Exhibit 10.5

 

 

 

 

 

SUPPLY AGREEMENT

 

BETWEEN

 

BIOMEDICA Life Sciences, S.A.

 

AND

 

MOLECULAR INSIGHT PHARMACEUTICALS, INC.

 

dated as of

October 19, 2009

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TABLE OF CONTENTS

 

Article 1

   2

Definitions

   2

Article 2

   4

Supply of Compound and Product

   4

Article 3

   6

Price, Purchase Commitment and Payment

   6

Article 4

   8

Exclusivity and Non-Compete

   8

Article 5

   8

Term and Termination

   8

Article 6

   9

Confidentiality

   9

Article 7

   10

Indemnification and Insurance

   10

Article 8

   12

Dispute Resolution

   12

Article 9

   12

General Provisions

   12

 

2

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SUPPLY AGREEMENT

This supply agreement (“Agreement”), dated this 19th day of October, 2009 (the
“Effective Date”) is entered into by and between Molecular Insight
Pharmaceuticals, Inc. (referred to herein as “MIP”), a corporation organized and
existing under the laws of The Commonwealth of Massachusetts and having its
principal office at 160 Second Street, Cambridge, MA 02142 USA, and BIOMEDICA
Life Sciences S.A., a corporation organized and existing under the laws of
Greece, with offices at 4 Papanikoli Str., 15232 Halandri, Athens, Greece
(referred to herein as “BIOMEDICA”), with Greek Tax ID of EL 094413470, from the
tax office of FAEE Athens; each a “Party” and collectively the “Parties” hereto.

WHEREAS the Parties have executed a Territory License Agreement dated
September 1, 2009;

WHEREAS, BIOMEDICA desires MIP to source and manufacture certain products
(defined below) and supply such products to BIOMEDICA in accordance with the
Territory License Agreement;

WHEREAS, MIP agrees to source and/or manufacture the products (defined below)
and supply such products to BIOMEDICA;

NOW, THEREFORE, in consideration of the mutual covenants hereinafter expressed
and for other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the Parties agree as follows:

1. DEFINITIONS

1.1. “Affiliate” shall mean any person, corporation, or other entity which
controls, is controlled by, or is under common control with, a Party to this
Agreement. A corporation or other entity shall be regarded as in control of
another corporation or entity if it owns or directly or indirectly controls more
than fifty percent (50%) of the voting stock or other ownership interest of the
other corporation or entity, or if it possesses, directly or indirectly, the
power to direct or cause the direction of the management and policies of the
corporation or other entity or the power to elect or appoint fifty percent
(50%) or more of the members of the governing body of the corporation or other
entity.

 

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1.2. “Agreement” shall mean this Agreement together with all 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.

1.3. “Compound” shall mean a lyophilized kit comprising the DOTA-chelated
somatostatin peptide analogue known as edotreotide plus excipients provided.

1.4. “Confidential Information” shall mean any information relating to the
scientific and business affairs of a Party disclosed to the other Party in
connection with this Agreement, regardless of whether such information is
specifically designated as confidential and regardless of whether such
information is in written, oral, electronic, or other form. Such Confidential
Information may include, without limitation, trade secrets, know-how,
Inventions, non-published Patent Rights, technical data or specifications,
materials formulations, compositions, processes, information, testing methods
and/or results, business or financial information and methods, research and
development activities, production and marketing plans, and customer and
supplier information.

1.5. “Dose” shall mean a unit consisting of one patient vial of Compound or
Product.

1.6. “Effective Date” shall mean the date first above written, which date
post-dates the beginning of the Term as such as defined herein.

1.7. “Good Clinical Practice” or “GCP” shall mean the generally accepted
standard of Good Clinical Practice within the pharmaceutical industry for the
design, conduct, performance, monitoring, auditing, recording, analyses and
reporting of clinical trials that provides assurance that the data and reported
results are clinical and accurate and that the rights, integrity and
confidentiality of the trial subjects are protected.

1.8. “Good Manufacturing Practices” or “GMP” shall mean the then current Good
Manufacturing Practices as such term is defined from time to time by the FDA or
other relevant governmental authority having jurisdiction over the development,
manufacture or sale of the Compound or the Product in the Territory.

