DISTRIBUTION AGREEMENT
THIS
DISTRIBUTION AGREEMENT (this "Agreement"), dated as of
November 15, 2009, is entered into by and between Oncura, Inc., a corporation
organized and existing under the laws of Delaware, having offices located at
0000 Xxxxx Xxxx, Xxxxxxxxx Xxxxxxx, XX 00000 ("Oncura") and IsoRay Medical, Inc., a
corporation organized under the laws of the State of Delaware, having offices
located at 000 Xxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxxxxxxx 00000 ("IsoRay").
PRELIMINARY
STATEMENTS
IsoRay
desires to: (i) obtain the non exclusive right to distribute the I-125 Products
in the Territory and (ii) use the Oncura Trademarks for the I-125 Products in
the Territory in connection with the foregoing, and Oncura desires to grant such
rights to IsoRay, on the terms and conditions set forth in this
Agreement.
NOW,
THEREFORE, in consideration of the foregoing preliminary statements and the
mutual agreements and covenants set forth herein, the Parties hereby agree as
follows:
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DEFINITIONS.
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As used
in this Agreement, the following terms shall have the meanings set forth in this
Section 1 unless context dictates otherwise:
1.1 "Accelerated Arbitration
Provisions" shall have the meaning assigned to such term in Section
12.13(b).
1.2 "Affiliate" of any Person
means any other Person directly or indirectly controlling, controlled by or
under common control with such Person; provided that for purposes of this
Agreement, neither IsoRay nor any of its Subsidiaries shall be deemed an
Affiliate of Oncura and neither Oncura nor any of its Subsidiaries shall be
deemed an Affiliate of IsoRay. For the purposes of this definition, "control" when used with
respect to any Person, means the possession, directly or indirectly, of the
power to direct or cause the direction of the management and policies of such
Person, whether through the ownership of voting securities, by contract or
otherwise; and the terms "controlling" and "controlled" have meanings
correlative to the foregoing.
1.3 "Breaching Party" shall have
the meaning assigned to such term in Section 10.2.
1.4 "cGMP" shall mean current
Good Manufacturing Practice as defined in Part 820 of Title 21 of the U.S. Code
of Federal Regulations, as may be amended from time to time, or any successor
thereto.
1.5 "Confidential Information"
shall have the meaning assigned to such term in Section 7.1.
1.6 "Effective Date" shall mean the date set
forth in the introductory paragraph of the Agreement.
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1.7 "FDA" shall mean the United
States Food and Drug Administration, or any successor thereto.
1.8 "Field" shall mean all
medical device applications for human health.
1.9 "Finished Product" shall mean
any formulation or dosage of an I-125 Product in finished form, including,
without limitation, any product labeling or other package inserts or materials
required by the applicable Regulatory Authority(ies) and, when used in the
plural, shall mean all formulations and dosages of an I-125 Product in finished
form, including, without limitation, all product labeling and other package
inserts and materials required by the applicable Regulatory
Authority(ies).
1.10
"GAAP" shall mean
generally accepted accounting principles in the United States, consistently
applied by the Party at issue.
1.11
"I-125 Products" shall
mean the brachytherapy products containing I-125 listed on Exhibit
1.11.
1.12
"Inability to Supply"
shall have the meaning assigned to such term in Section 5.11(a).
1.13
"Indemnitee" shall have
the meaning assigned to such term in Section 9.4.
1.14
"Infringement" shall
have the meaning assigned to such term in Section 6.3(a).
1.15
"Invention" shall mean
any new or useful process, manufacture, compound, composition of matter,
improvements, discoveries, claims, formulae, processes, trade secrets,
technologies and know-how (including confidential data and Confidential
Information), to the extent relating to, derived from and useful for the
manufacture, use or sale of a I-125 Product (including, without limitation, the
formulation, delivery or use thereof in the Field), including, without
limitation, synthesis, preparation, recovery and purification processes and
techniques, control methods and assays, chemical data, toxicological and
pharmacological data and techniques, clinical data, medical uses, product forms
and product formulations and specifications, whether patentable or unpatentable,
that (except for purposes of the definitions of Know-How and Patents set forth
herein in Sections 1.18 and 1.25, respectively) is conceived or first reduced to
practice or demonstrated to have utility during the term of this
Agreement.
1.16
"IsoRay" shall have the
meaning assigned to such term in the introductory paragraph.
1.17
"Know-How" shall mean
any and all unpatented Inventions that are generated, owned or controlled by
Oncura at any time before or during the term of this Agreement to the extent
relating to, derived from and useful for the manufacture, use or sale of the
I-125 Products in the Field in any country in the Territory.
1.18
"Long-Term Inability to
Supply" shall have the meaning assigned to such term in Section
5.11(c).
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1. 19
"Manufacturing
Standards" shall mean, with respect to any I-125 Product, cGMP and such
additional manufacturing specifications or standards as may be established by
mutual agreement of IsoRay and Oncura from time to time.
1.20
"Non-Breaching Party"
shall have the meaning assigned to such term in Section 10.2.
1.21
"Oncura" shall have the
meaning assigned to such term in the introductory paragraph.
1.22
"Oncura Trademarks"
shall mean those Trademarks that are owned by Oncura or which Oncura otherwise
has the right to use in the Territory.
1.23
"Party" shall mean
IsoRay or Oncura, as the case may be, and, when used in the plural, shall mean
IsoRay and Oncura.
1.24
"Patents" shall mean
the patents and patent applications set forth on Exhibit 1.25, together with any
patents that may issue therefrom in any country in the Territory, and any other
patents or patent applications in any country in the Territory owned by or
exclusively licensed to Oncura during the term of this Agreement that cover any
Inventions to the extent relating to, derived from and useful for the
manufacture, use or sale of the I-125 Products in the Field in any country in
the Territory, including any and all extensions, renewals, continuations,
continuations-in-part, divisions, patents-of-additions, reissues, supplementary
protection certificates or foreign counterparts of any of the
foregoing.
1.25
"Person" shall mean an
individual or a corporation, partnership, association, trust, or any other
entity or organization, including a government or political subdivision or an
agency or instrumentality thereof.
1.26
"Registration" shall
mean, with respect to each country in the Territory, approval of the
Registration Application for any I-125 Product filed in such country, including,
where applicable outside of the United States, pricing or reimbursement approval
by the Regulatory Authority in such country.
1.27
"Registration
Application" shall mean a 510K Application under the United States
Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder,
or a comparable filing for Registration in a country, in each case with respect
to a I-125 Product for application in the Field in the Territory.
1.28
"Regulatory Authority"
shall mean the FDA in the U.S., and any health regulatory authority(ies)
in any country in the Territory that is a counterpart to the FDA and holds
responsibility for granting regulatory marketing approval for an I-125 Product
in such country, and any successor(s) thereto.
1.29
"Specifications" shall
mean, with respect to an I-125 Product, the specifications for such I-125
Product as agreed upon by IsoRay and Oncura, in consideration of the regulatory
requirements in each country in the Territory, as may be amended from time to
time.
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1.30
"Subsidiary" means,
with respect to any Person, any corporation or other entity of which a majority
of the capital stock or other ownership interests having ordinary voting power
to elect a majority of the board of directors or other persons performing
similar functions are at the time directly or indirectly owned by such
Person.
1.31
"Technology" shall mean
the Valid Claims and Know-How, collectively.
1.32
The "Territory" shall
mean the United States and Canada.
1.33
"Testing Methods" shall
have the meaning assigned to such term in Section 5.7(c).
1.34
"Third Party" shall
mean any Person who or which is neither a Party nor an Affiliate of a
Party.
