Document:

Exhibit 10.7

 

Director Restricted Stock Award

 

R E S T R I C T E D  S T O C K  A W A R D  C E R T I F I C A T E

 

Non-transferable

 

GRANT TO

 

(“Grantee”)

 

by Clarion Property Trust Inc. (the “Company”) of

 

 

shares of its Class A common stock, $0.01 par value (the “Shares”)

 

pursuant to and subject to the provisions of the Clarion Property Trust Inc. Independent Directors Compensation Plan (the “Directors Compensation Plan”), which is operated as a subplan of the Clarion Property Trust Inc. Long-Term Incentive Plan (the “Incentive Plan” and, together with the Directors Compensation Plan, the “Plans”) and to the terms and conditions set forth on the following page (the “Terms and Conditions”).  By accepting the Shares, Grantee shall be deemed to have agreed to the Terms and Conditions set forth in this Award Certificate and the Plans.  Capitalized terms used herein and not otherwise defined shall have the meanings assigned to such terms in the Plans.

 

Unless vesting is accelerated as provided in Section 2 of the Terms and Conditions or otherwise in the discretion of the Board, the Shares will vest (become non-forfeitable) as to one hundred percent (100%) of the Shares on the first (1st) anniversary of the Grant Date, provided that Grantee is still serving as a director of the Company on such date.

 

IN WITNESS WHEREOF, Clarion Property Trust Inc., acting by and through its duly authorized officers, has caused this Award Certificate to be executed as of the Grant Date.

 

 

	
 
  	
CLARION PROPERTY TRUST INC.
  
	
 
  	
 
  	
 
  
	
 
  	
By:
  	
 
  
	
 
  	
 
  	
Its: Authorized Officer
  
	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  
	
 
  	
Grant Date:
  	
 
  
				

 

 

TERMS AND CONDITIONS

 

1.  Restrictions. The Shares are subject to each of the following restrictions. “Restricted Shares” mean those Shares that are subject to the restrictions imposed hereunder which restrictions have not then expired or terminated. Restricted Shares may not be sold, transferred, exchanged, assigned, pledged, hypothecated or otherwise encumbered. If Grantee’s service as a director of the Company terminates for any reason other than as described in (b) below, then Grantee shall forfeit all of Grantee’s right, title and interest in and to the Restricted Shares as of the date of termination, and such Restricted Shares shall be reconveyed to the Company without further consideration or any act or action by the Grantee. The restrictions imposed under this Paragraph shall apply to all shares of the Company’s Stock or other securities issued with respect to Restricted Shares hereunder in connection with any merger, reorganization, consolidation, recapitalization, stock dividend or other change in corporate structure affecting the Stock of the Company.

 

2.  Expiration and Termination of Restrictions.  The restrictions imposed under Paragraph 1 will expire on the earliest to occur of the following (the period prior to such expiration being referred to herein as the “Restricted Period”):

 

(a) on the date specified on the cover page hereof, provided Grantee is providing services as a director of the Company on such date; or

 

(b) the termination of Grantee’s service as a director of the Company by reason of his or her death or Disability; or

 

(c)  the effective date of a Change in Control.

 

3.  Delivery of Shares. The Shares will be registered in the name of Grantee as of the Grant Date and may be held by the Company during the Restricted Period in certificated or uncertificated form. If a certificate for Restricted Shares is issued during the Restricted Period, such certificate shall be registered in the name of Grantee and shall bear a legend in substantially the following form (in addition to any legend required under applicable state securities laws): “This certificate and the shares of stock represented hereby are subject to the terms and conditions contained in a Restricted Stock Award Certificate between the registered owner and Clarion Property Trust Inc.  Release from such terms and conditions shall be made only in accordance with the provisions of such Award Certificate, copies of which are on file in the offices of Clarion Property Trust Inc.”  Stock certificates for the Shares, without the above legend, shall be delivered to Grantee or Grantee’s designee upon request of Grantee after the expiration of the Restricted Period, but delivery may be postponed for such period as may be required for the Company with reasonable diligence to comply, if deemed advisable by the Company, with registration requirements under the 1933 Act, listing requirements of any national securities exchange, and requirements under any other law or regulation applicable to the issuance or transfer of the Shares.

 

4.  Voting and Dividend Rights. Grantee, as beneficial owner of the Shares, shall have full voting and dividend rights with respect to the Shares during and after the Restricted Period. Each dividend payment, if any, shall be made no later than the end of the calendar year in which the dividend is paid to the shareholders or, if later, the 15th day of the third month following the date the dividend is paid to shareholders. If Grantee forfeits any rights he may have under this Award Certificate, Grantee shall no longer have any rights as a shareholder with respect to the Restricted Shares or any interest therein and Grantee shall no longer be entitled to receive dividends on such stock. In the event that for any reason Grantee shall have received dividends upon such stock after such forfeiture, Grantee shall repay to the Company any amount equal to such dividends.

 

5.  No Right of Continued Service. Nothing in this Award Certificate shall interfere with or limit in any way the right of the Company to terminate Grantee’s service at any time, nor confer upon Grantee any right to continue in the service of the Company.

 

6.  Payment of Taxes. Upon issuance of the Shares hereunder, Grantee may make an election to be taxed upon such award under Section 83(b) of the Internal Revenue Code.  To effect such election, Grantee may file an appropriate election with the Internal Revenue Service within thirty (30) days after award of the Shares and otherwise in accordance with applicable Treasury Regulations.  Grantee will, no later than the date as of which any amount related to the Shares first becomes includable in Grantee’s gross income for federal income tax purposes, pay to the Company, or make other arrangements satisfactory to the Board regarding payment of, any federal, state and local taxes (including Grantee’s FICA obligation) required by law to be withheld with respect to such amount.  The obligations of the Company under this Award Certificate will be conditional on such payment or arrangements, and the Company will, to the extent permitted by law, have the right to deduct any such taxes from any payment of any kind otherwise due to Grantee.

 

7.  Plans Control.  The terms contained in the Plans are incorporated into and made a part of this Award Certificate and this Award Certificate shall be governed by and construed in accordance with the Plans. In the event of any actual or alleged conflict between the provisions of the Plans and the provisions of this Award Certificate, the provisions of the Plans shall be controlling and determinative.  In the event of any actual or alleged conflict between the provisions of the two Plans, the provisions of the Incentive Plan shall be controlling and determinative.

 

8.  Successors.  This Award Certificate shall be binding upon any successor of the Company, in accordance with the terms of this Award Certificate and the Plans.

 

9.  Severability.  If any one or more of the provisions contained in this Award Certificate is invalid, illegal or unenforceable, the other provisions of this Award Certificate will be construed and enforced as if the invalid, illegal or unenforceable provision had never been included.

 

10.  Notice.  Notices and communications hereunder must be in writing and either personally delivered or sent by registered or certified United States mail, return receipt requested, postage prepaid.  Notices to the Company must be addressed to Clarion Property Trust Inc., 230 Park Avenue, New York, NY 10169, Attn: Secretary, or any other address designated by the Company in a written notice to Grantee.  Notices to Grantee will be directed to the address of Grantee then currently on file with the Company, or at any other address given by Grantee in a written notice to the Company.Exhibit 10.9

 

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.

 

SALES AGREEMENT

 

CONTRACT NO: NTP CRT 09/005 BC

 

Entered into between:

 

NTP RADIOISOTOPES (PTY) LTD

 

 

and

 

LANTHEUS MEDICAL IMAGING, INC.