1.9. “Inventory” shall mean Compound or Product.

1.10. “Product” shall mean the yttrium radiolabeled Compound for therapeutic use
and indium-111 radiolabeled Compound for dosimetry purposes, both in a form
ready for use in human clinical trials and/or by the ultimate consumer with the
trademark of Onalta.

1.11. “Purchase Order” shall mean the order form to be completed and issued by
BIOMEDICA to MIP or MIP’s designee for the purpose of ordering Compound or
Product (Exhibit B).

1.12. “Qualified Manufacturer” shall mean a licensed manufacturer capable of
manufacturing commercial scale radiopharmaceuticals, in accordance with cGMP
requirements and all applicable national and European directives, laws and
regulations.

 

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1.13. “Specification(s)” shall mean the standards established for the
characteristics, quality, and quality control testing of the Compound or the
Product, and its constituents, components, and packaging, as described in the
IMPD, Section 2.1 SS.4, 2.1 SK.4 and 2.1.P.5 and MIP product specification and
as may be amended from time to time by the mutual written agreement of the
Parties (Exhibit A).

1.14. “Term” shall mean the period commencing on the September 1, 2009 (the
effective date of the Territory License Agreement) and continuing for 10 (ten)
years thereafter, with a renegotiation of the terms during year five (5) for the
second five (5) years. In no case shall the Term survive termination of the
Territory License Agreement.

1.15. “Territory” shall mean those countries as of the Effective Date belonging
to the European Union, the European Free Trade Association (Switzerland,
Iceland, Lichtenstein and Norway), Eastern Europe, Russia and the other former
Commonwealth of Independent States (CIS), the Middle East and Arabic States,
Turkey, and the North Africa region. “Territory” shall specifically exclude the
State of Israel unless and until such rights become available. For the sake of
clarity, as of the Effective Date, the Territory shall mean the specifically
enumerated countries listed in Exhibit F attached hereto.

The following Exhibits attached to this Agreement are hereby incorporated by
reference:

 

  Exhibit A: Specifications

  Exhibit B: Purchase Order

  Exhibit C: Ordering and Fulfillment Process

  Exhibit D: Monthly Minimum Payment Obligation

  Exhibit E: Example of Over Achievement /Underachievement Adjustments

  Exhibit F: Listing of Countries in Territory

 

2. SUPPLY OF COMPOUND AND PRODUCT

2.1 Engagement. During the Term and after the Effective Date of this Agreement,
BIOMEDICA hereby engages MIP and MIP accepts such engagement as BIOMEDICA’s
exclusive supplier of Compound and Product subject to the terms of this
Agreement.

2.2 Product and Specifications. MIP agrees to supply, directly or through a MIP
designee selected by MIP to be identified to BIOMEDICA immediately upon signing
of this Agreement, the Compound or the Product to BIOMEDICA according to the
Specifications (Exhibit A), in accordance with current good manufacturing
practices (“GMP”) and in accordance with any other applicable standards imposed
by law.

2.3 Orders of Compound or Product. BIOMEDICA shall submit to MIP or MIP’s
designee a binding Purchase Order substantially in the form attached hereto as
Exhibit B by

 

5

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facsimile (or other suitable means) at least 10 Business Days in advance of
intended shipment, (see Exhibit C Ordering and Fulfillment Process). Such
Purchase Orders shall specify the quantity of the Compound or Product ordered,
the delivery date, and shipping information. The Parties agree that the terms
and conditions of this Agreement shall control as to a particular Purchase Order
unless otherwise agreed to in writing by the Parties.

2.4 Prior to the first shipment of Compound or Product to any third party site,
BIOMEDICA or its licensee shall obtain and forward to MIP from such third Party
its license evidencing proper legal authority for the receipt and possession of
the Compound or Product. If and to the extent necessary, BIOMEDICA shall further
obtain all approvals, licenses and permits required to import Compound or
Product into each country in the Territory as directed by BIOMEDICA.

