Exhibit 10.6

FACILITY SETUP AND CONTRACT MANUFACTURING AGREEMENT

between

Eckert & Ziegler Nuclitec GmbH

Gieselweg 1

38110 Braunschweig

Germany

- hereinafter referred to as EZN -

and

Molecular Insight Pharmaceuticals, Inc

160 Second Street

Cambridge, MA 02142

USA

- hereinafter referred to as the MIPI -

 

  

 

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TABLE OF CONTENTS

 

1    DEFINITIONS    3 2    PURPOSE    6 3    TERM AND TERMINATION    7 4   
REMEDIES UPON TERMINATION    8 5    EXCLUSIVITY AND NON-COMPETE    9 6   
DEVELOPMENT AND KIT/SET SUPPLY PHASE    10 7    TECHNOLOGY TRANSFER    11 8   
CONSTRUCTION OF FACILITY – FACILITY PROGRAM COST    11 9    ASSET OWNERSHIP AND
ENVIRONMENTAL INDEMNITY OF FACILITY    12 10    MANUFACTURE AND SUPPLY OF FINAL
PRODUCT    13 11    ORDERS AND SHIPMENTS    14 12    PAYMENTS    15 13   
LICENSES, PATENTS AND TECHNOLOGY    16 14    REGULATORY MATTERS    17 15    DATA
MANAGEMENT    18 16    DISCLOSURE OF TECHNOLOGY    18 17    RIGHT OF FIRST
REFUSAL    18 18    RIGHT OF NEGOTIATION    18 19    CONFIDENTIALITY    19 20   
NOTICES    19 21    FORCE MAJEURE    20

 

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22    BACK-UP    20 23    INDEMNIFICATION AND INSURANCES    21 24    EXPORT
CONTROL    23 25    GOVERNING LAW    24 26    GENERAL    24

 

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PREAMBLE

 

A. MIPI is the worldwide licensee of an yttrium-90 radiolabeled somatostatin
peptide analog, formerly known as OctreoTher and now the brand name Onalta.
Onalta is one of MIPI’s lead radiotherapeutic product candidates under
development for the treatment of metastatic carcinoid and pancreatic
neuroendocrine cancer in patients whose symptoms are not controlled by
conventional somatostatin analog therapy.

 

B. In May 2009, the European Medicines Agency (EMEA) has approved the Phase 3
protocol for Onalta and it is now intended to proceed with the final clinical
trial that will position Onalta for marketing authorization in the EU expected
for end of 2013/beginning of 2014. The proposed Phase 3 protocol will evaluate
194 patients in several European study sites. Additionally, Onalta shall be
supplied to treatment centers participating in an approved compassionate use
program.

 

C. MIPI is interested in exclusively sourcing the centralized manufacturing of
Onalta and its distribution in certain countries in Europe, the Middle East,
North Africa, Russia and Turkey. The material shall be produced on a weekly
basis by a batch process using the critical components [Y-90] Yttrium Chloride
and a sterile pre-dispensed lyophilized preparation of DOTA-TOC in accordance
with current Good Manufacturing Practices (cGMP). In order to avoid shipping and
customs barriers to reliable and timely supply of the final drug product to
clinical units, MIPI wishes to partner with an existing GMP compliant facility
for the centralized production and distribution of radiolabeled [90Y]-Onalta.

 

D. EZN operates a nuclear licensed site in Braunschweig, Germany, for the
production and “cradle to grave” husbandry under ISO 9001 and ISO 13485 quality
systems of a diverse range radioactive isotopes used in industrial and medical
applications. The Braunschweig site includes an existing licensed
radiopharmaceutical manufacturing facility where Yttriga (Y-90 Chloride), an
EMEA approved “drug” is manufactured.

 

E. MIPI desires that EZN plans, designs and constructs a commercial high
throughput manufacturing facility suitable for the distribution of Onalta in the
specified territories under compassionate use and following EMEA marketing
authorization. Additionally, it is intended to provide a “provisional” cGMP
compliant interim supply capability for the supply of Phase 3 included patients.

NOW, THEREFORE, the parties agree as follows:

 

1. DEFINITIONS

 

  1.1 “Affiliated Company” shall mean either (a) a company which is at least
majority owned or majority controlled by a Party hereto or which holds at least
a majority interest or majority control in such Party; or (b) a parent company
to one of the Parties hereto.

 

  1.2 “Effective Date” shall mean the date of the last signature of this
Agreement.

 

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  1.3 “Agreement” shall mean this Agreement together with all exhibits,
schedules, and appendices attached to this Agreement, all as respectively
amended, modified or supplemented by the Parties in accordance with the terms of
this Agreement.

 

  1.4 “Commercially Reasonable Effort” shall mean the efforts and resources
customarily used in the industry by a company of similar size for a product with
an equivalent sales and profit potential to the Final Product.

 

  1.5 “Current Good Manufacturing Practices” or “cGMP” shall mean the Current
Good Manufacturing Practices followed by the pharmaceutical industry and biotech
firms to ensure that the products produced meet specific requirements for
identity, strength, quality, and purity and as defined from time to time by the
European Commission or other relevant Governmental Authority having jurisdiction
over the development, manufacture or sale of the products in the Territory
pursuant to its regulations, guidelines or otherwise.

 

  1.6 “Final Product” shall mean Onalta, ready to use radiolabeled product.

 

  1.7 “Y-90” shall mean Yttriga, a Yttrium-90 chloride solution with EMEA
Marketing Authorization to be supplied cGMP compliant by EZN.

 

  1.8 “Yttrium 90” shall mean Y90 chloride solution ordered by any Third Party
other than MIPI and/or MIPI licensee and supplied by any Third Party other than
EZN for the on-site labeling in treatment centers.

 

  1.9 “Kit” shall mean the sterile pre-dispensed lyophilized preparation of
DOTA-TOC to be supplied cGMP compliant by MIPI to EZN.

 

  1.10 “Set” shall mean Y90 and Kit to be provided separately for the onsite
labelling by radiopharmacists at treatment centers.

 

  1.11 “Dose vial(s)” shall mean the Final Product with 120 mCi Y90 at
calibration.

 

  1.12 “Batch” shall mean a production batch of Final Product manufactured by
EZN under this Agreement.

 

  1.13 “EZN Technology” shall mean all EZN or its Affiliated Company(s)
proprietary technology, including patents, copyrights, trademarks, know-how,
techniques, methods, processes and trade secrets which is required for the
purposes of performing the obligations of EZN under this Agreement and which is
owned by EZN or its Affiliated Company(s), or which EZN is authorized to use, or
which is licensed to EZN from third parties and which is in existence in the
form of a written, description, prototype or can otherwise be demonstrated to be
the property of EZN or its Affiliated Company(s), prior to the Effective Date.

 

  1.14 “MIPI Technology” shall mean all MIPI proprietary technology, including
patents, copyrights, trademarks, know-how, techniques, methods, processes and
trade secrets which is required for the purposes of performing the obligations
of MIPI under this Agreement and which is owned by MIPI, or which MIPI is
authorized to use, or which is licensed to MIPI from third parties and which is
in existence in the form of a written, description, prototype or can otherwise
be demonstrated to be the property of MIPI, prior to the Effective Date.

 

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  1.15 “EMEA” shall mean the European Medicines Agency.

 

  1.16 “Regulatory Authorities” shall mean the European Authority and/or the
United States Authority and/or any other corresponding regulatory authority in
any other geographic areas.

 

  1.17 “AMG” shall mean the German Medicinal Products Act (Arzneimittelgesetz)
as amended from time to time.

 

  1.18 “Clinical Trials” shall mean Phase 3 human trials for clinical
development of Onalta as approved by EMEA.