 

 

 

This Agreement is
effective from the 1st day of April, 2009 and once signed by all Parties
(hereafter the “effective date of this Agreement”).

 

THE PARTIES:

 

The Parties to
this agreement are:

 

NTP
Radioisotopes (Pty) Ltd, a commercial company registered and existing under the laws of
Republic of South Africa, having its registered office at Building 1700,
Pelindaba, Church Street West Extension, Brits District, North West Province of
South Africa (hereinafter called “NTP”), and

 

Lantheus
Medical Imaging, Inc., a corporation organized and existing under the laws
of Delaware with a place of business at 331 Treble Cove Road, North Billerica,
Massachusetts, United States of America 01862 (“Lantheus”).

 

RECITALS:

 

WHEREAS
NTP is a producer and supplier of Fission Molybdenum-99 (hereinafter “Product”)
and NTP has joint supply and back-up supply arrangements in place with another
producer and and supplier (****) of Product set forth on Exhibit B
(hereinafter called “The Subcontractor”); and

 

WHEREAS
Lantheus has secured permission from the United States to import into the
United States large amounts of Product (“Permissions”) from NTP and has also
secured such Permissions to import such amounts of Product into the United
States from NTP’s Subcontractor; and

 

WHEREAS,
Lantheus desires to purchase Product from NTP and such Subcontractor; and

 

WHEREAS,
NTP and its Subcontractor desire to cooperate with each other to supply
Lantheus with Product in an effective and safe manner.

 

NOW
THEREFORE in consideration of the mutual covenants set out below, the Parties
agree as follows:

 

SECTION 1
- PURCHASE AND SALE OF PRODUCT

 

1.1                                 NTP shall sell Product to Lantheus, and
Lantheus shall purchase Product from NTP, the specification of which is set
forth in Lantheus Purchasing Specification number 08-040-998 attached as
Exhibit A and which is for use in the manufacture of Technetium-99m generators
and Technetium-99m labeled products in Lantheus’ and its contract
manufacturers’ facilities located in North America and elsewhere, in accordance
with the terms set out in this Agreement.

 

1

 

1.2                                 NTP shall identify its preferred
Subcontractor to Lantheus, and if the parties hereto agree that such
Subcontractor shall supply Product to Lantheus hereunder, such Subcontractor
shall be set forth in Exhibit B and Lantheus shall secure Permissions to
import Product from the Subcontractor as soon as practicable.

 

1.3                                 Nothing herein shall prevent Lantheus and
its affiliates from selling such Technetium-99m generators and Technetium-99m
labeled products anywhere in the world.

 

SECTION 2
- ORDERS FOR PRODUCT

 

2.1                                 Lantheus shall buy from NTP, and NTP
shall supply to Lantheus, a **** of Product on a **** basis to be supplied and
delivered to John F. Kennedy International Airport, Jamaica, New York (“JFK”)
or Logan International Airport, Boston, Masssachusetts (“BOS”) (or other
mutually agreed upon delivery location), on **** with follow-on trucking delivery to the
Lantheus facility in North Billerica, Massachusetts. Lantheus shall provide NTP
with notice of its intention to change such location at least forty-five (45) days
in advance of the required inception date of such changes. Subject to
Section 5.1, such initial **** shall be at least **** (****) curies per ****
with a **** (****) day reference, and may be changed upon the mutual
written agreement of the parties hereto. NTP shall be responsible to ensure
that the full **** quota of Mo-99 (****Ci or the amended amount agreed to in
writing) is delivered to Lantheus other than during scheduled outages for
routine maintenance, unscheduled outages or failures of the production lines of
the NTP and its Subcontractor (i.e., under conditions of normal operations
prevailing at NTP and its Subcontractors facilities). At the discretion of the
Account Manager at NTP (“Account Manager”), such material shall be supplied by
NTP or its Subcontractor. Lantheus shall be advised in a timely way of the
manner in which supply obligations hereunder will be allocated amongst NTP and
its Subcontractor. NTP will schedule deliveries to Lantheus so as to compensate
for scheduled outages at either facility in such a way that the full supply
quota will be maintained under such circumstances. In the case of unscheduled
outages or production line failures for whatever reason at either facility the
Account Manager will employ best efforts to fulfill quotas. In situations where
a global supply shortage arises for whatever reason (and for Events of Force
Majeure (as hereinafter defined)) Lantheus will receive a share of Product
available that is not less than that which is directly proportional to its average
share of the total **** purchasing (averaged over the preceding **** (****)
days) from NTP and its Subcontractor. NTP has established and shall maintain
relationships with air carriers for the Lantheus route such that the
probability of a Lantheus shipment being refused by the carrier shall be highly
improbable. NTP shall liaise (via the Account Manager at NTP) with its
Subcontractor, taking into account the reactor, production and maintenance
schedules of each facility, and supply Lantheus **** (****) days in advance of
the first delivery of a ****, the supply schedule for the following ****
detailing clearly which supplier (NTP or a

 

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Subcontractor)
will supply which delivery. For clarity and as an example, NTP will provide
Lantheus the **** supply schedule on ****. This supply schedule will be binding
on NTP and its Subcontractor and will be used by Lantheus to register each
shipment with applicable U.S. governmental authorities as dictated by U.S. regulations.
If the airport of delivery is John F. Kennedy (JFK) then Product will be
available for pick-up by Lantheus no later than ****. If the airport of
delivery is Logan International (BOS) then Product will be available for
pick-up by Lantheus no later than ****. Pick-up time for any other delivery
location will be mutally agreed upon.

 

2.2                                 Should Lantheus wish to increase or
decrease the minimum contracted weekly volume of Product supplied by NTP by
more or less than **** percent (****%) of the regular **** **** Ci per **** for
a period of time less than **** (****) months, then Lantheus shall provide
NTP with notice of its intention to change such volume at least **** (****)
days in advance of the required inception date of such changes. NTP will make
every commercially reasonable effort to comply with any such request and will
confirm ability to accommodate the change at the latest **** (****) days before
the requested commencement of the delivery of the new volume of product.

 

2.3                                 Should Lantheus wish to increase or
decrease the minimum contracted **** volume of Product supplied by NTP by more
or less than **** percent (****%) of the regular **** **** Ci per **** for a
single delivery Lantheus shall provide NTP with notice of its intention to
change such volume in as timely a manner as possible prior to the date
requested. NTP will make every commercially reasonable effort to comply with
this request.

 

2.4                                 In cases of emergency and pending
Lantheus’ inability to register and obtain approval from applicable U.S.
governmental authorities, Lantheus may with less than one (1) month’s
notice, request to change the volume of Product to be supplied for any
shipment. NTP and its Subcontractor shall make best efforts to accommodate such
request for ad hoc changes.

 

2.5                                 The number of curies of Product shipped
from NTP or its Subcontractor shall be calibrated **** (****) hours from **** (****)
**** ****, at **** on the day of **** from the ****. This is equivalent to ****
hours in US Summer time and **** hours in US Winter time from **** on day of
dispensing at NTP.

 

2.6                                 Lantheus, NTP and the Subcontractor shall
engage one another in the periodic calibration of their respective
radioactivity measurement systems by reference to the U.S. National Institute
of Standards and Testing (NIST) or equivalent standard reference materials.

