Document:

Exhibit
10.12

 

CONFIDENTIAL TREATMENT REQUESTED

 

INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED IS OMITTED

AND NOTED WITH “****”.

AN UNREDACTED VERSION OF THIS DOCUMENT HAS ALSO BEEN PROVIDED TO THE

SECURITIES AND EXCHANGE

COMMISSION.

 

Execution
Version / Nordion DOC # 84734

MOLYBDENUM-99 PURCHASE & SUPPLY AGREEMENT

 

THIS AGREEMENT (this
“Agreement”)  is made and entered into effect as of
April 1, 2010 (the  “Effective Date”)  by and between:

 

Lantheus Medical Imaging, Inc.

331 Treble Cove Road,

North Billerica, MA
01862

(“LMI”)

 

and

 

MDS Nordion, a division of
MDS (Canada) Inc. 

447 March Road

P.O. Box 13500

Kanata, Ontario K2K 1X8

(“Nordion”)

 

A.    WHEREAS, Nordion is a
supplier of Sodium Molybdate Molybdenum- 99 (fission) (defined herein as “Product”)

 

B.    WHEREAS, Nordion desires to
make available quantities of Product to LMI for purchase by LMI pursuant to the
terms of this Agreement;

 

C.    WHEREAS, LMI desires to
purchase certain quantities of Product from Nordion on a non-exclusive basis
pursuant to the terms of this Agreement.

 

NOW, THEREFORE, in consideration of the foregoing
recitals, mutual covenants, agreements, representations and warranties
contained herein, the parties hereby agree as follows:

 

1.     Definitions

 

1.1     In this Agreement, the
following terms shall have the respective meanings set forth in this Section 1:

 

1.1.1.       “Agreement”
shall mean this Agreement and Schedules attached hereto.

 

1.1.2.       “Calendar
Week” means the period beginning on Sunday and ending the following Saturday.

 

1.1.3.       “CDA” means the Confidential Disclosure Agreement between
Nordion and LMI dated as of the 1st day of April, 2010, a copy of which is
attached as Schedule A to this Agreement.

 

 

1.1.4.       “Commencement
Date” means the first date after the Effective Date on which Atomic
Energy of Canada Ltd. (“NRU Reactor”)
begins to supply to Nordion commercial quantities of Molybdenum-99 material
used in the production of Product following the cessation of the shutdown of
the NRU Reactor in effect as of the Effective Date, which date shall be
notified by Nordion to LMT in writing.

 

1.1.5.       “Confidential
Information” shall have the meaning ascribed to such term in the
CDA.

 

1.1.6.       “Contract
Term” means the term of this Agreement, which shall commence as of
the Effective Date and terminate as of July 31, 2011 unless otherwise
extended or terminated pursuant to this Agreement.

 

1.1.7.       “Effective
Date” shall have the meaning ascribed in the preamble. 

 

1.1.8.       “Firm
Order(s)” shall have the meaning ascribed in Section 3.1 

 

1.1.9.       “Force
Majeure” shall have the meaning ascribed in Section 17.1 

 

1.1.10.     “Forecast”
shall have the meaning ascribed in Section 3.1.

 

1.1.11.     “Generator(s)”
shall mean a LMI generator containing Product, which Product has been supplied
by Nordion pursuant to this Agreement.

 

1.1.12.     “Governmental
Agencies” means various applicable federal, state, provincial and
local governmental agencies that control the manufacture, transit, distribution
and usage of Product in any country. Governmental Agencies include, but are not
limited to: U.S. Food and Drug Administration (“FDA”),
U.S. Nuclear Regulatory Commission (“NRC”), U.S.
Department of Transportation (“DOT”), U.S.
Customs and Border Patrol, Health Canada, Canadian Nuclear Safety Commission (“CNSC”), Transport Canada, IATA, IAEA, or corresponding
governmental agencies in any country Product may pass through, and any
successor agency thereto.

 

1.1.13.     “Product(s)” means Sodium Molybdate
Molybdenum-99 (fission). 

 

1.1.14.     “Product Fee”
shall have the meaning ascribed in Section 5.1.

 

1.1.15.     “Specifications”
means the characteristics of the Product, in conformance with Schedule C, as
amended by the mutual written agreement of the parties from time to time.

 

Schedules:

 

Schedule A - Confidential Disclosure Agreement 

Schedule B - Form of LMI Purchase Order

 

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Schedule C - Product Specifications 

Schedule D - Product Fees

Schedule E - Shipping Schedule

 

1.2     The headings in this
Agreement are inserted only for convenience and shall not affect the
construction hereof.

 

1.3     Where appropriate, words
denoting a singular number only shall include the plural and vice versa.

 

1.4     Reference to any statute,
regulation, regulatory provision or statutory provision includes a reference to
the statute, regulation, regulatory provision or statutory provision, as from
time to time amended, extended or re-enacted.

 

1.5     The words “herein”,
“hereof”, “hereunder”, “hereby” and other words of similar import refer to this
Agreement as a whole, including the schedules, annexes of and exhibits to this
Agreement, and not to any particular provision.

 

2.     Appointment

 

2.1     Pursuant to and subject to
the terms and conditions of this Agreement, LMI agrees on a non-exclusive
basis, to purchase Product from Nordion.

 

3.     Forecast; Orders

 

3.1     Orders. LMI shall, in
writing, submit to Nordion on the 1st  day of each month during the
Contract Term, a good faith, non binding rolling forecast of the estimated
quantity of Product LMI expects to order from Nordion during the **** (****)
day period following the date of the forecast (each such forecast, a “Forecast”). LMI shall issue a purchase order (“Firm Order”) in accordance with LMI’s **** purchase volume
commitments in Section 3.4. LMI’s Firm Order shall be provided to Nordion
at least **** (****) days in advance of the required date of Product shipment.
Nordion shall use commercially reasonable efforts to accept LMI’s Firm Orders
(issued in accordance with this Agreement) with respect to LMI’s **** purchase
volume commitments in accordance with Section 3.4. Each Firm Order shall
be subject to confirmation of acceptance by Nordion in writing. LMI may revise
a Firm Order accepted by Nordion by no more than ****% (subject to and not to
exceed or be inferior to, LMI’s **** purchase volume commitments in accordance
with Section 3.4) up to seven (7) days prior to shipment of Product
by Nordion. Any adjustment upward requested by LMI for Product in a Firm Order
is subject to availability and acceptance by Nordion. Nordion shall use
commercially reasonable efforts to fill such Firm Orders. LMI expects to
provide the first forecast in connection with the execution of this Agreement
with the understanding that this forecast will provide at least **** days
notice as of the Commencement Date.

 

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Subject to the terms of this Agreement, Nordion
shall notify LMI promptly in writing if at any time Nordion has reason to
believe that it will not be able to accept or fulfill a Firm Order.

 

3.2     Form of Order.  LMI  shall submit purchase orders for
Product in the form of the purchase order set out in Schedule B (the “Form Purchase Order”). Unless expressly agreed to by
Nordion, any standard terms and conditions appearing in LMI’s purchase order
(or reverse side thereof) in conflict with or different from the terms and
conditions contained in this Agreement, shall not apply.

 

3.3     Acceptance of Orders. Nordion shall
indicate its acceptance of LMI’s purchase orders for the Product by promptly
acknowledging acceptance of each purchase order in writing. Each such
acceptance shall include the anticipated ship date of the Product ordered. No
Firm Order issued and/or accepted pursuant to this Agreement shall extend to
delivery of Product beyond the Contract Term.

 

3.4     Purchase Volumes. Subject to
the terms of this Agreement including but not limited to Sections 4.4, 4.7 and
6.2 hereof and as of the Commencement Date and subject to Nordion’s ability to
supply Product to LMI meeting the requirements of this Agreement and acceptance
by Nordion of LMI’s Firm Orders sufficient to meet LMI’s **** purchase volume
commitments in this Section 3.4:

 

3.4.1.    during the portion of the
Contract Term when HFR Petten reactor is shut down and unable to produce
Molybdenum- 99 (the “HFR Shutdown Period”), LMI hereby commits to purchase from
Nordion **** to **** **** of Product (****-day ****) per **** during the HFR
Shutdown Period, and

 

3.4.2.    during the portion of the
Contract Term after the HFR Shutdown Period and return to service, which date
shall be acknowledged by the parties in writing, LMI hereby commits to purchase
from Nordion **** to **** **** of Product (****-day ****) per ****.

 

3.5     Spot Market Purchases. In addition
to the foregoing, LMI may, from time to time during the Contract Term, desire
to purchase from Nordion incremental orders for Product in a given **** in
excess of the LMI’s **** purchase volume commitments in Section 3.4.
Notwithstanding Section 3.1, acceptance by Nordion of any incremental
orders for Product issued by LMI in a given **** in excess of the **** LMI
purchase volume commitment in Section 3.4, shall be entirely at the
unfettered discretion of Nordion. Any such incremental order accepted (or not
accepted) by Nordion in a given **** shall not, in such **** or any other ****,
serve to diminish any LMI purchase volume commitment as set out in Section 3.4.
If such incremental orders are accepted by Nordion, the price for all Product
pursuant to such orders shall be the Product Fee (as hereinafter defined) and
Nordion shall use commercially reasonable efforts to fill such accepted
purchase orders.

 

4

 

4.     Terms of Supply

 

4.1     Shipping Schedule. Commencing on
the Commencement Date, Nordion shall deliver Product in accordance with the
initial shipping schedule set out on Schedule E. Nordion and LMI agree to enter
into good faith discussions, from time to time, to negotiate in good faith a
revised shipping schedule that reflects the needs of LMI’s customers and, the
parties as required and agreed, shall amend the shipping schedule as reasonably
necessary to meet those needs taking into account Nordion’s Product production
schedule, regulatory requirements, the availability of carriers and other
logistical circumstances that may impact the manufacture and shipping of
Product. In the event that the parties do not agree to a revised shipping
schedule, Nordion shall continue to ship Product in accordance with the initial
shipping schedule set out in Schedule E as unamended.

 

4.2     Product Delivery. Nordion shall
deliver Product to LMI on the date of shipment **** **** (INCO Terms 2000),
provided further, that it shall be LMI’s responsibility to load Product into
the air carrier. All right, title and interest in and to the Product and risk
of loss and damage to Product shall pass to LMI, **** **** (INCO Terms 2000).

 

4,3     Containers. Nordion shall
supply Product to LMI in containers which meet all applicable regulations of
Governmental Agencies having jurisdiction over transport of the Product. LMI
shall not use such containers for any other purpose.

 

4.4     Conformance to
Specification; Warranty. Nordion shall manufacture and supply the
Product in conformance with the Specifications and all applicable laws. Nordion
hereby provides a Product warranty such that on the date of receipt of the
Product at LMI’s facility, the Product shall be free from defects in material
and workmanship, provided further however that Nordion shall have no warranty
obligation in the event that the Product is subject to accident, misuse, abuse
or alteration. Any such warranty claim shall be notified to Nordion in writing
within seven (7) days of the receipt by LMI of Product, specifying the
details of the alleged defect. In the event that the warranty claim is well
founded, Nordion shall replace the defective Product at no charge (if the
purchase price therefore has already been paid by LMI) or alternatively LMI may
cancel such order and Nordion shall not require that LMI pay for such defective
Product that fails to meet the Specification (with a consequential reduction
with respect to the affected Calendar Week purchase volume commitment
requirement as set out in Section 3.4, as the case may be).

 

LMI ACKNOWLEDGES THAT NORDION IS MANUFACTURING AND
SUPPLYING PRODUCT TO MEET SPECIFICATION. EXCEPT AS EXPRESSLY SET OUT IN THIS
AGREEMENT, NORDION HEREBY DISCLAIMS ALL OTHER WARRANTIES OR CONDITIONS, WHETHER
EXPRESS OR IMPLIED STATUTORY OR OTHERWISE INCLUDING BUT NOT LIMITED TO ANY
IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE, APPLICATION OR USE.

 

5

 

4.5     Quality Control Release. LMI shall upon
receipt of the Product at its facility have the ability and responsibility to
verify, test, or otherwise inspect the Product, for the purpose of
determination of conformance to Specifications. LMI shall test or cause to be
tested all Products prior to LMI quality control (QA) release of Product for
sale to its customers. Notwithstanding the foregoing, the Product shall be
deemed conforming by LMI upon LMI quality control (QC) release of Product for
Generator manufacturing.

 

4.6     Dispute Resolution. In the event
that Nordion disputes LMI’s determination that the Product does not conform to
Specification or there is an unresolved measurement discrepancy, the parties
will appoint a joint technical team to review the issue and provide a
recommendation. In the event the joint technical team is unable to agree on a
recommendation then the parties will select a mutually acceptable outside
consulting firm which will be instructed to make a determination. If the
consulting firm confirms LMI’s determination, Nordion will in accordance with
this Agreement be considered to have failed to meet Specification, and Nordion
will pay the fees of such consulting firm. If the consulting firm dissents from
LMI’s determination, Nordion shall be entitled to be paid for such Product and
LMI shall pay the fees of the consulting firm.

 

4.7     Allocation of Product. In the event
during any **** that the total volume of Product available for sale by Nordion
is not sufficient to meet order commitments to all Nordion customers for such ****
because of any occurrence affecting supply of Molybdenum-99 to or supply of
Product from Nordion, then notwithstanding an accepted Firm Order or accepted purchase
order LMI’s allocation of Product available for purchase from Nordion during
such entire period of insufficiency will be based on the Allocation Percentage
(as hereinafter defined). “Allocation
Percentage” means, with respect to any ****, the percentage of
Product purchased by LMI from Nordion in the immediately previous **** (****)
calendar **** period (or, in the absence of a **** (****) calendar **** period,
such portion thereof) prior to such **** determined as the ratio of (i) LMI’s
Product purchases from and delivered by Nordion divided by (ii) the total
amount of Product purchased from and delivered by Nordion to all Nordion
customers (including LMI) during such **** (****) calendar **** period (or, in
the absence of a **** (****) calendar **** period, such portion thereof).

 

5.     Pricing and
Terms of Payment

 

5.1     Price. The purchase
price of Product shall be as set forth on Schedule D attached hereto (the “Product Fee”). During the Contract Term after the Commencement Date, the
Product Fee LMI pays for the Product shall not be **** than the purchase price
(as calculated consistent with calibration as set out in Schedule C) paid by
each **** (excluding purchases for research or other non-commercial purposes)
from Nordion for delivery into ****. For purposes of calculating the purchase
price paid by **** (excluding purchases for research or other non-commercial
purpose) for delivery into **** pursuant to a written contract with Nordion,
the parties agree that the purchase price, paid by such **** for delivery into ****
in a different currency than is applicable in this Agreement, shall be
determined taking into account the exchange rate of the United

 

6

 

States dollar against such different currency as at
the execution date of such contract. At any time reasonably requested by LMI
(but no more frequently than **** per calendar ****), Nordion will furnish to
LMI a certificate, executed by a duly authorized officer of Nordion, stating
that such officer has reviewed all of the sales of Product by Nordion during
the Contract Term and that Nordion has complied with this Section 5.1. To
the extent it is determined that Nordion is not in compliance with this Section 5.1,
Nordion will credit LMI with the difference between the Product Fee and the
amount otherwise contemplated by the second sentence of this Section 5.1,
and any such difference will, be paid by Nordion to LMI in the form of a ****
and shall only bear interest at the annual rate of ****%, calculated ****%
monthly, commencing from and after the date which is **** (****) days after the
date that LMI would have been entitled to such adjustment. In addition, the
parties acknowledge that noncompliance with this Section 5.1 will result
in an adjustment to the **** by LMI for Product purchased by LMI only during
the period in which the purchase price of Product to **** (excluding purchases
for research and other non-commercial purposes) for delivery into ****, was ****
than the ****.

