EXHIBIT 10.1
AMENDED AND RESTATED DEVELOPMENT,
SUPPLY, MARKETING AND
DISTRIBUTION AGREEMENT
THIS AMENDED AND RESTATED PRODUCT DEVELOPMENT,
SUPPLY, MARKETING AND DISTRIBUTION AGREEMENT (this
“Agreement”) is made and entered into as of
June 1, 2003, by and between E-Z-EM, INC., a Delaware
corporation (“EZEM”) and Vital Images, Inc., a
Minnesota corporation (“VTAL”).
RECITALS:
WHEREAS, the parties entered into a Development,
Supply, Marketing and Distribution Agreement dated as of
October 24, 2001 (the “Original Agreement”),
pursuant to which, inter alia , EZEM was appointed as
VTAL’s exclusive reseller of Appliances and EZEM received a
royalty with respect to the sale by VTAL of Options, all on the
terms and conditions set forth in the Original
Agreement;
WHEREAS, the parties have agreed that EZEM will
no longer sell Appliances;
WHEREAS, the parties have agreed to amend their
agreement with respect to the sale by VTAL of Options;
and
WHEREAS, to effect the foregoing and to effect
such other changes as the parties have agreed upon, the parties
desire to amend and restate the Original Agreement as set forth
herein.
AGREEMENT:
NOW, THEREFORE, EZEM and VTAL agree as
follows:
1.
ORIGINAL
AGREEMENT.
This Agreement amends and restates
the Original Agreement in its entirety, provided however that
notwithstanding the foregoing, the Original Agreement shall remain
in full force and effect with respect to sales of Options by VTAL
prior to June 1, 2003 and to sales of Appliances by
EZEM.
2.
DEFINITIONS:
As used in this Agreement, the
following terms shall have the meanings indicated (whether used in
the singular or plural form), unless otherwise expressly
provided:
2.1.
“ Person ” shall
mean an individual, a corporation, a partnership, an association, a
joint venture, limited liability company, government (or any agency
or political subdivision thereof), an unincorporated organization,
a trust or other entity, including, without limitation, an employee
pension, profit sharing or other benefit plan or trust.
1
2.2.
“ Vitrea 2
Software ” means the current Vitrea ® 2
software product of VTAL and any new versions thereof made
commercially available by VTAL (it being understood that VTAL
reserves the right to designate whether a software product
constitutes a new version of the Vitrea 2 software product
or a new product).
2.3.
“Specification”
shall mean the specification for the
virtual colonoscopy visualization and analysis software modules of
the Option; provided that such specification is intended only as a
general description of the parties’ expectations with respect
to the specification with respect to the Option, and shall be
subject to modification in accordance with Section 3.3
hereof.
2.4.
“Option”
means a virtual colonoscopy
visualization and analysis software product consistent with the
Specification, whether licensed as an option for use in conjunction
with Vitrea 2 Software, incorporated into the Vitrea
2 Software as a standard feature, licensed as a standalone product,
licensed on an OEM basis or otherwise made commercially available
by VTAL, including any upgrades or new versions thereof for which a
separate fee is charged and which is not provided as a part of
maintenance and support . For the avoidance of doubt,
no Colon Computer Aided Design (CAD) option is included in the term
“Option” for purposes hereof.
2.5.
“Appliance” means a virtual colonoscopy visualization and
analysis software product substantially consistent with the
Specification which (i) is designed to be licensed and function on
a standalone basis, that is, without need for a separate license
for Vitrea 2 Software and (ii) the principal functionality
of which is limited to CT virtual colonoscopy.
2.6.
“Affiliate” means, with respect to a designated Person, any
entity controlled by, in control of, or under common control with
such Person. For the purposes of this definition,
“control” means ownership or control, direct or
indirect, of more than fifty percent (50%) of the voting capital or
equity participation of an entity, or the possession otherwise,
directly or indirectly, of the power to direct the management or
policies of such Person.
2.7.
“Non-Affiliate”
means, with respect to a designated
Person, a Person which is not such Person or an Affiliate
thereof.
2.8.
“Intellectual
Property” means all
patents, patent applications and rights to file patent applications
throughout the world, including any substitutions, extensions,
reissues, renewals, divisions, continuations, or
continuations-in-part, and all copyrighted works, as well as any
Confidential Information, of a designated Person.