 

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SECTION 3
- DELIVERY TERMS

 

3.1                                 Product destined for Lantheus shall be
delivered by NTP and its Subcontractor to the airfreight carrier at the airport
of departure on a **** basis, which carrier and airport will be set forth in
the supply schedule provided pursuant to Section 2.2. “****” in this
Agreement shall be interpreted in accordance with INCOTERMS 2000 as amended.
All export permits and licenses shall be obtained by NTP or its Subcontractor,
as necessary to meet the shipping requirements set forth herein. NTP and its
Subcontractor shall use their best efforts to ensure that all Product destined
for Lantheus is loaded onboard a commercial airfreight carrier accepting
radioactive shipments and that such carrier actually departs the departure
airport with such Product. Upon execution of this Agreement, NTP shall commence
negotiations and use best efforts to obtain a firm, written commitment from the
relevant air carriers for delivery of at least the **** volume of Product
required to be purchased by and destined for Lantheus hereunder.

 

3.2                                 NTP and its Subcontractor shall procure
and manage transportation on Lantheus’ behalf by air or on land and in
accordance with Lantheus’ instructions for delivery to JFK. Lantheus shall make
all shipping arrangements to ship Product from JFK to the final destination.
NTP and its Subcontractor agree to assist Lantheus with making the arrangements
for the transshipment, including, without limitation, providing shipping
documentation such as air waybills. If the information provided by NTP in the
documentation provided by NTP is incorrect or incomplete and this incorrect or
incomplete information delays the delivery of Product to Lantheus to such an
extent that Lantheus cannot use Product at its scheduled production time then
Lantheus will be relieved of it’s obligation to purchase the delayed Product
and NTP shall grant Lantheus a purchase credit for the full amount of the price
of the Product.

 

3.3                                 All costs in respect of transporting any
shipment of Product on a **** basis from the airport of departure as set forth
above, shall be for the account of ****. NTP and its Subcontractor shall
pre-pay such shipping costs and invoice Lantheus accordingly for actual
out-of-pocket costs incurred.

 

3.4                                 Risk of loss and title to Product shall
transfer from NTP or its Subcontractor to Lantheus on **** (“****”) of such
shipment from the **** after acceptance of a Product shipment by the ****. For
clarity if Product is not on the **** at **** then title for Product shall
remain with NTP and Lantheus will not be obligated to purchase the Product.
Lantheus will work with NTP in good faith and at Lantheus’ sole discretion to
accept the Product at a later time. If a later delivery is agreed to NTP will
adjust the volume of the Product delivered to reflect decay over the time of
the delay.

 

3.5                                 Subject to the foregoing obligations of
this Section 3, shipping arrangements shall be subject to the availability
of commercial airfreight services accepting radioactive shipments on the days
necessary to meet the shipping requirements

 

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set
forth herein. In the event of changes in the availability of existing
airfreight services on such days, NTP or its Subcontractor shall promptly
notify Lantheus and, upon such notification, NTP and its Subcontractor and
Lantheus shall work together to find mutually acceptable alternatives.

 

3.6                                 All air waybill numbers of NTP or its
Subcontractor and the identification number of each container to be used for
each month’s scheduled shipments, shall be forwarded to Lantheus as mutually
agreed.

 

3.7                                 Promptly upon its receipt at Lantheus’
facility, Lantheus shall inspect Product and if Product does not conform to the
specifications set out in Exhibit A (including, without limitation,
calibration as provided in Section 2.1), Lantheus shall promptly notify
NTP of any such non-compliance with specification. Immediately upon NTP’s
receipt of such notice, NTP and its Subcontractor shall make arrangements, at
Lantheus’ sole discretion, either to replace such nonconforming Product at no
extra cost or to grant Lantheus a purchase credit in the amount of the price to
Lantheus of such nonconforming Product. Lantheus and NTP shall immediately
consult on the disposition of such nonconforming Product. Unless NTP and
Lantheus agree otherwise, Lantheus shall discard such nonconforming Product,
and NTP shall indemnify Lantheus for the cost of disposal. Alternatively, the
parties may agree that nonconforming Product may be returned to NTP for
disposal at NTP’s cost.

 

SECTION 4
- CONTAINERS FOR PRODUCT

 

4.1                                 Shipments of Product shall be delivered
and transported in containers complying with U.S. transport regulations for the
transport of radioactive materials. NTP and its Subcontractor agree to allocate
a sufficient number of containers for use by Lantheus in accordance with growth
in Lantheus’ purchase volume or change in shipping schedules which may arise
and to cover emergency shipments. NTP will package Product into containers in
such a way as to minimize the number used for each shipment. Such containers
shall at all times remain the property of NTP or its Subcontractor.

 

4.2                                 Risk of loss of containers shall pass to
Lantheus on an **** basis at the same time as risk of loss and title for the
Product shall pass, and such risk of loss shall revert back to NTP or its
Subcontractor upon Lantheus’ return of containers as set out below.

 

4.3                                 Lantheus shall return Seller’s empty
containers by prepaid airfreight to its appointed agent at the airport
specified by it. Prior to return of containers, Lantheus shall advise NTP or
its Subcontractor of shipment details regarding the delivery of containers,
including, without limitation, air waybill number, flight number, date of
shipment and serial numbers. Containers shall be returned to NTP or its
Subcontractor within **** (****) calendar days of their receipt at the Lantheus
facility in North Billerica, Massachusetts. Should any containers be

 

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received
later than **** (****) calendar days after receipt by Lantheus a demurrage fee
of **** U.S. dollars ($****) per day or part thereof may be levied for such
late returns.

 

SECTION 5
- PRICE AND PAYMENT

 

5.1                                 The price payable by Lantheus for Product
for the first term of this Agreement shall be as follows:

 

In
exchange for the commitment of Lantheus to purchase a sum of **** (****) curies
(with **** hour calibration time) of Product in any given **** (subject to
NTP’s ability to supply such amount in such ****), the unit price of Product
for such **** shall be **** fixed US dollars (U.S. $****) per Curie at
calibrated date and time as of the signing date of this Agreement. A price
adjustment to **** fixed US dollars (U.S. $****) per Curie will be made for all
Product purchased after ****. The calibration date and time above shall be in
accordance with Section 2.4. Such price will be adjusted **** upon mutual
agreement of the parties as of each subsequent **** of the Agreement on the
basis of market forces prevailing at the time, the then current cost of
production and any contractual sales obligations that Lantheus may have with
its customers and by negotiation and agreement by, at the latest the last day
of **** preceding the commencement of the new pricing term (**** of
each **** that the contract is in place). Lantheus shall have the right to
terminate the Agreement if the parties fail to agree on new pricing by such
last day of ****. Changes in contracted volumes not required during the course
of a contractual period, i.e., **** to **** of the following year,
the latter of which would be handled in terms of Clause 2.2, but applicable for
the ensuing contractual period shall be agreed at the same time as the annual
negotiations on product prices as outlined in 5.1 above.

 

NTP
shall invoice Lantheus at the end of each month for all Product supplied by NTP
or its Subcontractor in that month. Invoicing shall be in respect of the price
applicable to Product upon the delivery of such conforming Product to Lantheus
on an **** basis, and in respect of container charges as the same become
payable under this Agreement. Lantheus shall pay all invoices for shipments of
conforming Product in any given month (as reduced by any outstanding credits
for nonconforming Product) by the end of the following **** to NTP.

 

5.2                                 The prices set forth above include
packaging in accordance with normal shipping laws, regulations and industry
standards for Product [and do not include taxes, duties or other imposts levied
by any competent authority on the Products (other than income taxes levied on
NTP or its Subcontractor or their affiliates), which taxes, duties and imposts
shall be borne by Lantheus.

