Section Heading                                  Version:
1.4              (SYSREQ35563)


2.1  General Description                                                                                            


Background Info                                  Version:
6.0              (SYSREQ35564)


The console is intended for surgical treatment using
photonic energy to form lesions at locations in the cardiac anatomy that may
provide effective and appropriate conduction block. The system includes [**]









 



2.2  Basic System Configuration                                                                              



Section Heading                                  Version:
1.5              (SYSREQ35565)


2.2.1  Block Diagram                                                                                            



Background
Info                             Version:
2.3              (SYSREQ35566)


The diagram identifies [**]:


[**]


2.2.2  System Components                                                                                       


Background
Info                           Version: 10.0              (SYSREQ35567)


The console includes the following basic functional
block or components:


[**]


2.3  Useful Life                                                                                                                

Design Guideline                                Version:
2.2               (SYSREQ35568)


The console’s useful life shall exceed [**]


3  System Requirements                                                                                                      


Section Heading                                      Version: 3.3               (SYSREQ35569)


This section includes the functional and performance
requirements for the console, i.e. what functions the system must perform and
to what accuracy and/or precision those functions must
be performed.


 


3.1  General Tolerances                                                                                             



Traceable Requirement                    Version: 1.3              (SYSREQ36453)


Unless otherwise specified, the default tolerance for
specifications is [**]


This
requirement traces TO SUBTST36070: 
General Instructions


3.2  Laser Energy Generation                                                                                   



Section Heading                                Version:
1.5                 (SYSREQ35570)


3.2.1  Therapy Duration                                                                                        


Traceable
Requirement                Version:
2.2                 (SYSREQ35571)


The console shall monitor therapy duration [**]


This requirement traces TO SUBREQ35920:  OIC Countdown Therapy Timer


This
requirement traces TO SUBREQ35810:  UIC
Countdown Therapy Timer









 



 


3.2.2  Output Power Monitor                                                                                                


Traceable
Requirement                                 
Version: 6.4              (SYSREQ35572)


The console shall include means for directly or
indirectly monitoring output laser power from the console. Accuracy of the
power monitoring shall be [**].


This
requirement traces TO SUBTST36152:  Test
Protocol 002 - Laser Power Regulation


3.2.3  Output Port                                                                                                                      


Traceable
Requirement                                 
Version: 2.2              (SYSREQ35573)


The laser output from the console shall be compatible
with a standard SMA 905 optical connector.


This
requirement traces TO SUBREQ35993:  Laser
Output Port


3.2.4  Output Port NA                                                                                                            



Traceable
Requirement                                 
Version: 1.8              (SYSREQ35574)


The output NA of the laser output port into the
delivery fiber must be [**].


This
requirement traces TO SUBREQ35926: 
Output Port NA


3.2.5  Output Spot Size                                                                                                          



Design
Guideline                                 
Version: 1.4                      (SYSREQ35575)


The theoretical/calculated output spot size of the
laser output port into the delivery fiber must be [**].


The calculation used is:  [**].


3.2.6  Continuous Use                                                                                                           



Traceable
Requirement                          
Version: 4.2                    (SYSREQ35576)


The console shall be capable of operating at full
laser output power continuously for the following duty cycles. These duty
cycles represent one procedure.


[**]


[**]


This
requirement traces TO SUBTST36157:  Test
Protocol 006 - Continuous Use









 



 


3.2.7  **LASER SHUTOFF**                                                                                            



Traceable Requirement                                  Version:
2.0              (SYSREQ35577)


When the laser is shutoff due to a normal or abnormal
event, laser output must be reduced to [**].


Note: A Laser Shutoff event moves the laser from a
READY or ACTIVE state to a STANDBY state.


This requirement traces FROM SYSREQ35622:  Device Response: Alarm


This requirement traces FROM SYSREQ35619:  Device Response: Alert


This requirement traces FROM SYSREQ35620:  System Alarms


This requirement traces FROM SYSREQ35616:  System Alerts


This
requirement traces TO SUBREQ35922:  Laser
Shutoff


3.2.8  Max Power Formula                                                                                                  



Design
Guideline                                 
Version: 3.2              (SYSREQ35578)


The following formula should be used to determine if
the total power the user has requested exceeds the console capability. Max
Power is defined as the power delivered out the front of the optical block.


Max Delivered
Power = [**]


Max Power = [**]


3.2.9  Redundant Power Monitoring                                                                                  


Critical Requirement                                  Version:
2.2              (SYSREQ35579)


The console shall monitor the laser output both [**].


This
requirement traces TO SUBREQ35916: 
Closed-Loop Laser Output Control


3.3  Safety Interlocks                                                                                                                    


Section Heading                                             Version: 1.5                  (SYSREQ35580)


3.3.1  Output Port Interlock                                                                                                 



Critical Requirement                                  Version:
3.2                (SYSREQ35581)


The console shall require that an output fiber be
inserted into the console’s laser output connector [**].


Note: The Output Port Interlock is also known as the
Device Interlock.


This requirement traces TO SUBREQ35983:  Laser Enable Inputs


This
requirement traces TO SUBREQ35981: 
Output Port Interlocks









 



 


3.3.2  Remote Interlock                                                                                                        



Traceable Requirement                                  Version:
3.2              (SYSREQ35582)


The console shall include a remote interlock input and
the system shall require that the remote interlock be [**].


Note: The Remote Interlock is also known as the Door
Interlock.


