LICENSE AGREEMENT between IBt SA and IsoRay Medical Inc.
between
IBt
SA
and
IsoRay
Medical Inc.
1
Between:
IBt,
a
Société Anonyme incorporated in Belgium, having its registered office at 7180
Seneffe, Xxx Xxxxx Xxxxxx 0, Xxxx Xxxxxxxxxxxx X, Xxxxxxx,
hereby
duly represented by its legal representatives Xxxx Xxxxxx, Chairman, and
hereinafter
referred to as "IBt",
And:
IsoRay
Medical Inc.,
incorporated in Washington, USA, having its registered office at Xxxxxxxx,
XX
00000-0000, 000 Xxxxx Xxxxxx, Xxxxx 000, hereby
duly represented by its legal representatives Xxxxx X. Xxxxxx, hereinafter
referred to as "Iso",
IBt
and
Iso are hereinafter separately referred to as "Party"
and
jointly as "Parties".
WHEREAS,
IBt
has
developed certain technology relating to the production of a polymer based
encapsulation of seeds and is currently fabricating polymer encapsulated
seeds
("OptiSeed") for marketing in the USA;
IBt
has
developed certain technology relating to the formulation of a jetable fluid
(ink) containing the radioactivity to be used in connection with those seeds;
IBt
owns
certain intellectual property rights relating to the above mentioned technology,
including but not limited to patent rights and know-how;
Iso
owns
intellectual property rights relating to the production of a Cs-131
brachytherapy seed, and is currently producing and marketing a Titanium (Ti)
encapsulated Cs-131 brachytherapy seed;
Iso
wishes to obtain the right to produce polymer encapsulated Cs-131 brachytherapy
seeds and to use, sell or otherwise dispose of such products in the U.S.A.
under
the intellectual property rights related to the IBt proprietary
technology;
The
Parties have entered into a Letter of Intent dated 15 December 2005 according
to
which IBt would grant to Iso a license to produce certain products under
the
aforementioned intellectual property rights and the parties desire to document
the terms and conditions of this license.
NOW,
THEREFORE,
in
consideration of the premises and mutual covenants hereinafter
contained
2
IT
HAS BEEN AGREED AS FOLLOWS:
1
|
DEFINITIONS
|
In
this
Agreement (including the Schedules) the following capitalised words and
expressions shall have the following meanings whether used in the singular
or in
the plural:
"Agreement"
means
the present license agreement including the Schedules.
"Confidential
Information"
shall
mean confidential or proprietary information of one of the Parties. Confidential
Information may be in written, graphic, oral, physical or any other possible
form and may include scientific knowledge, know-how, processes, inventions,
techniques, formulae, products, business operations, customer requirements,
designs, sketches, photographs, drawings, specifications, reports, studies,
findings, data, plans or other records, biological materials, and/or software,
and, in the case of IBt, includes, among others, the information listed in
Schedule
3,
and, in
the case of Iso, includes, among others, the information listed in Schedule
4.
"Intellectual
Property Rights"
shall
mean collectively the Know-How, the Licensed Patents, the industrial models,
designs or copyrights which are vested in IBt or which IBt is entitled to
use or
which IBt may acquire or acquire the right to use.
"Know-How"
shall
mean technical and commercial information, relating to or useful in connection
with the Licensed Patents, and the manufacture, use and sale of polymer seeds
on
the basis of said Licensed Patents, as further specified in Schedule
1.
"Licensed
Patents"
shall
mean the patents and patent applications specified in Schedule
2.
"Net
Sales"
with
respect to a Product shall mean the gross amount billed or invoiced on sales
of
such Product by Iso less returns. The sale or transfer by Iso to a sub-licensee
or distributor shall not be considered as a sale for the purpose of this
definition, but the resale by such sub-licensee or distributor to third parties
shall be the Net Sale.
"OptiSeed"
shall
mean the polymer based seed fabricated by IBt on the basis of the Licensed
Patents.
"Person"
shall
mean any person, firm, corporate or unincorporated association, body or entity,
excluding IBt or Iso.
"Personnel"
shall
mean and includes any individual or company a Party employs as a partner,
employee or independent contractor.
"Products"
shall
mean a brachytherapy devices containing the isotope Cs-131 to be used for
the
therapy of any malignant tumor type for which Iso has received clearance
to
market in the Territory and (i) embodying at least one claim of one or more
of
the Licensed Patents and/or (ii) manufactured or used using the
Know-How.
"Schedule"
shall
mean an appendix to the present license agreement.
"Territory"
shall
mean the United States of America.