 

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SECTION 6 - EMERGENCY ORDERS

 

If, on an occasional or exceptional basis, Lantheus requires Product to be delivered in different quantities or at different times or to a different location or with different pre-calibration, to that stipulated in this Agreement, then NTP and its Subcontractor shall use reasonable best efforts to comply with such request.

 

SECTION 7 - PRODUCT WARRANTIES

 

7.1                               NTP and its Subcontractor warrants and covenants that Product delivered by it pursuant to this Agreement shall:

 

(1)                                 be free from defects in title, design, material and workmanship,

 

(2)                                 conform to all specifications set forth in this Agreement or as, from time to time, otherwise required by applicable laws and regulations,

 

(3)                                 be of merchantable quality, and fit for the purposes for which it is being bought or which is indicated by Lantheus to suppliers,

 

(4)                                 conform to the relevant manufacturer’s Drug Master File (if it is filed by Seller), and

 

(5)                                 be manufactured and tested in accordance with current good manufacturing practices (cGMP); comply with all applicable laws, regulations and industry standards relating to the manufacture, testing, labeling, storage and shipment of Products; and not be adulterated or misbranded within the meaning of the United States Federal Food, Drug and Cosmetic Act (21 U.S.C. 1 et seq.) at the time of delivery to the airfreight carrier.

 

7.2                               Notwithstanding anything herein and not in limitation of any other rights of Lantheus hereunder or under applicable law or regulation, Lantheus may reject any Product which does not conform to the above warranties and no charge shall be levied by NTP for any nonconforming Product. NTP shall reimburse Lantheus for all shipping or disposal costs associated with the return or disposal of nonconforming Product and all previously paid taxes and other expenses relating to such shipment. In the event of any circumstance coming to the attention of NTP or its Subcontractor with regard to any deviation from specification disclosed by quality control tests carried out at the site of origin of Product, suppliers shall promptly inform Lantheus of such circumstance.

 

7.3                               NTP and its Subcontractor shall retain an archive sample of each Product lot shipped hereunder for a period of four (4) weeks following its delivery.

 

7.4                               The specifications of Product set out in Section 1.1 may be amended only by a prior written agreement between NTP and Lantheus after the provision to

 

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Lantheus of free sample(s) of Product conforming to such amended specification sufficient in quantity to enable Lantheus to establish the suitability of such amended Product for use in the manufacture of Technetium-99m generators and Technetium-99m labeled products in its facilities. To the extent that a material change of process at NTP’s facilities is effected, Lantheus shall have the right in its sole discretion to accept such change, notwithstanding whether such change of process results in an amendment to the Product specification set forth in Section 1.1.

 

7.5                               The parties agree to the terms of the Quality Assurance Agreement, attached hereto as Exhibit C. The Quality Assurance Agreement as amended from time to time upon mutually written agreement of the parties shall apply to supplies of Product under this Agreement.

 

SECTION 8 - FORCE MAJEURE

 

8.1                               No party hereto shall be liable to the other parties for default or delay in the delivery of Product or in the ordering of Product due to a/an: Act of God; fire; flood; storm; riot; sabotage; explosion; strike or labour disturbance (excluding a strike or labour disturbance involving NTP’s or its Subcontractor’s facilities); national security disaster; change in governmental law, ordinance, rule or regulation; inability to obtain electricity or other type of energy or raw materials; or any similar or different contingency beyond its reasonable control (collectively called “Event of Force Majeure”). For the Subcontractor, where there is a dependence on sourcing from external reactors in Europe, major unscheduled shutdowns of such reactors are considered to be events of Force Majeure.

 

8.2                               Upon the occurrence of an Event of Force Majeure, the defaulting party shall:

 

(1)                            forthwith give notice to the other party of the occurrence of such Event of Force Majeure;

 

(2)                            use its best efforts to eliminate and/or minimize the effects of the Event of Force Majeure;

 

(3)                            forthwith give notice to the other party when such Event of Force Majeure has been eliminated, or has ceased to prevent the defaulting party from fulfilling such obligations.

 

8.3                               In the event that any shortage of Product is anticipated, NTP shall provide notice to Lantheus by telephone (followed by written confirmation) as soon as reasonably possible. If either NTP or its Subcontractor is at short notice unable to supply scheduled Product, then NTP and its Subcontractor will liaise and move delivery on a best effort basis to the other supplier in as far as Lantheus is able to register the change in delivery with its regulatory authorities. If such efforts fail to yield satisfactory results, NTP shall relieve Lantheus of its purchase

 

8

 

obligations hereunder in connection with such specific order and all other orders hereunder that NTP or its Subcontractor cannot supply. NTP shall allow Lantheus to purchase the amount of such shortfall from any third party of its choice. In such case, Lantheus may, at its sole discretion, cancel the initial order equivalent to such shortfall.

 

8.4                               If an Event of Force Majeure affects only a part of the capacity of the defaulting party to produce and deliver Product, NTP shall use best efforts pursuant to Section 8.3, and if NTP is nevertheless unable to fulfill Lantheus’ requirement, the defaulting party shall allocate production and delivery of Product to Lantheus on a first priority basis, based on Lantheus’ average purchases in the **** (****) days prior to the time such Event of Force Majeure affected production and delivery.

 

8.5                               If an Event of Force Majeure shall continue to exist for more than [**** (****)] consecutive days, Lantheus shall be entitled to terminate this Agreement without advance notice of such termination to NTP.

 

SECTION 9 - CONFIDENTIALITY

 

9.1                               Each party shall maintain in confidence and safeguard all business and technical information which is disclosed by one party to the other in connection with this Agreement and which is designated confidential at the time of disclosure, provided that the parties agree that the terms of this Agreement and all transactions conducted hereunder are deemed to be confidential information and subject to the protections set forth herein. The obligations under this Section shall not apply to:

 

(1)                                 information now in the public domain or which hereafter becomes available to the public through no fault of the receiving party;

 

(2)                                 information already known to the receiving party at the time of disclosure;

 

(3)                                 information disclosed to the receiving party by any third party who has a right to make such a disclosure;

 

(4)                                 information independently developed by the receiving party through the work carried by its employees, agent, or representatives;

 

(5)                                 information approved for release in writing by disclosing party; or

 

(6)                                 information as may be required to be disclosed by applicable law, regulation or order of a governmental authority of competent jurisdiction.

 

9.2                               The parties acknowledge that any disclosure or misappropriation of confidential information in violation of this Article may cause irreparable harm, the amount of which may be difficult to determine, thus potentially making any remedy at law

 

9

 

or in damages difficult to determine, thus potentially making any remedy at law or in damages inadequate, Each party, therefore, agrees that the other party shall have the right to apply to any court of competent jurisdiction for an order restraining any breach or threatened breach of the confidentiality provisions of this letter agreement and for any other appropriate relief. This right shall be in addition to, and not in lieu of, any other remedy available in law or equity.

 

9.3                               The obligation under this Article shall continue for five (5) years after the expiry or termination of this Agreement.

 

9.4                               NTP and its Subcontractor agree that Lantheus may disclose information with its shareholders upon their request. This Section shall survive termination or expiration of this Agreement.

 

SECTION 10 - INDEMNITY AND INSURANCE

 

10.1                        Each party (“Indemnifying Party”) shall indemnify the other (“Indemnified Party”) in respect of any costs, losses, judgments or any other liabilities incurred by the Indemnified Party, including, without limitation, any personal injury or death, or loss of or damage to property, suffered by a third party or by the Indemnified Party hereto, arising out of or as a result of the negligent acts or omissions of, or breach or alleged breach of this Agreement by, the Indemnifying Party, its directors, officers, employees or agents, during the performance of the Indemnifying Party’s obligations pursuant to this Agreement.