This requirement traces TO SUBREQ35983:  Laser Enable Inputs


This
requirement traces TO SUBREQ35980: 
Remote Interlock


3.3.3  Housing Interlock                                                                                                       



Critical Requirement                                  Version:
3.2              (SYSREQ35583)


The console shall require that the console housing
interlock be closed [**]


This
requirement traces TO SUBREQ35979: 
Housing Interlocks


3.4  IR Monitoring and Shut-off                                                                                              



Critical Requirement                                  Version:
8.0              (SYSREQ35584)


The console shall monitor [**]


This requirement traces TO SUBREQ35927:  IR Detector


This requirement traces TO SUBREQ35840:  Abort: Thermal Safety System Tripped


This
requirement traces TO SUBREQ35983:  Laser
Enable Inputs


3.4.1  Thermal Safety System                                                                                               



Critical Requirement                                  Version: 3.1              (SYSREQ35585)


The console shall perform a [**]


This requirement traces FROM SUBFMA36069:  User performs Therapy into Dustcap


This
requirement traces TO SUBREQ35740: 
Thermal Safety System BIT


3.4.2  Sampling Period                                                                                                         



Traceable Requirement                                  Version:
2.1              (SYSREQ35586)


The console shall sample [**]


This
requirement traces TO SUBTST36183:  Unit
and Integration Tests


3.4.3  Output Port Shield                                                                                                      



Traceable Requirement                                  Version:
6.0              (SYSREQ35587)


There will be an output port shield [**]


Note: The Output Port Shield is also known as a
Dustcap.


This requirement traces TO SUBREQ36004:  Laser Output Port Shield


This requirement traces TO SUBREQ35740:  Thermal Safety System BIT









 



 


3.4.4  Delivery Device Replacement                                                                                   



Traceable Requirement                                  Version:
5.0              (SYSREQ35588)


The console shall require the user to replace the
delivery device [**]


[**]


This requirement traces FROM SUBFMA36069:  User performs Therapy into Dustcap


This
requirement traces TO SUBREQ35840: 
Abort: Thermal Safety System Tripped


3.5  User Interface                                                                                                                          


Section Heading                                  Version:
1.6              (SYSREQ35589)


 


This
requirement traces TO SYSREQ36986:  Laser
State Transitions


3.5.1  Laser State Transitions                                                                                              



Background
Info                                 
Version: 1.3             
(SYSREQ36986)


The following diagram describes the laser state
transition.


This
requirement traces FROM SYSREQ35589:  h
User Interface


3.5.2  User Inputs                                                                                                                      


Section Heading                                  Version:
1.6              (SYSREQ35590


 


3.5.2.1  Input Checking                                                                                                   



Critical
Requirement                                 
Version: 3.2              (SYSREQ35591)


All user inputs will be checked for validity. The user
will not be allowed to proceed in the UI until invalid inputs are corrected.


This requirement traces TO SUBREQ35774:  Delivery Device Number Entry


This requirement traces TO SUBREQ35773:  Number Entry


This
requirement traces TO SUBREQ35771:  Pick
From List


3.5.2.2  Delivery Device
Number                                                                                   



Section Heading                                  Version:
4.0              (SYSREQ35592)


This section describes the behavior of the Device Number.
This number will be included with every completed delivery device.


3.5.2.2.1  Delivery Device Number Required                                                            


Critical Requirement                       Version: 4.0                   (SYSREQ35593)


The UI shall require that
the user enter in the Delivery Device Number before applying
therapy.


 


This requirement traces TO SUBREQ35774:  Delivery Device Number Entry


This
requirement traces TO SUBREQ35791: 
Required Fields









 



 


3.5.2.2.2  Delivery Device Number Format                                                                               


Traceable Requirement                                  Version:
6.0              (SYSREQ35594)


The Delivery Device
Number has the following format. The dashes are included to as an aid in
remembering the number for ease of entry.


[**]


This requirement traces TO SUBREQ35795:  Checksum Algorithm


This requirement traces TO SUBREQ35793:  Delivery Device Number Format


This
requirement traces TO SUBREQ35794: 
Encyption Algorithm


3.5.2.2.3  Delivery Device Number History                                                                               


Traceable  Requirement                                  Version:
3.0              (SYSREQ35595)


The console shall keep
track of the last [**]


 


This
requirement traces TO SUBREQ35796: 
Delivery Device Number Log


3.5.2.2.4  Prevent Reuse                                                                                                             



Traceable
Requirement                                 Version:
2.2              (SYSREQ35596)


A device number can be
reused in any of following cases. In all other cases, the number cannot be
reused.


·                  [**]


This
requirement traces TO SUBREQ35797: 
Delivery Device Number Reuse


3.5.2.2.5  Invalid Delivery
Device Number                                                                               


Traceable
Requirement                                  Version:
3.0              (SYSREQ35597)


If the user enters an
invalid Delivery Device Number, a message is displayed, and the Device number
field cleared.


 


This
requirement traces TO SUBREQ35798: 
Invalid Delivery Device Number Entry


3.5.2.3  Therapy Power                                                                                                                       


Traceable
Requirement                                  Version:
2.2              (SYSREQ35598)


The console shall provide
means for the user to enter therapy power.


 


This
requirement traces TO SUBREQ35787: 
Parameters Displayed


3.5.2.4  Therapy Duration                                                                                                                  


Traceable
Requirement                                 
Version: 2.4             
(SYSREQ35599)


The console shall provide
means for the user to enter maximum therapy duration with a resolution of [**].


 


This
requirement traces TO SUBREQ35787: 
Parameters Displayed









 



 


3.5.2.4.1  Therapy Timer
Increments                                                                                       


Traceable
Requirement                                  Version:
1.7              (SYSREQ35600)


Therapy duration time
will count down in [**] intervals whenever the system’s [**].


 


This requirement traces TO SUBREQ35920:  OIC Countdown Therapy Timer


This
requirement traces TO SUBREQ35810:  UIC
Countdown Therapy Timer


3.5.2.4.2  Reset at Therapy
Completion                                                                                    


Traceable
Requirement                                  Version:
1.5              (SYSREQ35601)


Therapy duration time
will be reset to the initial desired therapy time at the completion of therapy.


 


This
requirement traces TO SUBREQ35799:  Setup
Screen Reentry


3.5.2.4.3  Pre-therapy Temperature
Check                                                                            



Traceable
Requirement                                  Version:
3.1              (SYSREQ35602)


While on the Therapy
screen, prior to switching to READY mode, the software shall monitor the
temperature of the diodes. [**]


 


While waiting for the
current temperature to go down, the user can hit a softkey to go back to the
Setup screen.


 


This
requirement traces TO SUBREQ36460:  Diode
Temp Check Prior to Therapy


3.5.2.5  Therapy Operation                                                                                                                


Section Heading                                  Version:
4.0              (SYSREQ35603)


The following terms
define the operational states of the console:


 


	
  ·

  	
   

  	
  OFF:

  	
   

  	
  console is not supplied with AC power, all displays
  are blank and the laser is de-energized.