1.35
"Trademarks" shall mean
the trademarks registered to Oncura or IsoRay, as applicable.
1.36
"United States" or
"U.S." shall mean the
United States of America, including its possessions and
territories.
1.37
"Valid Claim" shall
mean any claim of any Patents issued or pending in a country in the Territory
relating to, derived from or useful for the use and sale of the I-125 Products
in the Field, which claim has not been held invalid or unenforceable by decision
of a court or other governmental agency of competent jurisdiction, unappealable
or unappealed within the time allowed for appeal, and which is not admitted to
be invalid through disclaimer or otherwise not admitted by the Party holding
such Patent to be invalid.
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GRANT
OF RIGHTS.
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2.1. Rights Granted to IsoRay.
Subject to the terms and conditions of this Agreement, Oncura hereby grants to
IsoRay a non-exclusive right to distribute the I-125 Products in the
Territory.
2.2. Oncura
Trademarks; Logos.
(a) Oncura
hereby grants IsoRay the non-exclusive right to use the Oncura Trademarks in the
Territory in connection with the I-125 Products, subject to the provisions of
this Agreement and for the term hereof. Solely in connection with IsoRay's
promotion, distribution and sale of I-125 Products in the Territory, IsoRay
shall market the I-125 Products throughout the Territory under the applicable
Oncura Trademarks for the relevant country in the Territory. The use
of Oncura Trademarks by IsoRay shall be subject to the terms and conditions set
forth in this Section 2.2. In the event that IsoRay's rights under Section 2.1
are terminated, IsoRay's rights to use the Oncura Trademarks pursuant to this
Section 2.2 shall terminate as well.
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(b) Whenever
IsoRay uses Oncura Trademarks in advertising or in any other manner in
connection with the I-125 Products, IsoRay shall clearly indicate Oncura's
ownership of the Oncura Trademarks. When using Oncura Trademarks under this
Agreement, IsoRay agrees to comply with all laws pertaining to trademarks in
force at any time in the Territory.
(c) If
necessary in any country in the Territory to permit IsoRay to use Oncura
Trademarks, Oncura shall make application to register IsoRay as a permitted user
or registered user of the Oncura Trademarks and, if necessary, or if requested
by Oncura, IsoRay undertakes to join in such application and to take such action
as may be necessary or requested by Oncura to implement such application or
retain, enforce or defend the Oncura Trademarks. If necessary in any country in
the Territory to maintain Oncura's rights in the Oncura Trademarks, IsoRay shall
enter into a registered user agreement or permitted user agreement regulating
its use of Oncura Trademarks.
(d) IsoRay
acknowledges that Oncura is the owner of the Oncura Trademarks. IsoRay shall not
at any time do, cause to be done, or permit any act or thing inconsistent with,
contesting or in any way impairing or tending to impair such ownership. IsoRay
agrees that all use of Oncura Trademarks by IsoRay shall inure to the benefit of
and be on behalf of Oncura. IsoRay acknowledges that nothing in this Agreement
shall give IsoRay any right, title or interest in Oncura Trademarks other than
the right to use the Oncura Trademarks in accordance with this Agreement. IsoRay
agrees that it will not challenge the title or ownership of Oncura to any of the
Oncura Trademarks or attack or contest the validity of any of the Oncura
Trademarks.
(e) Oncura
shall register and maintain, or cause to be registered and maintained, the
Oncura Trademarks in the Territory during the term of this Agreement at Oncura's
sole expense. If any Party learns of any actual, alleged or threatened
unauthorized use or other infringement of any Oncura Trademarks by others in the
Territory, such Party agrees to promptly notify the other Party of such
unauthorized use or other infringement. Oncura shall use all commercially
reasonable efforts to retain, enforce and defend the Oncura Trademarks in the
Territory.
(f) To
the extent permitted by law, all labeling, packaging, literature, promotional
material and advertising for any I-125 Product to be marketed, distributed or
sold in any country in the Territory shall contain Oncura's name and logo with
comparable prominence as the name and logo used by IsoRay. To the extent
practicable, or as required by applicable law to protect the Oncura Trademarks,
IsoRay shall include on any material bearing any Oncura Trademarks an
acknowledgement that such Trademark is the property of Oncura.
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DISTRIBUTION
AND PROMOTION.
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3.1. Generally. IsoRay shall use
commercially reasonable efforts to promote and sell the I-125 Products in the
Territory.
3.2. Responsibilities;
Rights.
(a) IsoRay,
either itself and/or by and through its Affiliates, shall be responsible for and
shall have the rights granted under Section 2.1.
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(b) In
connection with its responsibility for distribution, marketing and sales of the
I-125 Products in the Territory, IsoRay shall provide all sales force
(including, without limitation, sales administration and training), order entry,
customer service, reimbursement management, medical affairs, medical
information, marketing (including all advertising and promotional expenditures),
warehousing, physical distribution, invoicing, credit and collections,
production forecasting and other related facilities and services necessary or
desirable for such distribution, marketing and sales.
(c) IsoRay
agrees to refrain from making any claims about the I-125 Products which do not
conform to the Specifications, directions for use, product labeling, and
applicable Registrations for such I-125 Products. IsoRay further
agrees to immediately cease, following written notice by Oncura, making any
claims which Oncura reasonably objects to with respect to the I-125
Products.
3.3 Distribution and Marketing
Costs. From and after the Effective Date, IsoRay shall be solely
responsible for its distribution and marketing costs of whatever type, except as
expressly provided otherwise in this Agreement.
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PAYMENTS.
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4.1 Mode of Payment. IsoRay shall
make all payments required under this Agreement in U.S. Dollars.
4.2 Records Retention. Each Party
shall keep complete and accurate records pertaining to the purchase and sale of
I-125 Products for a period of three calendar years after the year in which such
purchases and sales occurred, and in sufficient detail to permit the other Party
to confirm the accuracy of each of the foregoing.
4.3 Taxes. In the event
that IsoRay is required to withhold any tax to the tax or revenue authorities in
any country in the Territory regarding any payment to Oncura due to the laws of
such country, such amount shall be deducted from the payment to be made and
IsoRay shall promptly notify Oncura of such withholding and, within a reasonable
amount of time after making such deduction, furnish Oncura with copies of any
tax certificate or other documentation evidencing such withholding. Each Party
agrees to cooperate with the other Party in claiming exemptions from such
deductions or withholdings under any agreement or treaty from time to time in
effect.
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MANUFACTURE
AND SUPPLY.
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5.1. Supply Obligations. Except as
mutually agreed by Oncura and IsoRay, commencing on the Effective Date, and
thereafter during the term of this Agreement, subject to the terms and
conditions of this Section 5, Oncura shall be responsible for the manufacture
and supply of all of IsoRay's requirements of I-125 Products for commercial
distribution in the Territory pursuant to this Agreement, but IsoRay
may purchase I-25 Products from suppliers other than Oncura at any time. IsoRay
shall place orders for the I-125 Products, and, at IsoRay's option, either have
Oncura ship directly to the final customers for such I-125 Products or to a
third party loading service.
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5.2 Processing of I-125
Products. Oncura shall be solely responsible for ensuring
compliance with all applicable requirements of the Regulatory Authorities within
the Territory. Oncura shall use commercially reasonable efforts to ensure that
all services, facilities and goods used in connection with such processing
comply with the applicable Manufacturing Standards in effect from time to
time.
5.3 Loading Services. The Parties
acknowledge and agree that IsoRay's final customers for the I-125 Products shall
have sole discretion over which third party loading services they may choose to
use to process the I-125 Products, and Oncura agrees to ship the I-125 Products
to any third party loading service specified on a valid purchase order submitted
by IsoRay.