 

5.2     LMI Payment. Upon or after
shipment of Product Nordion shall invoice LMI for any Product that LMI orders
and LMI shall pay such invoice within **** (****) days of the date of the
invoice. Nordion shall provide LMI with a copy of each invoice by electronic
mail (e.g., a “pdf” file) or other mutually agreed upon form of electronic communication
within **** (****) hours of the applicable invoice date. Overdue accounts shall
bear interest at the annual rate of ****%, calculated ****% monthly.

 

5.3     Payment Adjustments. In the event
the quantity of the Product shipped is greater or less than the quantity
reflected in Nordion’s invoice for such shipment, then within **** (****) days
after LMI’s receipt of such shipment, LMI shall notify Nordion concerning such
overage or shortage, and, unless Nordion disputes such notice (in which case
the dispute resolution mechanism in Section 4.6 shall apply), the amount
of such invoice shall be increased or reduced, as the case may be, to reflect
the actual quantity of the Product contained in such shipment and received by
LMI. In the event that LMI has already overpaid such invoice any amount of
overpayment shall be reimbursed or credited to LMI at LMI’s election. LMI and
Nordion shall work together to establish a procedure to validate the
instrumentation respectively used by each party to accurately verify the amount
of Product shipped by Nordion and received by LMI.

 

6.     Term;
Termination

 

6.1     Term. The supply of
Product by Nordion pursuant to this Agreement shall commence as of the
Commencement Date and shall continue thereafter during the Contract Term. Any
extension of this Agreement shall be in writing and shall require the mutual
agreement of the parties.

 

6.2     Termination for Breach. Except as
specifically otherwise provided, the failure by either Party (the “Defaulting Party”) to comply with its
material obligations under this Agreement shall entitle the other Party (the “Non-Defaulting Party”) to give to the

 

7

 

Defaulting Party notice specifying the nature of the
default and requiring the Defaulting Party to cure such default. Subject to the
provisions of Section 17 hereof, if such default (i) is not cured within
30 days after the receipt of such notice or, (ii) if such default cannot
reasonably be cured within such 30-day period and the Defaulting Party shall
not have commenced and be diligently continuing actions to cure such default during
such 30-day period, the Non-Defaulting Party shall be entitled, without
prejudice to any of the other rights conferred on it by this Agreement or
available to it at law or in equity to terminate this Agreement by giving
further notice to the Defaulting Party, to take effect immediately upon receipt
of such termination notice by the Defaulting Party.

 

In addition to and notwithstanding any remedies set
out in this Agreement or available in law or equity, in the event that LMI, in
accordance with this Agreement, fails to purchase any or all of its ****
purchase volume commitments in accordance with (and subject to the terms of)
Section 3.4 (and except in the event of an ongoing bona fide dispute
regarding a shipment of Product from Nordion to LMI), (i) Nordion shall
during the Contract Term be entitled to claim (and invoice) payment from LMI at
the Product Fee for an amount of such Product equal to the shortfall in such
purchase volume commitments and LMI shall make full payment for such Product
and/or (ii) Nordion, upon written notice to LMI, may immediately suspend
further supply of Product to LMI until such time as such amounts are paid in
full. In the event that Nordion suspends supply of Product to LMI, supply of
Product may, at Nordion’s election, not be resumed by Nordion until one (1) Calendar
Week after amounts due and owing by LMI to Nordion are paid in full.
Notwithstanding the foregoing, for the sake of clarity, the parties acknowledge
and agree that, to the extent Nordion exercises its right to suspend further
supply of Product to LMI pursuant to this Agreement, LMI shall have no
obligation to purchase the aforementioned purchase volume commitments during
the period of suspended supply of Product or make any payments with respect
thereto.

 

The right of termination as provided in this Section 6.2,
shall not be affected in any way by either party’s waiver or failure to take
action with respect to any previous default.

 

6.3     Termination for Bankruptcy. Subject to
any limitations imposed by applicable law, a party shall have the right to
terminate this Agreement by giving notice to the other party in the event that
such other party files a petition in bankruptcy, is adjudicated a bankrupt,
makes an assignment for the benefit of its creditors, or otherwise seeks relief
under or pursuant to any bankruptcy, insolvency or reorganization statute or
proceeding, or if a petition in bankruptcy is filed against it which is not
dismissed within ninety (90) days or proceedings are taken to liquidate the
assets of such party or a supervisor, receiver, administrator, administrative
receiver or other encumbrancer taking possession of or being appointed over, or
any distress, execution or other process being levied or enforced (and not
being discharged within seven days) upon, the whole or any substantial part of
the assets of the other party.

 

8

 

7.     Compliance, Certification, and
Related Matters

 

7.1     Compliance with Law. While Product
is in Nordion’s possession or under its control, Nordion shall be responsible
for complying with and shall comply with all applicable statutory and regulatory
requirements of the United States and Canada regarding the manufacture,
handling, storage, packaging, transportation, shipment and exporting of
Product. In performing its obligations under this Agreement, Nordion shall
comply with all applicable environmental and health and safety laws. Except as
otherwise set forth in this Agreement, Nordion shall be solely responsible for
determining how to carry out these obligations.

 

7.2     Licenses. Nordion shall
be responsible at its own expense for obtaining and maintaining all necessary
licenses including, without limitation, facility licenses, registrations,
authorizations and approvals, which are necessary to develop, manufacture,
handle, store, label, package, and transport Product under the applicable
regulatory requirements including, but not limited to, the possession, storage,
and transportation of radioactive materials. Nordion shall maintain and update
its existing regulatory filings with the FDA, NRC, DOT, CNSC, and any other
regulatory agency as may be required by applicable law.

 

7.3     Certification. For each
shipment of Product, Nordion shall certify in writing that each lot of Product
shipped was produced and tested in compliance with the Specifications.

 

7.4     Access to Nordion’s Facility. LMI shall
have reasonable access to Nordion’s facility and procedures no more frequently
than once per Contract Term (except in the event of Product recall or safety
concerns, in which case as reasonably required) for the sole purpose of
auditing Nordion’s Product manufacturing process. All such information
disclosed during such audit to LMI or its employees or agents shall be deemed
to be Nordion’s Confidential Information as such term is defined in this
Agreement.

 

7.5     Quality Assurance Program. Nordion shall
maintain production and quality assurance as required by government or
regulatory bodies with jurisdiction over Nordion’s manufacture of Product and
its sale and distribution. It is acknowledged by Nordion and LMI that as a
result of any in-house manufacturing and testing of Product, that the
Specifications may require amendment or modification. LMI and Nordion agree
that any such amendment or modification shall be discussed in good faith, and
shall be subject to the approval of LMI which shall not be unreasonably
withheld.

 

8.     Manufacturing Process

 

8.1     Change in Nordion’s
Processes. The parties acknowledge that this Agreement is
based on the current Nordion process for manufacturing and shipping of Product.
Any change in the processes used by Nordion, including, but not limited to, the
reactor used as the source of supply and the characteristics of the materials
used may or will require a new validation of the Product to confirm that it
meets the Specifications. Accordingly, Nordion shall notify LMI at least sixty
(60) days prior to instituting any change in its

 

9

 

processes. Subject to Nordion approval of the change
in process, where LMI has requested or necessitated the change in process, LMI
will bear the cost of validation. Where Nordion has requested or necessitated
the change in process, Nordion will bear the cost of validation.

 

9.     Contract Currency

 

9.1     All prices and payments
herein by LMI to Nordion shall be in ****.

 

10.  Confidentiality

 

10.1   The  CDA is incorporated by
reference and made a part of this Agreement.

 

11.  Nordion’s Representations

 

11.1   Nordion represents and
warrants as of the Effective Date that:

 

(i)         it has full right, power and
authority to enter into this Agreement;

 

(ii)        to its knowledge it is in
material compliance with all applicable laws and regulations of all relevant
Governmental Agencies in connection with the manufacture, distribution and sale
of the Product as contemplated by this Agreement and has not received any
notice or other correspondence from any relevant Governmental Agency in
connection with any alleged non-compliance in connection therewith;

 

(iii)       it has not received any
notice of adverse claim of infringement of any patent or other intellectual
property right, including, without limitation, misappropriation of trade
secret, in connection with the use and sale of Product or the data, information
and technology used with respect to the manufacture of Product;

 

(iv)       to the best of its knowledge
and belief (i) it is the owner or has the right to use all of the data,
information, know-how, intellectual property and technology to be used by
Nordion in carrying out its obligations hereunder, and (ii) development and
implementation of the process used in the manufacture of Product, and the
performance of Nordion’s obligations hereunder, do not infringe any valid third
party patent or pending published patent application or other intellectual
property right; and

 

(v)        there is no action or
proceeding pending or, to the best of its knowledge, threatened against Nordion
before any court, administrative agency or other tribunal which would have a
material adverse effect on Nordion’s ability to perform under this Agreement.

 

10

 

12.       LMI’s Representations

 

12.1        LMI represents and warrants as of the Effective Date that:

 

(i)                           it has full right, power and authority to enter into this Agreement;

 

(ii)                        it has not received any notice of adverse claim of infringement of any patent or other intellectual property right, including, without limitation, misappropriation of trade secret, in connection with the use of the Product or the data, information and technology used with respect to the manufacture and sale of Generators; and

 

(iii)                     there is no action or proceeding pending or, to the best of its knowledge, threatened against LMI before any court, administrative agency or other tribunal which would have a material adverse effect on LMI’s ability to perform under this Agreement.

 

(iv)                    to its knowledge it is in material compliance with all applicable laws and regulations of all relevant Governmental Agencies in connection with the use and sale of the Product and has not received any notice or other correspondence from any relevant Governmental Agency in connection with any alleged non-compliance in connection therewith.

 

13.       Regulatory Compliance

 

13.1        In the event that a Governmental Agency in any country shall allege or prove that a Product does not comply with applicable rules and regulations in a country where the Product is marketed, distributed and sold, LMI shall notify Nordion immediately, and both parties shall cooperate fully regarding the investigation and disposition of any such matter. If LMI is required to recall or should deem it appropriate, acting reasonably, to voluntarily withdraw a Product or a Generator, then Nordion’s liability shall be limited to reimbursement to LMI of the actual cost of the quantity of Product purchased by LMI subject to the recall to the extent that such recall or withdrawal is due to Nordion’s negligence, recklessness or wrongful intentional acts or omissions by, or strict liability of, or breach of any representation and warranty; otherwise, LMI shall bear all costs and expenses associated with such recall or withdrawal. For purposes of clarity, the parties acknowledge that nothing in this Section 13 shall affect or limit any right that a party may have to seek indemnification from the other party under Section 14 of this Agreement.

 

14.       Indemnification

 

14.1        Nordion Indemnification Obligations. Nordion agrees to indemnify, defend and hold harmless LMI and its affiliates and their respective directors, officers, employees and agents from and against any damages, claims, liabilities and expenses (including, but not limited to, reasonable attorney’s fees and disbursements) resulting from any third party claims or suits (“General Claims against LMI”) arising out of (a) Nordion’s manufacturing, handling, storage, labeling, or packaging of Product; (b) Nordion’s breach

 

11

 

of any of its obligations, warranties or representations hereunder; (c) Nordion’s negligent acts or omissions or willful misconduct; (d) any failure of Product to meet the Specifications; or (e) any failure of Nordion to manufacture, handle, store, label, package, transport or ship Product in accordance with any applicable laws, regulations or other requirements of any applicable Governmental Agency, including, but not limited to, any violation of applicable laws or regulations concerning radioactive material. Notwithstanding the foregoing, Nordion will not be required to indemnify, defend and hold harmless LMI and its affiliates and their respective directors, officers, employees and agents from and against any General Claims against LMI to the extent that such claims arise out of (i) LMI’s breach of any of its obligations, warranties or representations hereunder; (ii) LMI’s or its employees, representatives, agents contractors or customers negligent acts or omissions or willful misconduct, including but not limited with respect to the use, handling or sale, storage combination, labeling, packaging, transport or disposal of Product or Generators, or (iii) any failure of LMI, its employees, representatives, agents, contractors or customers to manufacture, handle, store, label, package, transport or ship Generators (including Product) in accordance with any applicable laws, regulations or other requirements of any applicable Governmental Agency, including, but not limited to, any violation of applicable laws or regulations concerning radioactive material. Notwithstanding anything in this Section 14.1, General Claims against LMI shall not include intellectual property claims against LMI as described in Section 14.4.

 

14.2        LMI Indemnification Obligations. LMI agrees to indemnify, defend and hold harmless Nordion and its affiliates and their respective directors, officers, employees and agents from and against any damages, claims, liabilities and expenses (including, but not limited to, reasonable attorney’s fees and disbursements) resulting from any third party claims or suits (“General Claims against Nordion”) arising out of (a) LMI’s or its customer’s use, handling or sale, storage, combination, labeling, packaging, transport or disposal of Product or Generators; (b) LMI’s breach of any of its obligations, warranties or representations hereunder; (c) LMI’s negligent acts or omissions or willful misconduct; or (d) any failure of LMI to manufacture, handle, store, label, package, transport or ship Product or Generators in accordance with any applicable laws, regulations or other requirements of any applicable Governmental Agency, including, but not limited to, any violation of applicable laws or regulations concerning radioactive material. Notwithstanding the foregoing, LMI will not be required to indemnify, defend and hold harmless Nordion and its affiliates and their respective directors, officers, employees and agents from and against any General Claims against Nordion to the extent that such claims arise out of (i) Nordion’s breach of any of its obligations, warranties or representations hereunder; (ii) Nordion’s or its employees, representatives, agents, contractors negligent acts or omissions or willful misconduct, including but not limited with respect to the manufacture, handling, storage, labeling or packaging of Product, (iii) any failure of Product to meet the Specifications attributable to Nordion; or (iv) any failure of Nordion, its employees, representatives, agents, contractors to manufacture, handle, store, label, package, transport or ship Product in accordance with any applicable laws, regulations or other requirements of any applicable Governmental Agency, including, but not limited to, any violation of applicable laws or regulations concerning

 

12

 

radioactive material. Notwithstanding anything in this Section 14.2 General Claims against Nordion shall not include intellectual property claims against Nordion as described in Section 14.3.

 

14.3        Intellectual Property Claims Against Nordion. LMI agrees to indemnify, defend and hold harmless Nordion and its affiliates and their respective directors, officers employees and agents from and against any damages, claims, liabilities and expenses (including, but not limited to, reasonable attorney’s fees and disbursements) resulting from any third party claims or suits arising out of any proceeding instituted by or on behalf of a third party based upon a claim that,

 

(i)                  the use or sale of LMI’s Generators or use, method of use or application of the Product sold by LMI in combination with another substance, and

 

(iii)            the performance of any of LMI’s obligations hereunder,

 

infringes any United States or other patent or any other proprietary rights of a third party.

 

14.4        Intellectual Property Claims Against LMI. Nordion agrees to indemnify, defend and hold harmless LMI and its affiliates and their respective directors, officers, employees and agents harmless from and against any damages, claims, liabilities and expenses (including, but not limited to, reasonable attorney’s fees and disbursements) resulting from any third party claims or suits arising out of any proceeding instituted by or on behalf of a third party based upon a claim that the process used in manufacturing Product, the Product, or the performance of any of Nordion’s obligations hereunder infringes a United States or other patent or any other proprietary right of a third party.

 

14.5        Indemnification Procedures. A party (the “Indemnitee”) which intends to claim indemnification under this Section 14 shall promptly notify the other party (the “Indemnitor”) in writing of any action, claim or other matter in respect of which the Indemnitee or any of its directors, officers, employees or agents intend to claim such indemnification; provided, however, the failure to provide such notice within a reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder except to the extent the Indemnitor is prejudiced by such failures. The Indemnitee shall permit, and shall cause its directors, officers, employees and agents to permit the Indemnitor, at its discretion, to settle any such action, claim or other matter. The Indemnitee agrees to the complete control of such defense or settlement by the Indemnitor, provided, however, such settlement does not adversely affect the Indemnitee’s rights hereunder, admit liability by Indemnitee or impose any obligations on the Indemnitee. No such action, claim or other matter shall be settled without the prior written consent of the Indemnitee, and the Indemnitee shall not be responsible for any attorney’s fees or other costs incurred other than provided herein. The Indemnitee and its directors, officers, employees and agents shall co-operate fully with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or other matter covered by this indemnification. The Indemnitee shall

 

13

 

have the right, but not the obligation, to be represented by counsel of its own selection and at its own expense.