 

10.2                        NTP and its Subcontractor shall each maintain, at all times during the term of this Agreement, at their own expense, Product Liability Insurance with a per occurrence limit of not less than the equivalent of **** U.S. dollars ($****) under a liability policy and/or under an umbrella policy. NTP and its Subcontractor shall provide Lantheus with certificates evidencing such insurance as soon as practicable after the effective date of this Agreement and after subsequent renewals of the policies.

 

Lantheus will maintain, at all times during the term of this Agreement, at Lantheus’ own expense, Product Liability Insurance with a per occurrence limit of not less than the equivalent of **** U.S. dollars ($****) under a liability policy and/or under an umbrella policy. Lantheus will provide NTP with certificates evidencing such insurance as soon as practicable after the effective date of this Agreement and after subsequent renewals of the policies.

 

SECTION 11 - TERM

 

11.1                        The term of this Agreement shall commence on the effective date of this agreement and end at midnight GMT on the 31st day of December 2013. Lantheus may terminate this Agreement for convenience by giving six (6) months written notice prior to the expiry of each term. Lantheus may also terminate this

 

10

 

Agreement immediately after three (3) supply failures in the space of any twelve (12) month period. Supply failures shall be considered to be events where an amount not exceeding 50% of the ordered activity of Mo-99 is delivered to Lantheus provided that the root cause of such failures was within or should have been within the control of NTP and its Subcontractor.

 

11.2                        Either party may terminate this Agreement (i) upon thirty (30) days written notice to the other party in the event of any material breach of any provision of this Agreement, provided that the breaching party is unable to cure the breach within such thirty (30) day period or (ii) immediately upon written notice if a trustee or receiver or similar officer of any court is appointed for a party or for a substantial part of the property of such party, whether with or without consent; or bankruptcy, composition, reorganization, insolvency or liquidation proceedings are instituted by or against such party without such proceedings being dismissed within ninety (90) days from the date of the institution thereof.

 

11.3                        Upon termination for any reason set forth herein, Lantheus shall have the option to purchase additional quantities of Product from NTP for an additional **** (****) month period, which orders shall be subject to the terms and conditions of this Agreement.

 

11.4                        Should NTP and Lantheus agree on a new Agreement prior to the termination date of this Agreement, then this Agreement shall terminate on the effective date of the new replacement Agreement.

 

11.5                        Should no notice be given by either party as per Section 11.1, then this Agreement, including without limitation the price terms in Section 5.1, will be automatically renewed for another term pending agreement being reached by both parties on pricing and volume issues.

 

SECTION 12 - NOTICE

 

12.1                        All notices, demands and other communications by one party to the other with respect to this Agreement shall be made in writing by registered airmail, postage prepaid, or facsimile, or electronic mail, or personal delivery at the addresses below, or at such other address as may be notified by such other party pursuant to the provisions of this Article from time to time, Note: For reasons of efficiency, certain communications relating to deliveries, QA and regulatory matters (and others that are relavant) will be made directly between the Subcontractor and Lantheus (with a simultaneous copy to NTP).

 

To Lantheus:

 

Lantheus Medical Imaging, Inc.
 331 Treble Cove Road
 North Billerica, MA 01862 U.S.A.

 

11

 

Attention: William Dawes, Jr.

 

with a copy to:

 

Lantheus Medical Imaging, Inc.
 331 Treble Cove Road
 North Billerica, MA 01862 U.S.A.
 Attention: Michael Duffy, Esq.

 

To NTP:

 

Building 1700
 Private Bag 582
 PRETORIA
 0001
 South Africa
 Attention: RG von Gogh or PA Louw

 

12.2                        All notices, demands and other communications mentioned above shall be deemed to have been given at the time of receipt when made by personal delivery, at the time of confirmation when made by facsimile or electronic mail, and seven (7) days after posting when made by registered airmail.

 

SECTION 13 - GENERAL TERMS

 

13.1                        No Party shall be entitled to assign all or any of its rights or obligations under this Agreement without the consent of the other Party hereto which shall not be unreasonably withheld. Any transfer or assignment of this Agreement made without the consent as required herein shall be of no effect whatsoever. Notwithstanding the foregoing, (i) either party may assign its rights and obligations under this Agreement, without the prior written consent of the other Party, to an affiliate or a successor of the relevant portion of the assigning party’s business by reason of merger, consolidation, change of control, sale of all or substantially all of its assets or any similar transaction, provided that such successor agrees in writing to be bound by this Agreement and (ii) Lantheus may assign this Agreement for the benefit of any lenders under any financing arrangement (including, without limitation, with Ableco Finance LLC), without the prior written consent of NTP. This Agreement shall inure to the benefit of and be binding upon the respective successors and permitted assigns of the Parties hereto.

 

12

 

13.2                        This Agreement constitutes the entire understanding between the Parties with respect to the subject matter hereof.

 

13.3                        Any modification, or addition, to any of the terms and conditions of this Agreement shall not be effective unless in writing and signed by the duly authorized representatives of all Parties.

 

13.4                        If any provision of this Agreement is found to be 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 unenforceable, it will be substituted with such provision as will most fully realize the intent of the Parties as expressed in this Agreement, to the fullest extent permitted by law.

 

13.5                        This Agreement shall be of no effect and shall not become binding on each Party until signed by the duly authorized representatives of all Parties. The obligations of NTP hereunder shall be binding on NTP’s Subcontractor, and NTP shall cause such Subcontractor to comply with such obligations.

 

13.6                        The waiver of strict compliance or performance of any of the terms of this Agreement or of any breach thereof on the part of each Party shall not be held or deemed to be a waiver of:

 

(1)                                 Any subsequent failure to comply strictly with or perform the same or any other term and condition of this Agreement; or

 

(2)                                 Any subsequent breach hereof.

 

13.7                        This Agreement shall be governed by and construed in accordance with the laws of England without out reference to its choice of law rules.

 

13.8                        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 sixty (60) days after commencing consultation, the disputes shall be settled by arbitration in London (under the rules of Arbitration of the International Chamber of Commerce as in force on the execution date of this agreement by one or more arbitrators appointed in accordance with the said rules. The award shall be final and binding upon the parties.

 

13.9                        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.

 

13

 

13.10                 A party shall not make any public announcement with respect to this Agreement specifically identifying the other party or referencing the trade name or trademark of the other party without the prior written consent of the other party, which shall not be unreasonably withheld or delayed, provided further that each party shall have the right to make any public statements related to market supply without the consent of the other party provided there is no reference specifically identifying the other party or referencing the trade name or trademark of the other party. In the event of required consent to an announcement required by this Section, the party making such announcement shall provide the other party with a copy of the proposed text prior to such announcement at least ten (10) days in advance of the scheduled release of such announcement to afford such other party a reasonable opportunity to review and comment upon the proposed text.

 

[Remainder of page intentionally left blank.]

 

14

 

IN WITNESS WHEREOF, the Parties hereto have duly executed this Agreement as of the date first written above.