3
2
|
GRANT
OF LICENSE
|
2.1
|
IBt
hereby grants to Iso an exclusive license under the Intellectual
Property
Rights in order to manufacture, have manufactured, promote, use
and sell
the Products in the Territory subject as hereinafter
provided.
|
2.2
|
Iso
intends to develop, produce and commercialize a Cs-131 containing
polymer
encapsulated seed and stranding to be used in conjunction with
said Cs-131
polymer encapsulated seed under this license. Should Iso decide
to
develop, produce and / or commercialize any other device falling
within
the definition of the “Products”, example; Cs-131 containing microspheres
or Cs-131 containing brachytherapy sources in a form other than
seeds
(collectively, “Other Devices”), Iso agrees to inform IBt of its intention
and further agrees not to proceed with such development without
the
written consent of IBt, such consent not to be unreasonably withheld
and
all development, production and commercialization of Other Devices
shall
be pursuant to the terms and conditions of this Agreement. Subsequently
in
this agreement, any reference to Products shall be understood to
include
Other Devices as Products.
|
2.3
|
The
rights and licenses granted by IBt to Iso under Article 2.1
may not be transferred or sublicensed by Iso without the prior
written
consent of IBt.
|
2.4
|
No
license is granted by IBt for any other isotope than Cs-131 and
for any
other territory.
|
2.5
|
The
license provided under this Article 2 shall only take effect in the
event the feasibility phase referred in Article 3.1 is terminated
with a positive confirmation, as provided in
Article 3.1.1.
|
3
|
FEASIBILITY
PHASE AND CONFIRMATION
|
3.1
|
Because
the most technologically challenging task in the development of
the
Products is, according to the Parties, the formulation of an ink
containing the required Cs-131 activity, the Parties agree to perform
the
Agreement in two steps as
follows :
|
3.1.1
|
Feasibility
phase
|
As soon as possible after the signing of the Agreement, technical teams of IBt and Iso shall meet at the offices of Iso to discuss requirements, constraints and potential candidate materials for the formulation of an acceptable Cs-131 ink. These meetings will be held for a maximum of three days and will be attended by two representatives of IBt, including Xxxx Xxxxxx. | |
Immediately after these meetings, Iso representatives will further study the feasibility of the project contemplated in this Agreement and will confirm in writing to IBt by 28 February 2006 at the latest, whether they believe in good faith that the project is feasible in their views and whether they want to go further into the implementation of the Agreement. | |
3.1.2
|
Final
development
|
Upon a positive written confirmation of Iso pursuant to Article 3.1.1, the Parties will further perform the Agreement and will collaborate in good faith to assess how to proceed with the development of the final ink, based on the outcome of the feasibility phase. This final development phase will be performed by Iso with assistance by IBt, should IBt agree to provide such assistance. [ **] | |
3.1.3
|
Absence
of a positive confirmation
|
Should Iso reach in good faith the conclusion that the project is not feasible and send a negative notification to IBt by the date provided in Article 3.1.1, IBt will pay back to Iso 25,000 USD out of the 50,000 USD already paid by Iso according to Article 5.7 and this Agreement shall automatically terminate, with the consequences provided in Article 15. Should Iso fail to provide notification, either positive or negative, by the date provided in Article 3.1.1, the Parties agree that this shall be construed as a positive notification and the program shall proceed as specified in this document. |
[**]Certain
information in this document has been omitted and filed separately with
the
Securities and Exchange Commission. Confidential
treatment
has been
requested with respect to the omitted portions
4
4
|
PROVISION
OF KNOW-HOW AND TECHNICAL
ASSISTANCE
|
4.1
|
IBt
shall disclose to Iso the Know-How as shall be necessary to enable
Iso to
perform the feasibility phase defined in Article 3 and then to enable
Iso to manufacture, use and sell the Products, as provided
below:
|
4.1.1
|
Facility
design, preparation and commissioning:
|
IBt will provide specifications for the equipment to be used by Iso and recommend suppliers for such equipment. Iso will place orders [**] for such equipment, shipping, any taxes or duty and any other costs associated with obtaining, installing or commissioning the required equipment. | |
IBt will provide access to [**]. The object of this technical assistance is to provide to Iso the skills required to install and commission its in-house Cs-131 polymer seed fabrication area. | |
The duration of this assistance period will be [**] and will be ended when IBt will have reached the objective and reasonable conclusion that all the necessary information has been provided to Iso, with a two (2) week notice to Iso. If required and when needed, IBt will, on a best effort basis, assist Iso in this process at the facilities of Iso [**]. | |
4.1.2
|
Manufacturing
procedures
|
IBt will provide Iso access to its relevant OptiSeed manufacturing procedures on an "as is" basis and without implied guarantee concerning their suitability for the manufacture of a Cs-131 polymeric seed. It will be the sole responsibility of Iso to decide what procedures are appropriate to use for its manufacturing process and how, if at all, they should be applied. | |
4.1.3
|
Regulatory
|
IBt will provide Iso [ **] and, within the limits specified in agreements between IBt and third parties, [**]. |
4.2
|
The
Know-How and the information provided by IBt or developed in cooperation
with IBt pursuant to the Agreement shall be used by Iso solely
for the
purpose of the development, manufacture, use and sale of the Products
in
the Territory during the term of this Agreement.