  
	
  ·

  	
   

  	
  STANDBY:

  	
   

  	
  console is powered-on,
  laser is de-energized. Laser can not enter the ACTIVE state (energize the
  laser) by pressing the footswitch.

  
	
  ·

  	
   

  	
  READY:

  	
   

  	
  console is powered-on,
  laser is de-energized. User can enter the ACTIVE state via footswitch
  activation.

  
	
  ·

  	
   

  	
  ACTIVE:

  	
   

  	
  console is powered-on,
  footswitch is activated and the laser is energized.

  



 









 



 


3.5.2.5.1  Start of Therapy                                                                                                            


Critical Requirement                                  Version:
10.1              (SYSREQ35604)


The following must have
occurred before therapy can start:


 


[**]


This requirement traces TO SUBREQ36418:  Delivery Device Irrigation Check Screen


This requirement traces TO SUBREQ35807:  Footswitch Open before READY


This requirement traces TO SUBREQ35983:  Laser Enable Inputs


This requirement traces TO SUBREQ36549:  Output Port Shield Still Attached


This requirement traces TO SUBREQ35787:  Parameters Displayed


This requirement traces TO SUBREQ35809:  Instruction Displayed


This requirement traces TO SUBREQ35975:  Keyed Power Switch


This
requirement traces TO SUBREQ35791: 
Required Fields


3.5.2.5.2  Therapy Pause                                                                                                               


Traceable
Requirement                                  Version:
1.9              (SYSREQ35605)


Therapy shall be paused
[**]  While therapy is paused, [**]


 


This requirement traces TO SUBREQ35812:  Cessation of Therapy


This requirement traces TO SUBREQ35822:  5 sec visible countdown


This requirement traces TO SUBREQ35821:  5 Second Maximum Pause Time


This requirement traces TO SUBREQ35824:  Displayed Information


This
requirement traces TO SUBREQ35823: 
Softkeys: Therapy Paused Screen


3.5.2.5.3  Therapy Complete                                                                                                        


Traceable
Requirement                                  Version:
1.5              (SYSREQ35606)


Therapy shall be complete
and the laser de-energized when remaining therapy duration time is [**]
seconds.


 


This requirement traces TO SUBREQ35920:  OIC Countdown Therapy Timer


This requirement traces TO SUBREQ35812:  Cessation of Therapy


This
requirement traces TO SUBREQ35810:  UIC
Countdown Therapy Timer


3.5.2.5.4  Therapy Abort                                                                                                               


Traceable
Requirement                                  Version:
8.3              (SYSREQ35607)


Therapy shall be
considered aborted and the laser de-energized in response to any of the
following conditions.


 


[**]


This requirement traces FROM SYSREQ35619:  Device Response: Alert


This requirement traces TO SUBREQ35821:  5 Second Maximum Pause Time


This requirement traces TO SUBREQ35812:  Cessation of Therapy


This requirement traces TO SUBREQ35843:  In READY State Too Long


This requirement traces TO SUBREQ35813:  Softkeys: Therapy Screen


This requirement traces TO SUBREQ36485:  Therapy Abort Conditions


This
requirement traces TO SUBREQ35825: 
Therapy Aborted Screen


 















 


3.5.2.6  LASER STOP                                                                      



Critical
Requirement                                 
Version: 4.0             
(SYSREQ35608)


The console shall provide means for the user to stop
therapy and de-energize the laser via a LASER STOP switch.


When the LASER STOP switch is activated, all power in
the console is interrupted.


This
requirement traces TO SUBREQ35974:  LASER
STOP Button


3.5.2.7  Delivery Device Replacement                                                          



Traceable
Requirement                                 
Version: 4.0             
(SYSREQ35609)


When the delivery device is removed (detected by
output port interlocks), all therapy parameters are reset to power up defaults.


This requirement traces TO SUBREQ35838:  Alert: Output Port Interlock


This
requirement traces TO SUBREQ35982:  Setup
Pameters Reset On Device Replacement


3.5.3  Outputs                                                                          



Section Heading                                  Version:
1.5              (SYSREQ35610)


 


3.5.3.1  Laser Energized                                                                     


Traceable
Requirement                                 
Version: 2.2              (SYSREQ35611)


The console shall provide a visual and audible
indication to the user whenever the laser is energized.


This requirement traces TO SUBREQ35811:  Audible & Visible Indication of
Laser On


This
requirement traces TO SUBREQ35904:  Audio
Transducer


3.5.3.1.1  Irrigation Prompt                                                                      



Traceable
Requirement                                 
Version: 3.2             
(SYSREQ35612)


The console shall provide
a prompt to the user before activating the laser regarding device irrigation.


 


This
requirement traces TO SUBREQ36418: 
Delivery Device Irrigation Check Screen


3.5.3.2  Laser State                                                                           



Critical
Requirement                                 
Version: 2.3             
(SYSREQ35613)


The console shall visually indicate to the user the
current state of the laser as being STANDBY, READY or ACTIVE.


This
requirement traces TO SUBREQ35769: 
Displayed Elements









 



 


3.5.3.3  Programmed Power                                                                           



Critical
Requirement                                 
Version: 2.2             
(SYSREQ35614)


The console will indicate programmed therapy power
with a resolution of [**]


This
requirement traces TO SUBREQ35808: 
Parameters Displayed


3.5.3.4  Remaining Therapy Time                                                                    


Critical
Requirement                                 
Version: 2.2             
(SYSREQ35615)


The console will indicate remaining therapy time with
a resolution of [**], to the user whenever the laser is energized .