 

  1.19 “Set Supply Phase” shall have the meaning set forth in Article 2.2.

 

  1.20 “Interims Phase” shall mean the period in which EZN supplies Final
Product for the clinical trials using a provisional cGMP compliant facility.

 

  1.21 “Kit Supply Phase” shall have the meaning set forth in Article 2.2.

 

  1.22 “Development Phase” shall mean the period commencing from the Effective
Date until completion of the facility setup of the commercial high throughput
production facility.

 

  1.22 “Marketing Authorization” shall mean, with respect to a country in the
Territory, the approval by the appropriate authority necessary for the
commercialization of the Final Product in that country. Marketing Authorization
shall not include the reimbursement approval.

 

  1.24 “Facility” shall mean the Hot Cell(s) and Equipment to be constructed by
EZN in its currently existing factory in Braunschweig, Germany, for the
manufacture, dispensing, sterilization, testing, release, packaging and despatch
of the Final Product.

 

  1.25 “Provisional Facility” shall mean the assets already owned, to be
purchased or manufactured by EZN for the supply of the Final Product for
clinical trials during the lnterims Phase.

 

  1.26 “Facility Program” shall mean Facility and Provisional Facility.

 

  1.27 “Hot Cell(s)” shall mean the compatible isolator boxes to be purchased or
manufactured by EZN for and on behalf of MIPI and installed in the currently
existing factory in Braunschweig for the term of this Agreement unless EZN
exercises the option under Article 9.3.

 

  1.28 “Equipment” shall mean the moveable assets already owned, to be purchased
or manufactured by EZN for the purpose of this Agreement, exclusive of the Hot
Cell(s).

 

  1.29 “Intellectual Property Rights” (IPR) shall mean all intellectual rights
(including but not limited to) rights to inventions, patent rights, know-how,
copyrights and design rights in any part of the world to the fullest extent and
for the full period thereof (including without limitation any extensions,
reversions and renewals) and all rights thereto and interests therein.

 

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  1.30 “Process” shall mean the process of formulation, preparation, labeling,
dispensing into dose vials, sterilization, inspection and testing of Final
Product initially transmitted by MIPI to EZN as set forth in Article 7.

 

  1.31 “Scaled up Process” shall mean the process resulting from the development
and improvement of the upon the Effective Date existing and initially
transmitted Process advancing and optimizing the production capacity,
manufacture and distribution of the Final Product.

 

  1.32 “Specification(s)” shall mean those specifications for the Final Product
set forth in Article 10.1 hereof.

 

  1.33 “Packaging” means all primary containers, including bottles, cartons,
shipping cases or any other like matter used in packaging or accompanying the
Kit, Set and/or Final Product.

 

  1.34 “Validation” shall mean the program by which documented evidence provides
assurance that the Process/Scaled up Process will consistently produce the Final
Product that meets Specifications and quality attributes, to the reasonable
satisfaction of the appropriate Regulatory Authorities.

 

  1.35 “Territory” shall mean those countries as of the Effective Date set forth
in Exhibit A.

 

  1.36 “Party” or “Parties” shall mean MIPI or EZN, or MIPI and EZN, whichever
the context admits.

 

  1.37 “Third Party” shall mean any Person or other entity other than MIPI, EZN
or their respective Affiliates.

 

2 PURPOSE

 

  2.1 The scope and object of the Agreement is to provide for the construction
of a Facility at EZN’s manufacturing site in Braunschweig, Germany, for the
exclusive manufacture and supply of Final Product during the term of this
Agreement within the Territory.

 

  2.2

Additionally, starting with the Effective Date of this Agreement, EZN will
exclusively provide either for the supply of Sets for Y90 direct labeling by
radiopharmacists at treatment centers in the Territory (Set Supply Phase) or
single Kits for Yttrium 90 direct labeling by radiopharmacists at treatment
centers in the Territory. (Kit Supply Phase). MIPI and MIPI licensee undertake
to request Set supply and Kit supply only for the period until the Final Product
can be delivered on a country-by country-basis for Clinical Trials, under
compassionate use program and/or following Marketing Authorization. MIPI and
MIPI licensee will apply for compassionate use and subsequent Marketing
Authorisation in all countries of the EU and any other country within the
Territory that duly requires such regulatory programs/approvals. It is further
understood between the Parties that until Final Product is available, Set supply
shall be the preferred method of supply. MIPI or MIPI licensee will communicate
in writing in any materials provided to the treatment centers that Yttriga is
the qualified active substance for the radioactive labeling with yttrium 90
chloride. MIPI and its licensee

 

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agree that the Yttrium 90 to be used for the direct labeling by radiopharmacists
at treatment centers will be delivered by duly qualified suppliers only, meaning
that they meet the Specifications provided by MIPI which will have to be proven
to MIPI or MIPI’s licensee.

 

  2.3 It is anticipated that during the Term of this Agreement later
duplication(s) of the Facility may be required by MIPI or its licensee at other
sites in order to follow market demands. If MIPI has the intention to conduct a
new site set-up within the Territory, EZN shall have a right of first refusal
for recontracting with MIPI as facility set-up and contract manufacturing
partner subject to the terms and conditions set forth herein.

 

3 TERM AND TERMINATION

 

  3.1 The term of this Agreement shall commence upon the Effective Date and,
unless terminated earlier pursuant to this Agreement, shall continue until the
tenth anniversary of the Effective Date (“Term”).

 

  3.2 Upon Forty-two (42) months following the Effective Date and for the
following six (6) months, the Parties agree to meet in order to discuss, in good
faith, the terms and conditions under which the Parties intend to continue the
term of this Agreement beyond the fifth anniversary of the Effective Date
(“Renegotiation Period”). If the Parties come to an agreement during the
Renegotiation Period, then for the remaining five (5) years of this Agreement
the renegotiated terms and conditions shall apply. In case the Parties will not
reach an agreement, either Party has the right to terminate this Agreement
giving to the other Party at least twelve (12) months written notice prior to
the fifth anniversary of the Effective Date otherwise the Agreement will
automatically continue for the remaining term on the terms and conditions set
forth herein.

 

  3.3 It is agreed between the Parties that in case of termination of the
Agreement as set forth in Article 3.2, the manufacture and supply of Kit, Set
and Final Product will continue on the terms and conditions as set forth in this
Agreement for eighteen (18) months following the termination notice.

 

  3.4 This Agreement may be terminated by either Party in the event of a
material breach by the other Party of the terms and conditions hereof; provided,
however, the other Party shall first give to the breaching Party written notice
of the proposed termination of this Agreement (“Breach Notice”), specifying the
grounds thereof. Upon receipt of such Breach Notice, the breaching Party shall
have thirty (30) days to respond by curing such breach. If the breaching Party
does not cure such breach within such period, the other Party may terminate the
Agreement without prejudice to any other rights or remedies which may be
available to the non-breaching Party.

 

  3.5 Material breach of MIPI’s obligations under this Agreement shall mean and
be limited to: (i) milestone payments for facility setup overdue for more than
three (3) months, (ii) monthly payments overdue for more than three (3) months,
(iii) payments for Final Product exceeding an accumulated amount of
***** overdue for more than three (3) month, (iv) funds held in the Escrow
Account have not been made available to EZN for the purpose of decontamination
and decommissioning of the Hot Cell(s) within three (3) month despite EZN’s
notification

 

 

*Confidential Treatment Requested*

 

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of commissioning of the high throughput facility, (v) breach of exclusivity
clause, and (vi) violation of EZN’s right of first refusal and/or right of first
negotiation.