|
4.3
|
Where
Iso's Personnel attend at the premises of IBt, Iso shall
[**].
|
[**]Certain
information in this document has been omitted and filed separately with
the
Securities and Exchange Commission. Confidential
treatment
has been
requested with respect to the omitted portions.
5
5
|
FEES
AND ROYALTIES
|
In
consideration for the rights granted to Iso pursuant to this Agreement, Iso
shall pay to IBt license fees (the "License Fee") and royalties as determined
below:
5.1
|
License
Fee:
|
The
License Fee amounts to $500,000, including the upfront payment
of $50,000
referred to in Article 5.7, the remaining of which Iso shall pay
to IBt as
follows: $225,000 no later than March 5, 2006 and (ii) $225,000
no later
than August 15, 2006.
|
|
Except
for 50 % of the upfront payment referred to in Article 5.7, the
License Fee shall not be refundable for whatever reason and shall
in all
cases be and remain the sole property of IBt.
|
|
5.2
|
Royalties
on sales:
|
Iso
shall pay to IBt royalties equal to the larger of the Royalty on
Net Sales
as calculated in 5.3 below or the Minimum Royalties as mentioned
in the
following table:
|
Year
|
Minimum
Royalties
|
Minimum
Royalties
|
|||||
(Annual)
|
(Quarterly)
|
||||||
2006
|
Initial
license fee
|
||||||
2007
|
$
|
400,000
|
$
|
100,000
|
|||
2008
through 2009
|
$
|
600,000
|
$
|
150,000
|
|||
2010
through end
|
$
|
800,000
|
$
|
200,000
|
5.3
|
Royalty
payment as a function of Net Sales
revenue:
|
Year | ||||
Net Sales | Royalty Rate | |||
[**] | [**] |
5.4
|
The
License Fee and the royalty payments shall be paid to IBt in USD
in
Belgium on account number [**], at ING bank with IBAN number [**]
with
mention “License Fee & royalty” or at such other place as IBt may
reasonably designate consistent with the laws and regulations controlling
in any foreign country.
|
5.5
|
Royalty
payments shall be made by Iso on a quarterly basis with payment
received
by IBt no later than the 45 days following the end of the quarter
and with
submission of the reports required by Article 6. All amounts due
under
this Agreement shall, if overdue, automatically bear interest until
payment at a per annum rate of eight percent (8%) above the prime
rate in
effect at the European Central Bank published on the due date.
The payment
of such interest shall not foreclose IBt from exercising any other
rights
it may have resulting from any late payment.
|
5.6
|
Any
failure or any delay by Iso of more than 60 days to fully pay the
License
Fee or the annual royalties owed to IBt as specified in this
Article 5 shall entitle IBt to terminate the Agreement in accordance
with Article 14.1 below. In this case, IBt shall have a first right
of
refusal to purchase from Iso all of the equipment used in the production
of the Products at book value and shall have access to the relevant
records and books of Iso to check that book value, as provided
in
Article 6. In the event IBt exercises this right of first refusal,
IBt shall have no right to produce the Products or use the equipment
for
production of the Products.
|
5.7
|
Upfront
payment
|
5.7.1
|
Upon
signing of the Letter of Intent referred to in the preamble, Iso
has paid
to IBt an upfront payment on the License Fee defined in Article 5.1
of $50,000.
|
5.7.2
|
If
a negative conclusion is reached in good faith by Iso at the end
of the
feasibility phase in accordance with Article 3.1.3 with the
consequence that Iso believe that an acceptable ink solution cannot
be
developed for Cs-131 seeds, $25,000 out of this upfront payment
shall be
reimbursed by IBt to Iso upon receipt of the notification mentioned
in
Article 3.1.3.
|
[**]Certain
information in this document has been omitted and filed separately with
the
Securities and Exchange Commission. Confidential
treatment
has been
requested with respect to the omitted portions.