 

 

	
For and on behalf of NTP:
  	
 
  
	
 
  	
/s/ DG Robertson
  
	
 
  	
DG Robertson
  
	
 
  	
Managing Director
  
	
 
  	
 
  
	
 
  	
 
  
	
For and on behalf of Lantheus:
  	
 
  
	
 
  	
/s/ Michael Duffy
  
	
 
  	
Michael Duffy
  
	
 
  	
VP and General Counsel
  
	
 
  	
 
  
	
 
  	
 
  
	
Witnessed by IRE:
  	
 
  
	
 
  	
/s/ Jean-Michel Vanderhofstadt
  
	
 
  	
Jean-Michel Vanderhofstadt
  
	
 
  	
General Manager
  

 

15

 

EXHIBIT A

 

PURCHASING SPECIFICATION 08-040-998

 

 

 

PURCHASING SPECIFICATION

 

	
1.
  	
 
  	
DESCRIPTION
  
	
 
  	
 
  	
 
  
	
 
  	
 
  	
Code: ****            ****
  
	
 
  	
 
  	
 
  
	
 
  	
 
  	
Code: ****        ****
  
	
 
  	
 
  	
 
  
	
1.1
  	
 
  	
The following container systems are acceptable to Lantheus Medical Imaging, Inc. (LMI).
  
	
 
  	
 
  	
 
  
	
1.1.1
  	
 
  	
Primary Container-**** or NTP
  
	
 
  	
 
  	
 
  
	
1.1.1.1
  	
 
  	
Fission produced Mo-99 solution contained in a ****
  
	
 
  	
 
  	
 
  
	
1.1.2
  	
 
  	
Secondary Containment
  
	
 
  	
 
  	
 
  
	
1.1.2.1
  	
 
  	
Approved by LMI and certified by appropriate regulatory agencies.
  
	
 
  	
 
  	
 
  
	
2.
  	
 
  	
MATERIAL
  
	
 
  	
 
  	
 
  
	
2.1
  	
 
  	
Contents
  
	
 
  	
 
  	
 
  
	
2.1.1
  	
 
  	
****
  
	
 
  	
 
  	
 
  
	
2.1.2
  	
 
  	
****
  
	
 
  	
 
  	
 
  
	
2.2
  	
 
  	
Purity (Ref. **** hours post receipt at **** Eastern Time (ET) LMI receipt)
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
2.2.1
  	
 
  	
1-131/Mo-99
  	
 
  	
**** microcurie/millicurie Mo-99 or ****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
2.2.2
  	
 
  	
Ru-103/Mo-99
  	
 
  	
**** microcurie/millicurie Mo-99 or ****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
2.2.3
  	
 
  	
Other Gammas/Mo-99
  	
 
  	
**** microcurie/millicurie Mo-99 or ****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
2.2.4
  	
 
  	
Se-89/Mo-99
  	
 
  	
**** microcurie/millicurie Mo-99 or ****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
2.2.5
  	
 
  	
Sr-90/Mo-99
  	
 
  	
**** microcurie/millicurie Mo-99 or ****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
2.2.6
  	
 
  	
Alpha/Mo-99
  	
 
  	
**** microcurie/millicurie Mo-99 or ****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
2.2.7
  	
 
  	
Concentration
  	
 
  	
**** at reference/activity calibration
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
3.
  	
 
  	
OTHER REQUIREMENTS
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
3.1
  	
 
  	
Subcontracting of orders, or any proposed changes to materials or shipping package, must be submitted in writing to LMI Purchasing and Quality Assurance departments for consideration and approval prior to implementation.
  

 

CONFIDENTIAL

 

This document is Lantheus Medical Imaging, Inc, confidential and proprietary information. Individuals using a copy of this document are responsible for ensuring that revisions to the document have not been issued since it was printed.

 

1

 

	
3.2
  	
 
  	
The vendor must notify LMI in the event of a shortfall or inability to deliver a confirmed order as soon as it is known.
  
	
 
  	
 
  	
 
  
	
3.3
  	
 
  	
As part of a supplier quality management program, LMI reserves the right to perform an audit of the supplier’s facilities and programs which impact upon the quality of the supplied material. Current Good Manufacturing Practices (cGMPs) are to be observed by the supplier.
  
	
 
  	
 
  	
 
  
	
3.4
  	
 
  	
Certificate of Analysis: A Certificate of Analysis (C of A) for the molybdenum solution must be provided for each master lot and contain information per section 2.2 at time of receipt. The C of A will state the actual values versus specifications. The C of A must state that the material has been manufactured and packaged in accordance with this Purchasing Specification.
  
	
 
  	
 
  	
 
  
	
 
  	
 
  	
NOTE:
  	
In process C of A may be submitted at time of shipment but all test results are required for release on day of receipt.
  
	
 
  	
 
  	
 
  
	
3.5
  	
 
  	
Technical Data Sheet: A Technical Data Sheet stating specific product information must be provided for each lot **** In each shipment and arrive with shipment. Information contained on the Technical Data sheet must reference **** Eastern Time (ET) on vendor’s reference or calibration date. The Technical Data Sheet at a minimum must state the following information:
  
	
 
  	
 
  	
 
  
	
3.5.1
  	
 
  	
Supplier name/address
  
	
 
  	
 
  	
 
  
	
3.5.2
  	
 
  	
Order Number
  
	
 
  	
 
  	
 
  
	
3.5.3
  	
 
  	
Catalogue Number
  
	
 
  	
 
  	
 
  
	
3.5.4
  	
 
  	
Product Name/Chemical Form
  
	
 
  	
 
  	
 
  
	
3.5.5
  	
 
  	
Physical Form
  
	
 
  	
 
  	
 
  
	
3.5.6
  	
 
  	
Shipment Date
  
	
 
  	
 
  	
 
  
	
3.5.7
  	
 
  	
Lot/Batch Number
  
	
 
  	
 
  	
 
  
	
3.5.8
  	
 
  	
Container I.D.
  
	
 
  	
 
  	
 
  
	
3.5.9
  	
 
  	
Volume (mL) of:
  
	
 
  	
 
  	
 
  
	
3.5.9.1
  	
 
  	
**** (Mo-99)
  
	
 
  	
 
  	
 
  
	
3.5.9.2
  	
 
  	
**** Added (equivalence)
  

 

2

 

	
3.5.9.3
  	
 
  	
Total volume in ****
  
	
 
  	
 
  	
 
  
	
3.5.10
  	
 
  	
Mo-99 Concentration (mCi/mL) at vendor’s Calibration or reference date/time ET
  
	
 
  	
 
  	
 
  
	
3.5.11
  	
 
  	
Ordered Activity (Ci) at Calibration date/time ET
  
	
 
  	
 
  	
 
  
	
3.5.12
  	
 
  	
Total Activity (Ci) at vendor’s calibration or reference date
  
	
 
  	
 
  	
 
  
	
3.5.13
  	
 
  	
Calibration Date and Time (time zone (ET))
  
	
 
  	
 
  	
 
  
	
4.
  	
 
  	
PACKAGING
  
	
 
  	
 
  	
 
  
	
4.1
  	
 
  	
**** containers must be licensed under US Nuclear Regulatory Commission (NRC) and Department of Transportation (DOT) regulations (Type B container program).
  
	
 
  	
 
  	
 
  
	
4.2
  	
 
  	
Containers must be compatible with LMI manufacturing systems and be properly labeled with contents, activity, calibration and I.D. number.
  
	
 
  	
 
  	
 
  
	
4.3
  	
 
  	
Mo-99 solution cannot be blended with material from other manufacturers unless approved by LMI.
  
	
 
  	
 
  	
 
  
	
5.
  	
 
  	
TRANSPORTATION: See current purchase order.
  
	
 
  	
 
  	
 
  
	
 
  	
 
  	
NOTE:
  	
This is a time sensitive shipment. The vendor must notify LMI as soon as possible of any potential and/or actual shipping delays.
  