This requirement traces TO SUBREQ35920:  OIC Countdown Therapy Timer


This requirement traces TO SUBREQ35808:  Parameters Displayed


This
requirement traces TO SUBREQ35810:  UIC
Countdown Therapy Timer


3.5.4  System Alerts                                                                



Traceable
Requirement                                 
Version: 3.3             
(SYSREQ35616)


Upon detection of
an alert condition, the UI shall generate visual and audible indications. [**]


 


This requirement traces TO SYSREQ35617:  Alert Conditions


This requirement traces TO SYSREQ35618:  Alerts Suppressed During Therapy


This requirement traces TO SUBREQ35812:  Cessation of Therapy


This requirement traces TO SYSREQ35577:  **LASER SHUTOFF**


This requirement traces TO SUBREQ35832:  Alerts/Alarms Visible & Audible


This requirement traces TO SUBREQ35831:  Alerts/Alarms Stop Therapy


This requirement traces TO SYSREQ35619:  Device Response: Alert


 


3.5.4.1  Alert Conditions                                                                    


Traceable
Requirement                                 
Version: 4.4             
(SYSREQ35617)


The console shall indicate the following alert
conditions to the user:


[**]


This requirement traces FROM SYSREQ35616:  System Alerts


This requirement traces TO SUBREQ35844:  Alert: Fan Failure


This requirement traces TO SUBREQ35838:  Alert: Output Port Interlock


This requirement traces TO SUBREQ35842:  Alert: OverTemp


This
requirement traces TO SUBREQ35839: 
Alert: Remote Interlock


3.5.4.2  Alerts Supressed During Therapy                                      


Traceable
Requirement                                 
Version: 2.1             
(SYSREQ35618)


During therapy, the following alerts are suppressed. [**]


[**]


This requirement traces FROM SYSREQ35616:  System Alerts


This requirement traces TO SUBREQ35844:  Alert: Fan Failure


This requirement traces TO SUBREQ35842:  Alert: OverTemp


This
requirement traces TO SUBREQ35834: 
Alerts Supression









 



 


3.5.4.3  Device Response: Alert                                                                     



Traceable
Requirement                                 
Version: 5.3              (SYSREQ35619)


In the event of an alert condition, the console shall
respond according to the alert response table. Note that the responses vary by
what state the laser is in.


[**]


 




	
  Alert

  	
   

  	
  STANDBY

  	
   

  	
  READY

  	
   

  	
  ACTIVE

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  ð[**]

  	
   

  	
  [**]

  
	
  [**]

  	
   

  	
  ð[**]

  	
   

  	
  ð[**]

  	
   

  	
  ð[**]

  
	
  [**]

  	
   

  	
  ð[**]

  	
   

  	
  ð[**]

  	
   

  	
  ð[**]

  
	
  [**]

  	
   

  	
  ð[**]

  	
   

  	
  ð[**]

  	
   

  	
  ð[**]

  
	
  [**]

  	
   

  	
  ð[**]

  	
   

  	
  ð[**]

  	
   

  	
  ð[**]

  






 


This requirement traces FROM SYSREQ35616:  System Alerts


This requirement traces TO SYSREQ35577:  **LASER SHUTOFF**


This requirement traces TO SUBREQ35834:  Alerts Supression


This requirement traces TO SUBREQ35831:  Alerts/Alarms Stop Therapy


This requirement traces TO SUBREQ35835:  Performing Therapy after an Alert


This requirement traces TO SUBREQ35838:  Alert: Output Port Interlock


This requirement traces TO SUBREQ35844:  Alert: Fan Failure


This requirement traces TO SUBREQ35839:  Alert: Remote Interlock


This
requirement traces TO SYSREQ35607: 
Therapy Abort


3.5.5  System Alarms                                                                             



Traceable
Requirement                                  Version: 3.3              (SYSREQ35620)


Upon detection of an alarm condition, the UI shall
generate a visual and audio alarm. Alarm indications must occur within [**]of
detection of an alarm condition. [**]


This requirement traces TO SYSREQ35577:  **LASER SHUTOFF**


This requirement traces TO SUBREQ35832:  Alerts/Alarms Visible & Audible


This requirement traces TO SUBREQ35831:  Alerts/Alarms Stop Therapy


This requirement traces TO SUBREQ35812:  Cessation of Therapy


 


3.5.5.1  Alarm Conditions                                                                               



Traceable
Requirement                                 
Version: 2.3             
(SYSREQ35621)


The console shall indicate the following alarm
conditions to the user:


[**]


This requirement traces TO SUBREQ35848:  Alarm: Inaccurate Laser Power


This requirement traces TO SUBREQ35849:  Alarm: POST Failed


This requirement traces TO SUBREQ35760:  Power Up Tests


This
requirement traces TO SUBREQ35761: 
Run-Time Diagnostics









 



 


3.5.5.2  Device Response: Alarm                                                                      


Traceable
Requirement                                 
Version: 2.1             
(SYSREQ35622)


In the event of an alarm condition, [**]


This requirement traces TO SYSREQ35577:  **LASER SHUTOFF**


This requirement traces TO SUBREQ35831:  Alerts/Alarms Stop Therapy


This requirement traces TO SUBREQ35833:  Alarm Silencing


This requirement traces TO SUBREQ35836:  Performing Therapy after an Alarm


 


3.5.6  Service/Engineering Mode                                                                       



Traceable
Requirement                                 
Version: 5.3             
(SYSREQ35623)


The UI shall include
a service/engineering mode of operation through the UI which provides [**]


 


This requirement traces TO SUBREQ35863:  Accessing Service Screen


This requirement traces TO SUBREQ35865:  Service Screen Options


This requirement traces TO SUBREQ36690:  TSS BIT Screen


This requirement traces TO SUBREQ36536:  Set TSS BIT Params


This requirement traces TO SUBREQ35873:  Dump Device Number History Log


This requirement traces TO SUBREQ35866:  Display Event Log


This requirement traces TO SUBREQ36533:  View System Runtime


 


3.5.6.1  Hours of Use                                                                        



Traceable
Requirement                                 
Version: 2.3             
(SYSREQ35624)


In service/engineering mode, the system shall be
capable of displaying “hours of use” of the laser diode module. [**]


[**]


This
requirement traces TO SUBREQ35892:  Laser
Usage Time


3.5.6.1.1  Reset Hours of Use                                                                    



Traceable
Requirement                                 
Version: 2.1             
(SYSREQ35625)


The console shall provide
a means to reset the “Hours Of Use” when a laser module is replaced.