 

  3.6 Material breach of EZN’s obligations under this Agreement shall mean and
be limited to: (i) EZN has failed, in any one contract year period, to fulfil
more than four (4) orders of Kit, Set or Final Product consistent with the
Specifications (a “Supply Breach”). It shall not be considered a Supply Breach
in the event that (i) the failure to supply is attributable, in whole or in
part, directly or indirectly, to MIPI or its licensee, (ii) EZN is able to
supply an additional replacement of Kit, Set or Final Product meeting the
Specifications in accordance with this Agreement within one (1) week of the
delivery date of the originally scheduled order of Kit, Set or Final Product, or
(iii) if the Kit, Set or Final Product failure is the result of conducting the
Process under a deviation at the request of MIPI. Any failure by EZN to supply
Kit, Set or Final Product due to maintenance, repairs and/or Force Majeure shall
not be a material breach or Supply Breach under this Agreement.

 

  3.7 Notwithstanding anything contained in this Agreement to the contrary, this
Agreement may be terminated by either Party in the event the other Party files a
petition in bankruptcy, is adjudicated a bankrupt, or files a petition or
otherwise seeks relief under or pursuant to any bankruptcy, insolvency or
reorganization statute or proceeding, or if a petition in bankruptcy is filed
against it which is not dismissed within sixty (60) days or proceedings are
taken to liquidate the assets of such Party which are not stayed within sixty
(60) days. Any assets jointly owned by the two Parties including the Jointly
Owned Arising IP shall become the property of the Party not seeking such relief.

 

  3.8 Notice of Termination and Breach Notice are to be sent by registered
letter.

 

4 REMEDIES UPON TERMINATION

 

  4.1 If EZN terminates this Agreement, under Article 3, EZN, in addition to any
claim for damages EZN may have, shall be entitled to:

(i) retain all amounts paid by MIPI to EZN prior to such termination;

(ii) except for the Hot Cell(s), return to MIPI all the Equipment which is owned
by MIPI and in EZN’s possession and for which MIPI has paid all amounts due to
EZN pursuant to this Agreement, unless MIPI requests that EZN decommissions the
Equipment by using the funds in the Escrow Account;

(iii) terminate all activities under this Agreement expeditiously so as to
minimize costs incurred by MIPI therefore;

(iv) deliver all undelivered Kits or Dose Vials to MIPI, or destroy all
undelivered Kits or Dose Vials, whichever MIPI may choose;

(v) immediately upon such termination, except as provided elsewhere in this
agreement, terminate all licenses granted by EZN to MIPI under this Agreement
which rights shall revert back to EZN; and

(vi) where applicable receive from MIPI written confirmation that the foregoing
steps have been taken and that it has ceased using all patents data,
information, technology, trade secrets and other intellectual property owned by
EZN pursuant to this Agreement

 

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MIPI shall further reimburse EZN for all reimbursable costs and work necessarily
and properly incurred in relation to the orderly cessation of the work and sums
owing but not invoiced prior to the effective date of any such termination by
EZN under this Agreement. In addition, MIPI will if EZN so opts, either promptly
transfer title of the Hot Cell(s) to EZN or allow the execution of the
Decontamination and Decommissioning work by using the funds in the Escrow
Account, whereupon MIPI shall have no further obligations under Article 9.4.

 

  4.2 If MIPI terminates this Agreement under Article 3, MIPI, in addition to
any claim for damages MIPI may have, shall be entitled to:

(i) within thirty (30) days of such termination at MIPI’s expense receive the
Equipment and all related materials, in its then current condition (subject to
decontamination);

(ii) exercise the option whether the Hot Cell(s) shall be returned by EZN to
MIPI at its own expense or whether they shall be decontaminated and
decommissioned by EZN by using the funds in the Escrow Account;

(iii) receive at MIPI’s expense all Kits and Dose Vials which have been ordered
but not delivered and in possession of EZN;

(iv) immediately upon such termination, terminate all licenses granted by MIPI
to EZN under this Agreement which rights shall revert back to MIPI; and

(v) receive from EZN written confirmation that the foregoing steps have been
taken and that it has ceased using all patents data, information, technology,
trade secrets and other intellectual property owned by MIPI pursuant to this
Agreement.

If MIPI terminates this Agreement, MIPI shall reimburse EZN for all reimbursable
costs and work necessarily and properly incurred in relation to the orderly
cessation of the work and sums owing but not invoiced prior to the effective
date of any such termination by MIPI under this Agreement. In addition, MIPI
will if EZN so opts, either promptly transfer title of the Hot Cell(s) to EZN or
allow the execution of the Decontamination and Decommissioning work by using the
funds in the Escrow Account, whereupon MIPI shall have no further obligations
under Article 9.4.

 

5 EXCLUSIVITY AND NON-COMPETE

 

  5.1 EZN shall not, and shall ensure that its Affiliates do not, directly or
indirectly, manufacture Final Product for any person or entity for sale in the
Territory other than MIPI or its licensee. MIPI shall not, and shall ensure that
its Affiliates and licensees do not, directly or indirectly, manufacture Final
Product destined for sale in the Territory.

 

  5.2 MIPI shall exclusively order from EZN all of MIPI’s, its Affiliates’ and
licensees’ Kit, Set and Final Product destined for the Clinical Trials,
Compassionate Use and Commercial Supply in the Territory.

 

  5.3

During the term of this Agreement and for a period of two (2) years following
the termination or expiration of this Agreement, EZN shall not manufacture
and/or sell Final Product or radio-labelled therapeutic somatostatin analogs
with a somatostatin subtype receptor binding behaviour similar to Final Product.
For the avoidance of doubt, diagnostic somatostatin analogs as well as
radionuclides either in chemical or

 

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pharm-grade form, and radiochemical and radiopharmaceutical synthesis, labelling
and dispensing technology devices, are not subject of this Non-compete
irrespective of their final use with the end user.

 

  5.4 It is agreed between the Parties that in case of termination of this
Agreement in accordance with Article 3.2 of this Agreement, the Non-compete term
is considered to start on the fifth anniversary of the Effective Date
irrespective any manufacturing and/or supply of Kit, Set or Final Product
extending the fifth anniversary of the Effective Date according to Article 3.3.

 

  5.5 In the event that MIPI or MIPI licensee decide to withdraw from the
manufacture, marketing and distribution of Final Product for whatever reason,
EZN’s obligation to non-compete shall cease.

 

6 DEVELOPMENT AND KIT/SET SUPPLY PHASE

 

  6.1 The Development Phase shall (a) optimise the Process and establish the
Scaled up Process for the cGMP manufacture of the Final Product, (b) provide for
the planning, design, construction, qualification and validation of the
Provisional Facility, (c) provide for the planning, design, construction,
qualification and validation of the Facility and (d) provide for the planning,
design and construction of IAEA compliant Type A packaging assembly for
international transportation (Development Phase Projects).

 

  6.2 Upon the Effective Date, EZN will prioritise the set up of a Provisional
Facility and construction of transportation assembly needed for the initial
Clinical Trial and Compassionate Use demand of Final Product which technical and
regulatory completion is anticipated within 3 to 6 months upon Effective Date.

 

  6.3 The completion of the Development Phase Projects may be reasonably delayed
to the extent that such activities are premised on the work or provision of
data, information or technology by the other Party which such other Party does
not provide on a timely basis. Each Party will undertake commercially reasonable
efforts in order to carry out their respective obligations and responsibilities
with regards to the timeline of the Project Plan attached hereto as Exhibit B
(“Project Plan”).

 

  6.4 The Parties acknowledge and agree that Exhibit B may be amended during the
course of the Development Phase to accommodate unforeseen events and results
beyond the reasonable control of the Parties. All such changes to Exhibit B
shall be made by written agreement of the Parties.