5.4 Orders for
Products. IsoRay shall place its firm non-custom
order with Oncura at least
one (1) day in advance of the delivery date, setting forth amounts, delivery
dates and shipping instructions, including delivery addresses, with respect to
each shipment of the I-125 Product (collectively, the "Deliverables"). IsoRay shall
place custom load or calibrated
service orders three (3) business days in advance of the delivery date.
IsoRay shall place custom
stranded service orders five (5) business days in advance of the delivery
date. All orders must be placed by 4:00 PM
CT. Oncura shall be required to accept such orders from
IsoRay, subject to the other terms and conditions of this Agreement. IsoRay's
orders shall be made pursuant to purchase orders which are in a form mutually
acceptable to Oncura and IsoRay, to the extent that such form is not
inconsistent with the terms of this Agreement. IsoRay shall notify
Oncura as soon as possible of an increase in its requirements for a given
Deliverable of greater than 300% of the orders for that Deliverable shipped in
the preceding calendar month.
5.5 Delivery. With respect to
exact shipping dates, Oncura shall use all reasonable commercial efforts to ship
or cause to be shipped quantities of Deliverables that Oncura is obligated to
supply pursuant to Section 5.4 on the dates specified in IsoRay's purchase
orders submitted and accepted in accordance with Section 5.4. Notwithstanding
any inconsistent term that may be specified on IsoRay's purchase order for a
Deliverable, all Deliverables to be delivered pursuant to this Agreement shall
be delivered in accordance with this Section 5.5, suitably packed in bulk
containers for shipment, and marked for shipment to the final destination point
indicated in the purchase order. The shipping packaging used in connection with
such deliveries shall be in accordance with cGMP with respect to protection of
the Deliverable during transportation, taking into consideration the mode(s) of
transport IsoRay has elected to use for each such shipment, the final
destination point of each such shipment and reasonable expectations regarding
shipment time duration and possible delays associated therewith. Transportation
of Deliverables may be made by xxxx, xxxx, xxx, xxx, xxxxxx waterway or by a
combination of such modes of transport. Title and risk of loss shall transfer to
IsoRay upon delivery to the carrier or Person designated by IsoRay.
5.6 Purchase
Price; Invoicing.
(a) The
purchase price for all Deliverables supplied pursuant to this Section 5 for
commercial use in the Territory shall be as indicated for each Deliverable on
Exhibit 5.6.
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(b) Oncura
shall submit invoices to IsoRay for Deliverables ordered promptly after
shipment. Payments shall be made by IsoRay within 30 days after its receipt of
the invoice. IsoRay has no obligation to pay for any shipment of Deliverables
that (i) Oncura and IsoRay agree does not to meet the Specifications and/or
Manufacturing Standards, or (ii) in accordance with Section 5.8, IsoRay has
found not to meet the Specifications and/or Manufacturing Standards while such
findings have not been contradicted by independent laboratory testing. Upon
Oncura's receipt of a notice from IsoRay claiming that a shipment of
Deliverables does not meet the Specifications and/or applicable Manufacturing
Standards, the time period for payment of such shipment shall toll until such
time as such non-conformity questions regarding such shipment or such batch are
resolved in accordance with Section 5.8. All relevant terms of Section 4 with
respect to payments shall apply to the payment of invoices for the supply of the
Deliverables.
5.7 Conformity;
Specifications; Quality Control.
(a) All
quantities of Deliverables supplied by Oncura pursuant to this Section 5 will
comply in all material respects with the Specifications and applicable
Manufacturing Standards and shall adhere in all material respects to all
applicable governmental laws and regulations relating to the manufacture, sale
and shipment of each shipment of the Deliverable at the time it is shipped by
Oncura hereunder.
(b) Oncura
shall conduct, or cause to be conducted, quality control testing of the
Deliverables prior to shipment, in accordance with the Specifications and
applicable Manufacturing Standards as are in effect from time to time and such
other quality control testing procedures adopted by the Parties from time to
time (collectively, the "Testing Methods"). Initially
and until decided otherwise by the Parties, the Testing Methods shall include
all FDA and other Regulatory Authority required testing, based upon the delivery
location of the I-125 Products, and Oncura shall undertake all such tests.
Oncura shall retain records pertaining to such testing, which shall be made
available to IsoRay upon request. Each shipment of Deliverables hereunder shall
be accompanied by a certified quality control protocol and certificate of
analysis for each lot of Deliverables therein as well as such customs and other
documentation as is necessary or appropriate.
(c) All
units of Finished Product manufactured pursuant to this Agreement will comply in
all material respects with the applicable Manufacturing Standards and
specifications for Finished Products determined by the Parties and shall adhere
in all material respects to all applicable governmental laws and regulations
relating to the manufacture, sale and shipment of each Finished Product at the
time it is manufactured and distributed hereunder.
5.8 Acceptance/Rejection; Interim
Replacement.
(a) IsoRay
or its designated customer shall have the right to reject any shipment of
Deliverables made to it under this Agreement that does not meet the
Specifications and applicable Manufacturing Standards in any material respects
when received by it or its designee at such destination. All claims by IsoRay of
non-conforming Deliverables shall be deemed waived unless made by IsoRay in
writing and received by Oncura within 10 days of IsoRay's receipt or that of its
designee of the Deliverable.
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(b) All
claims of non-conforming Deliverables shall be accompanied by the allegedly
non-conforming Deliverable. Oncura shall promptly undertake its own analysis, in
accordance with the Testing Methods, of such Deliverable after receiving such
claim from IsoRay or its
designed Customer. If, after its own analysis, Oncura does not confirm such
non-conformity, the Parties agree to submit the disputed Deliverable to an
independent testing laboratory, to be agreed upon by the Parties, for testing in
accordance with the Testing Methods. Notwithstanding Section 12.13, the findings
of such laboratory shall be binding on the Parties, absent manifest error.
Expenses of such independent testing shall be borne by either Oncura or IsoRay,
with Oncura bearing all such expenses if the Deliverable is found to be
non-conforming, and IsoRay bearing all such expenses if the Deliverable is found
to be conforming. In the event that any Deliverable shipment or batch thereof is
ultimately agreed or found not to meet the Specifications and/or applicable
Manufacturing Standards, Oncura agrees to replace such shipment or batch with
conforming Deliverables and pay for all reasonable out of pocket expenses
incurred by IsoRay and its designee in connection with shipping and/or storing
such replacement Deliverables and storing the non-conforming Deliverables. Such
replacement shipment of Deliverables shall be treated as a new, additional
shipment of Deliverables (that will be separately invoiced by Oncura) for all
purposes, including measuring its conformity to the Specifications and
applicable Manufacturing Standards, and IsoRay's payment for such additional
shipment. In the event that any Deliverables shipment or batch thereof is
ultimately agreed or found to meet the Specifications and applicable
Manufacturing Standards, IsoRay shall accept and pay for such shipment or batch
in accordance with Section 5.6.
(c) Upon
Oncura's receipt of a claim that a shipment or batch thereof of Deliverables
does not meet the Specifications and/or applicable Manufacturing Standards,
Oncura shall use commercially reasonable efforts to replace such shipment or
batch thereof with an additional shipment of Deliverables that does conform to
such standards as soon as practicable.
5.9 Inventory Management. Oncura
shall maintain inventory of I-125 Products in accordance with its usual and
customary inventory management practices that apply to its other brachytherapy
products.