 


This
requirement traces TO SUBREQ35871:  Reset
Laser Usage timer


3.5.6.2  Constant Current Mode                                                                    



Traceable
Requirement                                 
Version: 2.0             
(SYSREQ35626)


In service/engineering mode, the system shall provide
means for running the laser in constant current mode. [**]


This
requirement traces TO SUBREQ36466:  Set
Constant Current Mode


3.5.6.3  Power Calibration Mode                                                                     


Traceable
Requirement                                 
Version: 1.7             
(SYSREQ35627)


In service/engineering mode, the system shall provide
means for the user (service personnel) to perform a power calibration of the
laser.


This
requirement traces TO SUBREQ35943: 
Store/Read Laser Calibration Data









 



 


3.5.6.4  Current Calibration Mode                                                                               



Traceable
Requirement                                 
Version: 1.10             
(SYSREQ36411)


In service/engineering mode, the system shall provide
means for the user (service personnel) to perform a current calibration of the
laser.


This
requirement traces TO SUBREQ36486: 
Store/Read Laser Current Calibration Data


3.5.6.5  TSS Calibration                                                                     


Traceable
Requirement                                 
Version: 1.7             
(SYSREQ35628)


The system shall provide a means to calibrate the
Thermal Safety System from within the Service Mode.


This requirement traces TO SUBREQ35969:  Read Thermal Safety System Information


This
requirement traces TO SUBREQ36463:  Store
TSS Calibration Data


3.5.7  UI Components                                                                            



Section Heading                                  Version: 1.5              (SYSREQ35629)


 


3.5.7.1  Display and Keypad                                                                           



Section Heading                                  Version:
1.6              (SYSREQ35630)


 


3.5.7.1.1  Viewability                                                                  



Traceable
Requirement                                 
Version: 1.5             
(SYSREQ35631)


All electronically displayed information must be
readable from [**]


This
requirement traces TO SUBTST36182:  Test
Protocol 007 - Viewability


3.5.7.1.2  Display Angle                                                                             



Traceable
Requirement                                  Version: 1.6              (SYSREQ35632)


The display shall be mounted [**]


This
requirement traces TO SUBTST36182:  Test
Protocol 007 - Viewability


3.5.7.1.3  Room Lighting                                                                           



Design
Guideline                                 
Version: 1.4              (SYSREQ35633)


All user data must be
visible [**]


3.5.7.1.4  Keypad Actuation Force                                                             


Traceable
Requirement                                 
Version: 2.0             
(SYSREQ35634)


All user-input keys shall
have an actuation force between [**]


 


This requirement
traces TO SUBTST37660:  Test Protocol 003
- Keypad Force









 



 


3.5.7.1.5  Foreign Languages                                                                      


Future
Enhancement                                 
Version: 3.2             
(SYSREQ35735)


The laser console must
support the following foreign language requirements: [**]


 


3.5.7.1.6  Device Labeling                                                                         



Traceable
Requirement                                 
Version: 3.7             
(SYSREQ36192)


Device labeling shall be
in [**]


 


This requirement traces TO SUBREQ35861:  Languages


This requirement traces TO SUBREQ35767:  Languages


 


3.5.7.2  LASER STOP Switch                                                                         



Critical
Requirement                                 
Version: 4.0             
(SYSREQ35635)


The console shall have a red laser stop switch on the
front or top of the console. [**]


This
requirement traces FROM SUBFMA36068:  OIC
locked-up during therapy - loss of optical system control

This requirement traces TO SUBREQ35974: 
LASER STOP Button


3.5.7.3  Footswitch                                                                           



Critical
Requirement                                 
Version: 4.1              (SYSREQ35636)


The system shall include a footswitch, [**]


This
requirement traces TO SUBTST37661:  Test
Protocol 004 - Footswitch


3.5.7.4  Audio Transducer                                                                              



Traceable
Requirement                                 
Version: 3.0              (SYSREQ35637)


The system shall include a monotone audio transducer
[**]


This
requirement traces TO SUBREQ35904:  Audio
Transducer


3.6  Device Event Log                                                                    


Traceable
Requirement                                 
Version: 2.2             
(SYSREQ35638)

The console shall be capable of storing a history of the
events in non-volatile memory.


[**]


This requirement traces TO SUBREQ35878:  Common Format


This requirement traces TO SUBREQ35877:  Number of Events


 


3.6.1  Power On                                                                      



Traceable
Requirement                                  Version: 3.1              (SYSREQ35640)


An event will be
created when the console is powered on.


 


[**].


This
requirement traces TO SUBREQ35880: 
Event: Power Up









 



 


3.6.2  Change in Operation State (STANDBY, READY,
ACTIVE) 


Traceable
Requirement                                 
Version: 2.2             
(SYSREQ35641)


An event will be
recorded when the laser changes between STANDBY, READY, and ACTIVE mode.


 


This requirement traces TO SUBREQ35882:  Event: Go To Ready


This requirement traces TO SUBREQ35886:  Event: Therapy Abort


This requirement traces TO SUBREQ35885:  Event: Therapy Resume


This requirement traces TO SUBREQ35884:  Event: Therapy Pause


This requirement traces TO SUBREQ35887:  Event: Therapy Complete


This requirement traces TO SUBREQ35880:  Event: Power Up


This requirement traces TO SUBREQ36468:  Event: Alarm


This requirement traces TO SUBREQ35888:  Event: Alert


This requirement traces TO SUBREQ35883:  Event: Therapy Start


 


3.6.3  Therapy Start                                                                               



Traceable
Requirement                                  Version: 1.5              (SYSREQ35642)


An event will be generated when Therapy is started.


[**]


This
requirement traces TO SUBREQ35883: 
Event: Therapy Start


3.6.4  Therapy Complete                                                                      



Traceable
Requirement                                  Version: 2.2              (SYSREQ35643)


An event will be created when Therapy Completes.


[**]


This
requirement traces TO SUBREQ35887: 
Event: Therapy Complete


3.6.5  Therapy Paused                                                                           



Traceable
Requirement                                 
Version: 1.5             
(SYSREQ35644)


An event entry will be created when Therapy is Paused.