2.9.
“Claim”
means any claim, suit, action,
demand or judgment, whether sounding in tort, contract or otherwise
(including, without limitation, claims based on theories of
warranty or strict liability).
2.10.
“Remedial
Action” means any
recall, field corrective action or other regulatory action with
respect to any Option taken either by virtue of applicable federal,
state, foreign or other law or regulation or good business
judgment.
2.11.
“ Confidential
Information ” shall mean all information designated by a
party as confidential and which is disclosed by VTAL to EZEM, is
disclosed by EZEM to VTAL, or is embodied in the Option, regardless
of the form in which it is disclosed, relating to markets,
customers, products, patents, inventions, procedures, methods,
designs, strategies, plans, assets, liabilities, prices, costs,
revenues, profits, organization, employees, agents, resellers or
business in general, or, in the case of VTAL, the algorithms,
programs, user interfaces and organization of the
Option.
2.12.
“Act”
means the United States Food, Drug
and Cosmetic Act, as amended, and the regulations in force
thereunder from time to time.
2.13.
“FDA”
means the Food and Drug
Administration of the U.S. Department of Health and Human
Services.
2.14.
“ Government Approval
” shall mean any approvals, licenses, registrations or
authorizations of any federal, state or local regulatory agency,
department, bureau or other government entity, foreign or domestic,
necessary for use, marketing, sale or distribution of the Option in
a regulatory jurisdiction, including without limitation the
FDA.
2.15.
“ Territory ”
shall mean the entire world.
2.16.
“ Center of Excellence
” shall mean a radiology group or department with significant
clinical expertise in the area of CT colonography with whom both
VTAL and EZEM wish to develop a close cooperative relationship to
promote CT colonography.
2.17.
“Option Sales
Price” means the
gross sales prices of an Option sold by VTAL or any VTAL Affiliate
to a Non-Affiliate of VTAL, and not rejected under an
acceptance/rejection provision, net to the extent otherwise
included in such sales price of any transportation charges,
insurance charges and sales, use, excise or other taxes, duties or
imposts paid or allowed and any other governmental charges imposed
upon the importation, use or sale of the Option; provided that if
the Option is sold bundled with another product, including as an
integral unsegregated part of Vitrea 2 Software, the gross
sales price of the Option shall be comprised of only the part of
the price allocable to the Option as reasonably determined in good
faith by VTAL, which allocation, to the extent possible, shall be
based on the respective list prices of the component parts of such
bundled products on a stand-alone basis. It is understood
that the Option Sales Price does not include charges for hardware,
software other than the Option, services (including installation,
training and maintenance) or other fee or charges. While EZEM
acknowledges that, subject to the foregoing, VTAL has discretion
in
pricing the Vitrea 2 Software
and the Option, in the event VTAL discounts any of its software
products, including the Option, sold together from list price, such
discount shall for purposes of determining the Option Sales Prices
be allocated ratably over such software products based on their
respective list prices.
2.18.
“ Change in Control
” means with respect to a party hereto the occurrence of any
of the following events with respect to such party:
(a)
any
“person” as such term is used in Sections 13(d) and
14(d) of the Exchange Act (other than the Company, any trustee or
other fiduciary holding securities under any employee benefit plan
of the Company, or any corporation owned, directly or indirectly,
by the stockholders of the Company in substantially the same
proportions as their ownership of stock of the Company), is or
becomes, including pursuant to a tender or exchange offer for
shares of Common Stock pursuant to which purchases are made, the
“beneficial owner” (as defined in Rule 13d-3 under the
Exchange Act), directly or indirectly, of securities of such party
representing 50% or more of the combined voting power of such
party’s then outstanding securities; or
(b)
during any
thirty-six consecutive calendar months, the individuals who
constitute the board of directors of such party on the first day of
such period or any new director (other than a director whose
initial assumption of office is in connection with an actual or
threatened election contest, including but not limited to a consent
solicitation, relating to the election of directors of the Company)
whose appointment or election by such board or nomination for
election by such party’s stockholders was approved or
recommended by a vote of at least a majority of the directors then
still in office who either were directors on the final day of such
period, or whose appointment, election or nomination for election
was previously so approved or recommended, shall for any reason
cease to constitute at least a majority thereof; or
(c)
there is
consummated a merger or consolidation of such party or any direct
or indirect subsidiary of such party with any other corporation,
other than a merger or consolidation which would result in the
voting securities of such party outstanding immediately prior to
such merger or consolidation continuing to represent (either by
remaining outstanding or by being converted into voting securities
of the surviving entity or any parent thereof) more than 50% of the
combined voting power of the securities of such party or such
surviving entity or any parent thereof outstanding immediately
after such merger or consolidation, and in which no
“person” (as defined under subparagraph (a) above)
acquires 50% or more of the combined voting power of the securities
of such party or such surviving entity or parent thereof
outstanding immediately after such merger or consolidation;
or
(d)
the stockholders
of such party approve a plan of complete liquidation or dissolution
of such party not within Paragraph 14.2(a) hereof, or there is
consummated an agreement for the sale or disposition by such party
of all or substantially all of such party’s assets, other
than a sale or disposition by such party of all or substantially
all of such party’s assets to an entity, more than 50% of the
combined voting power of the voting securities of which are owned
by stockholders of such party in substantially the same proportions
as their ownership of such party immediately prior to such
sale.