 

  6.5 Progress of the Development Phase Projects will be reported by EZN via
milestone reports and, upon request of MIPI, via regular conference calls at
agreed preset times and quarterly review meetings. Both Parties will appoint
project managers for the purpose of reviewing the status of the project and to
assess the fulfilment of milestones.

 

  6.6

Within thirty (30) days upon the Effective Date, MIPI will provide EZN free of
charge with a reasonable minimum Kit inventory stock ensuring compatibility with
expected purchase volumes of Kits and Sets to be delivered for Clinical Trials
and Compassionate Use until the start of the Initial Phase. MIPI undertakes to
inform EZN, within fifteen (15) days upon the Effective Date at the latest, of
the storage conditions and

 

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handling requirements to enable EZN to take all appropriate measurements and
precautions for a duly transfer of Kits from MIPI to EZN. MIPI acknowledges that
for the validation of cooling equipment for the Kit storage (refrigerators), EZN
will need a lead time of at least eight (8) working days.

 

  6.7 Prior to the first dispatch of a Kit and/or Set, MIPI and EZN will
mutually determine and establish the process for packaging and distribution of
the Kits and/ or Sets to the final destination.

 

  6.8 For the ordering and shipment of the Kits and/or Sets the provisions of
Article 11 shall apply accordingly.

 

  6.9 In case the storage/shelf life of the Kits delivered by MIPI to EZN will
pass before the Kits have been ordered by MIPI, MIPI will at its own expense be
responsible for the Kits’ redemption and disposal and adequate replacement
deliveries.

 

  6.10 Additional development activities outside the scope of this Agreement
will be agreed upon and billed separately by the Parties.

 

7 TECHNOLOGY TRANSFER

 

  7.1 It is understood between the Parties that time is of essence in this
project and that delays due to slow transfer of MIPI Technology and/or EZN
Technology must be avoided.

 

  7.2 The Parties undertake to use commercially best efforts to exchange all
necessary Technology in a timely manner. MIPI and EZN will immediately upon the
Effective Date schedule for a mutual meeting at the Braunschweig facility during
which the Parties will disclose and exchange all information necessary for a
successful and timely completion of the Development Phase and the Set-up of the
Facility. If necessary, both Parties will, prior to the onsite meeting, exchange
an agenda outlining the questions that should be addressed. It is agreed upon
between the Parties that such a onsite meeting will take place within two
(2) weeks following the Effective Date.

 

  7.3 If and to the extent necessary, MIPI shall duly transmit additional
documentation and provide technical training and consulting on the Process. MIPI
will provide EZN within two (2) weeks following the Effective Date with the name
and details of a contact person responsible for all questions and issues
relating to technology transfer, documentation and training.

 

8 CONSTRUCTION OF FACILITY – FACILITY PROGRAM COST

 

  8.1 Subject to successful completion of the relevant planning and design of
the Facility Program to the satisfaction of MIPI, EZN shall conduct the Facility
Program at its site in Braunschweig, Germany to carry out the manufacture of
Final Product. EZN will use its commercially reasonable best efforts to complete
the Facility Program in accordance with the Project Plan attached herewith as
Exhibit B. Exhibit B may only be modified as agreed in writing by the Parties.

 

  8.2 The actual capital cost of the Facility Program has been calculated on a
time and materials basis. The budgeted capital cost for performance of the
Facility Program by EZN is estimated at the Effective Date to be ******,

 

 

*Confidential Treatment Requested*

 

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inclusive of contingency and EZN administration fees. Any cost in excess of the
estimated budgeted capital cost shall be subject to the prior written
authorization of MIPI.

 

9 ASSET OWNERSHIP AND ENVIRONMENTAL INDEMNITY OF FACILITY

 

  9.1 EZN will purchase or manufacture, on behalf of MIPI, the Hot Cell(s) and
Equipment, which will be installed in the Facility as described in the Project
Plan (Exhibit B). Upon completion of the purchase or manufacture of the Hot
Cell(s) and Equipment for the Facility, a warranty bill of sale in a form
reasonably acceptable to MIPI, shall be executed and delivered to MIPI
transferring full title to such Hot Cell(s) and Equipment dedicated to MIPI’s
requirements free and clear of all liens, claims, or encumbrances. Subject to
MIPI’s obligations to transfer ownership of the Hot Cell(s) and Equipment to EZN
under circumstances as set forth in this Agreement, MIPI shall at all times hold
all right, title and interest in the Hot Cell(s) and Equipment; provided,
however, that during the term of this Agreement, use thereof shall exclusively
be granted to EZN for the purposes of producing Final Product at the
Braunschweig site.

 

  9.2 EZN represents and warrants that during the term of this Agreement the Hot
Cell(s) and Equipment shall be used for the purpose of producing Final Product
only.

 

  9.3 In partial consideration of the services to be performed hereunder by EZN
and in consideration of the payment of ******, the sufficiency of which is
hereby acknowledged, on the earlier of the expiration or termination of this
Agreement by MIPI (for whatever reason other than the default of EZN), MIPI
agrees, at EZN’s option, to transfer all of MIPI right, title and interest in
and to the Hot Cell(s) and Equipment to EZN.

 

  9.4 Upon expiration or termination of this Agreement, the Hot Cell(s) and
Equipment have to be decontaminated and decommissioned in accordance with the
applicable laws and regulations. Decontamination and decommissioning shall be
the financial responsibility of MIPI unless agreed otherwise in accordance with
this Agreement. At the time of commissioning of the Facility, MIPI agrees to
furnish to EZN a lump sum deposit in the amount of ******. This amount shall be
deposited by MIPI into a German Escrow Account in the name of EZN issued by a
reputable bank or financial institution with a rating reasonably satisfactory to
EZN (the “Escrow Account”). A copy of proof of deposit is to be provided to EZN
within thirty (30) days at the latest following commissioning of the Facility.
Failure of MIPI to deposit said amount or proof the deposit shall be a material
breach and as such reason for termination of this Agreement in accordance with
Article 3.4 of this Agreement.

 

  9.5 If EZN does not exercise its option, or fails to be allowed to exercise
the option due to EZN’s default under this Agreement, to own the Hot Cell(s) and
the Equipment, then upon expiration or termination of this Agreement, the funds
established by MIPI in the Escrow Account shall be made available to EZN for
decontamination and decommissioning of the Hot Cell(s) and any other Equipment
used for manufacture of Final Product, prior to their removal by MIPI from the
Braunschweig site, in accordance with this Agreement. Decontamination,
decommissioning and removal of the Hot Cell(s) and Equipment shall take place
within six (6) months following expiration or termination of this Agreement.

 

 

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  9.6 If EZN exercises the option to own the Hot Cell(s) and the Equipment, then
the funds held in the Escrow Account shall be made available to EZN for the
purpose of decontamination and decommissioning of the Hot Cell(s) ad any other
Equipment or forming a reserve for future decommissioning. If the Escrow Account
has been made available to EZN, then MIPI shall have no further obligations
under this Article.

 

  9.7 Refund to Decommissioning Bond. If EZN’s revenues for Kits, Sets and Final
Product (excluding shipment and packaging costs) aggregated until the fourth
anniversary of completion of the high throughput facility exceed ****** then the
MIPI funds held in the EZN Escrow Account shall be reduced by ******. If EZN’s
revenues for Kits, Sets and Final Product (excluding shipment and packaging
costs) aggregated until the fourth anniversary of completion of the high
throughput facility exceed ****** then the MIPI funds held in the EZN Escrow
Account shall completely convert back to MIPI in the form that MIPI cancels the
Escrow Account.

 

  9.8 Except as may be provided in accordance with this Agreement, EZN shall
during the term of this Agreement not use or permit any Third Party to use the
Hot Cell(s) and Equipment.