 

15.       Effect

 

15.1                           This Agreement, together with the Schedules embodies and sets forth the entire agreement and understanding of the parties with respect to the subject matter hereof and there are no promises, terms, conditions or obligations, oral or written, expressed or implied, other than those contained in this Agreement, the Schedules and the CDA. The terms of this Agreement supersede all previous oral or written agreements that may exist or have existed between the parties relating to the subject matter of this Agreement. Neither party shall be entitled to rely on any agreement, understanding or arrangement that is not expressly set forth in this Agreement, the Schedules and the CDA. If LMI issues any purchase orders in connection with this Agreement, this Agreement shall be deemed to be incorporated by reference into the purchase order.

 

16.       Miscellaneous

 

16.1                           Binding Effect. The terms of this Agreement shall bind Nordion and LMI and their respective successors and permitted assigns.

 

16.2                           Use of Name. Except as otherwise provided herein, neither party shall have any right, express or implied, to use in any manner the name or other designation of the other party or any other trade name or trademark of the other party for any purpose in connection with the performance of this Agreement.

 

16.3                           Public Announcements. The parties agree that, except as set out in this Agreement or may otherwise be required by applicable law, no information concerning this Agreement and the transactions contemplated herein shall be made public by either party without the prior written consent of the other party. Each party shall however, have the right to make any public statements related to market supply without the consent of the other party provided there is no anticipated adverse impact or effect on the reputation of the other party and there is no reference specifically or which could reasonably be implied identifying the other party or referencing the trade name or trademark of the other party. In the event either party decides to issue a press release announcing the execution of this Agreement, it shall not do so without the prior written approval of the other party. A copy of any proposed press release shall be provided to the other party for approval at least four (4) business days prior to any proposed release. In the event that a disclosure is required pursuant to security exchange rules and regulations or rules and regulations of other Governmental Agencies or stock exchanges, LMI or Nordion as the case may be, shall provide reasonable notice to the other party prior to any such disclosure in order to permit, to the extent possible, such party to purge or otherwise redact the disclosure of Confidential Information to the extent permitted by applicable law, while enabling the other party to comply with the applicable Governmental Agency or applicable law. Each party may disclose this Agreement and the commercial relationship

 

14

 

contemplated herein to potential successors and permitted assigns or financing sources as may be required in connection with the due diligence (and after receipt of a bona fide expression of interest) obligations of such persons having a need to know such information. Prior to LMI or Nordion disclosing this Agreement and the commercial relationship contemplated herein to a potential successor or permitted assign that is a direct competitor or customer of the non-assigning party, the assigning party shall provide the non-assigning party an opportunity to redact or otherwise protect its information of commercially sensitive nature. In any event any such permitted disclosure shall be subject to confidentiality obligations of the type substantially similar to those contained in this Agreement including the CDA.

 

16.4                           Amendment or Modification. This Agreement may not be amended, modified, varied or supplemented, nor any provision hereof waived, except in writing signed by duly authorized representatives of the both parties.

 

16.5                           Assignment. Neither party shall be entitled to assign its rights under this Agreement hereunder without the express written consent of the other party hereto, which shall not be unreasonably withheld, except that LMI or Nordion may respectively assign their rights under this Agreement without consent to (i) an Affiliate (as defined in the CDA); or (ii) any assignee who acquires all or substantially all of its assets or the relevant product line or business division to which the Product pertains; or (iii) in the event of such party’s merger or consolidation or similar transaction. No such assignment shall be valid and effective unless and until the assignee shall agree in writing to be bound by the provisions of this Agreement. Any assignment not in accordance with this Section 16.5 shall be null and void.

 

16.6                           Sub-contracting. Either party may sub-contract any of the work to be performed hereunder by such party with the prior written consent of the other party, which consent shall not be unreasonably withheld. No such sub-contracting shall relieve such party of its obligations hereunder.

 

16.7                           Severability. If any provision or term of this Agreement is found unenforceable under any of the laws or regulations applicable thereto, all other conditions and provisions of this Agreement shall nevertheless remain in full force and effect. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the parties hereto shall negotiate in good faith to modify this Agreement to effect the original intent of the parties as closely as possible, in a mutually acceptable manner, in order that the transaction contemplated hereby be consummated as originally contemplated to the greatest extent possible.

 

16.8                           No Waiver. No failure or delay on the part of either Nordion or LMI to exercise or enforce any rights conferred on it by this Agreement shall be construed or operate as a waiver thereof nor shall any single or partial exercise of any right, power or privilege or further exercise thereof operate so as to bar the exercise or enforcement thereof at any time or times thereafter. Any waiver of a breach of any provision

 

15

 

hereof shall not be effective unless in writing and shall not affect either party’s rights in the event of any additional breach.

 

16.9                           No Consequential Damages. In no event shall either party or its respective employees, officers, directors or representatives be liable for indirect, contingent, special, incidental or consequential damages (including loss of profit or business opportunity). For purposes of clarity and notwithstanding the immediately foregoing sentence, the parties acknowledge that nothing in this Section 16.9 shall affect or limit any right that Nordion may have to seek full payment from LMI for failure by LMI to purchase and/or pay for its purchase volume commitments in accordance with Sections 3.4 and 6.2 of this Agreement.

 

16.10                     Survival. Sections 5.2, 14, 16.1 through 16.3, 16.5, 16.7 through 16.9, 18  (in accordance with its terms), and 20.1 and such other sections which by their nature survive, shall survive termination or expiration of this Agreement.

 

17.       Force Majeure

 

17.1                           Neither party shall be liable to the other for failure to perform or delay in performing its obligations under this Agreement by virtue of the occurrence of an event of Force Majeure. In the event of Force Majeure, the party affected shall promptly notify the other and shall exert commercially reasonable efforts to eliminate, cure or overcome such event and to resume performance of its obligations. In the event such Force Majeure affecting either party continues for more than **** (****) days, either party may terminate this Agreement. “Force Majeure” shall mean an occurrence which  prevents, delays or interferes with the performance by a party of any of its obligations hereunder, if such event occurs by reason of any act of God, flood, power failure, fire, explosion, casualty or accident, or war, revolution, civil commotion, acts of public enemies, acts of terrorism, blockage or embargo, or any law, order or proclamation of any government, failure of suppliers or usual suppliers to provide materials, equipment or machinery, or interruption of or delay in transportation, strike or labor disruption, or other similar cause beyond the reasonable control of such party.

 

LMI has been informed, acknowledges and agrees that as of the Effective Date, Nordion was, is and continues to currently be subject to an event of Force Majeure in that its usual supplier, the NRU Reactor, is unable to supply Molybdenum-99 material used in the production of Product, which Force Majeure may endure for a period of time, and as such Nordion may not be in a position to accept and/or fulfill any purchase order issued by LMI under this Agreement. LMI further acknowledges and agrees that Nordion has exerted commercially reasonable efforts to eliminate, cure or overcome such current Force Majeure.

 

18.       Insurance

 

18.1                           Comprehensive General Liability Insurance. During the Contract Term of this Agreement and for a period of **** (****) **** thereafter each party at its own cost shall

 

16

 

maintain in full force and effect Comprehensive General Liability insurance coverage with a reputable insurer including without limitation product liability, bodily injury, death and property damage, in an amount of not less than US$**** per occurrence and in the aggregate. Nothing contained in this Section 18 shall be deemed to limit in any way the indemnification provisions contained in this Agreement. Upon request each party shall provide to the other a certificate of insurance evidencing such coverage.

 

19.       Notices

 

19.1                           Contact Information. Any notice required or authorized to be given by a party to the other in accordance with the provisions of this Agreement shall, unless otherwise specifically stipulated, be in writing and delivered personally, by a nationally recognized overnight courier, or if by electronic facsimile confirmed by certified or registered mail. Notice shall be deemed delivered upon receipt.

 

	
If to NORDION, to:
  	
 
  	
If to LMI, to:
  
	
MDS Nordion
  	
 
  	
Lantheus Medical Imaging, Inc. 
  
	
447 March Road
  	
 
  	
331 Treble Cove Road,
  
	
P.O. Box 13500
  	
 
  	
North Billerica, MA 01862
  
	
Ottawa, Ontario K2K 1X8
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
Attention: Vice President Global Sales 
  	
 
  	
Attention: Vice President, Manufacturing 
  
	
Telephone: (613) 592-2790
  	
 
  	
Telephone: (978) 671-8853
  
	
facsimile: (613) 592-0767
  	
 
  	
Facsimile: (978) 671-9577
  
	
 
  	
 
  	
 
  
	
and
  	
 
  	
and
  
	
 
  	
 
  	
 
  
	
Attention: Associate General Counsel 
  	
 
  	
Attention: Vice President and General Counsel 
  
	
Telephone: 613 592-2790
  	
 
  	
Telephone: (978) 671-8408
  
	
Facsimile: 613 592-0571
  	
 
  	
Facsimile: (978) 671-8724
  

 

20.                               Governing Law

 

20.1                           Applicable Law. The construction, validity and performance of the Agreement shall be governed and construed in accordance with the laws of Ontario and the laws of Canada applicable therein, without giving effect to its choice of law rules. The application of the United Nations Convention on the International Sale of Goods is expressly excluded.

 

21.                               Dispute Resolution

 

21.1                           Except as set forth in Section 4.6 hereof, any and all disputes arising from this Agreement shall be amicably and promptly settled upon consultation among the parties. The parties agree that if an amicable settlement is not reached within seven

 

17

 

(7) days after commencing consultation, the disputes shall be escalated to the officers named in Section 19.1 hereof or their respective designees. In the event such officers fail to meet or, if they meet, fail to resolve the dispute within an additional ten (10) business days, then the dispute may be submitted to a court of competent jurisdiction.

 

[The remainder of this page is intentionally left blank.]

 

18

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their representatives thereunto duly authorized as of the Effective
Date.

 

	
  Lantheus Medical Imaging, Inc.

  	
   

  	
  MDS Nordion, a division of

  
	
   

  	
   

  	
  MDS (Canada) Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ William C. Dawes, Jr.

  	
   

  	
  By:

  	
  /s/ Steven M. West

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name:

  	
  William C. Dawes, Jr.

  	
   

  	
  Name:

  	
  Steven M. West

  	
  [SEAL]

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  V.P. Manufacturing & Supply Chain

  	
   

  	
  Title:

  	
  CEO MDS INC.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date:

  	
  4-23-10

  	
   

  	
  Date:

  	
  4-26-10

  	
   

  

 

19Exhibit
10.13

 

CONFIDENTIAL TREATMENT REQUESTED

 

INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED IS OMITTED

AND NOTED WITH “****”.

AN UNREDACTED VERSION OF THIS DOCUMENT HAS ALSO BEEN PROVIDED TO THE

SECURITIES AND EXCHANGE

COMMISSION.

 

Execution Counterpart

 

 

 

AMENDED AND RESTATED

CARDIOLITE® LICENSE AND SUPPLY AGREEMENT

 

by and between

 

LANTHEUS MEDICAL IMAGING, INC.

 

and

CARDINAL HEALTH 414, LLC

dated January 1, 2004

 

 

 

 

TABLE OF CONTENTS

 

	
   

  	
   

  	
   

  	
  Page

  
	
   

  	
   

  	
   

  	
   

  
	
  1.

  	
  DEFINITIONS

  	
  1

  
	
   

  	
   

  	
   

  
	
  2.

  	
  SESTAMIBI PRODUCTS

  	
  4

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.01.

  	
  Patent License

  	
  4

  
	
   

  	
  2.02.

  	
  Trademark License; Trade Dress, etc. and Promotional Materials

  	
  5

  
	
   

  	
  2.03.

  	
  Supply of Vials

  	
  6

  
	
   

  	
  2.04.

  	
  Price by Licensee

  	
  6

  
	
   

  	
  2.05.

  	
  Limitations

  	
  6

  
	
   

  	
  2.06.

  	
  Bailment Abuse

  	
  7

  
	
   

  	
  2.07.

  	
  Reports

  	
  7

  
	
   

  	
  2.08.

  	
  License Fee

  	
  8

  
	
   

  	
  2.09.

  	
  Additional License Fee

  	
  8

  
	
   

  	
  2.10.

  	
  Special License Fee

  	
  8

  
	
   

  	
  2.11.

  	
  Modification of VUB

  	
  9

  
	
   

  	
  2.12.

  	
  Modification of Licensed Pharmacy Locations

  	
  9

  
	
   

  	
  2.13.

  	
  Taxes

  	
  9

  
	
   

  	
  2.14.

  	
  Radiopharmacy Status

  	
  9

  
	
   

  	
  2.15.

  	
  Approved Sampling Programs

  	
  9

  
	
   

  	
  2.16.

  	
  Purchase Orders; Acceptance; Cancellation

  	
  10

  
	
   

  	
  2.17.

  	
  Shipments

  	
  10

  
	
   

  	
  2.18.

  	
  Invoicing and Payment

  	
  11

  
	
   

  	
  2.19.

  	
  Specifications

  	
  11

  
	
   

  	
  2.20.

  	
  Non-Conforming Product

  	
  11

  
	
   

  	
  2.21.

  	
  Compliance

  	
  11

  
	
   

  	
  2.22.

  	
  Territorial Limitations on Scope of Licenses

  	
  11

  
	
   

  	
  2.23.

  	
  Transfer of Vials

  	
  11

  
	
   

  	
  2.24.

  	
  Minimum Purchase Obligations

  	
  12

  
	
   

  	
  2.25.

  	
  Sole Supplier

  	
  14

  
	
   

  	
  2.26.

  	
  **** Pricing

  	
  14

  
	
   

  	
  2.27.

  	
  Sales of Sestamibi Products to Others

  	
  14

  
	
   

  	
   

  	
   

  	
   

  
	
  3.

  	
  TERM AND TERMINATION

  	
  15

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  3.01.

  	
  Term and Termination

  	
  15

  
	
   

  	
  3.02.

  	
  Survival

  	
  15

  
	
   

  	
  3.03.

  	
  Effect of Termination

  	
  15

  
	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
  WARRANTIES; INDEMNIFICATION

  	
  16

  
	
   

  	
   

  	
   

  
	
   

  	
  4.01.

  	
  Warranties

  	
  16

  
	
   

  	
  4.02.

  	
  Indemnification by Licensee

  	
  17

  
	
   

  	
  4.03.

  	
  Indemnification by BMS-MI 

  	
  17

  
	
   

  	
  4.04.

  	
  Indemnification Procedures

  	
  17

  

 

i

 

TABLE OF CONTENTS

(continued)

 

	
   

  	
   

  	
   

  	
  Page

  
	
   

  	
   

  	
   

  	
   

  
	
  5.

  	
  MISCELLANEOUS

  	
  18

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.01.

  	
  Governing Law

  	
  18

  
	
   

  	
  5.02.

  	
  Entire Agreement

  	
  19

  
	
   

  	
  5.03.

  	
  Recalls

  	
  19

  
	
   

  	
  5.04.

  	
  Adverse Event Reporting

  	
  19

  
	
   

  	
  5.05.

  	
  Audit Rights

  	
  19

  
	
   

  	
  5.06.

  	
  Compliance with Safe Harbors

  	
  20

  
	
   

  	
  5.07.

  	
  Severability

  	
  20

  
	
   

  	
  5.08.

  	
  No Partnership

  	
  21

  
	
   

  	
  5.09.

  	
  Compliance with Laws

  	
  21

  
	
   

  	
  5.10.