5.10 Shortage of
Supply. Oncura shall notify IsoRay: (i) as promptly as
possible, but in no event more than ten days after Oncura's receipt of a firm
order from IsoRay as provided in Section 5.4, or (ii) immediately upon becoming
aware that Oncura is unable to supply the quantity of a Deliverable to IsoRay
that Oncura is required to supply hereunder, if Oncura is unable to supply such
quantities of Deliverables. In such event, Oncura shall implement all
commercially reasonable efforts to remedy such
shortage. Notwithstanding anything in this Agreement to the contrary,
while such shortage is continuing, IsoRay may purchase I-125 Products from
suppliers other than Oncura.
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PATENTS;
TRADEMARKS.
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6.1 Ownership. Oncura shall have
all right, title and interest in and to its Patents, Know-How, and Trademarks,
whether in existence on the Effective Date or developed during the term of this
Agreement.
6.2.
Maintenance of the
Patents. Oncura shall have full responsibility for, and shall
control the preparation and prosecution of, all patent applications and the
maintenance of all patents relating to the I-125 Products. Oncura shall pay all
costs and expenses of filing, prosecuting and maintaining its
Patents.
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6.3.
Patent Enforcement. If IsoRay
learns of an infringement, unauthorized use, misappropriation or ownership claim
or threatened infringement or other such claim (any of the foregoing, an "Infringement") by a Third
Party with respect to any Technology or any Trademark within the Territory,
IsoRay shall promptly notify Oncura and shall provide Oncura with available
evidence of such Infringement.
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CONFIDENTIALITY;
NON-SOLICITATION.
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7.1 Confidentiality; Exceptions.
Except to the extent expressly authorized by this Agreement or otherwise agreed
in writing, the Parties agree that, during the term of this Agreement and for
ten years thereafter, the receiving Party, its Affiliates and its licensees
shall, and shall ensure that their respective employees, officers, directors and
other representatives shall, keep completely confidential and not publish or
otherwise disclose and not use for any purpose any information furnished to it
or them by the disclosing Party, its Affiliates or its licensees or developed
under or in connection with this Agreement, except to the extent that it can be
established by the receiving Party by competent proof that such information: (i)
was already known to the receiving Party, other than under an obligation of
confidentiality, at the time of disclosure by the disclosing Party; (ii) was
generally available to the public or otherwise part of the public domain at the
time of its disclosure to the receiving Party; (iii) became generally available
to the public or was otherwise part of the public domain after its disclosure
and other than through any act or omission of the receiving Party in breach of
this Agreement; or (iv) was disclosed to the receiving Party, other than under
an obligation of confidentiality, by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others (all such
information to which none of the foregoing exceptions applies, shall be deemed
"Confidential
Information").
7.2 Exceptions to Obligation. The
restrictions contained in Section 7.3 shall not apply to Confidential
Information that: (i) is submitted by the recipient to governmental authorities
to facilitate the issuance of Registrations for the I-125 Products, provided
that reasonable measures shall be taken to assure confidential treatment of such
information; (ii) is provided by the recipient to Third Parties under
confidentiality provisions at least as stringent as those in this Agreement, for
consulting, manufacturing development, manufacturing, external testing, or
marketing trials; or (iii) is otherwise required to be disclosed in compliance
with applicable laws or regulations or order by a court or other regulatory body
having competent jurisdiction, including but not limited to the U.S. Securities
and Exchange Commission; provided that if a Party is required to make any such
disclosure of the disclosing Party's Confidential Information such Party will,
except where impracticable for necessary disclosures (for example, to health
authorities and the U.S. Securities and Exchange Commission), give reasonable
advance notice to the disclosing Party of such disclosure requirement and,
except to the extent inappropriate in the case of patent applications, will use
its best efforts to secure confidential treatment of such Confidential
Information required to be disclosed.
7.3 Limitations on Use. Each Party
shall use, and cause each of its Affiliates and its licensees to use, any
Confidential Information obtained by such Party from the disclosing Party, its
Affiliates or its licensees, pursuant to this Agreement or otherwise, solely in
connection with the activities or transactions contemplated
hereby.
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7.4 Remedies. Each Party shall be
entitled, in addition to any other right or remedy it may have, at law or in
equity, to an injunction, without the posting of any bond or other security,
enjoining or restraining the disclosing Party, its Affiliates and/or its
licensees from any violation or threatened violation of this Section
7.
7.5 Non-Solicitation. Each Party
agrees that during the term of this Agreement, and for one (1) year thereafter,
it shall not (i) employ or retain on an independent contractor basis; or (i)
solicit for employment or for an independent contracting basis any person who
was, at any time during the immediately preceding twelve (12) month period,
employed by the other Party or any of its Affiliates.
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REPRESENTATIONS
AND WARRANTIES.
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8.1 Representations and Warranties of the
Parties. Each Party represents and warrants to the other Party, as of the
Effective Date, that:
(a) Such
Party is duly organized, validly existing and in good standing under the laws of
the jurisdiction of its incorporation and has full corporate power and authority
to enter into this Agreement and to carry out the provisions
hereof;
(b) Such
Party has taken all corporate action necessary to authorize the execution and
delivery of this Agreement and the performance of its obligations under this
Agreement and has full power and authority to enter into this Agreement and
perform its obligations under this Agreement;
(c) This
Agreement has been duly executed by such Party and constitutes a valid and
legally binding obligation of such Party, enforceable in accordance with its
terms, subject to and limited by: (i) applicable bankruptcy, insolvency,
reorganization, moratorium, and other laws generally applicable to creditors'
rights; and (ii) judicial discretion in the availability of equitable
relief;
(d) Such
Party is not required to obtain the consent, approval, order, or authorization
of any Third Party, or complete any registration, qualification, designation,
declaration or filing with, any federal, state, local, or provincial
governmental authority, in connection with the execution and delivery of this
Agreement and the performance by such Party of its obligations under this
Agreement, including, without limitation, the grant of rights to the other Party
pursuant to this Agreement, or such Party has done so;
(e) The
execution and delivery of this Agreement, and the performance by such other
Party of its obligations under this Agreement, including without limitation the
grant of rights to the other Party pursuant to this Agreement, will not: (i)
conflict with, nor result in any violation of or default under any such
instrument, judgment, order, writ, decree, contract or provision; (ii) give rise
to any event that results in the creation of any lien, charge or encumbrance
upon any assets of such Party or the suspension, revocation, impairment,
forfeiture or non-renewal of any material permit, license, authorization or
approval that applies to such Party, its business or operations or any of its
assets or properties; or (iii) conflict with any rights granted by such Party to
any Third Party or breach any obligation that such Party has to any Third
Party.
11
8.2 Representations and Warranties of
Oncura. Oncura represents and warrants to IsoRay, as of the
Effective Date, that:
(a) Oncura
is the owner of, or has exclusive rights to, all of its Patents and the Oncura
Trademarks in existence on the Effective Date, and has the exclusive right to
grant the rights granted under this Agreement therefor. All of its Patents and
the Oncura Trademarks are valid, in
full force and effect and have been maintained to date, and, to the knowledge of
Oncura, are not the subject of any interference or opposition
proceedings;
(b) To
the knowledge of Oncura, Oncura (i) is not aware of any asserted or unasserted
claims, interferences, oppositions or demands of any Third Party against its
Technology or the Oncura Trademarks in existence as of the Effective Date, and
(ii) to the knowledge of Oncura, IsoRay’s practice of any invention claimed in
Oncura’s Patents or the exercise of any rights to its Technology or the Oncura
Trademarks as contemplated by this Agreement will not infringe any patent or
other intellectual property right of any Third Party;
(c) Oncura
has rights to all of its Know-How in existence on the Effective Date and the
right to grant all rights with respect thereto granted to IsoRay pursuant to
this Agreement;
(d) To
the knowledge of Oncura, IsoRay’s use of the I-125 Products in the Field, in
accordance with the terms of this Agreement, would not infringe upon or conflict
with any patent or other proprietary rights in the Territory of any Third Party;
and
(e) All
of the data and information provided to IsoRay relating to Oncura’s Technology
and the Oncura Trademarks is accurate and complete in all material respects and
contains no material errors or omissions.