 

  9.9 Until MIPI has transferred ownership of the Hot Cell(s) and Equipment as
set out in this Agreement (the “Transfer Date”), EZN is granted a security
interest (Sicherungsübereignung) in and to the Hot Cell(s) and Equipment. The
security interest in the Hot Cell(s) and Equipment shall be perfected by
possession of the Hot Cell(s) by EZN and shall be effective as of the date of
commencement of installation of such Hot Cell(s) and Equipment and shall serve
as collateral for the obligations and responsibilities of MIPI under this
Agreement. MIPI shall execute all documents reasonably required to provide the
above mentioned security interest in and to the Hot Cell(s) and Equipment to
EZN.

 

  9.10 It is understood by the Parties that ownership of the Provisional
Facility used during the Interims Phase will be and remain with EZN including
the responsibility for decontamination and decommission.

 

10 MANUFACTURE AND SUPPLY OF FINAL PRODUCT

 

  10.1 EZN agrees to

(a) manufacture all Y-90 for the Final Product,

(b) produce the Final Product,

(c) test and release the Final Product,

(d) store Final Product until delivery, and

(e) deliver Final Product to any person or entity as identified to EZN by MIPI,

in each case in accordance with

(i) the relevant Specifications attached hereto as Exhibit C (the
“Specifications”),

 

 

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(ii) the terms and conditions of the Quality Agreement attached hereto as
Exhibit D (the “Quality Agreement”). The Parties agree to finalize and execute
the Quality Agreement within 30 days of the Effective Date.

(iii) all applicable laws, including, without limitation, health, safety and
environmental laws,

(iv) the terms and conditions of this Agreement.

 

  10.2 EZN shall promptly inform MIPI of decisions about, or changes to, the
facilities used in the manufacturing of the Final Product.

 

  10.3 EZN shall not make changes to Process and/or Scaled up Process without
MIPI’s prior written consent and otherwise as provided in the Quality Agreement.

 

  10.4 After the Facility is installed, EZN shall maintain such Facility, Hot
Cell(s) and Equipment in satisfactory operating condition, as required to enable
EZN to manufacture Final Product to Specification in accordance with the Scaled
up Process and all other applicable laws, regulations, rules or orders. Routine
repairs, preventive maintenance and service contracts for the Facility, Hot
Cell(s) and Equipment shall be arranged by EZN. Routine repairs are repairs to a
given asset entailing expenditures of the lesser of ******.

 

  10.5 In the event of any conflict between or change of the applicable laws,
regulations, rules or orders, EZN will notify MIPI of such conflict and the
Parties shall act in good faith to resolve such conflict or change. Any repair,
change, scale up or remodelling of the facility, Hot Cell(s) and/or equipment
that are not due to normal tear and wear and/or necessary under routine repairs
and preventive maintenance shall be the sole responsibility of MIPI. If
requested, EZN will provide MIPI with a cost estimate on such activities.

 

11 ORDERS AND SHIPMENTS

 

  11.1 During the term of this Agreement, MIPI or MIPI’s licensee will forward
orders to EZN by facsimile (or other suitable means) at least ten (10) Business
Days in advance of intended shipment. This lead time might be shorter in case of
Kit orders only or might be longer in case of intended delivery of Set and/or
Final Product outside the EU. Orders shall include at least the required
quantities, identity of the recipient, requested delivery dates and destination.
Delivery as directed by MIPI or MIPI’s licensee shall be ex-Works EZN’s facility
in Braunschweig, Germany. Risk and title for the Set and/or Final Product shall
pass to MIPI or MIPI’s licensee at point of delivery to the respective carrier.

 

  11.2 Prior to the first shipment to any Third Party site, MIPI or its licensee
shall obtain and forward to EZN from such Third Party its license evidencing
proper legal authority for the receipt and possession of the Kit, Set and/or
Final Product (Umgangsgenehmigung). If and to the extent necessary, MIPI or
MIPI’s licensee shall further obtain all approvals, licenses and permits
required to import Kit, Sets and/or Final Product into territories directed by
MIPI or its licensee.

 

 

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  11.3 EZN shall deliver Kit, Set and/or Final Product in accordance with the
quantities and requested delivery date(s) specified in the relevant order. EZN
will pack the Kit, Set and/or Final Product for shipment and storage in
accordance with the applicable Specifications given by MIPI.

 

  11.4 If requested by MIPI or MIPI licensee, EZN shall make shipping
arrangements with carriers from the ex-Works point to the delivery site. All
transportation and packaging costs incurred to deliver Kit, Set and/or Final
Product ordered by MIPI or MIPI licensee will be separately charged to and borne
by MIPI.

 

  11.5 If either Party or its designee discovers that a Batch and/or Dose Vial
does not meet the Specifications, then the discovering Party shall promptly
communicate in writing with the other Party to determine a mutually agreed
course of action. With respect to any such Batch and/or Dose Vial which do not
meet Specifications as a result of shortcomings in process or parameters under
the direct control of EZN, then EZN will promptly replace such Batch and/or Dose
Vial at no additional cost to MIPI.

 

12 PAYMENTS

 

  12.1 The purchase prices for the Y-90, Final Product and Kit handling shall be
as set forth in Exhibit E (“Product Price Table”).

 

  12.2 Payment for the development and set-up of the Provisional Facility and
Facility shall be as set forth in Exhibit F (“Milestone Schedule”). Upon
completion of a milestone calling for payment, EZN shall invoice MIPI.

 

  12.3 Transportation costs will be charged separately at rates to be calculated
individually for each country in the Territory. Upon request of MIPI, EZN will
forward a cost estimate of transportation costs to MIPI prior to delivery into
the respective country.

 

  12.4 Prices for the still to be designed and manufactured IAEA compliant Type
A packaging devices for international transportation will be mutually agreed
upon between the Parties following the first design and cost estimates provided
by EZN to MIPI during the Development Phase. It is agreed that EZN will provide
MIPI with a price for a separate shielded packaging container and MIPI will
order and acquire, from EZN, prior to the start of the Interims phase the amount
of shielded packaging containers MIPI considers reasonable to meet its demands.
Any orders shall be forwarded to EZN with appropriate lead time. In case MIPI
will place no orders with EZN, MIPI will reimburse EZN for the costs incurred
regarding the planning, design and price calculations on man-hours basis.

 

  12.5 Except as otherwise provided herein, all invoices shall be paid within
forty-five (45) days upon date of invoice. All payments, costs and prices
included in this Agreement are exclusive VAT and, unless otherwise specified,
shall be in Euros.

 

  12.6 For the term of this Agreement, EZN shall, additionally, be entitled to
monthly payments of ******. All Monthly Payments shall be paid in advance, on
the first day of each calendar month adding

 

 

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the legally applicable VAT, currently nineteen percent (19%). In case this
Agreement commences or expires later than the first day of a calendar month,
then the monthly payments shall be calculated on a pro rata basis assuming that
a month consists of thirty (30) days.

 

  12.7 It is understood that the costs of operating the Facility can be suddenly
increased as a result of direct or indirect Regulatory changes -such as via the
costs of conditioning and disposal of radioactive arisings. Should such
significant changes arise at any time after the Effective Date then EZN shall
immediately inform MIPI and the Parties shall agree a price increase based upon
EZN’s actual rise in costs.