2.19.
“Required
Station” means all
hardware and software which VTAL from time to time designates as
being that upon which a single copy of Vitrea2 software and
the Option, in each case with all updates to date, are to be
installed for use, that is, hardware and software of the same
specification as is then being sold by VTAL to its customers for
use with a single copy of Vitrea2 software and the Option,
in each case with all updates to date, all of which hardware shall
be in good operating condition and repair.
In addition to the foregoing, terms
such as “sale” and “purchase” and variants
and synonyms thereof are used herein for convenience only and refer
to transactions involving the grant of a software license for an
Option.
3.
DEVELOPMENT.
3.1.
Development Program
. VTAL will use commercially
reasonable efforts to continue the development of the Option in
accordance with the Specifications.
3.2.
Government Approvals
. VTAL shall, at its cost and
expense, be solely responsible for obtaining and maintaining, and
shall use commercially reasonable efforts to obtain and maintain
Government Approvals required for the fully authorized sale,
distribution and use of the Option in the USA, Canada and the
countries of the European Union as constituted on the date
hereof.
3.3.
Upgrades . The parties shall meet up to twice
annually, as reasonably requested by either party, to discuss the
evolution of and modifications and/or upgrades to the Option and
the associated engineering and development costs, however, the
evolution of the Option and the modifications and/or upgrades to be
made to it will be determined by VTAL in its discretion. For
purposes hereof modifications and/or upgrades will be deemed to
include patents and other technology, including code, acquired from
third parties and incorporated into or otherwise reflected in the
Option. Set forth on Exhibit 3.3 are VTAL’s anticipated
upgrade plans for 2004 and 2005.
VTAL and EZEM shall share equally in
the cost of all modifications and upgrades to the Option, including
the cost of any royalties or other payments made with respect to
patents and other technology, including code, acquired from third
parties after the date hereof and incorporated into or incurred in
relation to
the modification or upgrading of the
Option; provided that in no event shall
EZEM’s share of costs incurred pursuant to this
Section exceed Two Hundred Thousand Dollars (US$200,000) in
any twelve (12) month period unless it shall consent in writing to
the contrary.
Subject to the foregoing, VTAL shall
be entitled to set off against any royalty payable to EZEM under
Section 8.1 hereof EZEM’s share of the cost of such
modifications and upgrades incurred during the calendar quarter
with respect to which such royalty payment is made, and to the
extent the amount of such royalty is less than such share of the
costs, VTAL shall be entitled to invoice EZEM for all or the
balance of such costs following the end of such calendar quarter,
which invoice will be payable within thirty (30) days. In the
event the amounts payable to VTAL by EZEM in respect of the cost of
any such modifications or upgrades during any twelve (12) month
period exceeds the royalty payments payable to EZEM during such
twelve (12) month period, EZEM shall be entitled to terminate this
Agreement upon written notice given to VTAL within sixty (60) days
of the close of such twelve (12) month period as contemplated by
Section 14.2 (g).
4.
GENERAL
OBLIGATIONS OF EZEM
4.1.