9
|
RECALL; INDEMNIFICATION;
INSURANCE.
|
9.1 Investigation; Recall. In the
event that the Regulatory Authority in any country in the Territory shall allege
or prove that an I-125 Product does not comply with applicable rules and
regulations in such country, the Party so notified by the Regulatory Authority
shall notify the other Party immediately. Oncura shall conduct any appropriate
investigation and shall make a determination as to the disposition of any such
matter. If a Party is required or if Oncura should deem it appropriate to recall
any I-125 Product, Oncura shall bear the costs and expenses associated with such
recall, unless: the predominant cause of such recall results from IsoRay's
willful wrongdoing or negligence, in which case IsoRay shall bear all costs and
expenses associated with such recall.
9.2. Indemnification by IsoRay.
IsoRay shall indemnify, defend and hold harmless Oncura and its
Affiliates, and their respective directors, officers, employees and agents, from
and against any and all liabilities, damages, losses, costs and expenses
(including the reasonable fees of attorneys and other professionals) to the
extent arising out of or resulting from:
(a) negligence,
recklessness or wrongful intentional acts or omissions of IsoRay or its
Affiliates, and their respective directors, officers, employees and agents, in
connection with the fulfillment of IsoRay's rights or obligations under this
Agreement; or
12
(b) any
breach of any representation or warranty made by IsoRay under Section
8.1.
9.3. Indemnification by Oncura.
Oncura shall indemnify, defend and hold harmless IsoRay and its respective
Affiliates, and their respective directors, officers, employees and agents, from
and against any and all liabilities, damages, losses, costs and expenses
(including the reasonable fees of attorneys and other professionals) to the
extent arising out of or resulting from:
(a) Negligence,
recklessness or wrongful intentional acts or omissions of Oncura or its
Affiliates, and their respective directors, officers, employees and agents, in
connection with the fulfillment of Oncura's rights or obligations under this
Agreement;
(b) Due
to any negligence, recklessness or wrongful intentional actsrict liability of,
Oncura Affiliates, and its respective directors, officers, employees and
agents.
(c) any
breach of any representation or warranty made by Oncura under Sections 8.1 and
8.2.
9.4 Notice of Indemnification. In
the event that any Person (an "Indemnitee") entitled to
indemnification under Section 9.2 or 9.3 is seeking such indemnification, such
Indemnitee shall inform the indemnifying Party of the claim as soon as
reasonably practicable after such Indemnitee receives notice of such claim,
shall permit the indemnifying Party to assume direction and control of the
defense of the claim (including the sole right to settle it at the sole
discretion of the indemnifying Party, provided that such settlement does not
impose any obligation on, or otherwise adversely affect, the Indemnitee or any
of the other Parties) and shall cooperate as requested (at the expense of the
indemnifying Party) in the defense of the claim.
9.5
Complete
Indemnification. As the Parties intend complete indemnification, all
costs and expenses incurred by an Indemnitee in connection with enforcement of
Sections 9.2 and 9.3 shall also be reimbursed by the indemnifying
Party.
9.6
Insurance. IsoRay agrees
to maintain throughout the term of this Agreement, for so long as it is selling
I-125 Products, at its own expense, liability insurance (including product
liability insurance) from a U.S. insurance company with a Xxxxx'x rating of
"Baa" or higher, including insurance against claims from bodily injury and
property damage and with a limit of insurance of at least five million Dollars
($5,000,000) per occurrence and at least five million Dollars ($5,000,000) in
the aggregate, including a contractual liability endorsement or a coverage
provision which provides coverage to IsoRay's obligations to indemnify
Oncura. Oncura agrees to maintain throughout the term of this
Agreement, for so long as IsoRay is selling I-125 Products, at its own expense,
liability insurance (including product liability insurance) from a U.S.
insurance company with a Xxxxx'x rating of "Baa" or higher, including insurance
against claims from bodily injury and property damage and with a limit of
insurance of at least two million five hundred Dollars ($2,500,000) per
occurrence and at least five million Dollars ($5,000,000) in the aggregate,
including a contractual liability endorsement or a coverage provision which
provides coverage to Oncura's obligations to indemnify IsoRay. Each
Party shall provide the other Party, within 30 days after the execution of this
Agreement, with certificates or other evidence of insurance required by this
Section 9.6. Each Party shall keep all insurance coverages required by this
Agreement in full force and effect for a period of [3 years] after the earlier of
the termination of this Agreement or the termination of IsoRay's right to
distribute I-125 Products manufactured by Oncura. Each of the Parties
understands and acknowledges that the other Party is entering into this
Agreement in part because of the foregoing insurance covenant.
13
10
|
TERM;
TERMINATION.
|
10.1 Term. This Agreement shall
become effective as of the Effective Date and, unless earlier terminated
pursuant to the other provisions of this Section 10, shall expire on the first
(1st) anniversary of the Effective Date. This Agreement will automatically renew
for additional terms of one (1) year each upon the first and each subsequent
anniversary of the Effective Date unless either Party provides the other Party
with notice in writing at least ninety (90) days prior to the expiration of the
term or any extension thereof that it does not desire to renew this
Agreement.
10.2. Termination for
Cause. Either Party (as used in this subsection, the "Non-Breaching Party") may,
without prejudice to any other remedies available to it at law or in equity,
terminate this Agreement, in the event that the other party (as used in this
subsection, the "Breaching
Party") shall have materially breached or defaulted in the performance of
any of its material obligations hereunder, and such default shall have continued
for 60 days after written notice thereof was provided to the Breaching Party by
the Non-Breaching Party (or, if such default cannot be cured within such 60-day
period, if the Breaching Party does not commence and diligently continue actions
to cure such default during such 60-day period). Any such full or partial
termination shall become effective at the end of such 60-day period unless the
Breaching Party has cured any such breach or default prior to the expiration of
such 60-day period (or, if such default cannot be cured within such 60-day
period, if the Breaching Party has commenced and diligently continued actions to
cure such default). The right of the Non-Breaching Party to terminate this
Agreement in whole or in part, as provided in this Section 10.2 shall not be
affected in any way by its waiver or failure to take action with respect to any
previous default.
10.3 Termination Without
Cause. Either party may terminate this Contract without cause
at any time upon thirty (30) days’ prior written notice to the
other.
10.4 Effect of Expiration or
Termination. If this Agreement expires pursuant to its terms or is
terminated by any Party pursuant to this Section 10, in addition to any other
remedies available to the Parties at law or in equity: (i) IsoRay shall promptly
transfer to Oncura copies of all data, reports, records and materials in its
possession or control that relate to the I-125 Products and return to Oncura all
relevant records and materials in its possession or control containing
Confidential Information of Oncura (provided that IsoRay may keep one copy of
such Confidential Information of Oncura for archival purposes only); (ii) IsoRay
shall transfer to Oncura, or shall cause its designee(s) to transfer to Oncura,
ownership of all Registration Applications, Registrations and other regulatory
filings made or filed for I-125 Products (to the extent that any are held in
IsoRay's or such designee(s)'s name), if permitted by applicable laws and
regulations; and (iii) Oncura shall promptly return to IsoRay all relevant
records and materials in Oncura's possession or control containing Confidential
Information of IsoRay (provided that Oncura may keep one copy of such
Confidential Information of IsoRay for archival purposes only).