 

13 LICENSES, PATENTS AND TECHNOLOGY

 

  13.1 MIPI Technology shall be and remain the exclusive property of MIPI. MIPI
hereby grants to EZN a non-exclusive, non-transferable, non-sublicensable,
royalty free license during the term of this Agreement to use the MIPI
Technology owned by MIPI for the sole purpose of assisting EZN in carrying out
its obligations set out in this Agreement. To the extent the MIPI Technology
includes third party technology exclusively controlled but not actually owned by
MIPI (the “****** Technology”) exclusive of the Novartis patents which are
sublicensed hereunder, then no sublicense rights as to the ****** Technology is
granted to EZN but MIPI covenants that EZN shall have the right to use any
Intellectual Property Rights in such ****** Technology in the performance of
this Agreement, and MIPI will not assert any Intellectual Property Rights in
such ****** Technology against EZN while EZN is an authorized manufacturer. MIPI
shall hold EZN harmless of all damages and costs as a result of ****** asserting
that the ****** Technology is infringed by the manufacture, marketing or
distribution of Kit, Set or Final Product.

 

  13.2 EZN Technology shall be and remain the exclusive property of EZN. EZN
hereby grants to MIPI a non-exclusive, non-transferable, non-sublicensable
royalty free license during the term of this Agreement to use EZN Technology for
the sole purpose of assisting MIPI in carrying out its obligations set out in
this Agreement.

 

  13.3 All Intellectual Property Rights in any improvements conceived, written,
created, developed or first reduced to practice in and related to the
performance of this Agreement that relates to edotreotide and/or all
Intellectual Property Rights in the Scaled up Process (the “Joint Improvements”)
will be jointly owned by MIPI and EZN, irrespective of who conceives, writes,
creates, develops or first reduces to practice any such Joint Improvements, and
both MIPI and EZN shall, unless otherwise stated in this clause, have free use
of such Joint Improvements during the Term of this Agreement or, if applicable,
for as long as EZN is authorized to manufacture hereunder. Notwithstanding the
above, neither Party shall during the term of this Agreement utilize such Joint
Improvements in conjunction with any Third Party unless otherwise agreed upon
between the Parties. Upon expiration or termination of this Agreement the
Parties agree to the following restrictions on the use of Joint Improvements:
MIPI shall only utilize any Joint Improvements in connection with edotreotide
and MIPI’s other proprietary compounds publicly known as of the effective date
hereof; EZN shall not utilize any Joint Improvements in connection with
edotreotide other than with Novartis or any other Third Party being duly
authorized by MIPI or Novartis to use edotreotide.

 

 

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  13.4 In case of termination of this Agreement by MIPI according to 3.2 or in
case of termination of this Agreement by EZN due to a default of MIPI according
to Article 3.5, MIPI shall pay to EZN a lump sum payment of ****** for the
assignment of EZN’s Intellectual Property Rights in all Joint Improvements to
MIPI. The payment shall be due at the latest within thirty (30) days following
receipt of the respective termination notice. With due payment of the lump sum,
EZN assigns and transfers all its Intellectual Property Rights in the Joint
Improvements to MIPI who then shall be the sole owner of all Intellectual
Property Rights in the Joint Improvements. For the avoidance of doubt and
notwithstanding the full ownership of MIPI in all Intellectual Property Rights
in the Joint Improvements under this paragraph, EZN shall have the right to
freely use the Intellectual Property in the Joint Improvements for as long as
EZN is authorized to manufacture.

 

  13.5 EZN will use best efforts to preserve any Intellectual Property Rights
arising out of the performance of the Agreement and to perfect rights in any
Intellectual Property Rights to which MIPI can possibly be entitled, have a
right to or interest in. It is acknowledged by the Parties that any such
obligations will be subject to and be limited by the copyright and intellectual
property rights of Germany, in particular the Employee’s Inventions Act
(Arbeitnehmererfindungsgesetz) for claims to inventions of employees arising out
of the performance of the Agreement.

 

14 REGULATORY MATTERS

 

  14.1 It shall be the responsibility of MIPI or its licensee to file, obtain
and maintain such licenses, registrations, listings, authorizations and
approvals as the EMEA or any other competent Regulatory Authority may require to
enable the application, marketing and distribution of the Kit, the Set and Final
Product.

 

  14.2 EZN shall be responsible for obtaining and maintaining all necessary
facility licenses, registrations, authorizations and approvals for the
manufacture, handling, storage, packaging and release of the Sets and Final
Product in Germany.

 

  14.3 Each Party shall promptly notify the other Party in case it learns of new
regulatory requirements relevant to the manufacture, marketing and/or
distribution of Set and/or Final Product. In such case, the Parties will use
mutual commercially best efforts to comply with such requirements.

 

  14.4 MIPI shall, as mutually agreed in the Quality Agreement (Exhibit D) be
entitled to access to the Facility for the purpose of observing any Process or
to audit the Facility for compliance with MIPI’s Specifications and other
regulatory requirements. It is understood between the Parties that such right
shall not extend to any licensee, designee or any other Third Party unless EZN
and any such licensee, designee or other Third Party have entered into a
separate Agreement providing for terms and conditions including but not limited
to Disclosure, and Confidentiality, satisfactory to EZN.

 

  14.5 In case of discrepancies between this Agreement and the Quality Agreement
(Exhibit D), that relate to regulatory matters, the Quality Agreement shall
prevail.

 

 

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15 DATA MANAGEMENT

Either Party shall retain all essential documents or data for as long as
required by the applicable laws and guidelines. Essential documents shall be
archived in a way that ensures that they are readily available, upon request, to
the competent authorities. The Parties shall install security measures that
prevent unauthorized access to archives.

 

16 DISCLOSURE OF TECHNOLOGY

Except as otherwise set out in this Agreement, it is agreed that disclosure of
data, information or technology by MIPI or EZN to the other Party shall not,
except to the extent granted herein, constitute any grant, option or license
under any patent, technology or other rights held by MIPI or EZN.

 

17 RIGHT OF FIRST REFUSAL

 

  17.1 If MIPI has the intention to propose the initiation of a new
manufacturing site in the Territory to a Third Party, EZN shall have a right of
first refusal for a new contract with MIPI as facility set-up and contract
manufacturing partner.

 

  17.2 In the event MIPI desires to accept a bona fide Third Party offer for the
initiation of a new manufacturing site in the Territory, MIPI shall promptly
deliver to EZN written notice of the intended disposition (“Disposition Notice”)
and the basic terms and conditions thereof.

 

  17.3 EZN shall, for a period of sixty (60) days following receipt of the
Disposition Notice, have the right to accept the facility set-up and
manufacturing upon the same terms and conditions specified in the Disposition
Notice. Such right shall be exercisable by written notice (the “Exercise
Notice”) delivered to MIPI prior to the expiration of the sixty days exercise
period. If such right is exercised, then MIPI and EZN shall enter into a new
Facility Set-up and Manufacturing Agreement upon the terms set forth in the
Disposition Notice not more than thirty (30) days after the delivery of the
Exercise Notice.

 

  17.4 In the event the Exercise Notice is not received by MIPI within sixty
(60) days of the Disposition Notice, EZN shall be deemed to have waived its
right of first refusal.

 

18 RIGHT OF NEGOTIATION

 

  18.1 If MIPI has the intention to propose the initiation of a new
manufacturing site in any other geographic area to a Third Party, then MIPI
undertakes to inform EZN immediately of such intention and EZN shall have a
right of negotiation with MIPI as facility set-up and contract manufacturing
partner.

 

  18.2 If MIPI or its licensee has the intention to offer radiochemical and
radiopharmaceutical synthesis labelling and dispensing technology devices to any
treatment sites purchasing Kit, Set or Final Product, MIPI or its licensee will
recommend EZN or its respective affiliates as supplier for such devices.