6
6
|
REPORTS
AND RECORDS
|
6.1
|
Iso
shall keep records containing all particulars necessary to show
the
amounts payable to IBt under the Agreement. The books of account
shall be
kept at Iso's principal place of business. The books and supporting
data
shall be open at all reasonable times for three (3) years following
the
end of the calendar year to which they pertain, for inspection
by IBt or
its agents to the extent necessary to verify Iso's royalty statement
or
compliance in other respects with this Agreement, provided, however,
that
such inspection shall take place no more frequently than once every
six
(6) months. Iso agrees to permit such books and records to be examined
at
ordinary business hours with reasonable prior notice to Iso. Such
examination is to be made under appropriate confidentiality restrictions,
at the expense of IBt, except that if such inspection leads to
the
discovery of discrepancy in reporting which is greater than five
percent
(5%) to IBt's detriment, Iso agrees to pay the full cost of such
inspection.
|
6.2
|
Iso
shall provide to IBt a written annual report on or before 31 January
of
each calendar year. The annual report shall summarize progress
on research
and development, regulatory approvals, manufacturing, sublicensing
if
authorised, marketing and sales during the preceding twelve (12)
months,
and plans for the coming year.
|
6.3
|
After
the first commercial sale of a Product, Iso shall provide quarterly
reports to IBt. The quarterly reports shall be delivered within
forty five
(45) days after March 31, June 30, September 30, and December 31
of each
year. The quarterly reports shall give particulars of the business
conducted by Iso during the preceding quarter that are pertinent
to a
royalty accounting, including:
|
|
[**]
|
7
|
PROPRIETARY
RIGHTS ON DEVELOPMENTS
|
7.1
|
The
Intellectual Property Rights and all new intellectual property
rights or
know how developed by either Party during the performance of the
Agreement
in connection with the formulation, preparation and rationale for
the
composition and the processing selection of the ink shall remain
the
exclusive property of IBt. However, these rights will be automatically
licensed to Iso pursuant to this Agreement for its use in the fabrication
of Cs-131 seeds exclusively and their sale in the Territory and
for the
duration of this Agreement.
|
7.2
|
Any
intellectual property right or know how developed in relation to
the
production, separation and purification of Cs-131 for use in a
brachytherapy device shall remain the exclusive property of Iso
and shall
not be used by IBt without the express prior consent of
Iso.
|
[**]Certain
information in this document has been omitted and filed separately with
the
Securities and Exchange Commission. Confidential
treatment
has been
requested with respect to the omitted portions.
7
8
|
INFRINGEMENT
|
8.1
|
Iso
shall forthwith give notice in writing to IBt of any infringement
or
suspected or threatened infringement in the Territory of the Intellectual
Property Rights that shall at any time during the term of this
Agreement
come to its knowledge.
|
8.2
|
IBt
and Iso shall thereupon discuss what steps should be taken to prevent
or
terminate such infringement, including the institution of legal
proceedings where necessary.
|
8.3
|
If
it is decided to take any such steps, Iso and IBt shall provide
or procure
to the other Party such assistance (including the furnishing of
documents
and information and the execution of all necessary documents) as
the other
Party may reasonably request.
|
9
|
MAINTENANCE
OF THE INTELLECTUAL PROPERTY RIGHTS
|
IBt
shall pay all costs and fees and do all such acts and things as
may be
reasonably necessary to obtain the registration of and shall during
the
period of this Agreement pay all renewal fees and do all such acts
and
things as may be necessary to maintain the Intellectual Property
Rights.
|
8
10
|
CONFIDENTIALITY
|
10.1
|
Each
Party shall use the Confidential Information disclosed by the other
Party
("Disclosing
Party")
only for the execution of the Agreement and shall not otherwise
use or
exploit the Disclosing Party's Confidential Information for its
own
benefit or the benefit of another party without the prior written
consent
of the Disclosing Party. The Party receiving Confidential Information
("Receiving
Party")
shall not file or (try to) obtain any intellectual property rights
on
results or ideas arising from the evaluation of Confidential
Information.
|
10.2
|
The
Receiving Party undertakes to the Disclosing Party that for the
period of
this Agreement and thereafter it shall keep and it shall procure
that its
Personnel keeps secret and confidential the Confidential Information
communicated to it by the Disclosing Party and shall not disclose
the same
or any part thereof to any person whatsoever other than to its
Personnel
directly concerned with the execution of the Agreement provided
that
before any such disclosure the Receiving Party shall procure that
its
Personnel concerned shall execute a confidentiality undertaking
in a form
approved by the Disclosing Party.