 

3

 

EXHIBIT B

 

Subcontractor

 

NTP and Lantheus agree that the following Subcontractor be used by NTP for alternative supply of Product to Lantheus under the rules of this Agreement:

 

·             **** of ****. (hereafter “****”)

 

 

EXHIBIT C

 

Quality Assurance Agreement

 

 

 

QUALITY AGREEMENT

 

Parties to this Agreement:

 

(1)                                  Lantheus Medical Imaging Company

(2)                                  NTP Radioisotopes (Pty) Ltd.

 

1.                                      GUIDING PRINCIPLES

 

This quality agreement, (written in accordance with the principles defined in Section 16 of the ICH Q7A Guideline “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”), specifies the relationship between NTP Radioisotopes (Pty) Ltd., Pelindaba, Pretoria, South Africa and Lantheus Medical Imaging Company, 331 Treble Cove Rd., North Billerica, MA 01862 USA for the final materials, listed in Appendix A. These final materials are manufactured, packaged, QC tested and released by NTP to LMI and/or its affiliates or partners around the world.

 

Unless otherwise specified, “LMI” refers to Lantheus Medical Imaging Company, represented by its affiliates or agents who are signatories to this agreement. “Material Supplier” refers to NTP, represented by its agents, who are signatories of this document.

 

Quality Contacts are listed in Appendix B.

 

2.                                      PRIMARY RESPONSIBILITIES

 

2.1                                 NTP has the responsibility to purchase all starting/raw materials and to ensure that the final material is manufactured, packaged, quality control tested and released in compliance with cGMPs, the Product Registration, applicable laws or regulations and LMI requirements.

 

2.2                                 A summary of the division of responsibilities between LMI and NTP is listed in Appendix C.

 

3.                                      CHANGE CONTROL

 

3.1                                 NTP will not make any changes that affect the validated state of the final material without first notifying LMI and obtaining LMI’s prior written consent. All change controls will be managed in accordance with NTP’s requirements.

 

4.                                      MATERIAL RELEASE PROCEDURES

 

4.1                                 Starting/Raw Materials

 

NTP will purchase, inspect, test and release starting/raw materials according to approved in house procedures and technical specifications. When applicable, all starting/raw materials will be tested to comply with the requirements defined in pharmacopoeias relevant to the markets being supplied. Where the starting Material is not defined in a pharmacopoeia, it will be tested to comply with the specifications registered by NTP.

 

1

 

4.2                                 Final Material

 

4.2.1                        NTP will ensure that all manufacturing operations are in compliance with ICH Q7A and applicable regulatory agency requirements, NTP shall inform LMI immediately of any deviations from such regulatory guidelines that effect product quality.

 

4.2.2                        NTP will notify LMI immediately in the event of any deviation(s) that may affect Final Material integrity. Any significant problems experienced during manufacturing and any test that reveals contamination, degradation, or other failure in any batch of Final Material, will be notified to LMI prior to shipment.

 

4.2.3                        Raw Material testing, batch record review and batch release of Final Material to LMI will be the responsibility of NTP’s Quality unit who will ensure that the Final Material meets specification and was manufactured in accordance with master manufacturing documents, the product registrations, applicable laws or regulations and cGMPs.

 

4.2.4                        For each batch of Final Material released to LMI by NTP, a Certificate of Analysis (CoA) and a Certificate of Conformance (CoC) will be supplied to LMI (these may be combined into a single document). The CoA will contain the Final Material name, lot number, reference/calibration date, test name, numerical result vs. LMI specification. The Technical Data Sheet supplied by NTP. contains the activity concentration and diluent amounts for the products supplied. In addition, it will include the Final Material name, lot number, date, volume per bottle of Raw Material supplied and total number of containers supplied. The CoC will include a statement that the Final Material has been manufactured and packaged in compliance with cGMP, the product registration, applicable laws or regulations and tested according to the approved specifications. The CoC will include a statement indicating whether any deviations were experienced during manufacturing with the deviation report attached. Rework or reprocessing is not applicable to the products supplied. Also, NTP’s Quality unit must sign all Final Material release documents.

 

4.15                           NTP must have a formal retest policy and procedure in place for handling out of specification test results that is in accordance with applicable laws and regulations.

 

5.                                      BATCH RECORD RETENTION

 

5.1                                 Originals of all batch and laboratory documents (including raw data) will be retained by NTP or their contract laboratory for nine (9) years or in accordance with any applicable laws or regulations, whichever is longer.

 

5.2                                 LMI will have access to the complete original batch documents upon site visit or audit, for all Final Material supplied to LMI when requested within a reasonable time frame.

 

6.                                      RETAIN SAMPLES

 

NTP will retain samples of Final Material under the proper storage conditions as required to comply with retain sample requirements and/or registration commitments but in no case less than the amount needed to perform two complete sets of Raw Material testing. The retain samples will be stored in containers that simulate the same packaging system in which the Final Material is stored or one that is equivalent. Any issues will be immediately notified to LMI.

 

NTP will have written records to support the final material shelf life. Stability testing will be performed on the product in accordance with approved SOPs for stability testing.

 

2

 

7.                                      COMPLAINTS

 

7.1                                 Final Material complaint reports received by LMI from its customers that relate to the Final Material supplied by NTP will be summarized and sent to NTP.

 

7.2                                 NTP will investigate all complaints related to the manufacture of the Final Material for LMI and provide a written report within fifteen (15) business days. In the event that NTP receives a Product complaint, NTP will forward the complaint to LMI within three (3) business days. NTP will provide LMI with confirmation of closeout for individual complaints, and summaries of complaints received at least annually.

 

8.                                      RECALL

 

LMI will be ultimately responsible for performing recalls of product sold by LMI that contain the Final Material. NTP and LMI have the responsibility to provide any date or information that could result in product recall within an appropriate time frame.

 

9.                                      AUDITS

 

9.1                                 LMI will schedule periodic audits of NTP facilities used to manufacture the Final Material supplied to LMI. LMI shall have the right to visit the facility where the Final Material products are manufactured on any business day upon reasonable prior notice provided that the visit does not unreasonably interfere with the operations at NTP’s facility. During any such visit, LMI auditors shall have the right to audit the manufacturing, quality system, material handling, packaging, records, laboratories and facilities to ensure that NTP complies with the product registrations, cGMPs, applicable laws or regulations and LMI requirements.

 

9.2                                 NTP shall cooperate fully in such an inspection and shall take a course of action and resolution acceptable to LMI in the event that LMI finds any contractual or regulatory deficiencies during the audit. LMI shall be entitled to continue auditing the facility until the contractual or regulatory deficiency is resolved to LMI satisfaction.

 

10.                               VENDOR QUALIFICATION

 

NTP must maintain a formal vendor qualification and management program for materials procured by NTP. Selection, qualification and management of vendors is the responsibility of NTP but shall be reviewed from time to time by LMI during audits.

 

11.                               STORAGE

 

11.1                           NTP will ensure that the Final Materials are stored and shipped within the material label storage range.

 

12.                               SUBCONTRACTING

 

NTP will not subcontract any final product or testing services related to Raw Materials to a third party without receiving prior written approval from LMI.

 

3

 

13.                               TRAINING

 

13.1                           Each person engaged in the manufacturing, processing, packing or testing of a Raw Material shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.

 

13.2                           Training shall be in the particular operations that the employee performs and in current applicable manufacturing regulations as they relate to the employee’s functions. Training in cGMPs shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to ensure that employees remain familiar with requirements applicable to them. This training must be documented in a training record for each employee and NTP shall retain evidence of the employee’s full understanding.