Marketing . EZEM shall have the following
obligations with respect to the marketing of the Option:
(a)
To use its
commercially reasonable efforts to further the promotion and
marketing of the Option in the Territory and to refer all leads
with respect to potential customers for the Option in the Territory
to VTAL, provided that EZEM shall not have any minimum expenditure
requirement in connection therewith;
(b)
To provide VTAL
with reasonable assistance with respect to specific sales as
reasonably requested by VTAL;
(c)
To provide VTAL
with appropriate details of all complaints and bugs found in the
Option, whether such complaints or bugs were discovered by EZEM or
customers of EZEM;
(d)
To attend and
participate, in its sole discretion and where commercially
reasonable, in key radiology and GI tradeshows/meetings, fairs and
exhibitions in the Territory where such participation will promote
the Option, provided that EZEM shall so attend and participate at a
minimum at the annual meetings of the Radiological Society of North
America (RSNA), the European Congress of Radiology (ECR) and the
International Symposium on Virtual Colonscopy. For these
three tradeshows/meetings, the responsibilities of EZEM to
provide hardware and software are as set forth in Section 6.1
hereto. For all other tradeshows/meetings, fairs and
exhibitions, where EZEM determines, in its discretion, that it is
necessary
and appropriate
to provide hardware and software to promote the Option, the
responsibilities of EZEM to provide hardware and software are as
set forth in Section 6.1;
(e)
To provide VTAL
with its target CT injector customer list on a quarterly basis,
which list shall be considered Confidential Information subject to
Section 12.1 hereof and shall be used by VTAL only for the
purpose of selling the Option; and
(f)
To conduct its
business in a professional manner, which will reflect positively
upon VTAL and the Option.
4.2.
EZEM Demonstration
License. EZEM
shall on and prior to June 30, 2004 maintain up to twelve (12)
software licenses for the Option, and thereafter shall maintain
eighteen (18) such licenses, at no cost to EZEM solely for its own
customer demonstration and promotional uses (including, without
limitation, CME courses), subject to the provisions of the
Demonstration License Agreement attached hereto as Exhibit
4.2. VTAL will provide additional software licenses, at no
cost, as reasonably requested by EZEM to support EZEM’s sales
and marketing efforts.
4.3.
Promotional Materials and
Packaging .
(a)
VTAL shall be responsible for the
development of data sheets, brochures and other marketing materials
for the Option, which materials shall be made available by VTAL to
EZEM.
(b)
The packaging, manuals and labeling
for the Option will each prominently state at least once that the
Option “was developed, manufactured and supplied by VTAL and
is co-marketed by VTAL and EZEM.”
(c)
In the event EZEM desires to develop
its own marketing and sales materials relating to the Option it may
do so (including materials concerning both the Option and EZEM
products), subject to review and approval of such materials by
VTAL, such approval not to be unreasonably withheld. All such
material shall in any event prominently display the logo of VTAL at
least once and attribution to it as the developer, manufacturer and
supplier of the Option, and to the extent such materials include
any images or screen shots generated through or simulating the
output of the Option, they shall include any text and VTAL
attribution of the type displayed when using the Option in
production. In the event that EZEM submits marketing and sales
materials relating to the Option to VTAL, VTAL shall review such
materials and respond to EZEM within four (4) weeks following
submission by EZEM. In no event shall EZEM distribute any
promotional materials for or related to the Option that have not
been previously approved in writing by VTAL.
4.4.
Ownership . EZEM hereby acknowledges VTAL retains
all right, title and interest in and to the copyrights and other
intellectual property protecting or embodied in the Option.
EZEM shall not reverse engineer, decompile or disassemble the
Option.
4.5.
Competing Products
. During the term of this
Agreement, EZEM shall not manufacture, clinically test, sell, rent,
market, distribute, promote or solicit the sale of any software
products which permit virtual endoscopy.
4.6.
EZEM Expenses
. EZEM assumes full
responsibility for all its own costs and expenses incurred in
carrying out its obligations under this Agreement, including but
not limited to all rents, salaries, commissions, advertising,
demonstrations, travel and accommodations; provided, however, VTAL
will provide training (including refresher training and training
concerning improvements) to EZEM at no charge for a reasonable
number of EZEM’s sales and technical support staff, at
VTAL’s facilities or at any other mutually-agreeable
location, in the function and application of the Option; provided,
however, EZEM shall pay the salaries and all transportation and
living expenses for its staff.
5.
GENERAL
OBLIGATIONS OF VTAL
5.1.
General Obligations.