  	
  Arbitration

  	
  21

  
	
   

  	
  5.11.

  	
  Confidentiality

  	
  22

  
	
   

  	
  5.12.

  	
  Force Majeure

  	
  23

  
	
   

  	
  5.13.

  	
  Notices

  	
  23

  
	
   

  	
  5.14.

  	
  Failure or delay in performance

  	
  24

  
	
   

  	
  5.15.

  	
  Assignment

  	
  24

  
	
   

  	
  5.16.

  	
  Amendments

  	
  24

  
	
   

  	
  5.17.

  	
  Absence of Presumptions

  	
  25

  
	
   

  	
  5.18.

  	
  Third Party Beneficiaries

  	
  25

  
	
   

  	
  5.19.

  	
  Consents

  	
  25

  
	
   

  	
  5.20.

  	
  Successors and Assigns

  	
  25

  
	
   

  	
  5.21.

  	
  Compliance with terms

  	
  25

  
	
   

  	
  5.22.

  	
  Headings

  	
  25

  
	
   

  	
  5.23.

  	
  Exhibits

  	
  25

  
	
   

  	
  5.24.

  	
  Counterparts

  	
  25

  
	
   

  	
  5.25.

  	
  Publicity

  	
  25

  

 

	
  Exhibit A

  	
  Licensed Pharmacy
  Locations

  
	
  Exhibit B

  	
  Pricing Information

  
	
  Exhibit C

  	
  Weekly Dose Volume Reports

  
	
  Exhibit D

  	
  Quarterly Share
  Calculation Reports

  
	
  Exhibit E

  	
  Required Monthly Vial and
  Unit Dose Reports

  
	
  Exhibit F

  	
  Required Monthly End User
  Data Reports

  
	
  Exhibit G

  	
  Computation of Monthly Additional
  License Fee

  

 

ii

 

Amended and Restated
Cardiolite® License and Supply Agreement

 

This Amended and Restated Cardiolite® License and
Supply Agreement (this “Agreement”), entered into as of January 1, 2009 (“Amendment
Date”) and effective as of January 1, 2004 (the “Effective Date”),
is made by and between Lantheus Medical Imaging, Inc., a corporation duly
organized and existing under the laws of the state of Delaware, with its
offices located at 331 Treble Cove Road, North Billerica, Massachusetts (“LMI”),
and Cardinal Health 414, LLC, a limited liability company duly organized and
existing under the laws of the state of Delaware doing business as Cardinal
Health Nuclear Pharmacy Services, with its principal place of business located
at 7000 Cardinal Place, Dublin, Ohio (“Company” together with LMI, the “Parties”
and, individually, each a “Party”).

 

WHEREAS, LMI (formerly known as Bristol Myers Squibb
Medical Imaging, Inc.) and Company (formerly known as Cardinal Health 414, Inc.)
previously entered into that certain Cardiolite® License and Supply Agreement,
dated January 1, 2004, and as amended from time to time (including as of March 17,
2008) (“Prior Agreement”); and

 

WHEREAS, the Parties now wish to replace and
supersede the Prior Agreement in its entirety by the terms and conditions of
this Agreement as set forth herein.

 

In consideration of the mutual covenants established
herein, the Parties hereby agree as follows:

 

1.             Definitions

 

1.01        “Additional License Fee” has the meaning set
forth in Section 2.09.

 

1.02        “Additional Special License Fee” has the
meaning set forth in Section 2.10.

 

1.03        “AE” means any
untoward medical occurrence in a patient or clinical investigation subject,
which results in any unfavorable and unintended sign, symptom, or disease
temporally associated with the use of a medicinal product, whether or not
considered, related to the medicinal product. All noxious and unintended
responses to a medicinal product related to any dose should be considered
adverse drug reactions. Responses to a medicinal product means that a causal
relationship between the product and AE is at least a reasonable possibility
(i.e., the relationship cannot be ruled out or cannot be determined). The
failure of a Sestamibi Product to localize as expected shall not be deemed an
adverse experience, whereas a significant failure of expected pharmacologic
action would be considered an adverse event.

 

1.04        “Affiliate,” when
used with reference to any Party, means any other entity, which Controls, is
Controlled by or is under common Control with such Party.

 

1.05        “Amendment Date” has
the meaning set forth in the Preamble.

 

1.06        “Anti-kickback Provisions”
has the meaning set forth in Section 5.06.

 

1

 

1.07        “Approved Sampling
Program” has the meaning set forth in Section 2.15.

 

1.08        “**** Sestambi Product”
means Sestamibi Product ****. 

 

1.09        “Cardiolite®” means
the trademark “Cardiolite®.”

 

1.10        “cGMP” means all
current good manufacturing practices under Title 21 of the United States Code
of Federal Regulations, as amended from time to time.

 

1.11        “Company” has the meaning
set forth in the Preamble.

 

1.12        “Competitor” means a
commercial enterprise that, as of the Amendment Date, owns (or an Affiliate of
which owns) a new drug application or an abbreviated new drug application for a
technetium-based myocardial perfusion imaging agent.

 

1.13        “Confidential Information”
has the meaning set forth in Section 5.11

 

1.14        “Control”, when used
with respect to any Party or entity, means the power to direct the management
and policies of such Party or entity, directly or indirectly whether through
the ownership of voting securities, by contract, or otherwise. “Controlled” and
“Controlling” have correlative meanings.

 

1.15        “Demand” has the
meaning set forth in Section 5.10.

 

1.16        “Dispute” has the
meaning set forth in Section 5.10.

 

1.17        “Effective Date” has
the meaning set forth in the Preamble. 

 

1.18        “FDA” has the meaning
set forth in Section 2.02.

 

1.19        “Federal Food, Drug, and
Cosmetic Act” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321
et seq., as amended, and any regulations promulgated or adopted thereunder.

 

1.20        “Fee Per Dose” means
the Fee Per Dose set forth on Exhibit B.

 

1.21        “Force Majeure” means
any war, rebellion, mutiny, terrorist attack, epidemic, act of God (e.g.,
landslide, lightning, earthquake, fire or hurricane, flood, sinking, drought),
explosion, act or decision of any duly constituted municipal, state or national
governmental authorities or of any court of law, supply or batch failure, equipment
failure or malfunction, shortages of fuel, power or raw materials, which
failure, malfunction or shortage is not under the reasonable control of the affected
party, or any other cause or event which is not under the reasonable control of
the affected party.

 

1.22        “including”, “includes”
and derivates thereof shall be deemed to be followed by “without limitation”.

 

1.23        “Indemnified Party”
has the meaning set forth in 4.04(a).

 

2

 

1.24        “Indemnifying Party”
has the meaning set forth in 4.04(a).

 

1.25        “Licensed Pharmacy
Locations” means the radiopharmacies controlled by Licensee that are
located in the United States at the addresses set forth on Exhibit A, as such Exhibit
may be modified from time to time pursuant to Section 2.12.

 

1.26        “Licensee” means the
Company and all Affiliates of Company that own and operate one or more
radiopharmacies, and restricted to the operations of the foregoing in the
United States.

 

1.27        “Parties” has the
meaning set forth in the Preamble.

 

1.28        “Party” has the
meaning set forth in the Preamble.

 

1.29        “Patents” means U.S.
Patent Nos. 4,452,774, 4,894,445 and 4,988,827.

 

1.30        “**** Product” means
Sestamibi Product that will be ****.

 

1.31        “Quarter” means each
of the three (3) month periods ending on March 31, June 30, September 30 and December
31 of any Year provided that the last quarter shall end on the date of
termination of this Agreement.

 

1.32        “Quarterly Share
Calculation Report” has the meaning set forth in Section 2.07.

 

1.33        “Reporting Quarter”
means the Quarter with respect to which Required Monthly reports and Quarterly
Share Calculation Reports are submitted.

 

1.34        “Required Monthly End
User Data Report” has the meaning set forth in Section 2.07.

 

1.35        “Required Monthly Reports”
means the Required Monthly Vial and Unit Dose Report and the Required Monthly
End User Data Report.

 

1.36        “Required Monthly Vial
and Unit Dose Report” has the meaning set forth in Section 2.07.

 

1.37        “Serious AE” means
any untoward medical occurrence that at any dose: results in death; is
life-threatening (defined as an event in which the subject or patient was at
risk of death at the time of the event; it does not refer to an event which
hypothetically might have caused death if it were more severe); requires
inpatient hospitalization or causes prolongation of existing hospitalizations;
results in persistent or significant disability/incapacity; results in a
congenital anomaly/birth defect; is an important medical event (defined as a
medical event(s) that may not be immediately life-threatening or result in
death or hospitalization, but based upon appropriate medical and scientific
judgment, may jeopardize the patient/subject or may require intervention, e.g.,
medical surgical, to prevent one of the other serious outcomes listed in the
definition above). Examples of such events include, but are not limited to,
intensive treatment in an emergency room

 

3

 

or at home for allergic bronchospasm; blood
dyscrasias or convulsions that do not result in hospitalization. For reporting
purposes, LMI also considers the occurrences of cancer, pregnancy, or overdose
(accidental or intentional and regardless of adverse outcome) as events that
must be expeditiously reported as important medical events.

 

1.38        “Sestamibi Products”
means Sestamibi sold by LMI to Licensee, comprising **** Product and ****
Product.

 

1.39        “Sestamibi Unit Dose”
means a syringe of technetium and any Sestamibi Product that is prepared in
Licensee’s place of business and is intended to be injected into a single
patient during one administration of an injection.

 

1.40        “Special License Fee”
has the meaning set forth in Section 2.10.

 

1.41        “Specifications” has
the meaning set forth in Section 2.19.

 

1.42        “Third Party Claim”
has the meaning set forth in 4.04(a).

 

1.43        “Trademarks” means
trademarks, service marks, trade dress, logos and other identifiers of source,
including all goodwill associated therewith and all common law rights,
registrations and applications for registration thereof.

 

1.44        “Unit Dose Equivalent”
means, with respect to reconstituted (multidose or hot) vials transferred
pursuant to Section 2.23, the aggregate volume of such transfers (in mCi),
divided by ****.

 

1.45        “Usage Guidelines”
has the meaning set forth in Section 2.02(b).

 

1.46        “Vial Price” means
the Vial Price set forth on Exhibit B.

 

1.47        “Vial Utilization Base”
the initial Vial Utilization Base set forth on Exhibit B, as such Vial
Utilization Base is modified from time to time pursuant to Section 2.11.

 

1.48        “VUB Adjustment
Percentage” means the VUB Adjustment Percentage set forth on Exhibit B.

 

1.48        “Year” means a
calendar year commencing on January 1 and ending on December 31 during the term
of this Agreement.

 

2.             SESTAMIBI
PRODUCTS

 

2.01        Patent License. LMI hereby
grants to Licensee, subject to Section 2.22, a non-exclusive, non-transferable,
non-sublicenseable license under the Patents, through expiration of the
Patents, to (a) reconstitute and radiolabel with technetium solely at the
Licensed Pharmacy Locations the Sestamibi Products supplied in vials by LMI to
Licensee pursuant to the provisions of this Article 2, and (b) prepare at, and
sell or otherwise supply from, the Licensed Pharmacy Locations, Sestamibi

 

4

 

Unit Doses prepared from such vials of Sestamibi
Products to end-user customers solely for their own use in the United States.
However, the rights granted Licensee hereunder to use the Patents shall in no
way affect LMI’s ownership of such Patents. No other right, title or interest
in the Patents is established hereby, and nothing herein shall be construed to
grant any right or license to Licensee to use the LMI Patents other than as
specifically set forth herein. In the event that the terms of this Agreement
conflict or are inconsistent with the terms of the label license affixed to a
package of vials of the Sestamibi Products supplied by LMI, the terms of this
Agreement shall control.

 

2.02        Trademark Licensee, Trade Dress, etc. and
Promotional Materials.

 

(a)           Subject to Section 2.22,
unless LMI otherwise agrees in writing, Licensee shall have the right to sell
from the Licensed Pharmacy Locations, in packages bearing the applicable
Trademark, Sestamibi Unit Doses prepared from vials of Sestamibi Products
supplied by LMI to Licensee and the right to use said Trademarks in any
advertising circulars or other promotional materials relating to the Sestamibi
Products in the United States, provided that such circulars or materials comply
with all applicable laws, including all rules and regulations of the U.S. Food
and Drug Administration (the “FDA”) and all terms and conditions of the
FDA’s approval of LMI’s Sestamibi Products. However, the rights granted
Licensee hereunder to use the Trademarks shall in no way affect LMI’s ownership
of such Trademarks. No other right, title or interest in the Trademarks is
established hereby, and nothing herein shall be construed to grant any right or
license to Licensee to use the Trademarks other than as may be specifically set
forth herein.

 

(b)           Licensee shall provide to
LMI for its review and consent copies of all proposed uses of the Trademarks,
in any form, in connection with any product or any activity, except when used
in accordance with any usage guidelines that may be provided by LMI from time
to time (the “Usage Guidelines”). Without limiting the foregoing, (i) Licensee
shall indicate in connection with any usage of any Trademark that the Trademark
is the registered Trademark of LMI and (ii) Licensee shall ensure that all
packaging, labeling, trade dress, advertising circulars and other promotional
materials or materials used in connection with the distribution of the
Sestamibi Products or Sestamibi Unit Doses (whether or not bearing any of the
Trademarks) shall comply with all applicable laws, including all rules and regulations
of the FDA and all terms and conditions of the FDA’s approval of LMI’s
Sestamibi Products.

 

(c)           LMI may modify the Usage
Guidelines from time to time in its sole discretion upon not less than
forty-five (45) days’ written notice to Licensee, and, except for deviations
consented to in writing by LMI, Licensee shall comply with such Usage
Guidelines in all respects, provided that in the event of a modification of the
Usage Guidelines Licensee shall be entitled to continue to use any then
existing stocks of packaging, labeling, trade dress, advertising circulars and
other promotional materials or in other materials used in connection with the

 

5

 

distribution of the
Sestamibi Products or Sestamibi Unit Doses that bear any of the Trademarks and
that comply with the Usage Guidelines that were superseded by such modified
Usage Guidelines and with applicable law until such stocks are exhausted.

 

(d)           If Licensee fails to follow
in any material respect any of the Usage Guidelines provided by LMI or has
otherwise misused the Trademarks or has failed to comply in any material
respect with this Section, then LMI may terminate this Agreement by giving
written notice to Licensee effective on such date as may be specified in such
notice if Licensee fails to cure such breach within twenty (20) days notice
thereof from LMI,

 

2.03        Supply of Vials. During the
term of this Agreement LMI shall supply vials of Sestamibi Products in
accordance with Sections 2.16 and 2.17, provided that **** Product will be
supplied after ****. Delivery by LMI of such vials of Sestamibi Products to
Licensee is made pursuant to the license and other terms set forth herein in
consideration for payment of the Vial Price, Additional Fee, Special License
Fee, and Additional Special License Fee, as provided for in Sections 2.08, 2,09
and 2.10 but shall not be construed as a sale. The contents of each vial
delivered hereunder shall remain the property of LMI until such time as the
contents are reconstituted, radiolabeled and removed from such vial as a
Sestamibi Unit Dose. Title to the Sestamibi Products included in any Sestamibi
Unit Dose shall pass to Licensee when doses are removed from the vial. Upon
removal from a vial of the last Sestamibi Unit Dose prepared by Licensee from
such vial, title to such vial and to any remaining contents shall pass to
Licensee solely for purposes of disposing of such vial and its contents. Licensee
shall bear all risk of loss with respect to the Sestamibi Products following
delivery thereof to (or to the order of) Licensee. Licensee hereby represents
and warrants that Licensee will properly dispose of such material in accordance
with the rules and regulations promulgated by the U.S. Nuclear Regulatory
Commission and all other applicable state and federal Government regulations,
including those covering pollution, hazardous substances, or the protection of
human health, the environment or natural resources.