2.5 MIP or MIP’s designee shall deliver Compound or Product in accordance with
the quantities and requested delivery date(s) specified in the relevant order.
MIP or MIP’s designee will pack the Compound or Product for shipment and storage
in accordance with the applicable Specifications.

2.6 Delivery. MIP or MIP’s designee shall ship the Compound or the Product to
BIOMEDICA’s facility (or as otherwise reasonably directed by BIOMEDICA in
writing) using a carrier of BIOMEDICA’s selection, approved by MIP or MIP’s
designee. MIP or its designee shall ship the Compound and the Products to
BIOMEDICA or it’s designees in accordance with all appropriate regulations.
BIOMEDICA shall be responsible for providing evidence of proper legal authority
for the receipt and possession of Compound or Product in each country in the
Territory. BIOMEDICA shall obtain all approvals, licenses appointing any customs
brokers, and acquiring any necessary licenses or permits, including but not
limited to obtaining the necessary import licenses from the appropriate
governmental authorities. Delivery of Final Product as directed by BIOMEDICA
shall be FCA (INCOTERMS) MIP or MIP designee’s facility shipping dock. Title and
risk of loss for the goods shall pass to BIOMEDICA at point of delivery by MIP
or MIP’s designee to the selected carrier. All transportation and packaging
costs incurred to deliver Compound or Product ordered by BIOMEDICA shall be
borne by BIOMEDICA.

2.7 Packaging Information. Packages will consist of one Dose per package. The
package design for the Product will be IAEA compliant Type A packaging for
international transportation. BIOMEDICA is solely responsible for compliance of
the text of the package labels with applicable regulations in the Territory
countries for both the Product and the Compound. It is the intent of the Parties
that the package label will indicate BIOMEDICA as the Party for whom the
Compound and/or Product is manufactured.

2.8 If either Party or its designee discovers that the Compound, Product and/or
Dose does not comply with Specifications, then the discovering Party shall
within 1 (one) business day inform the other Party of such non-compliance to
determine a mutually agreed course of action. With respect to any such Compound,
Product and/or Dose which do not comply with Specifications as a result of
shortcomings in process or parameters under the direct control of

 

6

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MIP or MIP’s designee, then MIP or MIP’s designee promptly will replace such
Compound, Product and/or Dose at no additional cost to BIOMEDICA.

2.9 BIOMEDICA shall not modify the Compound or the Product, or use alternative
radioisotopes with the Compound or Product. Yttrium-90 isotope supply must meet
Specifications (Exhibit A) and be qualified and validated for the Product and/
or Compound. MIP will provide BIOMEDICA with two (2) qualified and validated
suppliers of Yttrium-90. BIOMEDICA shall not be limited to these two suppliers
to the extent additional suppliers of qualified and validated Ytrrium-90 may
also be available.

2.10 During the period that precedes availability of the Product, MIP agrees to
provide the Compound for purposes of radiolabeling by BIOMEDICA in connection
with its Onalta compassionate use and clinical study activities in the Territory
subject to BIOMEDICA first securing and providing MIP with evidence of receipt
of all relevant licenses and regulatory approvals required in each relevant
country in the Territory. The final formulation and doses of Compound will be
compounded at the treatment center or designated site and coordinated by
BIOMEDICA. BIOMEDICA shall be solely responsible for preparing or having
prepared any Product and insuring compliance with GMP (Good Manufacturing
Practices) and GCP (Good Clinical Practices) standards required or customary in
the Territory.

2.10.1 Certificates of Manufacturing Compliance. At the request of BIOMEDICA and
at BIOMEDICA’s expense, MIP shall provide or cause to be provided for such
Compounds or Products purchased, a certificate of manufacturing compliance,
containing the types of information reasonably agreed upon by BIOMEDICA and MIP.
Such certificate shall certify that the Compounds or Products were manufactured
in accordance with the specifications provided by BIOMEDICA and in compliance
with all local laws in the country of manufacture.

2.10.2 Prior to the initial release and shipment of the Compound or Product in
each country in the Territory, BIOMEDICA shall provide MIP or MIP’s designee
with applicable radioactive license(s) and regulatory documentation authorizing
the use and administration of the Compound or the Product in humans.