|
10.3
|
The
Receiving Party will only make copies of the Confidential Information
if
strictly required for the execution of the Agreement.
|
10.4
|
All
obligations created by this Article 10 shall remain in full force
and
effect during twenty (20) years after the date of disclosure of
the
Confidential Information. Notwithstanding this Agreement, the Receiving
Party may use or disclose Confidential Information of the Disclosing
Party
to the extent it is clearly able to demonstrate, by clear and convincing
evidence, that such Confidential
Information:
|
(a)
|
was
in the public domain or the subject of public knowledge at the
time of
disclosure, or becomes part of the public domain or the subject
of public
knowledge through no fault, negligence or breach of contract of
the
Receiving Party or any party to whom the Receiving Party has disclosed
the
Confidential Information;
|
(b)
|
was
lawfully in its possession or in the possession of its affiliates
and
known to it prior to disclosure as evidenced by documents antedating
the
date of disclosure;
|
(c)
|
becomes
available to the Receiving Party or its affiliates from a third
party not
in breach of a legal obligation of confidentiality in respect
hereof;
|
(d)
|
was
subsequently and independently developed as shown by written records
by
its Personnel who had no knowledge of such information,
or
|
(e)
|
was
required to be disclosed by law, court or governmental order, provided
that the Receiving Party in such case shall immediately notify
the
Disclosing Party in writing of such obligation and shall provide
adequate
opportunity to the Disclosing Party to object to such disclosure
or
request confidential treatment thereof.
|
Exceptions (a) through (e) shall not permit the Receiving Party to disregard the obligations of confidentiality herein merely because individual portion(s) of the Confidential Information may be found within such exceptions, or because the Confidential Information is implicitly but not explicitly disclosed in Confidential information falling within such exceptions. |
10.5
|
During
the period of this Agreement and at any time thereafter the Receiving
Party agrees that it will, upon the request of the Disclosing Party
but at
its own expense, take such steps as the Disclosing Party may require
to
enforce any such confidentiality undertaking given by Personnel
of the
Receiving Party, including in particular but without prejudice
to the
generality of the foregoing obligation, the initiation and prosecution
of
any legal proceedings and the enforcement of any judgement obtained.
All
such steps as aforesaid to be taken by the Receiving Party shall
be taken
as expeditiously as possible and the Receiving Party agrees that
in
respect of its obligation to enforce such confidentiality undertakings
as
aforesaid time shall be of the essence in complying with the requirements
of the Disclosing Party.
|
10.6
|
All
Confidential Information disclosed pursuant to this Agreement shall
be and
remain the Disclosing Party's property. Upon termination for any
reason or
expiry of the Agreement, all the Confidential Information and all
copies
thereof shall be immediately returned to the Disclosing Party upon
its
request, or destroyed at its
option.
|
9
11
|
LIABILITIES
AND WARRANTIES
|
11.1
|
Except
as otherwise provided in this Agreement, each Party shall at all
times
during the term of this Agreement and thereafter, indemnify, defend
and
hold the other Party or, as the case may be, any other prejudiced
party,
harmless against all claims, liabilities, damages, expenses or
costs
(including attorneys’ and experts’ fees) of any kind whatsoever, arising
out of a breach by this Party of its obligations under this Agreement.
In
addition, Iso shall be liable for any negligence, act or omission
of its
Personnel and any other third party having obtained information
regarding
the Agreement from Iso which would result in the infringement of
the
Intellectual Property Rights or the other rights of IBt.
In
addition, IBt shall be liable for any negligence, act or omission
of its
Personnel and any other third party having obtained information
regarding
the Agreement from IBt which would result in the infringement of
the
intellectual property rights or the other rights of Iso.
|
11.2
|
Except
as otherwise provided in this Agreement, IBt, its Personnel and
affiliates
make no warranties of any kind, including but not limited to warranties
of
merchantability, fitness for a particular purpose, feasibility
of the
project contemplated under this Agreement, validity of Licensed
Patents.