VTAL shall have the
following obligations with respect to performing its obligations
hereunder:
(a)
To use its
commercially reasonable efforts to further the promotion and
marketing of the Option in the Territory;
(b)
To be solely
responsible for all aspects of the sale, demonstration, pricing,
manufacture, supply, installation, training with respect to,
technical support, maintenance and service of the Option; except
for the demonstration obligations of EZEM as contemplated
hereby;
(c)
To use its
commercially reasonable efforts to improve the Option, including
those improvements set forth on Schedule 5.1(c);
(d)
To abide by all
applicable laws, rules and regulations in the Territory, including
without limitation those portions of the Act, as amended, which
apply to the manufacture, sale and distribution of medical software
and devices, current FDA Quality System Regulations and the U.S.
Foreign Corrupt Practices Act;
(e)
To provide or
cause to be provided adequate training and instruction to EZEM
personnel in order to allow them to properly promote and market the
Option;
(f)
To provide EZEM
with appropriate details of all material complaints and bugs found
in the Option, whether such complaints or bugs were discovered by
VTAL, customers of VTAL, EZEM or customers of EZEM;
(g)
To provide EZEM
on a quarterly basis with a list of purchasers (including
installation locations) of Vitrea 2 Software sold by it (and
if known, by its licensees), which list shall be considered
Confidential Information subject to Section 12.1 hereof and
shall be used by EZEM only for the purpose of providing its
“VC tool kit” and other virtual colonoscopy products to
such purchasers;
(h)
To provide
technical support for CME sponsored courses;
(i)
To maintain an
adequately trained and staffed technical, engineering and
manufacturing support group in order to fulfill its obligations
hereunder; and
(j)
To conduct its
business in a professional manner, which will reflect positively
upon EZEM and the Option.
5.2.
VTAL Expenses
. VTAL assumes full
responsibility for all its own costs and expenses incurred in
carrying out its obligations under this Agreement.
6.
ADDITIONAL
AGREEMENTS BETWEEN VTAL AND EZEM
6.1.
EZEM is to maintain and provide on
and prior to June 30, 2004 up to twelve (12) Required
Stations, and thereafter shall maintain and provide up to eighteen
(18) Required Stations, having resident thereon Vitrea2
software and the Option provided by VTAL as contemplated by
Section 4.2 hereof, for use at all radiology and GI
tradeshows/meetings, fairs and exhibitions and all continuing
medical education programs desiring to utilize the Option, ,
together with all related applications support and transport
thereof to the site. VTAL shall (i) upgrade all EZEM licenses
for its demonstration systems (including without limitation those
provided pursuant to Section 4.2) and CME systems (including
without limitation those provided pursuant to Section 7) at no
charge to EZEM, and shall continue to upgrade all such EZEM
licenses at no charge to EZEM as and when upgrades are available,
and (ii) shall provide set-up and training to users at such
radiology and GI tradeshows/meetings, fairs and exhibitions and all
continuing medical education programs.
6.2.
VTAL shall have the option of
offering the EZEM “VC tool kit” as a starter pack for
VC procedures. If VTAL exercises such option, EZEM agrees to
sell the “VC tool kit” to VTAL at its standard
wholesale price and on its standard terms and
conditions.
6.3.
EZEM and VTAL agree to meet (i) not
less often than every six (6) months at a location proposed
alternatively by VTAL and EZEM and approved by the other party,
which approval may not be unreasonably withheld, to discuss
development, marketing and other support programs, and selling
issues and (ii) not less often than every two (2) years to review
the strategic plan and any issues relating to the implementation of
this Agreement and the business relationship
contemplated
thereby, which discussions shall in
each case include a discussion of the pricing of the
Option.
7.
CENTERS OF
EXCELLENCE
EZEM shall use commercially
reasonable efforts to enter into arrangements with at least five
institutions from among those identified in Exhibit 7. As well as
such other institutions, if any, as upon which the parties may
agree in writing, to establish and manage Centers of Excellence to
validate and promote the use of virtual colonoscopy and the use of
the Option. VTAL shall cooperate and assist EZEM, at
VTAL’s expense, in the establishment of each Center of
Excellence as EZEM shall reasonably request, and VTAL shall further
supply (without charge subject to the last sentence of this
Section) one Option per Center of Excellence (which may be an
Appliance), together with installation of such Option and
maintenance thereof. Except as specifically set forth above,
EZEM shall bear all cost associated with the establishment and
support of each Center of Excellence, including cost of training
with respect to use of the Option, which EZEM agrees to provide to
each Center. Any revenue derived from the sale of an Option
to a Center for Excellence shall be shared equally by the
parties.