 

2.04        Price by Licensee. Licensee
shall have sole control and discretion as to the price that its customers will
pay for each Sestamibi Unit Dose that Licensee sells.

 

2.05        Limitations. In no event
shall Licensee sell, loan, transfer, give or otherwise supply a vial of
Sestamibi Products to any third party. In no event shall Licensee reconstitute
or radiolabel with technetium any Sestamibi Products at any location other than
the Licensed Pharmacy Locations. In no event shall Licensee or any of its
subsidiaries or Affiliates sell, loan, transfer, give or otherwise supply a
Sestamibi Unit Dose from any location other than the Licensed Pharmacy Locations.
LMI may terminate this Agreement immediately by giving written notice to
Licensee, effective on such date as may be specified in such notice, in the
event of a failure to comply with the foregoing covenants.

 

6

 

2.06        Bailment Abuse. Licensee
shall not engage in or facilitate dose splitting with respect to any Sestamibi
Unit Dose or engage in or facilitate any other bailment abuse. Licensee shall
use commercially reasonable efforts to prevent its end-user customers from
engaging in dose splitting with respect to any such Sestamibi Unit Dose or
engaging in any other bailment abuse. Licensee shall promptly notify LMI in the
event Licensee learns of any dose splitting or other bailment abuse by any of Licensee’s
end-user customers.

 

2.07        Reports.

 

(a)           Weekly Dose Volume Reports. Not later
than five (5) business days after the end of each week that ends during the
period from the Effective Date through December 31, 2009, Licensee shall
provide to LMI a timely and accurate report, in substantially the form of Exhibit
C, that sets forth the total number of Sestamibi Unit Doses sold or supplied by
Licensee during such week in such detail as described in such Exhibit and such
other data specified in such Exhibit, as the same may be modified from time to
time pursuant to Section 2.07(e) (the “Weekly Dose Volume Reports”).

 

(b)           Quarterly Reports. Not later
than fifteen (15) calendar days after the end of each quarter that ends during
the term hereof, Licensee shall provide to LMI a timely and accurate report, in
substantially the form of Exhibit D, that sets forth the total number of
Sestamibi Unit Doses sold or supplied by Licensee during such quarter in such
detail as described in such Exhibit and such other data specified in such
Exhibit, as the same may be modified from time to time pursuant to Section 2.07(e)
(the “Quarterly Share Calculation Reports”).

 

(c)           Required Monthly Reports.

 

(i)            Not later than fifteen (15)
days after the end of each month that ends during the term hereof, Licensee
shall provide to LMI timely and accurate reports for **** Sestamibi Product and
separately for **** Product, each in substantially the form of Exhibit E, that
set forth the vial usage data, unit dose data, charge and billing information
and other data specified in such Exhibit, as the same may be modified from time
to time pursuant to Section 2.07(e) (the “Required Monthly Vial and Unit
Dose Report”).

 

(ii)           Not later than thirty (30)
days after the end of each month that ends during the term hereof, Licensee
shall provide to LMI reports for **** Sestamibi Product and separately for ****
Product, each in substantially the form of Exhibit F, that sets forth (A) name,
street, address, city, state and zip code of each customer of Licensee that
purchased Sestamibi Unit Doses or received no-charge Sestamibi Unit Doses
during such month but does not include the name (or personal identifying
information) of any patient to whom any Sestamibi Unit Dose

 

7

 

may be administered, (B) the number of
Sestamibi Unit Doses purchased or otherwise received by such customer during
such month, and (C) and other data specified in such Exhibit, as the same
may be modified from time to time pursuant to Section 2,07(e) (the “Required
Monthly End User Data Report”).

 

(d)                                Form of Reports. Such reports
shall be provided in electronic form reasonably satisfactory to LMI or in such
other form as the Parties may agree to from time to time and shall be sent to
such person at such address as LMI may specify from time to time.

 

(e)                                 Modifications
to Reporting Form. LMI may modify the required format of such reports
upon at least ninety (90) days’ written notice to Licensee. Licensee shall use
reasonable efforts to accommodate such modifications. The data required to be
reported in such reports may be modified only by mutual agreement of the
Parties. At the beginning of each Year, the Parties will review all such data
required hereunder, and agree to such modifications that are necessary to meet
business needs and to eliminate any unnecessary information.

 

(f)                                   Separate
Reports for Licensee’s Affiliate. Licensee acknowledges and agrees
that reports required in this Section 2.07 shall be submitted for all Licensed
Pharmacy Locations in the aggregate; provided, however, that such reports may
be submitted separately for the following Licensed Pharmacy Locations
controlled by Licensee’s Affiliate ****,: ****.

 

(g)                                Certification. All reports
provided by Licensee hereunder will be signed and certified by a duly
authorized officer of Licensee, to the effect that all information in such
reports is true, correct and complete.

 

2.08                          License Fee. Licensee
shall pay a license fee to LMI equal to the then effective Vial Price for each
vial of each Sestamibi Product delivered to it by LMI during the term of this
Agreement. Such payment shall entitle Licensee to prepare and sell from the
Licensed Pharmacy Locations a number of Sestamibi Unit Doses from each vial
equal to the Vial Utilization Base. Such payment shall be due and payable as
set forth in LMI’s invoice.

 

2.09                          Additional
License Fee. Licensee also shall pay to LMI an additional
license fee every month during the term of this Agreement (the “Additional
License Fee”) calculated in accordance with Exhibit G. Any Additional
License Fee shall be due and payable as set forth in LMI’s invoice.

 

2.10                          Special License
Fee. Company shall pay LMI **** U.S. dollars (US $****) (the “Special
License Fee”) simultaneously with the execution of this Agreement, which
fee shall be fully refunded to Company if LMI does not make available to
Licensee the **** Product by ****. Licensee

 

8

 

further shall pay to LMI **** U.S. dollars (US $****)
(the “Additional Special License Fee”) immediately upon LMI’s delivery
of **** Product to Licensee, provided that such delivery occurs on or prior to ****.

 

2.11                          Modification of
VUB. The Parties may from time to time mutually agree to modify the Vial
Utilization Base and shall act in a commercially reasonable manner and work
cooperatively to set a Vial Utilization Base that meets commercially reasonable
market norms; provided that such Vial Utilization Base shall (i) not
exceed a percentage equal to the then effective VUB Adjustment Percentage of
the average number of Sestamibi Unit Doses per vial sold by Licensee during the
**** (****) **** period immediately preceding such notice or, if this
Agreement has been effective for a period of time less than **** (****) ****,
such shorter period or during such other period as the Parties may mutually
elect to use from time to time, and (ii) shall in no event be lower than **** (****).

 

2.12                          Modification of
Licensed Pharmacy Locations. LMI may at its sole option
and discretion, effective immediately upon notice by LMI to Licensee, remove
any radiopharmacy from Exhibit A that fails to maintain all necessary
state, federal and local licenses or that is no longer owned or controlled by
Licensee. If Licensee acquires a radiopharmacy in the United States, such
radiopharmacy shall be included in Exhibit A upon notice to Supplier,
subject to LMI’s right, as provided above, to remove such radiopharmacy.

 

2.13                          Taxes. Licensee
shall be responsible for any and all federal, state, county, or municipal sales
or use tax, healthcare tax, excise, customs charges, duties or similar charges,
or any other tax assessment (other than that assessed against LMI’s income),
license, fee or other charge lawfully assessed or charged on the sale, license
or transportation of each Sestamibi Product licensed pursuant to this Agreement
or the license fees or other amounts payable to LMI hereunder.

 

2.14                          Radiopharmacv
Status. Licensee represents and warrants to LMI that each radiopharmacy
listed on Exhibit A holds all state, federal and local licenses necessary
for the lawful conduct of its business as a radiopharmacy. Licensee shall
notify LMI promptly in the event that any such radiopharmacy fails to maintain
all necessary state, federal, and local licenses, but in any event not later
than ten (10) days following the expiration, suspension, termination,
cancellation, non-renewal or other loss of any such license.

 

2.15                          Approved
Sampling Programs. LMI may in its sole discretion develop one or more
programs to provide or facilitate the provision of samples of Sestamibi
Products (or Sestamibi Unit Doses) to promote the development of the market for
Sestamibi in compliance with the Prescription Drug Marketing Act of 1987, 21
U.S.C. § 301 et seq., its implementing regulations, and any applicable state
laws. Any such sampling program is referred to herein as an “Approved
Sampling Program.”

 

9

 

2.16                          Purchase Orders;
Acceptance; Cancellation

 

(a)                                 LMI shall use
commercially reasonable efforts to supply Sestamibi Products in the quantities
ordered by Licensee, subject at all times to the reasonable capacity and supply
constraints of LMI. Licensee shall place orders for Sestamibi Products
hereunder in written, electronic or verbal form which shall specify: (i) the
amount of each Sestamibi Product being ordered, (ii) the requested
shipping date, (iii) the location of delivery (e.g., F.O.B. LMI’s dock)
and (iv) the shipping destination and requested method of shipment.
Licensee may order Sestamibi Products in each purchase order only in quantities
of **** (****) vial kits or greater or in such other minimum quantities as
may be agreed upon by the Parties from time to time. All orders are subject to (1) LMI’s
normal ordering requirements and lead times as in effect from time to time, (2)
LMI’s discretion to determine the method of shipment and (3) acceptance by LMI,
which shall not be unreasonably withheld. In the event of any conflict between
the terms of any purchase order, purchase order acceptance or purchase order
confirmation and the terms of this Agreement, the terms of this Agreement shall
control.

 

(b)                                Subject to Section 2.15(a),
LMI may cancel any outstanding purchase order submitted by Licensee (or any
portion thereof) upon at least fourteen (14) days prior written notice to
Licensee. In such case LMI shall not be required to sell to Licensee any
Sestamibi Products to be supplied pursuant to such purchase order after the
date of cancellation.

 

2.17                          Shipments. Delivery of
each Sestamibi Product shall be as follows:

 

(a)                                 ****. (****),
if the purchase order for such Sestamibi Product specifies LMI’s dock as its
delivery location. In such case, freight and insurance shall be for the account
of Licensee, and the risk of loss, delay or damage in transit shall be with
Licensee from and after delivery to Licensee’s carrier (which must be a
qualified carrier) at LMI’s dock;

 

(b)                                ****. (****),
if the purchase order for such Sestamibi Product specifies a Licensed Pharmacy
Location as its delivery location. In such case, freight and insurance shall be
for the account of LMI, and the risk of loss, delay or damage in transit shall
be with LMI until delivery to the Licensee radiopharmacy; or

 

(c)                                 ****. (any
other location, as agreed to in writing by the Parties) if the purchase order
for such Sestamibi Product specifies any other location as its delivery
location. Freight and insurance shall be for the account of LMI, unless
otherwise agreed by the Parties, and the risk of loss, delay or damage in
transit shall be LMI, unless otherwise agreed to by the Parties, until delivery
to the location specified in the purchase order for such Sestamibi Product.

 

10

 

2.18                          Invoicing and
Payment. LMI shall provide an invoice to Licensee for the Sestamibi Products
then delivered. All payments shall be due and payable as set forth in LMI’s
invoice.

 

2.18                          Specifications. Each
Sestamibi Product supplied to Licensee pursuant to this Agreement shall be
manufactured by LMI in accordance with LMI’s specifications for such Sestamibi
Products as in effect from time to time (the “Specifications”).

 

2.19                          Non-Conforming
Product. Licensee may reject a shipment of any Sestamibi Product only if such
shipment fails to conform to (A) the type and quantity of Sestamibi Products
ordered by Licensee or (B) the Specifications; provided that Licensee
notifies LMI in writing of any such rejection within ten (10) days after
receipt by Licensee of such shipment of Products. Licensee’s sole remedy with
respect to any non-conforming Products shall be to receive replacement
quantities for any non-conforming Product or credit for the purchase price
thereof against future purchases of Products; provided that LMI shall be
entitled to make reasonable substitutions. Licensee may reject any such
shipment by following the customary procedures for rejection of Sestamibi
Products as is established by LMI or as otherwise agreed to by the Parties from
time to time.

 

2.21                          Compliance. Company shall
cause its Affiliates to comply with this Agreement.

 

2.22                          Territorial
Limitations on Scope of Licenses. The licenses granted under
Sections 2.01 and 2.02 are granted solely under and with respect to United
States patents and United States trademarks. Nothing herein shall be construed
as granting Licensee any rights under non-United States patents, trademarks or
otherwise to (a) reconstitute, radiolabel, prepare, sell or otherwise
supply Sestamibi Unit Doses outside the United States, (b) sell Sestamibi
Unit Doses under the Trademarks outside the United States, (c) use said
Trademarks in any advertising circulars or other promotional materials outside
the United States or (d) undertake any activities with respect to
Sestamibi Products outside the United States. Accordingly, the reconstitution,
radiolabeling, preparation, sale, transfer, delivery or supply by Licensee of
any Sestamibi Unit Doses outside the United States is strictly prohibited.

 

2.23                          Transfer of
Vials. Notwithstanding Section 2.05, Licensee may, on an emergency
basis or at LMI’s discretion in circumstances, where because of the location of
Licensee’s customer, the delivery of Sestamibi Unit Doses is not commercially
practical and consistent with Licensee’s past practice, transfer vials of
Sestamibi Products to a customer (including vials that have been reconstituted
or radiolabeled with technetium by Licensee). Licensee shall pay to LMI an
amount equal to (a) ****% of Licensee’s aggregate revenue from such
transfers of unreconstituted (cold) vials, less (b) the aggregate Vial
Price paid hereunder with respect to such vials and plus (c) the product
of (i) the number of reconstituted (multidose or hot) vial Unit Dose
Equivalents transferred pursuant to this Section, multiplied by (ii) the
Fee Per Dose, in each case as part of the additional license fee as provided in
Section 2.09. LMI may, at any time by written notice to

 

11

 

Licensee, terminate Licensee’s right to transfer
vials of Sestamibi Products pursuant to this Section.

 

2.24                          Minimum
Purchase Obligation. Licensee guarantees, subject to LMI’s ability to
supply, a minimum purchase of Sestamibi Products as set forth in this Section.

 

(a) Licensee shall purchase from LMI at least
the Minimum Quantity (as hereinafter defined) of Sestamibi Products. Compliance
with such Minimum Quantity will be determined on ****, ****, and at the end of
each **** thereafter (each a “Compliance Period”). In any Compliance Period in
which Licensee does not purchase at least the applicable Minimum Quantity of
Sestamibi Products from LMI, Licensee shall within twenty (20) days of the end
of such Compliance Period (i) purchase the Shortfall Amount (as
hereinafter defined) for such Sestamibi Products and (ii) in the event any
such Shortfall Amount is greater than **** percent (****%) of such applicable
Minimum Quantity, in addition to such purchase obligation, shall pay LMI an
additional **** ($****) per dose for all doses in such Shortfall Amount. Within
three (3) weeks prior to the end of any Compliance Period, Licensee shall (i) make
a good faith estimate of additional amounts of **** Sestamibi Product and ****
Product necessary for Licensee to purchase to be in compliance with the Minimum
Quantity for such Compliance Period, and (ii) use commercially reasonable
efforts to place purchase orders for such additional amounts.

 

“Minimum Quantity” means:

 

	
  January 1, 2009 to ****

  	
   

  	
  ****% of all Technetium99-based myocardial perfusion imaging doses
  sold by Licensee

  	
   

  
	
  **** to ****

  	
   

  	
  ****% of all Technetium99-based myocardial perfusion imaging doses
  sold by Licensee

  	
   

  
	
  **** to ****

  	
   

  	
  ****% of all Technetium99-based and thallium-based myocardial
  perfusion imaging doses sold by Licensee

  	
   

  
	
  **** to ****

  	
   

  	
  ****% of all Technetium99-based and thallium-based myocardial perfusion
  imaging doses sold by Licensee

  	
   

  
	
  **** for the duration of this Agreement

  	
   

  	
  ****% of all Technetium99-based and thallium-based myocardial perfusion
  imaging

  	
   

  

 

12

 

	
   

  	
   

  	
  doses sold by Licensee

  	
   

  

 

provided that if the thallium-based myocardial
perfusion imaging doses sold by Licensee exceed **** percent (****%) of all
Technetium99-based and thallium-based myocardial perfusion imaging doses sold
by Licensee during the applicable period, then such doses in excess of ****
percent (****%) shall be excluded from the calculation of all
Technetium99-based and thallium-based myocardial perfusion imaging doses for
such period.