14
10.5.
Accrued
Rights; Surviving Obligations.
(a) Termination,
relinquishment or expiration of this Agreement for any reason shall be without
prejudice to any rights that shall have accrued to the benefit of any Party
prior to such termination, relinquishment or expiration. Such termination,
relinquishment or expiration shall not relieve any Party from obligations which
are expressly indicated to survive termination or expiration of this Agreement.
All obligations which are not expressly indicated to survive termination or
expiration of this Agreement shall terminate upon the termination or expiration
of this Agreement.
(b) All
of the Parties' rights and obligations under, and/or the provisions contained
in, Sections 1, 4, 6.1, 6.3, 7, 9, 10.2, 10.4, and 12 shall survive termination,
relinquishment or expiration of this Agreement.
11
|
FORCE
MAJEURE.
|
11.1 Events of Force Majeure.
Neither Party shall be held liable or responsible to the other Party nor be
deemed to be in default under, or in breach of any provision of, this Agreement
for failure or delay in fulfilling or performing any obligation of this
Agreement when such failure or delay is due to force majeure, and without the
fault or negligence of the Party so failing or delaying. For purposes of this
Agreement, force majeure is defined as causes beyond the control of the Party,
including, without limitation, acts of God; acts, regulations, or laws of any
government; war; civil commotion; destruction of production facilities or
materials by fire, flood, earthquake, explosion or storm; labor disturbances;
epidemic; and failure of public utilities or common carriers. In such event
IsoRay or Oncura, as the case may be, shall immediately notify the other Party
of such inability and of the period for which such inability is expected to
continue. The Party giving such notice shall thereupon be excused from such of
its obligations under this Agreement as it is thereby disabled from performing
for so long as it is so disabled and the 30 days thereafter. To the extent
possible, each Party shall use reasonable efforts to minimize the duration of
any force majeure.
12
|
MISCELLANEOUS.
|
12.1 Relationship of Parties.
Nothing in this Agreement is intended or shall be deemed to constitute a
partnership, agency, employer-employee or joint venture relationship between the
Parties. No Party shall incur any debts or make any commitments for the other,
except to the extent, if at all, specifically provided herein.
12.2 Assignment. No Party shall be
entitled to assign its rights or delegate its obligations hereunder without the
express written consent of the other Parties hereto, except that (i) IsoRay may
assign its rights and transfer its duties hereunder, without the consent of
Oncura, to a directly or indirectly wholly-owned subsidiary of IsoRay (provided
that, such subsidiary remains so owned, IsoRay guarantees the obligations of
such subsidiary under this Agreement in form and substance satisfactory to
Oncura, and no such assignment shall relieve IsoRay of any of its obligations
under this Agreement), (ii) Oncura may assign its rights and transfer its duties
hereunder, without the consent of IsoRay, to (A) a directly or indirectly
wholly-owned subsidiary of Oncura (provided that such subsidiary remains so
owned, Oncura guarantees the obligations of such subsidiary under this Agreement
in form and substance satisfactory to IsoRay, and no such assignment shall
relieve Oncura of any of its obligations under this Agreement), or (B) to any
assignee of all or substantially all of its business (or that portion of its
overall business of which this Agreement is a part (e.g. all of its
brachytherapy business)) or in the event of Oncura's merger, consolidation or
involvement in a similar transaction; provided that, in the case of (A) or (B),
the assignee agrees in writing to be bound by the terms of this Agreement. No
assignment or transfer shall be valid or effective unless done in accordance
with this Section 12.2.
15
12.3 Books and Records. Any books
and records to be maintained under this Agreement by a Party or its Affiliates
shall be maintained in accordance with GAAP.
12.4. Notice. Any notice,
request or other communication required or permitted to be given under or in
connection with this Agreement shall be deemed to have been sufficiently given
if in writing and personally delivered or sent by facsimile transmission
(receipt verified) or overnight express courier service (signature required),
prepaid, to the Party for which such notice is intended, at the address set
forth for such Party below:
In the
case of Oncura to:
Attention:
Xxxxx X. Xxxxxxx, Director of Sales
Facsimile
No: 000-000-0000
Telephone
No: 000-000-0000
With a
copy to:
Attention:
Xxxxxx Xxxxxxx, Esq.
000
Xxxxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000-0000
Telephone:
000-000-0000
Fax:
000-000-0000
In the
case of IsoRay, to:
000 Xxxxx
Xxxxxx, Xxxxx 000
Xxxxxxxx,
XX 00000
Attention:
Xxxxxx Xxxxxxx, CEO
Facsimile
No: (000) 000-0000
Telephone
No: (000) 000-0000
With a
copy to:
Xxxxxx
Xxxxxxxx, PLC
0000
Xxxxx Xxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxx,
XX 00000-0000
Attention:
Xxxxxxx X. Xxxxxxxxxx, Esq.
Facsimile
No: (000) 000-0000
Telephone
No: (000) 000-0000
16
or to
such other address for such Party as it shall have specified by like notice to
the other Party, provided that notices of a change of address shall be effective
only upon receipt thereof. If delivered personally or by facsimile transmission,
the date of delivery shall be deemed to be the date on which such notice or
request was given. If sent by overnight express courier service, the date of
delivery shall be deemed to be the next business day after such notice or
request was deposited with such service.
12.5 Use of Name. Except as
otherwise provided herein, IsoRay, on the one hand, and Oncura on the other
hand, shall not have any right, express or implied, to use in any manner the
name or other designation of the other or any other trade name, trademark or
logos of the other (including, without limitation, its Trademarks) for any
purpose in connection with the performance of this Agreement.
12.6
Public Announcements.
Except as required by applicable law, neither of the Parties shall make any
public announcement concerning this Agreement or the subject matter hereof
without the consent of the other Party.
12.7
Waiver. A waiver by any
Party of any of the terms and conditions of this Agreement in any instance shall
not be deemed or construed to be a waiver of such term or condition for the
future, or of any subsequent breach hereof. All rights, remedies, undertakings,
obligations and agreements contained in this Agreement shall be cumulative and
none of them shall be in limitation of any other remedy, right, undertaking,
obligation or agreement of any Party.
12.8
Compliance with Law.
Nothing in this Agreement shall be deemed to permit a Party to export, reexport
or otherwise transfer any I-125 Product sold under this Agreement without
compliance with applicable laws.
12.9
Severability. When
possible, each provision of this Agreement will be interpreted in such manner as
to be effective and valid under applicable law, but if any provision of this
Agreement is held to be prohibited by or invalid under applicable law, such
provision will be ineffective only to the extent of such prohibition or
invalidity, without invalidating the remainder of this Agreement.
12.10
Amendment. No amendment,
modification or supplement of any provisions of this Agreement shall be valid or
effective unless made in writing and signed by a duly authorized officer of each
Party.
12.11
Governing Law. This
Agreement shall be governed by and interpreted in accordance with the laws of
the State of Delaware without regard to conflicts of law
principles.
12.12. Arbitration.
(a) Except
as expressly otherwise provided in this Agreement, any dispute arising out of or
relating to the interpretation of any provisions of this Agreement or the
failure of any Party to perform or comply with any obligations or conditions
applicable to such Party pursuant to this Agreement shall be finally settled by
arbitration. The arbitration shall be held in The State of Delaware
under the then current commercial arbitration rules of the American Arbitration
Association, in accordance with the terms set forth in this Section
12.13(a):
17
(i) Unless
the Parties can agree on a single arbitrator, such arbitration shall be
conducted by three arbitrators, one appointed by each of Oncura and IsoRay and
the third selected by the first two appointed arbitrators. Each arbitrator shall
be a person with relevant experience in the medical device industry. Oncura and
IsoRay shall instruct such arbitrators to render a determination of any such
dispute within four months after the appointment of the third
arbitrator.