2.10.3 Compound Radiolabeling Tech Transfer Support. MIP will provide up to
****** hours for Compound radiolabeling tech transfer support to BIOMEDICA
personnel without a labor charge but with reimbursement for all reasonable
expenses incurred. At BIOMEDICA’s request, MIP will provide BIOMEDICA additional
tech transfer support, for which support, BIOMEDICA agrees to reimburse MIP for
at a daily rate range of ****** depending on the technical expertise and
experience level required for the specific assistance requested by BIOMEDICA,
plus reasonable expenses incurred. BIOMEDICA will provide MIP an advance notice
of 30 days for requested support.

 

* Confidential Treatment Required *

 

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3. PRICING, PURCHASE COMMITMENT AND PAYMENT

3.1 Minimum Purchase Obligation. During the Term of this Agreement BIOMEDICA
commits to purchase or otherwise pay MIP certain guaranteed monthly minimum
amounts. Such guaranteed monthly minimum amounts shall commence at the beginning
of Q3 2010 and continue through Q4 2013 inclusive. The cumulative guaranteed
monthly minimum amount due in any given quarter shall define a target guaranteed
quarterly minimum amount for calculating any underachievement adjustment or
overachievement adjustment to be received by BIOMEDICA in an immediately
subsequent quarter under the conditions set forth in 3.1.1 and 3.1.2.

3.1.1 Adjustments Underachievement Associated with Minimum Purchase Obligation.
****** of any payment made by BIOMEDICA to meet a Minimum Purchase Obligation
amount in any particular quarter will be applied by MIP as an Underachievement
Adjustment against any overachievement amount in excess of a subsequent
quarter’s Guaranteed Quarterly Minimum Purchase Amount. In no case shall such an
underachievement adjustment exceed any payment due by BIOMEDICA to MIP in excess
of the minimum payment required in the subsequent quarter. In no case will the
underachievement adjustment survive beyond such subsequent quarter. In no event
will the underachievement adjustment reduce the subsequent quarter’s target
Guaranteed Quarterly Minimum Amount to less than zero. ******

3.1.2 Adjustments Overachievement Associated with Minimum Purchase Obligation.
****** of any amount paid by BIOMEDICA in excess of the Guaranteed Quarterly
Minimum Amount due in any particular quarter for Compound and/or Product, where
such payment has taken into account any overachievement or underachievement
adjustments, will be applied by MIP as an Overachievement Adjustment against any
underachievement amount that may be owed by BIOMEDICA toward the subsequent
quarter’s target Guaranteed Quarterly Minimum Amount. In no case will the
overachievement adjustment survive beyond such subsequent quarter. In no event
will the overachievement adjustment reduce the subsequent quarter’s target
Guaranteed Quarterly Minimum Amount to less than zero. ******

3.1.3. For purposes of this section, “Material Change” shall mean an
identifiable event or events that give rise to a significant and material
adverse change in demand for Compound and/or Product in any given quarter by
more than ****** of projected figures contained in the BIOMEDICA Business Plan
attached and incorporated into the Territory License Agreement between the
Parties dated September 1, 2009 for that quarter. A change in demand for either
Compound or Product of less than ******, or a change in demand attributed
substantially and directly to conduct within BIOMEDICA’S reasonable control, or
where the cause of the event is not identifiable with reasonable certainty,
shall not constitute a Material Change. Any increase beyond projections of
Compound or Product shall not constitute a Material Change. BIOMEDICA and MIP

 

* Confidential Treatment Required *

 

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agree to account for Material Changes in the demand for Compound and/or Product
only during the portion of the Term during which minimum purchase obligations
are applicable.

3.1.3.1 MIP agrees that if BIOMEDICA can demonstrate that a Material Change
outside of BIOMEDICA’s reasonable control has occurred, such as major
regulatory, legal or reimbursement change, the Parties will promptly meet to
discuss in good faith an appropriate reforecast of the minimums. During the
period of good faith discussions, the Parties agree that the existing minimum
monthly purchase obligations as set forth in this Agreement will continue to be
paid by BIOMEDICA. Upon agreement on reforecasted minimums, any overpayment made
by BIOMEDICA from the date on which the Material Change was demonstrated will be
refunded to BIOMEDICA.