8.
ROYALTIES
8.1.
Royalties . VTAL shall pay to EZEM an amount equal
to twenty-three percent (23%) of the Option Sales Price for each
Option sold in the Territory. Such payment shall be made
within thirty (30) days of the close of the calendar quarter during
which such Option was shipped, as evidenced by an accompanying
report showing quarterly shipments of the Option and the Option
Sales Price with respect thereto (including the manner of
calculation of the Option Sales Price if the Option Sales Price is
not broken out for the customer).
8.2.
Record-keeping; Inspection and
Audit . VTAL agrees
to keep and maintain accurate records throughout the term of this
Agreement of all sales of the Option sufficient to permit
calculation/confirmation of the amounts payable under this
Article 8, but shall only be required to maintain such records
for a period of five (5) years after the end of the calendar
quarter to which such records relate. EZEM shall have the
right, from time to time, upon twenty (20) days written notice to
VTAL and at EZEM’s expense, to have an independent certified
public accountant reasonably acceptable to VTAL, audit the books or
accounts relating to calculation/confirmation of such amounts
payable to the extent necessary to verify the facts necessary to
determine the accuracy thereof. EZEM shall bear the cost of
any such accounting by it, unless the audit shows a discrepancy in
EZEM’s favor of more than 10%, in which case VTAL shall be
responsible for all costs and expenses related to the audit.
EZEM agrees to treat VTAL’s books, accounts, and records as
confidential at all times.
9.
ADVERSE
REACTIONS; PRODUCT RECALLS
9.1.
Compliance
. VTAL shall comply with all
applicable regulatory requirements. VTAL shall comply with
all health registration laws, regulations and orders of any
government entity within the Territory and with all other
governmental requirements relating to the manufacture and sale of
the Option in each country in the Territory. VTAL and EZEM shall
each comply with all health registration laws, regulations and
orders of any government entity within the Territory and with all
other governmental requirements relating to the promotion and
marketing of the Option in each country in the Territory.
EZEM shall submit all advertising claims to VTAL for written
approval prior to their first use by any party, such consent not to
be unreasonably withheld. VTAL shall review such advertising
claims and respond to EZEM within four (4) weeks following
submission by EZEM.
9.2.
Adverse Event
Reporting . Each
party shall advise the other party by telephone or facsimile,
within twenty-four (24) hours after it becomes aware of any adverse
event from the use of any Option. VTAL shall be responsible
for contacting the FDA or any other comparable regulatory agency
elsewhere in the world as required in the event of any adverse
events regarding the Option.
9.3.
Corrective Action
.
(a)
Notice of
Corrective Action . If VTAL believes that
a corrective action with respect to the Option is desirable or
required by law, or if any governmental agency having jurisdiction
(including, without limitation, the FDA) shall request or order any
corrective action with respect to the Option, including any recall,
customer notice, restriction, change, corrective action or market
action or any Option change, VTAL shall promptly notify EZEM.
Any and all corrective actions with respect to the Option shall be
conducted at the expense of VTAL. This Section 9.3 shall
not limit the obligations of either party under law regarding any
corrective action with respect to the Option required by law or
properly mandated by governmental authority.
(b)
Inspections.
VTAL will
notify EZEM within two (2) business days of the completion of any
inspection activity directed at the Option by any regulatory
authority, including without limitation the FDA, and shall promptly
provide EZEM with the results therefrom, including without
limitation any FDA form 483 or warning letters.
10.
INDEMNIFICATION;
INSURANCE
10.1.
Indemnification
.
(a)
VTAL shall
defend, indemnify and hold EZEM , its agents, employees and
independent contractors harmless from and against any and all
claims, damages, loss and expenses including without limitation,
reasonable
attorney’s
fees, which may hereafter be asserted against or suffered by EZEM ,
its agents, employees and independent contractors for injury or
death, damage to property or other third party claims to the extent
such claims arise from the Option, the Vitrea 2 Software,
any VTAL product incorporating the Option or the Vitrea 2
Software, or the fault o