[**]


This
requirement traces TO SUBREQ35884: 
Event: Therapy Pause


3.6.6  Alert or Alarm Occurance                                                                         



Traceable
Requirement                                 
Version: 1.6             
(SYSREQ35645)


A device history event entry will be made for any
alert or alarm condition.


[**]


This
requirement traces TO SUBREQ36468: 
Event: Alarm

This requirement traces TO SUBREQ35888: 
Event: Alert









 



 


3.7  External Serial Port                                                                               


Traceable
Requirement                                 
Version: 2.2             
(SYSREQ35646)

The console shall include an external serial interface
port.


This
requirement traces TO SUBREQ35988: 
Serial Port


3.7.1  Available Data                                                                            



Design
Guideline                                 
Version: 2.4             
(SYSREQ35647)


Data available via the external serial port includes
the following:


[**]


3.7.2  Physical Implementation                                                                          



Traceable
Requirement                                 
Version: 1.5              (SYSREQ35648)


The serial interface will be implemented [**]


This requirement traces TO SUBREQ35989:  Connector


This requirement traces TO SUBREQ35990:  Pinout


 


3.7.3  Baud Rate                                                                     



Traceable
Requirement                                 
Version: 1.10             
(SYSREQ35649)


The external
serial port shall provide communications at a baud rate of [**]


 


This
requirement traces TO SUBREQ35932: 
Serial Port Parameters


3.8  Regulatory Requirements                                                                  



Section Heading                                  Version: 1.5              (SYSREQ35650)


3.8.1  Device Classifications                                                                   


Design
Guideline                                 
Version: 4.0             
(SYSREQ35651)


The Laser Console
shall be designed to meet the requirements of the following safety and
regulatory classifications:


 


[**]


 


3.8.2  U.S. Regulatory                                                                           



Critical
Requirement                                 
Version: 5.0             
(SYSREQ35652)


 


The console shall
be designed and verified to comply with the following standards.


 


UL 60601-1 Medical
Electrical Equipment, PART 1: General Requirements for Safety


 


21 CFR 1040.10 and
1040.11 Performance Standards for Light Emitting Products, except for
deviations pursuant to CDRH Laser Notice No. 50


 


This
requirement traces TO SUBTST36177:  Test
Protocol 001 - Safety Regulations









 



 


3.8.3  O.U.S. Regulatory                                                                       



Critical
Requirement                                 
Version: 15.0             
(SYSREQ35653)


The console shall
be designed and verified to comply with the following standards:


 


CAN/CSA C22.2 No. 601-1
M90 - Except Languages


Medical Electrical
Equipment - PART 1: General Requirements For Safety


 


EN 61000-3-2
Electromagnetic Compatibility (EMC) - Part 3-2: Limits - Limits for
Harmonic Current Emissions (Equipment Input Current <= 16 A per Phase)


 


EN 61000-3-3
Electromagnetic Compatibility (EMC) - Part 3-3: Limits - Limitation
of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-Voltage
Supply Systems, for Equipment With Rated Current <= 16 A per Phase and Not
Subject to Conditional Connection)


 


CISPR 11 / EN
55011 Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment -
Electromagnetic Disturbance Characteristics - Limits and Methods of Measurement


 


IEC 60601-1
/ BS EN 60601-1 Medical Electrical Equipment - PART 1: General
Requirements For Safety


 


IEC 60601-1-2
/ EN 60601-1-2 Medical Electrical Equipment - Part 1: General
Requirements for Safety, Section 2 - Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests


 


IEC 60825-1
/BS EN 60825-1 Safety of Laser Products - Part 1: Equipment
Classification, Requirements And User’s Guide


 


IEC 60601-1-4
/ EN 60601-1-4 Medical Electrical Equipment - Part 1-4:
General Requirements for Safety -


 


Collateral
Standard: Programmable Electrical Medical Systems


 


This
requirement traces TO SUBTST36177:  Test
Protocol 001 - Safety Regulations


3.9  General Safety Requirements                                                                            



Section Heading                                  Version:
1.5              (SYSREQ35654)


3.9.1  Fail-safe Condition                                                                    



Design
Guideline                                  Version: 2.2              (SYSREQ35655)


The console must “fail-safely” in the event of a [**]


3.9.2  System Diagnostics                                                                     



Critical
Requirement                                 
Version: 2.4             
(SYSREQ35656)


The console should
include appropriate diagnostics and self-tests [**]


 


This requirement traces TO SUBREQ35760:  Power Up Tests


This requirement traces TO SUBREQ35832:  Alerts/Alarms Visible & Audible


This requirement traces TO SUBREQ35849:  Alarm: POST Failed


This requirement traces TO SUBREQ35761:  Run-Time Diagnostics


 









 



 


3.9.3  Power On Self Tests                                                                    



Critical
Requirement                                 
Version: 6.2             
(SYSREQ35657)


Start-up self
tests shall test or monitor the following functional blocks:


[**]


 


This
requirement traces TO SUBREQ35760:  Power
Up Tests


3.9.4  Single Fault Impact                                                                      


Design
Guideline                                 
Version: 1.4             
(SYSREQ35658)


Except for faults
that trigger a LASER SHUTOFF condition, no single fault condition shall change
the laser output [**]


 


3.9.5  Defibrillator Proof                                                                      



Traceable
Requirement                                 
Version: 4.0             
(SYSREQ35659)

The console shall be defibrillator proof.


[**]


This
requirement traces TO SUBTST36178:  Test
Protocol 002 - Defibrillator Proof


3.9.6  Watchdog Timers                                                                        



Critical
Requirement                                 
Version: 3.4             
(SYSREQ35661)


The [**], will be
monitored by watchdogs.


 


This requirement traces TO SUBREQ35923:  Heartbeat


This requirement traces TO SUBREQ36470:  OIC Watchdog


This requirement traces TO SUBREQ36469:  UIC Watchdog


 


3.10  Power Requirements                                                                         



Section Heading                                  Version:
1.6              (SYSREQ35662)


 


This
requirement traces TO SYSREQ36464:  Power
Key Switch


3.10.1  AC Power Source                                                                           



Traceable
Requirement                                 
Version: 2.2             
(SYSREQ35663)


The console’s [**]
power source will be AC line power (Mains voltage).