 

14                                  VALIDATION / QUALIFICATION

 

Validation studies should be prospective in nature and in accordance with FDA and ICH Guidelines. Critical parameters and acceptance criteria must be documented. NTP must maintain a formal validation program including a validation plan, where applicable, for:

 

·        Facilities

·        Equipment

·        Analytical Methods

·        Cleaning Processes

·        Cleaning Methods

·        Manufacturing Process

·        Computer Systems (where applicable)

·        Laboratories

·        Utilities (HVAC, Process Water, Clean Steam, Clean Compressed Air, etc.)

 

15.                               TSE

 

15.1.                        NTP shall immediately provide written notification to LMI of the use or the planned use of any animal-derived raw materials, intermediates, or components to be manufactured in the Facility. Under no circumstance shall NTP use any animal-derived material unless proper documentation is accepted by LMI.

 

15.2.                        In addition, NTP shall take any and all precautions to prevent the transmission of Transmissible Spongiform Encephalopathy (TSE) in its Facility. TSE includes Bovine Spongiform Encephalopathy (BSE) and all other forms of animal or human spongiform encephalopathies. These precautions must extend to TSE-associated prior proteins, and any other material associated with TSE.

 

15.3.                        NTP shall on a periodic basis provide TSE compliance documentation to LMI stating that all of the raw materials and the products in its Facility are TSE-free, i.e., compliance documentation may include the completed LMI TSE Questionnaire, vendor declarations, certifications, and/or European Pharmacopoeia TSE Certificates of Suitability. NTP shall maintain all required TSE declarations and certifications for their starting materials, intermediates, cleaning agents, and product-contact materials, and these shall be subject to audit by LMI.

 

16.                               COMPLIANCE WITH LOCAL REGULATIONS

 

NTP undertakes to obtain and maintain the appropriate authorization to manufacture the Final Materials. NTP shall inform LMI about any change or withdrawal of such authorization without undue delay.

 

4

 

17                                  GOVERNMENTAL AND REGULATORY INSPECTIONS

 

NTP shall notify LMI of any inspections by a regulatory authority relating to the manufacturing, packaging and testing of Raw Materials supplied to LMI, within five (5) business days of the inspection. When Final Materials supplied to LMI are implicated in regulatory inspection findings, NTP will provide redacted copies of all correspondence, reports, notices, findings and any other material pertinent to such inspections or otherwise relating to the production, use, or sale of the LMI products.

 

18.                               HISTORY

 

	
Version
 Number
  	
 
  	
Comment
  	
 
  	
Issue Date
  
	
0
  	
 
  	
First issue of the Quality Agreement between LMI and NTP
  	
 
  	
01 July 2008
  

 

Issue date: This is defined as the date the document received final signature

 

 

	
Lantheus Medical Imaging Company Approval:
  
	
 
  	
 
  
	
Name:
  	
Thomas Feller
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Position:
  	
Manager, QA
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Signature:
  	
/s/ Thomas Feller
  	
 
  	
Date:
  	
6/12/2008
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Name:
  	
Valerie Heeter
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Position:
  	
Director Quality
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Signature:
  	
/s/ Valerie Heeter
  	
 
  	
Date:
  	
12-June-2008
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
NTP Approval:
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Name:
  	
DG Robertson
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Position:
  	
Managing Director
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Signature:
  	
/s/ DG Robertson
  	
 
  	
Date:
  	
1-07-2008
  

 

5

 

APPENDIX A:

 

List of Final Materials:

 

Molybdenum Mo-99

 

6

 

APPENDIX B:

 

Quality Contact Lantheus Medical Imaging Company:

 

Thomas Feller

Manager QA Operations & Support

Lantheus Medical Imaging Company

 

Phone: (978) 436-7554

Fax: (978) 436-7075

e-mail: thomas.feller@bms.com

 

Quality Contact NTP:

 

Gerhard Bruwer

Quality Assurance Manager

NTP Radioisotopes

 

Phone: [+27] (0) 12 305 5195

Fax: [+27] (0) 12 305 5680

e-mail: gerhardb@utp.co.za

cell phone: [+27] (0) 82 901 1344

 

7

 

APPENDIX C:

 

Division of pharmaceutical responsibilities*

 

	
LMI:
  	
 
  	
Lantheus Medical Imaging
  
	
 
  	
 
  	
 
  
	
NTP:
  	
 
  	
Final Material Supplier
  

 

	
 
  	
 
  	
NTP
  	
 
  	
LMI
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Maintenance of registration documents
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Starting/Raw Materials (s):
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Key Raw Material 
  	
 
  	
****
  	
 
  	
****
  
	
Specification
  	
 
  	
****
  	
 
  	
****
  
	
Supply/Procurement 
  	
 
  	
****
  	
 
  	
****
  
	
Testing
  	
 
  	
****
  	
 
  	
****
  
	
Release
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Other Raw Materials:
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Specification
  	
 
  	
****
  	
 
  	
****
  
	
Supply/Procurement 
  	
 
  	
****
  	
 
  	
****
  
	
Testing
  	
 
  	
****
  	
 
  	
****
  
	
Release
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Process Intermediates:
  	
 
  	
 
  	
 
  	
 
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Specification
  	
 
  	
****
  	
 
  	
****
  
	
Manufacturing directions
  	
 
  	
****
  	
 
  	
****
  
	
In-process control 
  	
 
  	
****
  	
 
  	
****
  
	
Manufacture/manufacturing record
  	
 
  	
****
  	
 
  	
****
  
	
Review of manufacturing documentation
  	
 
  	
****
  	
 
  	
****
  
	
Testing directions
  	
 
  	
****
  	
 
  	
****
  
	
Quality control/test record
  	
 
  	
****
  	
 
  	
****
  
	
Release
  	
 
  	
****
  	
 
  	
****
  
	
 
  	
 
  	
 
  	
 
  	
 
  
	
Final Material
  	
 
  	
 
  	
 
  	
 
  
	
Specification
  	
 
  	
****
  	
 
  	
****
  
	
Manufacturing directions 
  	
 
  	
****
  	
 
  	
****
  
	
Assignment of batch number
  	
 
  	
****
  	
 
  	
****
  
	
In-process control
  	
 
  	
****
  	
 
  	
****
  
	
Manufacture/manufacturing record
  	
 
  	
****
  	
 
  	
****
  
	
Review of manufacturing documentation
  	
 
  	
****
  	
 
  	
****
  
	
Quality control/test record
  	
 
  	
****
  	
 
  	
****
  
	
Release
  	
 
  	
****
  	
 
  	
****
  
	
Certificate of analysis 
  	
 
  	
****
  	
 
  	
****
  
	
Certificate of conformance 
  	
 
  	
****
  	
 
  	
****
  
	
Release for dispatch
  	
 
  	
****
  	
 
  	
****
  
	
Retain Samples
  	
 
  	
****
  	
 
  	
****
  
	
Stability Testing
  	
 
  	
****
  	
 
  	
****
  
	
Qualification and Validation
  	
 
  	
****
  	
 
  	
****
  
	
Transportation to LMI
  	
 
  	
****
  	
 
  	
****
  
	
Storage Specification 
  	
 
  	
****
  	
 
  	
****
  
	
Written notification of the use or planned use of animal-derived components or materials
  	
 
  	
****
  	
 
  	
****
  
	
Periodic notification of TSE compliance
  	
 
  	
****
  	
 
  	
****
  

 

8

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