 

If LMI does not make available to Licensee a ****
Product on or before ****, the Minimum Quantity shall be reduced to ****% for ****,
****% for **** and ****% for **** and the remaining duration of the Agreement.

 

“Shortfall Amount” means, with respect to an
applicable Compliance Period, an amount of doses of Sestamibi Products for any
remaining portion of the applicable Minimum Quantity not invoiced prior to the
end of such Compliance Period. The Fee Per Dose for Sestamibi Products
constituting a Shortfall Amount shall be the same as in effect during the
Compliance Period to which the Shortfall Amount relates, and any purchases of
doses of Sestamibi Products to satisfy the Shortfall Amount for such Compliance
Period shall not count towards, and not be included in the calculation of, any
Minimum Quantity for the next succeeding Compliance Period hereunder. In
calculating the number of vials of Sestamibi Products doses to be purchased to
satisfy the Shortfall Amount, doses per vial shall be calculated by reference
to the most recently available Required Monthly Vial and Unit Dose Report by
dividing line K thereon by line D thereon to determine the most recent vial
utilization rate. Licensee shall specify to Supplier the destination for
shipment of any excess vials purchased pursuant to this Section 2.24(a) otherwise
in accordance with this Agreement.

 

(b)         If, after giving effect to
the purchase of additional doses as contemplated by Section 2.24(a) hereof,
in the most recently completed Compliance Period, the **** Sestamibi Product
doses purchased comprise less than the **** Product Percentage (as hereinafter
defined) of the Minimum Quantity, Licensee will promptly pay to LMI an
adjustment payment equal to: (i) the difference between the **** Sestamibi
Product and the **** Product prices set forth on Exhibit B, multiplied by (ii) the
difference between (a) the Minimum Quantity of doses multiplied by the ****
Product Percentage and (b) the **** Sestamibi Product doses actually
purchased.

 

“**** Product Percentage” means the following
percentage of the Minimum Quantity of doses of Sestamibi Product purchased by
Licensee hereunder:

 

	
  July 1, 2009 to ****

  	
   

  	
  ****%

  
	
  **** to ****

  	
   

  	
  ****%

  

 

13

 

	
  **** to ****

  	
   

  	
  ****%

  
	
  **** for the duration of
  this Agreement

  	
   

  	
  ****%

  

 

(c) For the final Compliance Period under this
Agreement, notwithstanding the termination of this Agreement as of the last day
of such Compliance Period, the provisions of this Section 2.24 shall be
deemed to survive such termination and be binding upon the Parties until such
time as all Sestamibi Product has been purchased and payments made pursuant
hereto for such Compliance Period.

 

2.25                          Sole Supplier. Neither
Licensee nor its Affiliates shall purchase, have manufactured, or otherwise
acquire sestamibi from any third party during the term of this Agreement until
Licensee sells its own generic sestamibi in the United States manufactured
pursuant to an approved abbreviated new drug application owned by Licensee or
one of its Affiliates (but not under an abbreviated new drug application of any
third party). For the avoidance of doubt, the minimum purchase obligations
described in Section 2.24 will remain applicable for the duration of this
Agreement notwithstanding any such sale of its own generic Sestamibi by
Licensee.

 

2.26                          **** Pricing. LMI shall
offer to Licensee **** net pricing for **** Product and **** Sestamibi Product
offered by LMI or any of its Affiliates to any third party non-governmental
customer of LMI (not including radiopharmacies owned by LMI or its Affiliates)
in the United States on the terms and conditions set forth herein. LMI agrees
to notify Licensee promptly upon entering into any contract with any such third
party that would provide such third party with such **** net pricing. Upon the
written request of Licensee at the end of any Quarter during the term of this
Agreement, an authorized officer of LMI shall certify in writing to Company
that LMI did not enter into any such contract during such Quarter. The term “net
pricing” as used herein shall mean the totality of (a) the price for ****
Product or **** Sestamibi Product, as applicable, and (b) all other
economic terms and conditions relating to the purchase of such **** Product or ****
Sestamibi Product, as applicable, including volume commitments, warranty terms,
payment terms, indemnification, and specific credits, rebates, allowances,
refunds, and discounts. Company may elect to have all prices and corresponding
economic terms and conditions adjusted hereunder pursuant to the terms and
conditions of such third party contract, in which case the Parties shall amend
this Agreement to reflect the same.

 

2.27                          Sales of
Sestamibi Products to Others. LMI shall not sell
quantities of (i) **** Products to any other radiopharmacy account prior
to **** or (ii) any Sestamibi Products to a Competitor during the term of
this Agreement.

 

14

 

3.0                                 TERM AND
TERMINATION

 

3.01                          Term and
Termination. This Agreement shall be effective commencing on
the Effective Date and shall remain in effect until December 31, 2012, unless
sooner terminated as provided below;

 

(a)                                 Either Party
may terminate this Agreement, by giving written notice to the other Party
effective immediately or on such date as may be specified in such notice, if
the other Party materially breaches any material provision of this Agreement
and fails to cure such breach within twenty (20) days notice thereof from such
non-breaching Party.

 

(b)                                LMI may
terminate this Agreement, by giving at least one hundred eighty (180) days
prior written notice to the Licensee effective on such date as may be specified
in such notice, if Licensee ceases to do business, or otherwise terminates its
business operations in the nuclear medicine industry.

 

(c)                                 LMI may
terminate this Agreement by giving written notice to Licensee effective on such
date as may be specified in such notice if (A) Licensee does not submit to
LMI all of the Required Monthly Reports and Quarterly Share Calculation Reports
for the applicable Reporting Quarter by the deadline for the submission of such
reports in accordance with Section 2.07 or (B) at any time Licensee
has not paid LMI all amounts due to LMI as set forth on any invoices previously
submitted to Licensee by LMI for Sestamibi Products in accordance with the
terms of payment provided for in the invoices, and in the case of each of the
foregoing (A) and (B) Licensee fails to cure such failure to make
such submission or payment, as the case may be, within twenty (20) days notice
thereof from LMI.

 

(d)                                LMI may
terminate this Agreement as expressly permitted by Sections 2.02(d), 2.05,
5.05, 5.09, 5.12 and 5.15, and Licensee may terminate this Agreement as
expressly permitted by Sections 5.12 and 5.15.

 

3.02                          Survival. Any
termination of this Agreement shall be without prejudice to any rights or
remedies that have accrued prior to the date of termination, and Sections 2.09,
2.24(c), 3.03 and 2.13 and Articles 4 and 5 of this Agreement shall survive the
termination of this Agreement.

 

3.03                          Effect of
Termination. Upon the termination of this Agreement, for any
reason, Licensee shall return to LMI all vials of the Sestamibi Products
provided hereunder that have not been reconstituted and radiolabeled with
technetium. LMI shall refund to Licensee any consideration paid to LMI for such
vials that are

 

15

 

returned by Licensee to LMI in their original,
unopened packaging. Not later than fifteen (15) days after the end of the month
in which the termination takes place, Licensee shall provide to LMI the
Required Monthly Reports for such month. Not later than thirty (30) days after
the end of the Quarter in which the termination takes place, Licensee may
provide to LMI the Quarterly Share Calculation Reports for such Quarter.

 

4.                                       WARRANTIES;
INDEMNIFICATION

 

4.01                          Warranties.

 

(a)                                 LMI warrants
that the Sestamibi Products supplied hereunder; will (i) be free from
defects in material and workmanship; (ii) conform to the Specifications; (iii) not
be (a) adulterated or misbranded within the meaning of the Federal Food,
Drug, and Cosmetic Act, as amended, or (b) an article which may not be
introduced in interstate commerce within the provisions of Sections 404 and 405
of such Act, as amended; (iv) otherwise be produced in accordance with
applicable cGMPs to the extent such cGMPs affect salability of the Sestamibi
Products; and (v) to LMI’s knowledge, not infringe any patent, or
trademark right of any third party.

 

(b)                                EXCEPT AS
EXPRESSLY SET FORTH HEREIN OR STATED IN THE LABELING AND INFORMATION PROVIDED
BY LMI AND ACCOMPANYING EACH VIAL OF THE SESTAMIBI PRODUCTS, LMI MAKES NO OTHER
WARRANTY, EXPRESSED OR IMPLIED, WITH RESPECT TO THE SESTAMIBI PRODUCTS, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE AND ALL
SUCH WARRANTIES ARE HEREBY EXCLUDED. Licensee shall not give or make any
guarantees, warranties, or representations as to the condition, quality,
durability, performance, merchantability or fitness for a particular use or
purpose or any other feature of any Sestamibi Product or any Sestamibi Unit
Dose other than or different from those provided by LMI hereunder. Any such
other guarantee, warranty or condition, whether express or implied, made by
Licensee to its customers shall be and remain the sole responsibility of
Licensee and shall not impose any obligation on LMI.

 

(c)                                 NEITHER PARTY
SHALL BE LIABLE TO THE OTHER PARTY FOR, AND EACH PARTY WAIVES ANY AND ALL CLAIMS
AGAINST THE OTHER PARTY FOR, ALL SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL,
PUNITIVE, OR EXEMPLARY DAMAGES, WHICH MAY BE CAUSED BY, OR IN ANY WAY
RESULT FROM, THE SESTAMIBI PRODUCTS OR THAT MAY ARISE UNDER OR AS A RESULT
OF THIS AGREEMENT, INCLUDING ANY SUCH DAMAGES RESULTING FROM DELAYS IN
DELIVERY, OR FAILURE TO DELIVER, ANY PRODUCT, OR FAILURE TO PURCHASE ANY
PRODUCT, WHETHER BASED ON

 

16

 

NEGLIGENCE, TORT, BREACH OF
WARRANTY, STRICT LIABILITY OR ANY OTHER CAUSE OF ACTION.

 

4.02                          Indemnification
by Licensee. Licensee, jointly and severally, shall indemnify
and hold harmless LMI, its Affiliates, and their respective directors,
officers, employees and agents from and against any suits, claims, losses,
demands, liabilities, damages, costs and expenses (including reasonable
attorney’s fees and reasonable investigative costs) in connection with any
suit, demand or action by any third party arising out of or resulting from (a) any
breach of this Agreement by Licensee or (b) any negligence or willful
misconduct by Licensee, except to the extent that any of the foregoing arises
out of or results from the breach of this Agreement by LMI or the negligence or
willful misconduct of LMI.

 

4.03                          Indemnification
by LMI. LMI shall indemnify and hold harmless Licensee, its Affiliates, and
their respective directors, officers, employees and agents from and against any
suits, claims, losses, demands, liabilities, damages, costs and expenses (including
reasonable attorney’s fees and reasonable investigative costs) in connection
with any suit, demand or action by any third party arising out of or resulting
from (a) any breach of this Agreement by LMI or (b) any negligence or
willful misconduct by LMI, except to the extent that any of the foregoing
arises out of or results from the breach of this Agreement by Licensee or the
negligence or willful misconduct of Licensee.

 

4.04                          Indemnification
Procedures. All claims for indemnification under this
Agreement shall be asserted and resolved as follows:

 

(a)                                 Party claiming
indemnification under this Agreement (the “Indemnified  Party”)
shall promptly notify the Party from whom indemnification is sought (the “Indemnifying
Party”) of any claim by a third party against the Indemnified Party that
could give rise to a right of indemnification under this agreement (“Third Party
Claim”). The Indemnifying Party shall have the right to defend, at its sole
cost and expense, such third party claim, on its own behalf and on the behalf
of the Indemnified Party, by all appropriate proceedings, which proceedings
shall be prosecuted diligently by the Indemnifying Party to a final conclusion
or settled at the discretion of the Indemnifying Party; provided, however, that
the Indemnifying Party may not enter into any compromise or settlement that involves
equitable relief against the Indemnified Party unless the Indemnified Party
consents thereto, which consent shall not be unreasonably withheld, delayed or
conditioned. If requested by the Indemnifying Party, the Indemnified Party
shall, at the sole cost and expense of the Indemnifying Party (excluding the
internal costs and expenses of the Indemnified Party), cooperate with the
Indemnifying Party and its counsel in contesting any third party claim that the
Indemnifying Party elects to contest, including, without limitation, the making
of any related counterclaim against the Person asserting the third party claim
or any cross-complaint against such person.

 

17

 

 

(b)                                Notwithstanding the Indemnifying Party’s
election to assume the defense of any third party claim, the Indemnified Party
shall have the right to employ separate counsel and to participate in the
defense of such third party claim, and shall bear the costs and expenses of
such separate counsel, if (i) the use of counsel chosen by the
Indemnifying Party to represent both the Indemnifying Party and the Indemnified
Party would present such counsel with a conflict of interest, (ii) the
actual or potential defendants in, or targets of, any such third party claim
include both the Indemnifying Party and the Indemnified Party, and the
Indemnified Party shall have reasonably concluded that there may be a legal
defense available to it which is different from or additional to the defenses
available to the Indemnifying Party in which case the Indemnifying Party shall
not have the right to assume the defense of such third party claim on behalf of
the Indemnified Party), (iii) the Indemnifying Party shall not have employed
counsel reasonably satisfactory to the Indemnified party to represent the
Indemnified Party within a reasonable time after notice of the institution of
such third party claim or (iv) the Indemnifying Party authorizes the
Indemnified Party to employ separate counsel at the Indemnified Party’s cost
and expense.

 

(c)                                 If the Indemnifying Party fails to notify
the Indemnified Party within ninety (90) days after receipt of notice in
accordance with Section 4.04(a) hereof that the Indemnifying Party
elects to defend the Indemnified Party pursuant to this Section 4.04, or
if the Indemnifying Party elects to defend the Indemnified Party pursuant this Section
4.04 but fails to defend the third party claim diligently and promptly, then
the Indemnified Party shall have the right to defend, at the sole cost and
expense of the Indemnifying Party, the third party claim by all appropriate
proceedings, which proceedings shall be promptly and vigorously defended by the
Indemnified Party with respect to a third party claim for which the Indemnified
Party is entitled to indemnification hereunder.

 

(d)                                No Indemnified Party shall have the right
to recover punitive or consequential damages in a claim against an Indemnifying
Party pursuant to this Agreement; provided, however, that such limitation shall
not apply to damages paid or payable to a third party by an Indemnified Party
for which the Indemnified Party is entitled to indemnification hereunder.

 

5.                                      MISCELLANEOUS

 

5.01                          Governing Law. This Agreement shall be governed by and
construed in accordance with the laws of the State of New York, without giving
effect to the conflict of laws provisions thereof.

 

18

 

5.02                          Entire Agreement. This Agreement constitutes the entire
agreement between the Parties with respect to the subject matter hereof, and
supersedes any and all prior or contemporaneous agreements (whether written or
oral).

 

5.03                          Recalls. In the event that LMI determines that a recall
or withdrawal of the Sestamibi Products from the market is necessary, Licensee
shall take all actions appropriate in order to reasonably assist LMI with such
recall or withdrawal. The costs of the recall (including all costs of
collecting, shipping and disposing of the recalled Product) shall be borne by
LMI unless the circumstances leading to the recall result from the fault of
Licensee.

 

5.04                          Adverse Event Reporting. Licensee shall report AEs to LMI within
24 hours of the date that Licensee first becomes aware of an AE associated with
a Sestamibi Product that is reported to Licensee or of which Licensee or any of
its agents, including sales representatives or local radiopharmacists, are
otherwise made aware.