 


This
requirement traces TO SUBTST36156:  Test
Protocol 002 - Mains Power


3.10.2  Mains Tolerances                                                                          



Traceable
Requirement                                 
Version: 3.0             
(SYSREQ35664)


The console will
support [**]


 


This
requirement traces TO SUBTST37664:  Test
Protocol 003 - Input Voltage Range


 















 


 


3.10.3 Mains Receptacle                  
Critical Requirement                      Version:
2.2     (SYSREQ35665)

The console power input shall incorporate an [**]


This
requirement traces TO SUBTST36156: Test Protocol 002 - Mains Power


3.10.4 UL Recognized Components          
Critical Requirement                      Version:
1.6     (SYSREQ35666)

AC mains components must be UL recognized.


This
requirement traces TO SUBREQ35977: AC Components UL Listed

This requirement traces TO SUBTST36156: Test Protocol 002 - Mains Power


3.10.5 Power Status LED          
Critical Requirement                 Version: 2.2          (SYSREQ35667)

The console shall have an LED on the front panel indicating that power
is on.


This
requirement traces TO SUBREQ35976: Power On Indicator


3.10.6 Mains Fused      
Critical Requirement                 Version: 2.2          (SYSREQ35668)

The console will have fuses in the mains.


This
requirement traces TO SUBTST36156: Test Protocol 002 - Mains Power


3.10.7 Isolation             
Critical Requirement                 Version: 1.5          (SYSREQ35669)

Applied parts will be electrically isolated from secondary circuits and
earth ground [**]


This
requirement traces TO SUBTST36172: Test Protocol 002 - EMC / EMI


3.10.8 Power Key Switch          

Traceable Requirement             Version:
3.1          (SYSREQ36464)

The console shall have a front panel key switch, which energizes the
console.


This
requirement traces FROM SYSREQ35662: h Power Requirements


This
requirement traces TO SUBTST36181: Test Protocol 001 - Enclosure


3.11 Physical Requirements               
Section Heading                    Version: 1.5          (SYSREQ35670)




3.11.1 Size      
Design Guideline        Version:
2.2          (SYSREQ35671)

The maximum footprint of the laser console should be [**]









 



 


3.11.2 Weight                

Design Guideline        Version:
2.2          (SYSREQ35672)

The weight of the total laser console, unpackaged, should be less than
or equal to [**].


 


3.11.3 Forced Air         

Traceable Requirement             Version:
2.3          (SYSREQ35673)

Internal temperature control for the laser console shall be implemented
via forced air cooling.


 


This
requirement traces TO SUBTST37663: Test Protocol 006 - Internal Cooling


3.11.4 AC Power Cable Length                 

Critical Requirement                 Version: 2.2          (SYSREQ35674)

The console power cable connecting to AC power shall be [**]


 


This
requirement traces TO SUBTST36156: Test Protocol 002 - Mains Power


3.12 Environmental Requirements  

Section Heading                 Version: 1.5          (SYSREQ35675)

The following sections provide environmental requirements that are in
addition to requirements stipulated by the standards noted in Section 1.2.1.


 


3.12.1 Operating Conditions             

Section Heading         Version:
1.5          (SYSREQ35676)


 


3.12.1.1 Ambient
Temperature                  
Traceable Requirement             Version:
2.2         (SYSREQ35677)

The console will operate over an ambient temperature range of [**].


This
requirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity


3.12.1.2 Humidity         
Traceable Requirement             Version:
2.2          (SYSREQ35678)

The console will operate over a relative humidity range of [**].


This
requirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity


3.12.1.3 ESD                                                


Traceable Requirement            Version:
3.0          (SYSREQ35679)

During IEC 60601-1-2 specified ESD exposure, [**]


This
requirement traces TO SUBTST36172: Test Protocol 002 - EMC / EMI









 



 


3.12.1.4 EMI             
Traceable Requirement        Version:
7.0          (SYSREQ35680)

The console shall meet EMI exposure requirements specified in [**].


This
requirement traces TO SUBTST36172: Test Protocol 002 - EMC / EMI


3.12.1.5 Drip Proof               

Critical Requirement            Version:
4.0          (SYSREQ35681)

The console will be drip proof per [**].


This
requirement traces TO SUBTST36173: Test Protocol 003 - Drip Proof


3.12.1.6 Surface Temperature             
Critical Requirement            Version:
2.2          (SYSREQ35682)

Surface temperature of the laser console shall not exceed [**] when the
unit is operating in the defined ambient temperature range.


This
requirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity


3.12.1.7 Unpackaged Drop Test        

Traceable Requirement        Version:
5.0          (SYSREQ35683)

The console shall withstand a [**]


This
requirement traces TO SUBTST36174: Test Protocol 004 - Drop and Vibration


3.12.1.8 Unpackaged Vibration Test  
Traceable Requirement        Version:
4.1          (SYSREQ35684)

The console must function properly in the presence of vibration per
[**]


This
requirement traces TO SUBTST36174: Test Protocol 004 - Drop and Vibration


3.12.1.9 Chemical Exposure              

Traceable Requirement        Version:
1.6          (SYSREQ35685)

Exposed surfaces must withstand wiping (not scrubbing) with [**]


This
requirement traces TO SUBTST37563: Test Protocol 007 - Chemical Exposure


3.12.2 Storage and Transport Conditions                      

Section Heading                    Version:
1.5          (SYSREQ35686)


3.12.2.1 Humidity    
Traceable Requirement        Version:
2.2          (SYSREQ35687)

The console while packaged must withstand exposure of [**]


This
requirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity









 



 


3.12.2.2 Temperature              
Traceable Requirement        Version:
2.2          (SYSREQ35688)

The console while packaged must withstand environment temperatures from
[**] and remain capable of proper functionality when returned to normal
operating conditions.


