Exhibit
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