Nothing in this Agreement shall be construed as a warranty that
the
practice by Iso of the Licensed Patents shall not infringe the
intellectual property rights of any third party. IBt, its Personnel
and
affiliates shall not be liable for indirect damages except if due
to their
will-full misconduct. IBt's liability under the Agreement shall
in any
event be limited to the amounts paid by Iso to IBt under the
Agreement.
|
12
|
FORCE
MAJEURE
|
12.1
|
It
is agreed that neither IBt nor Iso shall be liable under this Agreement
for delay or failure to carry out its provisions to the extent
that such
failure is caused by sabotage, fire, flood, acts of God, civil
commotions,
strikes, slow-downs or industrial action of any kind, riots,
insurrections, wars, acts of any governmental authority, priorities
granted at the request or for the benefit directly or indirectly
of any
government agency or any cause (whether similar to the foregoing
or not)
beyond their respective control. IBt or Iso (as the case may be)
shall
promptly inform the other of the existence of such conditions of
force
majeure and they shall consult together to find a mutually acceptable
solution.
|
13
|
TERM
|
13.1
|
The
license and the other rights granted under this Agreement are,
unless
terminated by the provisions of Article 14 hereof, granted for
fifteen
(15) years from the date of signing. At the end of this fifteen
(15) year
term, the Agreement may be extended for further five (5) year periods
upon
mutual written agreement of the
Parties.
|
14
|
EARLY
TERMINATION
|
Without
prejudice to any other rights that it may have under the terms
of this
Agreement or pursuant to the law, IBt may, at its option, immediately
terminate this Agreement and the license therein granted forthwith
by
notice in writing to such effect and without intervention of a
court ("de
plein droit"):
|
14.1
|
if
Iso fails to pay the License Fee or the annual royalties owed to
IBt as
required in Article 5;
|
14.2
|
if
Iso is in material or persistent breach of any of the terms and
conditions
of this Agreement and, if such breach is capable of remedy, fails
to
remedy the same within thirty (30) days after receiving written
notice
from IBt specifying the default and requiring it to be remedied;
or
|
14.3
|
if
Iso is placed into voluntary or compulsory liquidation or compounds
with
its creditors or has a receiver appointed of all or any part of
its assets
or takes or suffers any similar action in consequence of
debt.
|
10
15
|
CONSEQUENCES
OF TERMINATION
|
15.1
|
In
the event of termination of this Agreement howsoever arising, Iso
shall,
at its own costs, return promptly to IBt all technical material
including
but not limited to production records in its possession relative
to the
development or the manufacturing of the Products, the Intellectual
Property Rights, the Know-How, Confidential Information owned by
IBt, and
any other proprietary rights of IBt developed in the meantime,
and all
copies thereof. Also in the event of termination of this Agreement
howsoever arising, IBt shall, at its own costs, return promptly
to Iso all
technical material including but not limited to production records
in its
possession relative to the development or the manufacturing of
the
Products, Iso's intellectual property rights, Iso's know-how, Confidential
Information owned by Iso, and any other proprietary rights of Iso
developed in the meantime, and all copies thereof. For the avoidance
of
doubt, the Parties stress and agree that this will include any
documentation, production records or any other materials that might
allow
a third party to replicate a polymer seed production process.
|
15.2
|
In
the event of termination or expiry of this Agreement howsoever
arising,
all rights and licences granted to Iso hereunder shall cease automatically
to be of any force and effect.
|
15.3
|
Without
prejudice to Article 5.5, in the event of termination or expiry of
this Agreement howsoever arising, Iso may complete the sale of
the
Products, provided that Iso shall liquidate such stocks with due
diligence
and under the supervision of IBt and
provided, however, all sums due to IBt have first been
paid.
|
15.4
|
Termination
shall be without prejudice to (a) IBt's rights and obligations
pursuant to
Article 5
(Royalties and Fees) to the extent that the obligation to pay the
License
Fee or any royalties has arisen but said royalties and/or License
Fee have
not yet been paid, and (b) IBt' rights and Iso's obligations pursuant
to
Article 7 (Proprietary Rights on Development), Article 9
(Maintenance of Intellectual Property Rights), Article 10
(Confidentiality) and (c) IBt' and Iso's rights and obligations
pursuant
to Article 6 and 11 (Reports and Liabilities and
warranties).
|
15.5
|
Termination
shall be without prejudice to any cause of action or claim of IBt
accrued
or to accrue because of any breach or default by Iso. Termination
shall be
without prejudice to any cause of action or claim of Iso accrued
or to
accrue because of any breach or default by
IBt.
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16
|
NON
HIRING AND NON COMPETITION
|
16.1
|
Except
as the other Party
expressly authorizes in writing in advance, neither Party shall
solicit,
offer work to, employ, or contract with, whether as a partner,
employee or
independent contractor, directly or indirectly, any of the other
Party’s
Personnel during the Agreement or
during the twelve (12) months thereafter. In the event of a breach,
the
breaching Party shall pay compensation to the non-breaching Party
in the
form of liquidated damages equal to the greater of one (1) year’s
compensation either (a) offered to the Personnel by the breaching
Party or
(b) paid or offered to the Personnel by the non-breaching Party.