 

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19 CONFIDENTIALITY

 

  19.1 During the term of this Agreement and for a period of five (5) years
thereafter, each Party hereto shall maintain in confidence all technology
including MIPI Technology, EZN Technology, Jointly Owned Arising IP and
know-how, data, processes, methods, techniques, formulas, test data and other
information disclosed to such Party by the other Party whether or not it is
identified as “Confidential Information” by the disclosing Party (collectively
“Confidential Information”). Each Party shall necessarily be free to disclose
its own Technology under the terms of its own established process for the
disclosure of its Confidential Information. If either Party needs to disclose
Confidential Information pertaining to the manufacturing process covered by this
Agreement to a Third Party then this shall be accommodated by the creation of a
three way Confidential Information disclosure agreement. This obligation of
confidentiality shall not apply to the extent that it can be established by the
Party in receipt of such Confidential Information, that the information:

 

  i) was already known to the receiving Party at the time of disclosure;

 

  ii) was generally available to the public or otherwise part of the public
domain at the time of its disclosure;

 

  iii) became generally available to the public or otherwise part of the public
domain after its disclosure to the receiving Party through no act or omission of
the receiving Party;

 

  iv) was disclosed to the receiving Party by a Third Party who had no
obligation to restrict disclosure of such information; or

 

  v) was independently developed by the receiving Party without any use of
Confidential Information of the disclosing Party.

Notwithstanding the foregoing, MIPI and EZN may both disclose Confidential
Information to an Affiliate or permitted assign provided that the Affiliate or
permitted assign is bound by confidentiality to the same extent as MIPI and EZN
hereunder. The Party disclosing Confidential Information to such Affiliate or
permitted assign shall be liable for any unauthorized use or disclosure of the
Confidential Information by the Affiliate or permitted assign.

 

20 NOTICES

All notices and other communications hereunder shall be sent with reference to
the contract name and number:

 

To MIPI:      Name:    Paul Granger, General Counsel Address:    Molecular
Insight Pharmaceuticals, Inc.    160 Second Street    Cambridge, MA 02142 USA
E-mail address:    pgranger@molecularinsight.com Phone:    617-492-5554 Fax:   
617-871-6983

 

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To EZN:    Name:    Dr. André Hess Address:    Robert-Roessle-Str.10 E-mail
address:    andre.hess@ezag.de Phone:    +49 30 941084 141 Fax:    +49 30 941084
160

 

21 FORCE MAJEURE

Neither party shall be liable to the other for failure to perform or delay in
performing its obligations under this Agreement by virtue of the occurrence of
an event of Force Majeure. In the event such Force Majeure affecting either
party continues for more than ninety (90) days the party not subject of the
Force Majeure may, upon thirty (30) days written notice terminate this
Agreement. In the event such Force Majeure affecting either party continues for
more than six (6) months either party, may upon thirty (30) days written notice
terminate this Agreement. “Force Majeure” shall mean an occurrence arising from
unforeseen circumstances beyond a party’s reasonable control which prevents,
delays or interferes with the performance by such party of any of its
obligations hereunder including without limitation an event that occurs by
reason of any act of God, flood, power failure, fire, explosion, casualty or
accident, failure of suppliers or usual suppliers to have available for supply
sufficient raw materials, equipment or machinery, or war, revolution, civil
commotion, acts of public enemies, act of terrorism, blockage or embargo,
government acts or regulations, prohibitions or interventions, interruption of
or delay in transportation, strike or labor disruption. In the event of Force
Majeure, the party affected shall promptly notify the other and shall exert
commercially reasonable efforts to eliminate, cure or overcome such event and to
resume performance of its obligations.

 

22 BACK-UP

Upon completion of the high throughput facility at the latest, the Parties will
enter into negotiations regarding the set-up of a back-up manufacturing facility
for the unlikely case of unforeseen manufacturing stops or interruptions at
EZN’s Braunschweig facility. MIPI and EZN will act in good faith to negotiate,
complete and enter into a definite Back-up Facility Agreement.

EZN undertakes to enter into back-up cooperations to assure for a secondary
supply of Yttrium 90 for the unlikely case of Y-90 shortages at the Braunschweig
facility.

 

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23 INDEMNIFICATION AND INSURANCES

 

  23.1 MIPI Insurance

From the Effective Date of this Agreement and for as long as MIPI continues to
make, sell, licence or otherwise commercialize the Kit, Set and/or Final
Product, MIPI shall maintain in force and effect all insurance normally
associated with the activities contemplated under this Agreement and in doing
business generally, including but not limited to Third Party insurance, product
liability insurance, general liability, business interruption, property and
casualty insurance. Such insurances shall be issued by a reputable insurance
company with a rating satisfactory to EZN. The product liability insurance shall
(a) insure against damages resulting from or caused by (or claimed to be
resulting from or caused by) the operation or use of any Kit, Set and/or Final
Product manufactured, marketed or distributed by MIPI, and (b) shall have
coverage limits of not less than ****** per occurrence and ****** in the annual
aggregate. Upon request of EZN, MIPI will deliver to EZN copies of all policies
effecting such insurance with a certificate (in English) of MIPIs insurance
broker stating that all premiums then due have been paid.

The sponsor of the Clinical Trial shall establish separate insurance cover for
the risks associated with the period of clinical trials and compassionate use as
required by the pharmaceutical laws of the countries in the Territory. From the
start of the commercial phase of this Agreement and for as long as MIPI or its
licensee is marketing and distributing the Final Product under its name, MIPI or
its licensee shall establish separate insurance cover for the risks associated
with the administration of a medicinal product intended for human use as
provided for in §§ 94, 88 AMG for the marketing and distribution in Germany or
any comparable insurance required for the marketing and distribution in other
countries in the Territory. MIPI will be liable towards EZN for any failure in
establishing and duly maintaining such insurances.

 

  23.2 EZN INSURANCE

From the Effective Date of this Agreement and for as long as MIPI continues to
make, sell, licence or otherwise commercialize the Kit, Set and/or Final Product
with the participation of EZN, EZN agrees to maintain in force and effect all
insurance normally associated with the activities contemplated under this
Agreement and in doing business generally, including but not limited to
insurances covering loss or damage to:

 

  (i) the Facility;

 

  (ii) any asset owned by MIPI in the possession of EZN under this Agreement;

 

  (iii) EZN’s facility located at Braunschweig, Germany.

In addition, from the Effective Date of this Agreement and for as long as EZN
continues to make and sell to MIPI the Y-90, Set and/or Final Product, EZN shall
maintain in force and effect product liability insurance issued by a reputable
insurance company with a rating reasonably satisfactory to MIPI. Such insurance
shall (a) include coverage insuring against Damages resulting from or caused by
(or claimed to be resulting from or caused by) the operation or use of the Y-90,
Set and/or Final Product manufactured,

 

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assembled and dispatched by EZN, and (b) shall have coverage limits of not less
than ****** per occurrence and ****** in the annual aggregate. Upon request of
MIPI, EZN will deliver to MIPI copies of all policies affecting such insurance
with a certificate (in English) of EZN’s insurance broker stating that all
premiums then due have been paid.

Each Party will notify the other without delay in the event that the cover is
(or is to be) cancelled or made subject to a material change. The insurance
coverages hereunder shall limit the liabilities of the Parties imposed by this
Agreement.

 

  23.3 WARRANTY/LIABILITY EZN

EZN shall not have any other obligations towards MIPI than those arising from
the services described herein and shall therefore have no other liability
towards MIPI than arising from default of such obligations.

In case of defects occurring during the performance of this Agreement, EZN is
obligated to remedy such defects or to supply services or products free from
defects as set forth in Article 3 of this Agreement. MIPI shall not have the
option to terminate the Agreement unless the removal of defects fails or does
not take place as set forth in Article 3 of this Agreement.

 

  23.4 WARRANTY/LIABILITY MIPI

MIPI shall not have any other obligations towards EZN than those arising from
the services described herein and shall therefore have no other liability
towards EZN than arising from default of such obligations.