3.2 Pricing Commitment. The agreed upon pricing for the Compound and the Product
shall be as follows:

3.2.1 Pricing ******

 

  •  

Compound Transfer Price is set at ****** per Dose

 

  •  

Product for clinical trials is set at ****** per Dose

 

  •  

Product Transfer Price. The BIOMEDICA price per dose of the Product will be
determined by the national competent authority of each country of the Territory
in which the Product will be launched. If the price per dose for the Product by
the national competent authority is set below ****** then the Parties will
renegotiate in good faith the transfer price for Product in that country in the
Territory.

 

Price Per Dose*

   Transfer
Price    Percentage
of Onalta
Price Per
Dose**

******

   ******    ******

******

   ******    ******

******

   ******    ******

******

   ******    ******

******

   ******    ******

******

   ******    ******

******

   ******    ******

******

   ******    ******

******

   ******    ******

******

   ******    ******

******

   ******    ******

 

* Minimum transfer price is set at ****** for the initial five year period

** Governing equation

 

* Confidential Treatment Required *

 

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  3.2.2

Pricing ****** Product Transfer Price. BIOMEDICA and MIP will negotiate new
transfer prices after the ****** anniversary of the Supply Agreement during year
******, governing ******. One of the three mechanisms set forth below will be
selected, at the choice of BIOMEDICA, to determine the re-negotiated transfer
price for Product. BIOMEDICA will notify MIP in writing within ****** days of
the ****** of the Supply Agreement of the mechanism BIOMEDICA has selected.

 

  3.2.2.1 Comparator Pricing with BIOMEDICA. In the event that BIOMEDICA, or a
BIOMEDICA affiliate, submits a bid as a Qualified Manufacturer, MIP will source
bids from ****** other Qualified Manufacturers, for the manufacturing of Product
for years ****** of this Agreement. In the event that BIOMEDICA’s bid is the
lowest, such bid will be adjusted to be at least ****** of the lowest Qualified
Manufacture bid secured by MIP. If BIOMEDICA selects this comparator pricing
option, BIOMEDICA will offer MIP the option to match the quoted price of the
vendor selected by BIOMEDICA, plus a ****** premium (i.e. MIP will continue to
supply Product ****** of the lowest bid price secured by BIOMEDICA).

 

  3.2.2.2 Comparator Pricing without BIOMEDICA. In the event that BIOMEDICA or a
BIOMEDICA affiliate does not wish to provide a quotation to manufacture then
BIOMEDICA needs ****** qualified manufacturer quotation to be provided to MIP.
If BIOMEDICA selects this comparator pricing option, BIOMEDICA will offer MIP
the option to match the quoted price of the vendor selected by BIOMEDICA, plus a
****** (i.e. MIP will continue to supply Product ****** of the lowest bid price
secured by BIOMEDICA). Such transfer price will be amortized ******.

 

  3.2.2.3 Best Price with Quantity Discount. BIOMEDICA may request as an
alternative to the Comparator Pricing option above in 3.2.2.1 or 3.2.2.2 that
MIP provide BIOMEDICA with a best price quotation, to continue to supply the
Product during ******.

 

* Confidential Treatment Required *

 

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3.3 Advance Payment on Inventory. BIOMEDICA shall provide MIP advance payments
for Inventory on the following quarterly schedule, payable within 10 business
days of the start of each quarter:

 

  •  

Qtr-4 2009 ******

  •  

Qtr-1 2010 ******

  •  

Qtr-2 2010 ******

  •  

Qtr-3 2010 ******

  •  

Qtr-4 2010 ******

  •  

Qtr-1 2011 ******

  •  

Qtr-2 2011 ******

3.3.1 Advance Payment Refund.

 

  •  

Upon cumulative payments from BIOMEDICA to MIP for Product transfer of ******
the refund will be ****** of the ****** advance payment ******.