(ii) Any
award rendered by the arbitrators shall be final and binding upon the Parties.
Judgment upon any award rendered may be entered in any court having
jurisdiction, or application may be made to such court for a judicial acceptance
of the award and an order of enforcement, as the case may be. Each Party shall
pay its own expenses of arbitration, and the expenses of the arbitrators shall
be equally shared between Oncura and IsoRay unless the arbitrators assess as
part of their award all or any part of the arbitration expenses of a Party
(including reasonable attorneys' fees) against the other Party.
(iii) This
Section 12.13(a) shall not prohibit a Party from seeking injunctive relief from
a court of competent jurisdiction in the event of a breach or prospective breach
of this Agreement by any other Party which would cause irreparable harm to the
first Party.
(b) Whenever
a dispute arising out of or relating to the interpretation of any provisions of
this Agreement or the failure of any Party to perform or comply with any
obligations or conditions applicable to such Party pursuant to this Agreement
arises and such dispute is expressly designated as one to be resolved through
the Accelerated Arbitration Provisions, then such dispute shall be finally
settled by arbitration in accordance with the terms set forth in this subsection
(b) (the "Accelerated
Arbitration Provisions"). The arbitration shall be held in Richland,
Washington if instituted by Oncura, or in Princeton, NJ if instituted by IsoRay,
under the then current expedited procedures applicable to the then current
commercial arbitration rules of the American Arbitration
Association.
(i) Unless
the Parties can agree on a single arbitrator, such arbitration shall be
conducted by three arbitrators, one appointed by each of Oncura and IsoRay and
the third selected by the first two appointed arbitrators. Each arbitrator shall
be a person with relevant experience in the medical device industry. Oncura and
IsoRay shall instruct such arbitrators to render a determination of any such
dispute within 15 business days after the appointment of the third arbitrator.
Oncura and IsoRay must make their respective appointments within five business
days of notice being given to a Party by the other Parties of its intention to
resolve such dispute through these arbitration provisions. Such appointed
arbitrators must select the third arbitrator within five business days of the
last to occur of their respective appointments. The dispute shall be resolved by
submission of documents unless the arbitration panel determines that an oral
hearing is necessary. The arbitration panel shall, within the overall 15
business day time constraint, determine what shall be conclusively deemed to be
fair and appropriate deadlines for submitting documents and dates, if any, of
oral hearings.
18
(ii) Any
award rendered by the arbitrators shall be final and binding upon the Parties.
Judgment upon any award rendered may be entered in any court having
jurisdiction, or application may be made to such court for a judicial acceptance
of the award and an order of enforcement, as the case may be. Each Party shall
pay its own expenses of arbitration, and the expenses of the arbitrators shall
be equally shared between Oncura and IsoRay unless the arbitrators assess as
part of their award all or any part of the arbitration expenses of a Party
(including reasonable attorneys' fees) against the other Party.
(iii) This
Section 12.13(b) shall not prohibit a Party from seeking injunctive relief from
a court of competent jurisdiction in the event of a breach or prospective breach
of this Agreement by any other Party which would cause irreparable harm to the
first Party.
12.14
Entire Agreement. This
Agreement constitutes the entire agreement among the Parties with respect to the
subject matter of this Agreement and supersedes all prior agreements and
understandings, both oral and written, among the Parties with respect to the
subject matter of this Agreement.
12.15
Parties in Interest. All
of the terms and provisions of this Agreement shall be binding upon, inure to
the benefit of and be enforceable by the Parties hereto and their respective
permitted successors and assigns.
12.16
Descriptive Headings.
The descriptive headings of this Agreement are for convenience only, and shall
be of no force or effect in construing or interpreting any of the provisions of
this Agreement.
12.17
Counterparts. This Agreement
may be executed simultaneously in any number\of
counterparts, any one of which need not contain the signature of more than one
Party but all such counterparts taken together shall constitute one and the same
agreement.
12.18
Rebates. Eligible
rebates will be paid to designated IsoRay department by the [**].
[Signature
Page Follows]
[**]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.
19
IN
WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by
its duly authorized representative as of the day and year first above
written.
ISORAY
MEDICAL, INC.
|
|
By:
|
/s/ Xxxxxx Xxxxxxx
|
Name:
Xxxxxx Xxxxxxx
|
|
Title:
Chief Executive Officer
|
ONCURA,
Inc.
|
|
By:
|
/s/ Xxxxxxx Xxxxxxxxx
|
Name:
Xxxxxxx Xxxxxxxxx
|
|
Title: President,
Oncura, Inc.
|
20
Exhibit
1.11
I-125
PRODUCTS & PRICING*
U.S.
Quarterly
Rebate
|
||||||||||||||
Product
Code
|
Product
|
UOM
|
UOM
Qty.
|
Price
|
Tier
1
<
[**]
Seeds
|
Tier
2
[**]
Seeds
|
Tier
3
>
[**]
Seeds
|
|||||||
6711
|
OncoSeed
Individual Seed
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6711C
|
OncoSeed
Individual Calibrated Seed
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6717-I125NVG
|
OncoSeed
Loaded in Oncura Needle
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6719-I125NVG
|
OncoSeed
Loaded in Other Specified Needles
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6719-RL
|
OncoSeed
Preloaded in Needle (Vari-Load™)
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6715
|
OncoSeed
Sterile Convenience Pack (SCP)
|
CTG.
|
15
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6788
|
OncoSeed
Sterile Convenience Pack (SCP)
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
7000
|
RAPID
Strand (Strand of 10 Seeds)
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
7007-I125NRVG
|
RAPID
Strand Loaded in Oncura Needle
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
7008-I125NRVG
|
RAPID
Strand Loaded In Customer Needles
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
7009-I125NRVG
|
RAPID
Strand Loaded In Other Needles
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
I125RSRX-RND
|
RAPID
Strand RX loaded in Round Hub Needle
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
I125RSRX-SQR
|
RAPID
Strand RX loaded in Square Hub Needle
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
I125RSRX-CUST
|
RAPID
Strand RX loaded in Customer Provided Needle
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6716-I125CCPNSR
|
OncoSeed
Stranded Loaded CCP Needle Round Hub
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6716-I125CCPNSS
|
OncoSeed
Stranded Loaded CCP Needle Square Hub
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6719-RSRL
|
OncoSeed
Stranded in Needle (Vari-Strand™)
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
671010-I125-RCAA
|
OncoSeed
Loaded Reuseable Mick Cartridge 10% Assay/Sterilized
|
CTG.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
671010-I125DCA
|
OncoSeed
Loaded Disposable Mick Cartridge 10% Assay
|
CTG.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
671010-I125DCAA
|
OncoSeed
Loaded Disposable Mick Cartridge 10% Assay/Sterilized
|
CTG.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
671010-I125SV
|
OncoSeed
Loose 10% Assay Charge
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
671010-I125SVG
|
OncoSeed
Loose 10% Assay/Sterilized
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
671100-I125SV
|
OncoSeed
Loose 100% Assay Charge
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
671100-I125SVG
|
|
OncoSeed
Loose 100% Assay/Sterilized
|
|
EA.
|
|
1
|
|
[**]
|
|
[**]
|
|
[**]
|
|
[**]
|
[**]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.