 

In
addition, Licensee shall provide LMI with immediate (or as soon as practicable)
notification by telephone of any fatal or life-threatening Serious AE. If
an answering machine is encountered, a message should be left providing
detailed information regarding such Serious AE and further attempts to speak
directly with LMI should be made.

 

The
telephone report should contain as much information as is available concerning
such event to permit LMI to file a MedWatch Form 3500A report that
satisfies regulatory guidelines for content and timeliness.

 

Licensee
shall insure prompt follow-up as necessary to provide LMI with reasonably
complete information known or otherwise available to Licensee with respect to
any Serious AE or AEs. If follow-up information is received after reporting an
AE, Licensee also must report such information within 24 hours of the date that
Licensee first became aware of such information.

 

All
reports and any related communications made hereunder shall be sent to:

 

Lantheus
Medical Imaging, Inc.

331
Treble Cove Road

North
Billerica, Massachusetts 01862 

Attn:
General Counsel

Facsimile:
(978) 671-8724

 

5.05                          Audit Rights. Licensee shall maintain records
documenting the information required to be provided in the Required Monthly
Reports and Quarterly Share Calculation Reports provided by Licensee, including
but not limited to invoices. Such records shall be maintained for a period of
not less than three (3) years after the end of such applicable month or
Quarter. For three (3) years after the end of

 

19

 

the
period covered by any such report, Licensee shall permit an independent
accounting firm retained by LMI to examine such records and other information
to confirm the accuracy of such reports and to confirm that Licensee has not
used, sold, lent, transferred, given, delivered or otherwise supplied or
disposed of any vial of any Sestamibi Product in ways not expressly permitted
by Article 2 and that Licensee has otherwise complied with this Agreement.
Such examination shall be conducted not more than once each Year at each
Licensed Pharmacy Location and once Each Year at the corporate offices of
Licensee and shall be conducted during normal business hours and after
reasonable written notice to Licensee of not less than three (3) business
days. Such accounting firm shall be permitted to disclose to LMI only that
information that relates to the accuracy of such report and facts pertaining to
any use, sale, delivery or disposition of any vial of any Sestamibi Product in
ways not expressly permitted by Article 2. If such examination indicates
that additional monies are owed to LMI with respect to the period of time
covered by such report, Licensee shall pay any such additional money as set
forth in LMI’s invoice. If at any time Licensee is in violation of its
obligations under Article 2 hereof, LMI may, at its sole option, terminate
this Agreement by giving written notice to Licensee effective on such date as
may be specified in such notice if Licensee fails to cure such violation within
twenty (20) days notice thereof from LMI.

 

5.06                          Compliance with Safe Harbors. It is the intent of the Parties for any
financial relationship between the Parties under this Agreement to comply with
any state and the federal anti-kickback statute (42 U.S.C. §1320a-7b(b)) and
the federal “safe harbor” regulations regarding discounts, rebates, or other
reductions in price (42 C.F.R.§1001.952(h)) (collectively, the “Anti-kickback
Provisions”). Any prices offered by LMI under this Agreement may include from
time to time a reduction in prices as that phrase is defined under the
Anti-kickback Provisions. Should there be a reduction in price, then under the
Anti-kickback Provisions, Licensee may have an obligation to report any such
reduction in price, and must provide such information upon request, to any
state or federal health care program or other government agency. Licensee
represents and warrants that it will satisfy any and all requirements that may
be imposed on Licensee by the Anti-kickback Provisions including, when required
by law, to accurately report under any state or federal health care program the
net cost actually paid by Licensee and to appropriately reflect such net costs
if cost reporting such governmental program is applicable.

 

Licensee
further represents and warrants that it will inform its customers of its customers’
obligations to properly report any reductions in price and will use reasonable
efforts to assist its customers in properly reporting and appropriately reflecting
the amount of any reductions in price in its customers’ claims for payment filed
with any state or federal health care program.

 

5.07                          Severability. In the event that any provision of this
Agreement is found to be invalid or unenforceable, then the offending provision
shall not render any other

 

20

 

provision
of this Agreement invalid or unenforceable, and all other provisions shall
remain in full force and effect and shall be enforceable, unless the provisions
which have been found to be invalid or unenforceable shall substantially affect
the rights or obligations granted or undertaken by either Party.

 

5.08                          No Partnership. Both Parties are independent
contractors under this Agreement. Nothing contained in this Agreement is to be
construed so as to constitute LMI and Licensee as partners or agents with
respect to this Agreement or to create a partnership or joint venture. Neither
Party hereto shall have any right or authority to assume or create any
obligations on behalf of, or in the name of, the other Party or to bind the
other Party to any contract, agreement or undertaking with any third party.

 

5.09                          Compliance with Laws. Licensee represents and warrants that
it shall ascertain and comply in all material respects with (i) all
applicable laws, statutes, rules, regulations, orders, judgments, or
injunctions imposed by regulations or laws of any government or governmental
authority, (ii) with Licensee’s internal policies and procedures regarding
marketing and sales, (iii) the Pharmaceutical Research and Manufacturers
of America (PhRMA) Code on Interactions with Healthcare Professionals and (iv) any
guidance from the Health and Human Services (or any successor agency) Office of
Inspector General relating to Licensee’s obligations under this Agreement,
including, without limitation, the use and handling of Sestamibi Products, the
provision of no-charge Sestamibi Unit Doses and use, sale and distribution of
any Sestamibi Unit Dose. In the event Licensee fails to comply with this Section in
any material respect, LMI may terminate this Agreement, effective upon notice
by LMI to Licensee on such date as LMI may specify in such notice, and provided
if such non-compliance is curable, Licensee fails to cure such non-compliance
within twenty (20) days of the notice thereof from LMI.

 

5.10                          Arbitration. Any dispute, controversy or claim
arising out of or relating to compliance with, or alleged breach,
interpretation or validity of this Agreement, (each a “Dispute”) shall
be exclusively resolved by binding arbitration, which arbitration may be
commenced by sending a written notice to the other Party demanding arbitration
of such Dispute (the “Demand”). In that event, the Dispute shall be
finally resolved by arbitration in accordance with the United States
Arbitration Act and the Commercial Arbitration Rules of the American
Arbitration Association. The place of the arbitration shall be New York, New
York. The arbitration will be conducted in the English language before a panel
of three arbitrators. Each Party shall name one arbitrator, and the two so
named shall name the third arbitrator, who will act as chairman. If the two
party arbitrators cannot agree on a third arbitrator within thirty (30) days
after the Demand, such third arbitrator shall be selected by the American
Arbitration Association. The arbitrators will promptly meet, fix the time, date
and place of the hearing and notify the Parties. The arbitration shall be
conducted within ninety (90) days after any Demand. All documents, exhibits,
testimony or other

 

21

 

information
that is not in the English language shall be translated into the English
language at the expense of the Party proffering the evidence requiring
translation. The decision of the arbitrators may (depending on the equities of
the case) include an award of legal fees, costs of arbitration and interest.
The panel of arbitrators will promptly transmit an executed copy of its
decision to the Parties. The decision of the arbitrators will be final, binding
and conclusive upon the Parties. Judgment on the award rendered by the
arbitrators may be entered in any court having jurisdiction thereof. Each Party
retains the right to seek from a court any interim or provisional relief that
may be necessary to protect the rights or property of that Party pending the
establishment of the arbitrators’ determination of the merits of the
controversy, and any such action shall not be deemed incompatible with this
Agreement to arbitrate or a waiver of the right to arbitration. The obligations
of the Parties under this Section are specifically enforceable and will
survive any termination of this Agreement. Unless the decision of the
arbitrators provides otherwise, the Parties shall bear their own costs in
preparing for the arbitration and the costs of the arbitrators shall be equally
divided between the Parties.

 

Each
Party waives any right to claim special, indirect, consequential, incidental,
punitive or exemplary damages against each other and in the event of a dispute,
each shall be limited to recovery of actual damages.

 

5.11                          Confidentiality. LMI acknowledges that the data
concerning Licensee contained in the reports provided to LMI pursuant to Section 2.07
are confidential and proprietary to Licensee, and such data shall be considered
Confidential Information of Licensee. Each Party acknowledges that the
disclosure of the content of this Agreement (including the terms and conditions
hereof and all pricing information related to the Sestamibi Products under this
Agreement, including actual prices, price differentials between **** Product and **** Sestamibi Product, and the occurrence,
timing or amount of any price reductions), would be detrimental to the other
Party and that the content of this Agreement shall be considered Confidential
Information of each Party. Each Party shall (i) maintain the Confidential
Information of the other Party in confidence from and after the Effective Date
until the seventh anniversary of the termination of this Agreement and (ii) use
such Confidential Information solely for the purpose of performing its
obligations or exercising its rights under this Agreement, promoting the growth
of the Sestamibi business and marketing Sestamibi Products and for internal and
administrative purposes. Each of the Parties covenants that (i) it shall
not disclose any of the Confidential Information of the other Party except to
its parent company or any of its parent company’s employees, agents, board of
directors, or any other person under its authorization who are obligated to
maintain the confidentiality of such Confidential Information, and (ii) it
shall establish and implement a commercialization plan within such Party’s
respective organization that will indicate serious disciplinary action
including and up to dismissal in the event that a representative makes an
unauthorized disclosure. The foregoing confidentiality obligations shall not
apply

 

22

 

to
information that (i) is required to be disclosed by a court or tribunal,
legal process, applicable law or the rules of any applicable stock
exchange, in which case the Party obligated to make and disclose such
information, shall promptly notify the other Party of such disclosure and the
procedures, such as a protective order, instituted to protect the confidentiality
of such information to be disclosed, (ii) is or hereafter becomes generally
available to the public other than by reason of any default by a Party with
respect to a confidentiality obligation or (iii) is disclosed to the
recipient by a third party that is not in default of any confidentiality
obligation to the disclosing Party. The Parties agree that should the foregoing
confidentiality obligations be breached, money damages may be inadequate to
remedy such a breach, and the non-breaching Party shall be entitled to seek,
and a court of competent jurisdiction may grant, specific performance and
injunctive or other equitable relief as a remedy for any such breach or
threatened breach. Such remedy shall be in addition to all other remedies, including
money damages, available to a non-breaching Party at law or in equity.

 

5.12                          Force Majeure. No Party shall be liable for any
failure to perform its obligations under this Agreement or pursuant to any
purchase order submitted pursuant to this Agreement by reason of Force Majeure.
Such Party shall give the other Party prompt notice of any interruption of
performance on account of Force Majeure, and of the resumption of such
performance, and shall keep the other Party informed on a current basis as to
the steps being taken to remove, and the anticipated time of removal of, the
circumstances resulting in such Force Majeure. Notwithstanding the foregoing,
nothing in this Section shall excuse or suspend the obligation to make any
payment due under this Agreement in the manner and at the time provided herein,
provided that Licensee shall be allowed to purchase from another supplier such
quantities of Sestambi that LMI is unable to supply hereunder on account of a
Force Majeure and Licensee shall not be in violation of Section 2.24
(Minimum Purchase Obligation) in connection with such quantities. In the case
of a Force Majeure that prevents performance of this Agreement by a Party for a
period of **** (****) consecutive days, the other Party shall
be entitled to terminate this Agreement upon prior written notice to the
affected Party.

 

5.13                          Notices. All notices to be provided to LMI hereunder shall be
delivered to:

 

Lantheus
Medical Imaging, Inc. 

331
Treble Cove Road

North
Billerica, Massachusetts 01862 

Attn:
President

Facsimile:
(978) 671-8079

 

with
copies to:

 

Lantheus
Medical Imaging, Inc. 

331
Treble Cove Road

 

23

 

North
Billerica, Massachusetts 01862 

Attn:
General Counsel

Facsimile:
(978) 671-8724

 

All
notices to be provided to Licensee hereunder shall be delivered to the address
set forth on Exhibit B. Either Party may change its notice address by
giving notice to the other Party pursuant to this Section.

 

5.14                          Failure or delay in performance. Except for the payment of money,
neither Party shall be liable to the other for failure or delay in performance
of its obligations (including shipping delays) if such performance is prevented
or delayed by any cause beyond such Party’s reasonable control.

 

5.15                          Assignment. Neither this Agreement, nor any right, interest or
obligation hereunder, may be assigned, or otherwise transferred by either
Party, whether by operation of law or otherwise, without the prior written
consent of the other Party; provided, however that (x) either Party may
assign or otherwise transfer any or all of its rights, or delegate any or all
of its respective duties or obligations, under this Agreement without the prior
written consent of the other Party to (i) an acquirer of, or successor to,
all or substantially all of the assets of such Party, or (ii) the
surviving entity in any merger, consolidation, equity exchange or
reorganization to which such Party is a party, provided that, in each case
contemplated by this clause (x), (a) such acquirer, successor or surviving
entity, as the case may be, agrees to he bound by all of the obligations of
such Party under this Agreement, and (b) the acquirer, successor or
surviving entity is not a Competitor, or if such assignee, successor, or
surviving entity is a Competitor, such other Party shall be deemed to have
consented to such assignment and transfer in all respects unless such other
Party shall elect to terminate this Agreement in writing within **** (****) days of receipt of written notice of
such assignment or transfer to such Competitor; and (y) LMI may assign or
otherwise transfer any or all of its rights, or delegate any or all of its
duties or obligations, under this Agreement to an acquirer of, successor to, or
other transferee with respect to all or substantially all of the assets used in
or related to the manufacture, sale and distribution of the Sestamibi Products
or otherwise to the business of LMI to which this Agreement relates, provided
that, in each case contemplated by this clause (y), (1) such acquirer,
successor or transferee, as the case may be, agrees to be bound by all of the
obligations of LMI under this Agreement, and (2) such acquirer, successor
or transferee is not a Competitor, or if such assignee, successor, or
transferee is a Competitor, Licensee shall be deemed to have consented to such
assignment and transfer in all respects unless Licensee shall elect to
terminate this Agreement in writing within **** (****) days of receipt of written notice of
such assignment or transfer to such Competitor.

 

5.16                          Amendments. Except as permitted by Sections 2.07 and 2.11, this
Agreement may not be supplemented, amended or modified except in a writing
executed by all the Parties. Notwithstanding the preceding sentence but without
limiting the

 

24

 

rights
of the Parties under Article 3 of this Agreement, the Parties agree that
in the event that there is a change in law or regulation that makes this
Agreement (or any terms hereof) or the performance of any of the terms of this
Agreement illegal in any respect, the Parties shall negotiate in good faith to
amend this Agreement in a manner consistent with such change in applicable law
or regulation.

 

5.17                          Absence of Presumptions. The Parties hereto understand and agree
that each and every term and condition of this Agreement, have or has been
mutually negotiated, prepared and drafted, and in connection with the
interpretation of construction of any such term or condition or this Agreement,
no consideration will be given to the issue of which Party prepared, drafted or
requested any term or condition of this Agreement.

 

5.18                          Third Party Beneficiaries. None of the provisions of this
Agreement shall be for the benefit of or enforceable by any third party including,
without limitation, any creditor of any Party hereto. No third party shall
obtain any right under any provision of this Agreement or shall by reason of
any such provision make any claim in respect of any debt, liability or
obligation (or otherwise) against any Party hereto.

 

5.19                          Consents. Any consent or approval to any act or matter
required under this Agreement must be in writing and shall apply only with
respect to the particular act or matter to which such consent or approval is
given and shall not relieve any Party from the obligation to obtain consent or
approval, as applicable, wherever required under this Agreement to any other
act or matter.

 

5.20                          Successors and Assigns. This Agreement shall be binding upon
and inure to the benefit of the Parties hereto and their respective successors
and permitted assigns.

 

5.21                          Compliance with terms. If any of the radiopharmacies
operated at the Licensed Pharmacy Location is operated by an entity other than
Licensee, Licensee shall cause such entity to comply with the terms of this
Agreement.

 

5.22                          Headings. Headings in this Agreement are for convenience of
reference only and shall not be considered in interpreting or construing this
Agreement.