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16.2
|
Nothing
in the Agreement shall
restrict Iso's ability to exploit its own intellectual property
rights,
and thus to produce, sell and provide products and services which
in no
way incorporate or are produced, sold or provided using the Intellectual
Property Rights or the Know How. In the event of a dispute, Iso
shall bear
the burden of proving that any products which it may produce or
sell or
any services it may provide were produced, sold and provided without
in
any way using the Intellectual Property Rights or the Know How.
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11
17
|
GENERAL
PROVISIONS
|
17.1
|
The
failure of either Party at any time to require performance by the
other
Party of any provisions of this Agreement shall in no way affect
the right
of such Party to require performance of any provisions. Any waiver
by any
Party of any breach of any provisions of this Agreement shall not
be
construed as a waiver of any continuing or succeeding breach of
such
provisions or any other provisions of this Agreement. The rights
and
remedies provided in this Agreement are cumulative and not exclusive
of
any rights and remedies provided by law.
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17.2
|
Any
provisions of this Agreement which are prohibited or unenforceable
in any
jurisdiction shall as to such jurisdiction be ineffective to the
extent of
such prohibition or unenforceability, without invalidating the
remaining
provisions hereof and any such prohibition or unenforceability
in any
jurisdiction shall not invalidate or render unenforceable such
provisions
in any other jurisdiction and in the event of any provisions being
severed, there shall be deemed substituted a like provision to
accomplish
the intent of the Parties to the extent permitted by the applicable
law save
that if Article 10 (Confidentiality) above shall be deemed to be
prohibited or unenforceable in whole or in part, then notwithstanding
anything to the contrary herein, this Agreement shall forthwith
cease and
terminate.
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17.3
|
Any
governmental impost payable in the Territory in connection with
the
registration or approval of this Agreement shall be for the account
of
Iso.
|
17.4
|
Any
notice or communication to be given or made hereunder shall be
deemed to
be properly given or made:
|
17.4.1
|
Three
(3) working days after being sent to the intended recipient by
pre-paid
recorded delivery post (special courier), addressed to its registered
office marked for the attention of a principal officer;
|
or
|
|
17.4.2
|
Twenty-four
(24) hours after the time of dispatch of a facsimile or e-mail
message.
|
17.5
|
The
rights and licenses granted by IBt in this Agreement may not be
assigned
by Iso to another party (other than a wholly owned subsidiary to
which Iso
may assign this License Agreement at any time); without the prior
written
consent of IBt.
|
17.6
|
This
Agreement contains the entire agreement of the Parties hereto with
regard
to the object to which it refers and contains everything the Parties
have
negotiated and agreed upon within the framework of this
Agreement.
|
17.7
|
No
amendment or modification of this Agreement shall take effect unless
it is
in writing and is executed by duly authorized representatives of
both
Parties.
|
17.8
|
This
Agreement may be executed in one or more counterparts, each of
which when
so executed shall be deemed to be an original, and all of which
together
shall constitute one and the same instrument.
|
17.9
|
In
respect to the public nature of both Parties, the Parties agree
to not
disclose the existence or the content of this Agreement to the
public
without mutual consultation, coordination and
consent.
|
18
|
GOVERNING
LAW AND JURISDICTION
|
This
Agreement shall be governed by and construed and interpreted in
accordance
with the laws of the Grand Duchy of Luxemburg. Any litigation relating
to
the conclusion, validity, interpretation or performance of this
Agreement,
or of subsequent contracts or operations derived herefrom, as well
as any
other litigation concerning or related to the this Agreement, without
any
exception, shall be submitted to the exclusive jurisdiction of
the
Luxemburg Courts.
|
AS
WITNESS
the
hands of the duly authorized representatives of the Parties hereto the day
and
year first above written.
Signed
in
Atlanta, Georgia, USA on February 2, 2006, in two original copies, each Party
acknowledging having received one of these copies,
IBt | |||
By |
/s/
Xxxx Xxxxxx
|
||
Name |
Xxxx
Xxxxxx
|
||
Capacity
|
Chairman
|
||
|
|||
Iso | |||
By |
/s/
Xxxxx X. Xxxxxx
|
By | |
Name |
Xxxxx
X. Xxxxxx
|
Name | |
Capacity
|
CEO/Chairman
|
Capacity
|
12
SCHEDULE
1: KNOW-HOW
a)
|
Certain
know-how of IBt relating to the fabrication of OptiSeed and the
formulation preparation and rationale of a jetable fluid
(ink);
|
b)
|
identity,
design and purpose for all equipment used in the preparation of
jetable
fluid (ink) and the identity, purpose and rationale for the choice
of all
equipment used in the dispensing of inks.