*These products shall be paid monthly
but all reconciliations shall be made on a quarterly basis.
1
Exhibit
1.11
125
PRODUCTS & PRICING*
CANADA
Quarterly
Rebate
|
||||||||||||||
Product
Code
|
Product
|
UOM
|
UOM
Qty.
|
Price
|
Tier
1
<
[**]
Seeds
|
Tier
2
[**]
Seeds
|
Tier
3
>
[**]
Seeds
|
|||||||
6711
|
OncoSeed
Individual Seed
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6711C
|
OncoSeed
Individual Calibrated Seed
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6717-I125NVG
|
OncoSeed
Loaded in Oncura Needle
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6719-I125NVG
|
OncoSeed
Loaded in Other Specified Needles
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6719-RL
|
OncoSeed
Preloaded in Needle (Vari-Load™)
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6715
|
OncoSeed
Sterile Convenience Pack (SCP)
|
CTG.
|
15
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6788
|
OncoSeed
Sterile Convenience Pack (SCP)
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
7000
|
RAPID
Strand (Strand of 10 Seeds)
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
7007-I125NRVG
|
RAPID
Strand Loaded in Oncura Needle
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
7008-I125NRVG
|
RAPID
Strand Loaded In Customer Needles
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
I125RSRX-RND
|
RAPID
Strand RX loaded in Round Hub Needle
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6717-I125CCPNSS
|
OncoSeed
Stranded Loaded CCP Needle Square Hub
|
EA.
|
1
|
[**]
|
[**]
|
[**]
|
[**]
|
|||||||
6719-RSRL
|
|
OncoSeed
Stranded in Needle (Vari-Strand™)
|
|
EA.
|
|
1
|
|
[**]
|
|
[**]
|
|
[**]
|
|
[**]
|
*These products shall be paid
monthly but all reconciliations shall be made on a quarterly basis.
2
Attachments
I-125
Activity & Availability Schedule
Median mCi
|
Median Air Kerma
|
|
0.234
|
0.297
|
|
0.254
|
0.323
|
|
0.275
|
0.349
|
|
0.299
|
0.380
|
|
0.324
|
0.411
|
|
0.352
|
0.447
|
|
0.382
|
0.485
|
|
0.414
|
0.526
|
|
0.449
|
0.570
|
|
0.487
|
0.618
|
|
0.529
|
0.672
|
|
0.574
|
0.729
|
|
0.623
|
0.791
|
|
0.676
|
0.859
|
|
0.733
|
0.931
|
|
0.796
|
1.011
|
*OncoSeed
is packaged with labeling information on air kerma strength and apparent
activity per seed, total air kerma strength and apparent activity, reference
date, number of seeds, and order I.D.
Air
kerma strength is specified in units of microGray meter squared per hour
(uGym(2)/h), and apparent activity have units of milliCurie (mCi)
1
Oncura I-125 Seed Calibration
Guide
|
||||||||||||||||
Order
Activity
|
(mCi)
|
Decay
Formula:
|
(EXP(-(LN(2)*t)/59.43))*Order
Activity
|
|||||||||||||
s
|
Tuesday
Delivery is 1st available activity for Friday
Calibration
|
|||||||||||||||
FRI.
|
SAT.
|
SUN.
|
MON.
|
TUES.
|
WED.
|
THUR.
|
FRI.
|
|||||||||
0.937
|
0.926
|
0.915
|
0.905
|
0.894
|
0.884
|
0.874
|
0.863
|
|||||||||
0.863
|
0.853
|
0.843
|
0.833
|
0.824
|
0.814
|
0.805
|
0.796
|
|||||||||
0.796
|
0.787
|
0.778
|
0.769
|
0.760
|
0.751
|
0.742
|
0.733
|
|||||||||
0.733
|
0.725
|
0.716
|
0.708
|
0.700
|
0.691
|
0.683
|
0.676
|
|||||||||
0.676
|
0.668
|
0.660
|
0.653
|
0.645
|
0.638
|
0.630
|
0.623
|
|||||||||
0.623
|
0.616
|
0.609
|
0.602
|
0.595
|
0.588
|
0.581
|
0.574
|
|||||||||
0.574
|
0.567
|
0.561
|
0.554
|
0.548
|
0.541
|
0.535
|
0.529
|
Sterile
Convenience Pack
|
||||||||
0.529
|
0.523
|
0.517
|
0.511
|
0.505
|
0.499
|
0.493
|
0.487
|
|||||||||
0.487
|
0.481
|
0.476
|
0.470
|
0.465
|
0.459
|
0.454
|
0.449
|
|||||||||
0.449
|
0.444
|
0.439
|
0.434
|
0.429
|
0.424
|
0.419
|
0.414
|
|||||||||
0.414
|
0.409
|
0.404
|
0.400
|
0.395
|
0.391
|
0.386
|
0.382
|
|||||||||
0.382
|
0.378
|
0.373
|
0.369
|
0.365
|
0.360
|
0.356
|
0.352
|
|||||||||
0.352
|
0.348
|
0.344
|
0.340
|
0.336
|
0.332
|
0.328
|
0.324
|
|||||||||
0.324
|
0.320
|
0.317
|
0.313
|
0.309
|
0.306
|
0.302
|
0.299
|
|||||||||
0.299
|
0.296
|
0.292
|
0.289
|
0.285
|
0.282
|
0.279
|
0.275
|
|||||||||
0.275
|
0.272
|
0.269
|
0.266
|
0.262
|
0.259
|
0.256
|
0.254
|
|||||||||
0.254
|
0.251
|
0.248
|
0.245
|
0.242
|
0.240
|
0.237
|
0.234
|
|||||||||
0.234
|
0.231
|
0.229
|
0.226
|
0.223
|
0.221
|
0.218
|
0.215
|
|||||||||
0.215
|
0.213
|
0.210
|
0.208
|
0.205
|
0.203
|
0.200
|
0.199
|
|||||||||
0.199
|
0.197
|
0.194
|
0.192
|
0.190
|
0.188
|
0.186
|
0.183
|
|
2
Product
Order, Availability & Return Schedule
Standard Delivery Service:
All direct non
custom I-125 orders are shipped for next day delivery. For custom services,
ONCURA requests that all orders are placed by 4:00 PM CT three (3) business days
before the implant. Please allow five (5) business days for custom
stranding services.
Standard Delivery Fees: $40
per order.
Order Information: All non
custom I-125 product orders are shipped directly from G.E. Healthcare’s
manufacturing facility in North Arlington Heights, IL, or via a designated
radiopharmacy. Orders can be placed by
calling Oncura @ 0-000-000-0000,
or 0-000-000-0000.
FAX orders can be placed @ 0-000-000-0000. Electronic
orders can be placed through XxxxxxxXxxxxxXXX@Xxxxxx.xxx.
All orders are shipped via FEDEX for overnight delivery.
Returned
Goods Policy:
Returns
for Disposal - No
return fee.
Return
for Credit - 100%
credit to account if a patient is unable to undergo treatment, based on a
medical condition not previously identified, or for any unforeseen circumstances
beyond physician or facility control, and if Oncura customer service is notified
by 4:00 PM CT on scheduled day of implant. Please note that a signed physician
statement supporting this decision is required. Oncura Products may be returned
for credit or disposal with prior authorization from our Customer Service
Department. The required Return Material Authorization (RMA) number and
applicable shipping labels will be provided by the Oncura Customer Support Group
(000) 000-0000. All approved credits will be issued within 30 days after receipt
of product. Products returned for credit should be returned unused in
the original packaging and in good condition.
3