 

5.23                          Exhibits. The Exhibits attached to this Agreement are an integral
part hereof and all references to this Agreement include such Exhibits.

 

5.24                          Counterparts. This Agreement may be executed in one
or more counterparts, and by the different Parties in separate counterparts,
each of which when executed shall be deemed to be an original but all of which
when taken together shall constitute one and the same agreement.

 

5.25                          Publicity. Neither Party will make any press release or other
public disclosure regarding this Agreement or the transactions contemplated
hereby that mentions

 

25

 

or
identifies the other Party without the other Party’s prior written consent,
except as required by a government or governmental authority and applicable law
or the rules of any applicable stock exchange, in which case the Party
required to make the press release or public disclosure shall use commercially
reasonable efforts to obtain the approval of the other Party as to the form,
nature and extent of the press release or public disclosure prior to issuing
the press release or making the public disclosure. Promptly after the execution
of this Agreement, the Parties shall collaborate to develop a mutually
satisfactory press release concerning transactions contemplated by this
Agreement. Each Party agrees, on behalf of itself and its Affiliates, not to
do, or authorize to be done, any act or thing that disparages the other Party
or the Sestamibi Products, and Licensee agrees, on behalf of itself and its
Affiliates, not to do, or authorize to be done, any act or thing which may
reduce or dilute the value or distinctiveness of the Trademarks of LMT licensed
under this Agreement.

 

IN
WITNESS WHEREOF, the undersigned duly authorized representatives have executed
this Agreement as of the date first above written

 

	
   

  	
  LANTHEUS MEDICAL
  IMAGING, INC

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Donald R.
  Kiepert

  
	
   

  	
   

  	
  Name:

  	
  Donald R.
  Kiepert

  
	
   

  	
   

  	
  Title:

  	
  President and
  CEO

  
	
   

  	
   

  	
   

  
	
   

  	
  CARDINAL HEALTH
  414, LLC

  
	
   

  	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ John C.
  Rademacher

  
	
   

  	
   

  	
  Name:

  	
  John C.
  Rademacher

  
	
   

  	
   

  	
  Title:

  	
  President

  

 

26

 

EXHIBIT A

LICENSED PHARMACY LOCATION(S)

 

	
Location
 Code
  	
 
  	
BUSINESS STREET
  	
 
  	
BUSINESS STREET 2
  	
 
  	
CITY
  	
 
  	
ST
  	
 
  	
ZIP
  
	
1001
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1002
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1003
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1004
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1005
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1007
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1008
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1010
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1011
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1012
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1013
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1014
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1016
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1017
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1020
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1021
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1022
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1023
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1024
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1025
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1026
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1027
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1028
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1029
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1030
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1031
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1032
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1033
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1034
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1036
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1037
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1038
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1039
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1040
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1041
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1042
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1043
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1044
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1045
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  

 

27

 

	
1046
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1047
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1048
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1049
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1050
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1051
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1052
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1053
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1055
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1056
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1057
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1058
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1059
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1060
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1061
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
1063
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1064
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1066
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1067
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1068
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1069
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1070
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1071
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1072
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1073
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1074
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1075
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1076
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1077
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1078
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1080
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1081
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1083
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1084
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1085
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1086
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1087
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1088
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1089
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1091
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1092
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1095
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1096
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1097
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  

 

28

 

	
1098
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1100
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1102
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1103
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1104
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1106
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1108
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1109
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1110
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1112
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1113
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1115
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1118
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1119
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1120
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1123
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1126
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1127
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1128
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1130
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1131
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1139
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1142
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1145
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1149
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1150
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1151
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1152
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
1153
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1154
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1155
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1156
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1157
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1158
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1159
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1160
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1162
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1163
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1169
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1172
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1173
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1175
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1179
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1181
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  

 

29

 

	
1182
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1183
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1184
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1188
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
1225
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
2212
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
2214
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
2215
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
2216
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
2217
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
2218
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
2222
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
2224
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
2227
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
2229
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
3306
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
3309
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
3341
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
5045
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
5080
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
5250
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
5260
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
5300
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
5350
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
6200
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  
	
6201
  	
 
  	
****
  	
 
  	
 
  	
 
  	
****
  	
 
  	
****
  	
 
  	
****
  

 

30

 

EXHIBIT B

 

PRICING INFORMATION

 

From and after the Amendment Date, the “Fee Per Dose” means:

 

	
January 1, 2009 to ****
  	
 
  	
$****
  
	
 
  	
 
  	
 
  
	
**** to ****
  	
 
  	
$**** for **** Product

 

$**** for **** Sestamibi Product, unless LMI does not make available to Company **** Product on or before ****, in which case the Fee Per Dose for **** Sestamibi Product will be $****
  
	
 
  	
 
  	
 
  
	
**** to ****
  	
 
  	
$**** for **** Product 

 

$**** for **** Sestamibi Product
  
	
 
  	
 
  	
 
  
	
**** to ****
  	
 
  	
$**** for **** Product

 

$**** for **** Sestamibi Product
  
	
 
  	
 
  	
 
  
	
**** for the duration of this Agreement
  	
 
  	
$**** for **** Product 

 

$**** for **** Sestamibi Product
  

 

Vial Price = Fee Per Dose multiplied by the Vial Utilization Base

 

Vial Utilization Base = **** Sestamibi Unit Doses from each vial of Sestamibi Products. 

 

VUB Adjustment Percentage = ****%

 

31

 

LICENSEE NOTICE ADDRESS

 

Cardinal Health, Nuclear Pharmacy Services

7000 Cardinal Place

Dublin, Ohio 43017

Attention:  President

Facsimile:  614-757-7105 

Telephone:  614-757-7467

 

with a copy to:

 

Cardinal Health 414, LLC 

7000 Cardinal Place

Dublin, Ohio 43017

Attention:  Vice President, General Counsel - NPS 

Facsimile:  614-757-5051

Telephone:  614-757-5187

 

32

 

 

EXHIBIT C

 

WEEKLY DOSE VOLUME REPORT

 

	
Licensee Name:
  	
 
  	
 
  	
Reporting Period:(1)
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
MM/DD/YY
  
	
 
  	
 
  	
 
  
	
Completed By:
  	
 
  	
 
  	
Title:
  	
 
  
	
 
  	
 
  	
 
  
	
Contact Phone #:
  	
 
  	
 
  	
Date:
  	
 
  
						

 

AGGREGATE DATA FOR ALL LICENSED PHARMACY LOCATIONS

 

	
Total number of **** Sestamibi Unit Doses sold during the reporting period:
  	
 
  	
 
  
	
Total number of **** Sestamibi Unit Doses sold during the reporting period:
  	
 
  	
 
  

 

(1) The Reporting Period must be a period of seven days beginning on a Saturday and ending on the following Friday.

 

33

 

EXHIBIT D

 

QUARTERLY SHARE CALCULATION REPORT

 

	
Licensee Name:
  	
 
  	
 
  	
Reporting Period:(2)
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
MM/DD/YY
  
	
 
  	
 
  	
 
  
	
Completed By:
  	
 
  	
 
  	
Title:
  	
 
  
	
 
  	
 
  	
 
  
	
Contact Phone #:
  	
 
  	
 
  	
Date:
  	
 
  
						

 

AGGREGATE DATA FOR ALL LICENSED PHARMACY LOCATIONS

 

	
Total number of Sestamibi Unit Doses sold during the reporting period:
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
Total number of **** Unit Doses sold during the reporting period:
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
Total number of Technetium99-based myocardial perfusion imaging doses sold during the reporting period*:
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
Total number of Technetium99-based and thallium-based myocardial perfusion imaging doses sold during the reporting period**:
  	
 
  	
 
  

 

(2) The Reporting Period must be a calendar quarter.

* This particular entry terminates as of quarter ending December 31, 2009 

** This particular entry commences January 1, 2010

 

34

 

EXHIBIT E

 

REQUIRED MONTHLY VIAL AND UNIT DOSE REPORT

 

	
Licensee Name:
  	
 
  	
Account Number:
  
	
P.O. Number:
  	
 
  	
P.O. Expires:
  
	
Reporting Period:
  	
 
  	
 
  
	
MM/YY(3)
  	
 
  	
 
  
	
AGGREGATE DATA FOR ALL LICENSED PHARMACY LOCATIONS
  	
 
  	
 
  	
 
  
	
VIAL USAGE DATA (SESTAMIBI PRODUCTS)
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
(A) Vials in inventory on begin date:
  	
 
  	
 
  	
 
  
	
(B) Plus (+), Vials invoiced during reporting period:
  	
 
  	
 
  	
 
  
	
(C) Minus (-), Vials inventory on end date:
  	
 
  	
 
  	
 
  
	
(Cl) Minus (-), Unconstituted (cold) Vials transferred (pursuant to Section 2.23):
  	
 
  	
 
  	
 
  
	
(D) Equals (=), Vials used or consumed for unit dose preparation and reconstituted (multidose or hot) vials transferred (pursuant to Section 2.23) (V):
  	
 
  	
 
  	
 
  
	
UNIT DOSE DATA
  	
 
  	
 
  	
 
  
	
(E) Total Sestamibi Unit Doses Compounded during reporting period (the sum of lines (F), (G), (H), (K), and (L)):
  	
 
  	
 
  	
 
  
	
(F) Total Sestamibi Unit Doses sold (net of returns) (excluding samples for LMI approved clinical trails and Approved Sampling Programs) during reporting period: 
  	
 
  	
 
  	
 
  
	
(G) Total no-charge Sestamibi Unit Doses supplied (excluding samples for LMI approved clinical trials and Approved Sampling Programs) during reporting period:(4)
  	
 
  	
 
  	
 
  
	
(H) Total Sestamibi Unit Doses returned during reporting period:
  	
 
  	
 
  	
 
  
	
(I) Total Sestamibi Unit Doses supplied for LMI approved clinical trials during reporting period:
  	
 
  	
 
  	
 
  
	
(J) Total Sestamibi Unit Doses supplied for Approved Sampling Programs during reporting period:
  	
 
  	
 
  	
 
  
	
(K) Total Sestamibi Unit Doses for calculating ALF (sum of lines (F), (G), and (J)) (SUD):
  	
 
  	
 
  	
 
  
	
(L) Total Unit Dose Equivalents represented by reconstituted (multidose or hot) vials transferred pursuant to Section 2.23 (UDE):
  	
 
  	
 
  	
 
  
	
CHARGE AND BILLING INFORMATION
  	
 
  	
 
  	
 
  
	
(M) Fee Per Dose (FPD):(5)
  	
 
  	
$
  	
x.xx
  	
 
  
	
(N) Vial Utilization Base (VUB)(6)
  	
 
  	
 
  	
 
  
	
(S1) Aggregate charges by Licensee for unreconstituted (cold) vials transferred pursuant to Section 2.23
  	
 
  	
$
  	
x.xx
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Completed By:
  	
Title:
  	
 
  	
 
  	
 
  
	
Contact Phone #
  	
Date:
  	
 
  	
 
  	
 
  
								

 

(3) Must be a calendar month.

(4) Note: No-charge Sestamibi Unit Doses are subject to Section 5.09 (Compliance with Laws.)

(5) “Fee Per Dose” means the Fee Per Dose as set forth in Exhibit B, or modified pursuant to the Agreement and in effect at the time such vial is delivered.

(6) “Vial Utilization Base” means the Vial Utilization Base as set forth in Exhibit B.

 

35

 

DATA FOR EACH LICENSED PHARMACY LOCATION

 

	
Pharmacy Name:
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
Street Address: 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
City:
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
State:
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
Zip Code:
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
Reporting Period:
  	
 
  	
 
  	
 
  
	
 
  	
MM/YY
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
UNIT DOSE DATA:
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
Total Sestamibi Unit Doses sold during period:
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  
	
Completed By:
  	
 
  	
 
  	
Title:
  	
 
  
	
Contact Phone #
  	
 
  	
 
  	
Date:
  	
 
  

 

36

 

EXHIBIT F

 

REQUIRED MONTHLY END USER DATA REPORT

 

	
License Name:
  	
 
  	
 
  	
Reporting Period:
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
MM/YY
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Completed By:
  	
 
  	
 
  	
Title:
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Contact Phone#
  	
 
  	
 
  	
Date:
  	
 
  
						

 

	
Cardinal
 Account
 Number
  	
 
  	
End Customer
 Name
  	
 
  	
Street Address
  	
 
  	
City
  	
 
  	
State
  	
 
  	
Zip Code
  	
 
  	
Number of
 Sestamibi
 Unit Doses

Sold
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  	
 
  

 

37

 

EXHIBIT G

COMPUTATION OF MONTHLY ADDITIONAL LICENSE FEE

 

The “Additional License Fee” or “ALF” shall be calculated based on the information required to be contained in the Required Monthly Vial and Unit Dose Report (see Exhibit E) for such month. The ALF for a month shall be calculated as follows:

 

ALF = (FPD x (SUD – (V x VUB))

 

	
Where
  
	
 
  
	
FPD
  	
=
  	
the Fee Per Dose applicable during such month (line (M) on Exhibit E).
  
	
 
  	
 
  	
 
  
	
SUD
  	
=
  	
the number of Sestamibi Unit Doses sold or supplied by Licensee in such month, net of returns (line F, Exhibit E), and any no charge Sestamibi Unit Doses supplied by Licensee for clinical trials approved by LANTHEUS (line G on Exhibit E). (Also see paragraph (iv) below.)
  
	
 
  	
 
  	
 
  
	
V
  	
=
  	
the number of vials of Sestamibi Products used or consumed by Licensee in such month (line (D) on Exhibit E). (See paragraph (iv) below.)
  
	
 
  	
 
  	
 
  
	
VUB
  	
=
  	
the Vial Utilization Base applicable to those vials used or consumed by Licensee in such month (line N on Exhibit E). (See paragraph (iv) below.)
  

 

The Additional License Fee may not be less than zero. Negative amounts may not be carried over to subsequent periods. The foregoing restriction is not intended to prohibit subsequent adjustments to the Additional Licensee Fee in the event of a miscalculation or other error in the calculation of the Additional License Fee for a period.

 

(i)                                          For purposes of determining such number of Sestamibi Unit Doses (SUD) and such number of vials (V) used or consumed by Licensee in the applicable month, Licensee shall aggregate the number of Sestamibi Unit Doses (SUD) and the number of vials used or consumed from all of the Licensed Pharmacy Locations.

 

(ii)                                       In the event that Licensee provides no-charge Sestamibi Unit Doses to end user customers other an approved clinical trial, such no-charge Sestamibi Unit Doses shall be included in the number of Sestamibi Unit Doses (SUD) sold or supplied for purposes of determining any Additional License Fee (ALF).

 

(iii)                                In the event that any Sestamibi Unit Doses are returned to Licensee, such returned Sestamibi Unit Doses shall not be included in the number of Sestamibi Unit Doses (SUD) sold or supplied for purposes of determining any Additional License Fee (ALF).

 

38

 

(iv)                              If a new Vial Utilization Base (VUB) is established in accordance with Section 2.11, the new Vial Utilization Base (VUB) shall apply only to vials delivered during such month (and thereafter) and the former Vial Utilization Base (VUB) shall apply to vials delivered prior to such month. The Additional License Fee (ALF) shall be calculated separately for the vials to which the new Vial Utilization Base (VUB) applies and the vials to which the former Vial Utilization Base (VUB) applies. For purposes of such separate computation, (A) the Sestamibi Unit Doses (SUD) shall be the number of Sestamibi Unit Doses sold or supplied by Licensee in such month from the vials to which such computations are applicable, determined in the manner described in paragraph (ii) above and (B) the vials held in Licensee’s inventory shall be deemed to be used or consumed on a first-in-first-out (FIFO) basis.

 

(v)                                 If ALF, as calculated above, is a negative number, no Additional Licensee Fee shall be payable and Licensee shall not be entitled to any refund.

 

39

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