MIPI hereby warrants to EZN that all insurances necessary and appropriate for
the performance of this Agreement have been issued and coverage has been paid
prior to the first supply.

 

  23.5 INDEMNIFICATION BY MIPI

MIPI agrees to indemnify, defend and hold EZN and its Affiliates and their
respective directors, officers, employees and agents, harmless from and against
any damages, claims, liabilities and expenses (including, but not limited to,
reasonable attorney’s fees) resulting from any third party claims or suits
(“General Claims Against EZN”) arising out of (a) MIPI’s, MIPI licensee’s or any
other third party’s development, manufacture, use, handling, shipping,
marketing, sale, distribution or other disposition of or treatment with Kit, Set
or Final Product (b) MIPI’s breach of any of its material obligations,
warranties or representations hereunder, (c) MIPI’s negligent acts or omissions
or wilful misconduct, or (d) any failure of the Kit to meet applicable
specification. Notwithstanding the foregoing, MIPI will not be required to
indemnify, defend and hold EZN and its Affiliates and their respective
directors, officers, employees and agents harmless from and against any General
Claims Against EZN to the extent that such claims arise out of (i) EZN’s breach
of any of its obligations, warranties or representations hereunder; (ii) EZN’s
negligent acts or omissions or wilful misconduct; (iii) any failure of EZN to
manufacture, handle, store, package and dispatch of Kit, Set or Final Product
inconsistent with the Specifications, the Quality Agreement and the terms and
conditions of this Agreement.

 

* Confidential Treatment Required *

 

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  23.6 INDEMNIFICATION BY EZN

EZN agrees to indemnify, defend and hold MIPI and its Affiliates and their
respective directors, officers, employees and agents, harmless from and against
any damages, claims, liabilities and expenses (including, but not limited to,
reasonable attorney’s fees) resulting from any third party claims or suits
(“General Claims Against MIPI”) arising out of (a) EZN’s failure to manufacture,
handle, store, package and dispatch of Kit, Set or Final Product inconsistent
with the Specifications, the Quality Agreement and the terms and conditions of
this Agreement (b) EZN’s breach of any of its material obligations, warranties
or representations hereunder; or (c) EZN’s negligent acts or omissions or wilful
misconduct; Notwithstanding the foregoing, EZN will not be required to
indemnify, defend and hold MIPI and its Affiliates and their respective
directors, officers, employees and agents harmless from and against any General
Claims Against MIPI to the extent that such claims arise out of (i) MIPI’s
breach of any of its obligations, warranties or representations hereunder;
(ii) MIPI’s negligent acts or omissions or wilful misconduct; (iii) any defect
or failure of Kits to meet applicable specifications; (iv) MIPI’s, MIPI
licensee’s or any other third party’s development, manufacture, use, handling,
shipping, marketing, sale, distribution or other disposition of or treatment
with Kits, Sets, or Final Product or (v) MIPI’s or MIPI licensee’s incorrect
information regarding Kit, Set and/or Final Product or failure of due disclosure
to EZN of any risks regarding Kit, Set and/or Final Product.

 

  22.7 DISCLAIMER OF CONSEQUENTIAL DAMAGES

In no event shall either Party be liable to the other for indirect, contingent,
incidental, special or consequential damages, including, but not limited to, any
claim for damages based on lost profits, cost of capital, loss of business
opportunity or loss of time.

 

24 EXPORT CONTROL

 

  24.1 The Parties understand that materials and information resulting from the
performance of this Agreement may be subject to export control laws and, except
as otherwise provided in a separate Technical Agreement, MIPI and/or MIPI’s
licensee will be responsible and liable for the compliance with such laws.

 

  24.2 MIPI understands that the export of Kit, Set and/or Final Product will be
conditional upon the issuance of a customs number for and the appointment of a
Person Responsible for Export Control (Ausfuhrverantwortlicher) by MIPI or
MIPI’s licensee as the party being responsible for the marketing and
distribution of the Kit, Set and Final Product to the final destination.

 

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25 GOVERNING LAW

 

  25.1 This Agreement shall be construed in accordance with the laws of Germany.
The Convention on the International Sale of Goods and the Law transforming the
CISG into national law shall not apply.

 

  25.2 All disputes arising out of or affecting this Agreement which cannot be
resolved amicably shall be submitted to the exclusive jurisdiction of the courts
of Basel Stadt, Switzerland.

 

26 GENERAL

 

  26.1 This Agreement, including the Schedules hereto which are incorporated
herein, constitute the entire agreement of the Parties with respect to the
subject matter hereof and supersedes all proposals, oral or written, and all
negotiations, conversations, or discussions. This Agreement may not be modified,
amended, rescinded, cancelled or waived, in whole or in part, except by written
amendment signed by both Parties hereto.

 

  26.2 The Parties agree that, except as may otherwise be required by applicable
laws, regulations, rules or orders, no information concerning this Agreement and
the transactions contemplated herein shall be made public by either Party
without the prior written consent of the other, which consent shall not be
unreasonably withheld or delayed. In the event either Party decides to issue a
press release announcing the execution of this Agreement, it shall not do so
without the prior written approval of the other Party, which approval shall not
be unreasonably withheld or delayed. A copy of any proposed press release shall
be provided to the other Party at least three (3) business days prior to any
proposed dissemination. The Parties agree that they will use reasonable efforts
to coordinate the initial announcement or press release relating to the
existence of this Agreement.

 

  26.3 This Agreement shall endure to the benefit of and shall be binding upon
the heirs, executors, administrators, successors and permitted assigns of the
Parties. Neither MIPI nor EZN shall assign any portion of this Agreement without
the written approval of the other Party, which approval shall not be
unreasonably withheld or delayed. However, either Party has the right, without
the consent of the other Party, to assign this agreement to an Affiliate, but in
such case shall remain liable to the other Party for the performance of its
Affiliate and shall indemnify the other Party and hold it harmless from and
against all costs, claims, judgements and other expenses arising from the
Affiliate’s performance or failure of performance.

EZN shall be entitled without prior written consent of MIPI to subcontract to
third parties parts of its obligations set out in this Agreement in order to
carry out its obligations hereunder; provided, however, that such subcontractor
shall agree to be bound by all of the relevant provisions hereof.

 

  26.4 This Agreement shall be carried out in compliance with all relevant laws,
bylaws, rules, regulations and orders of government or manifestations thereof of
Germany and the European Union.

 

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  26.5 Failure by either Party to enforce at any time any of the provisions of
this Agreement shall not be construed as a waiver of its rights hereunder. Any
waiver of a breach of any provision hereof shall not affect either Party’s
rights in the event of any additional breach.

 

  26.6 If any provision or term of this Agreement is found unenforceable under
any of the laws or regulations applicable thereto, all other conditions and
provisions of this Agreement shall nevertheless remain in full force and effect
so long as the economic or legal substance of the Agreement or transactions
contemplated herein are not affected in any manner materially adverse to any
Party. Upon such determination that any term or other provision is invalid,
illegal or incapable of being enforced, the Parties hereto shall negotiate in
good faith to modify this Agreement to effect the original intent of the Parties
as closely as possible in a mutually acceptable manner, in order that the
transaction contemplated hereby be consummated as originally contemplated to the
greatest extent possible.

Berlin, this 20th day of October 2009

 

/s/ Charles Abdalian

   

/s/ Andre Hess & Andreas Eckert

MIPI     EZN

EXHIBIT A – LISTING OF COUNTRIES IN TERRITORY

EXHIBIT B – PROJECT PLAN

EXHIBIT C – SPECIFICATIONS

EXHIBIT D – QUALITY AGREEMENT

EXHIBIT E – PRODUCT PRICE TABLE

EXHIBIT F – MILESTONE SCHEDULE

 

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