|
c)
|
Proprietary
designs and techniques related to the manufacturing and processing
of
plastic seeds for the therapy of any malignant tumor type for which
Iso
has received clearance to market in the Territory.
|
SCHEDULE
2: LICENSED PATENTS
United
States Patent
|
6,589,502
|
Xxxxxxxxxx
, et al.
|
July
8, 2003
|
Radioisotope
dispersed in a matrix for brachytherapy
Abstract
Therapeutic
sources for use in the practice of brachytherapy are fabricated from radioactive
composites of a radioactive powder of palladium-103, yttrium-90, phosphorus-32
or gold-198 and a biocompatible polymeric matrix. The particles of radioactive
powder are dispersed within the polymer essentially randomly throughout a
particular volume. The polymeric matrix is desirably manufactured with
pre-selected flexibility suitable to its intended use, e.g. in the form of
a
rod, hollow rod, suture, film, sheet, or microspheroidal particles. The
radioactive composites produce therapeutic sources which generate a radiation
field that is substantially uniform in all directions. The therapeutic source
may assembled from the radioactive composite during a medical procedure to
emit
the desired amount of therapeutic radiation. Optionally, the polymer is selected
to dissolve or degrade in the body at a predetermined rate, the rate chosen
depending upon the half life of the radioisotope used in the therapeutic
source.
United
States Patent
|
6,461,433
|
Xxxxxx,
Jr. , et al.
|
October
8, 2002
|
Fluid-jet
deposition of radioactive material
Abstract
d)
|
A
method and apparatus for precisely applying radioactive material
to a
substrate such as a brachytherapy device is disclosed. A radioactive
fluid
adapted to cure rapidly is deposited as discrete dots onto a surface
with
a fluid-jet printhead. The apparatus comprises a fluid-jet printhead
in
communication with a chamber containing radioactive fluid to be
applied by
the printhead. The printhead is microprocessor driven, and the
microprocessor may be provided with feedback from a station where
the
radioactivity deposited on a preceding substrate in a batch is
measured,
permitting the system to be recalibrated on an ongoing basis as
the batch
of printed devices is produced. Compensation for attenuation of
radiation
by a casing may also be made part of the feedback technique. Also
disclosed is a brachytherapy device having printed on a surface
dots of
radiation-emitting material, in a pattern comprising various bands,
dots
or areas. Fluids suitable for printing by a fluid-jet printhead
comprise a
binder such as an acrylic resin or silicate, and a radioactive
salt,
compound or complex, dissolved in a radiation resistant solvent.
Alternative fluids comprise radioactive salts, compounds, or complexes
adsorbed onto a microparticulate carrier, or elemental microparticles,
dispersed in a rapidly curable radiation-resistant fluid
medium.
|
SCHEDULE
3 CONFIDENTIAL INFORMATION OWNED BY IBT
Confidential
Information of IBt includes without being limited thereto, any and all
information relating to OptiSeed, IBt’s activities and Know-How disclosed by or
on behalf of IBt. It is stressed that confidential information of IBt includes,
in relation to the ink, materials used in its current ink formulations, all
considerations relating to the choice of these materials, identity, design
and
purpose for all equipment used in the preparation of inks and the identity,
purpose and rationale for the choice of all equipment used in the dispensing
of
inks to fabricate seeds. IBt is entering into this agreement with the
understanding that Iso will take all steps necessary to safeguard this
information.
SCHEDULE
4 CONFIDENTIAL INFORMATION OWNED BY ISO
Confidential
Information of Iso includes, but is not limited to, any and all information
related to Cs-131 production, Cs-131 incorporation into brachytherapy products,
trade secrets and know-how disclosed by or on behalf of Iso. Confidential
information of Iso includes methods of Cs-131 separation and purification,
means
to produce carrier-free, or substantially carrier-free Cs-131 products, methods
of preparing barium precursors to Cs-131 production, as well as the identity,
design, and purpose of materials and equipment used in the producing ultra-pure
Cs-131 for medical and other uses. Confidential information of Iso also includes
certain method of attaching Cs-131 to components of brachytherapy products,
means of producing finished products for delivering radiation from Cs-131
directly to malignant tissue, and methods for optimizing the distribution
of
radiation emitted from a Cs-131 brachytherapy device. Iso is entering into
this
agreement with the understanding that IBt will take all steps necessary to
safeguard this information as if it were their own.
13