This
requirement traces TO SUBTST36171: Test Protocol 001 - Temperature and Humidity


3.12.2.3 Shock and Vibration            

Traceable Requirement        Version:
5.1          (SYSREQ35689)

The console while packaged must withstand the environmental extremes
identified in [**]


This
requirement traces TO SUBTST36175: Test Protocol 005 - Shipping


3.13 Quality Requirements                 
Section Heading                 Version: 1.5          (SYSREQ35690)


3.13.1 Verification Testing      

Traceable Requirement             Version:
2.2          (SYSREQ35691)

[**]


This
requirement traces TO SUBTST36179: Test Protocol 003 - Development Processes


3.13.2 Testability          
Design Guideline        Version:
1.4          (SYSREQ35692)

[**]


3.14 Manufacturing Guidelines        
Section Heading                 Version: 1.5          (SYSREQ35693)


3.14.1 In-circuit Programming for Programmable Devices 
Design Guideline        Version:
1.4          (SYSREQ35694)

Programmable electronic devices should be designed for in-circuit
programming where possible.


3.14.2 System MTBF 
Design Guideline        Version:
2.2          (SYSREQ35695)

Mean time between failure (MTBF) for the console shall be [**].


3.15 Service Guidelines       
Section Heading                 Version: 1.5          (SYSREQ35696)


3.15.1 Software Upgrades           
Design Guideline        Version:
3.2          (SYSREQ35697)

Software upgrades for the console must be easily installed [**].









 



 


3.15.2 Not User Serviceable       
Critical Requirement                 Version: 2.2          (SYSREQ35698)

The console is not intended to be user serviceable.


This
requirement traces TO SUBTST36184: Test Protocol 008 - Not User Serviceable


3.16 Future Upgradeability               
Future Enhancement         Version:
3.2          (SYSREQ35699)

The laser system design should include consideration of the following
potential feature or functional upgrades. [**]


3.17 Irrigation Control       
Section Heading                 Version: 2.3          (SYSREQ35700)

This section describes the irrigation control in the console.


3.17.1 Pinch Valve       
Traceable Requirement             Version:
4.0          (SYSREQ35701)

There will be a pinch valve in the system [**]


This
requirement traces TO SUBREQ35996: Pinch Valve External


3.17.2 Pinch Valve Shutoff when TSS Trips         
Traceable Requirement             Version:
1.5          (SYSREQ35702)

The pinch valve shall close when the Thermal Safety System trips.


This
requirement traces TO SUBREQ35998: Pinch Valve & TSS Shutoff


3.17.3 Activated During Footswitch Down          

Traceable Requirement             Version:
2.2          (SYSREQ35703)

The Pinch Valve will have a normally closed position. The pinch valve
will open when the footswitch is depressed during therapy.


This
requirement traces TO SUBREQ35997: Pinch Valve Operation


3.17.4 Irrigation - Softkey Activation   

Traceable Requirement             Version:
2.5          (SYSREQ36414)

The device shall be capable of pinch valve control, via softkey
control, while not in therapy mode.


This
requirement traces TO SUBREQ35997: Pinch Valve Operation

This requirement traces TO SUBREQ36424: Softkeys: Delivery Device Irregation


3.18 Laser Output Specific Requirements       
Section Heading                 Version: 2.6          (SYSREQ35726)









 



 


3.18.1 Wavelength        
Traceable Requirement             Version:
2.2          (SYSREQ35727)

The console shall be capable of producing output laser energy at a
wavelength of [**]


This
requirement traces TO SUBREQ36006: Wavelength


3.18.2 Power                
Traceable Requirement             Version:
6.2          (SYSREQ35728)

The console shall be capable of coupling laser energy [**]


[**]


This
requirement traces TO SUBREQ36007: Power


3.18.3 Max Power Allowed        
Traceable Requirement             Version:
2.4          (SYSREQ35729)

The Max Power allowed by the setup parameters shall be [**]


This
requirement traces TO SUBREQ36008: Max Power Allowed


3.18.4 Aiming Beam    
Traceable Requirement             Version:
1.6          (SYSREQ35731)

There will be an aiming beam. [**]


This
requirement traces TO SUBREQ36010: Red Aiming Beam


3.18.5 Therapy Delivery Device Parameters         
Traceable Requirement             Version:
9.0          (SYSREQ35733)


[**]


	
   

  	
   

  	
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This
requirement traces TO SUBREQ36013: Therapy Device Parameters


3.18.6 Product Name                 
Design Guideline        Version:
5.0          (SYSREQ35734)

The console shall be labeled “Model 60980: Optiwave 980TM Laser Console”.









 



 


3.18.7 System Cost Target          
Design Guideline        Version:
1.5          (SYSREQ35736)

The manufacturing cost of the device [**]


 















 


 


Schedule 2.1(a)

Universal Functionality
Specifications


The Universal
Functionality Specifications shall mean the following changes to the
specifications set out as Exhibit A above:


Section 3.5.2.2.2
Delivery Device Number Format the word Endocardial will be deleted and replaced with the word Universal


Section 3.18.5
Therapy Delivery Device Parameters the word Endocardial will be deleted and replaced with the word Universal. Need to also change abbreviation
“(Endo)” to “(Uni)”


Section 3.18.5
Therapy Delivery Device Parameters under Power in W/cm2 the Range of [**] is being replaced with [**]


Section 3.18.5
Therapy Delivery Device Parameters under Duration in Seconds the Range of [**] is being replaced with [**]









 



 


Schedule 2.4

Endo Handpiece Inventory


 


	
  PLC Part #

  	
   

  	
  Edwards

  Part #

  	
   

  	
  Description (Edwards)

  	
   

  	
  Exp. Date

  	
   

  	
  Qty on

  Hand

  	
   

  	
  PLC Cost $

  	
   

  	
  PLC EXT Cost

  	
   

  
	
  [**]

  	
   

  	
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  $

  	
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  $

  	
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  [**]

  	
   

  	
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  $

  	
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  $

  	
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  [**]

  	
   

  	
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  $

  	
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  $

  	
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  [**]

  	
   

  	
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  $

  	
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  $

  	
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  $

  	
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  Total

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  $

  	
  [**]

  	
   

  



 









 



 


Schedule 3.12


Regulatory Approvals


1.               PLC shall file the
2005 Annual Laser Product Report with the FDA


2.               PLC shall send a
Notification Letter to the FDA transferring ownership of the Laser and 510K
from PLC to Edwards.