 

  •  

Upon cumulative payments from BIOMEDICA to MIP for Product transfer of ****** an
additional refund of ****** of the ****** advance inventory payment ****** will
be made.

 

  •  

Upon cumulative payments from BIOMEDICA to MIP for Product transfer of ****** an
additional refund of ****** of the ****** advance inventory payment ****** will
be made.

 

  •  

Upon cumulative payments from BIOMEDICA to MIP for Product transfer of ******
the final refund of ****** of the ****** advance inventory payment ****** will
be made.

3.4 Payment Terms. MIP shall invoice BIOMEDICA as shipped based upon shipments
of actual orders of Compound and Product as well as for any additionally
required guaranteed minimum monthly payment amounts owed to MIP as provided for
and agreed to in section 3.1 of this Agreement. BIOMEDICA shall pay such
invoice(s) within 60 days of date of shipment with the following terms: ******.
All payments for the Compound and Product shall be made in EURO.

 

4. EXCLUSIVITY AND NON-COMPETE

4.1 During the Term of the Supply Agreement, MIP is excluded from entering into
any other supply agreements with other third parties for ****** therapeutic
products that are similar to the Compound or Product within the defined
Territory (Exhibit F).

 

* Confidential Treatment Required *

 

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4.2 During the Term of the Supply Agreement, BIOMEDICA is precluded from
distributing any product similar to the Compound or Product in the Territory
(Exhibit F), specifically products that are targeted to ****** using a ******
targeting molecule attached to a radionuclide.

5. TERM AND TERMINATION

5.1 Term. This Agreement shall commence on the Effective Date, and unless
terminated sooner in accordance with its terms and conditions in this Agreement,
shall continue in effect until expiration of the Term.

5.2 Termination for Breach. This Agreement may be terminated by either Party in
the event of breach by the other Party of a material term or condition hereof;
provided, however, the other Party shall first give to the breaching party
written notice of the proposed termination of this Agreement (a “Breach
Notice”), specifying the grounds of any alleged breach. Upon receipt of such
Breach Notice, the breaching party shall have such time as necessary, but in any
event not more than sixty (60) days to (i) cure such alleged breach, or
(ii) dispute in writing the grounds of the alleged breach set out in the Breach
Notice in good faith. Upon failure to cure or dispute by the breaching party,
the non-breaching party may terminate the Agreement without prejudice to any
other rights or remedies which may otherwise be available to the non-breaching
party.

5.2.1 In the event of termination for Breach by MIP under this section, MIP
shall be entitled to retain all amounts paid by BIOMEDICA to MIP as well as the
full value of any Compound or Product ordered (and ready for delivery) by
BIOMEDICA at the time of termination.

5.2.2 In the event of termination under such section by BIOMEDICA, BIOMEDICA
shall be entitled to (i) recover the available balance of any advance payments
under Article 3.3 received by MIP from BIOMEDICA and (ii) receive all Compound
and Product which have been ordered but not delivered.

5.2.3 In the event of a timely received dispute by the non-breaching party in
response to its Breach Notice to the breaching party, the non-breaching party
may not unilaterally terminate this Agreement and shall only seek redress under
the terms set out in Articles 8.1 and 9.10 of this Agreement regarding
resolution of disputes by the Parties Neither Party may enter into an agreement
with any manufacturer precluding such manufacturer from selling to the other
Party at any time during the Term of this Agreement.

5.3 Termination for MIP Failure to Supply. With respect to the supply of
Compound or Product by MIP or MIP’s designee pursuant to purchase orders placed
in accordance with this Agreement, MIP or MIP’s designee failure to supply
Compound or

 

* Confidential Treatment Required *

 

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Product in a timely manner and consistent with such Purchase Orders and the
Specifications shall not be considered a material breach by MIP or MIP’s
designee unless and until such failure by MIP or MIP’s designee occurs four
(4) times in a consecutive 12 month period (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 BIOMEDICA,
(ii) MIP or MIP’s designee is able to supply an additional replacement of
Compound or Product meeting the Specifications in accordance with this Agreement
within one (1) week of the delivery date of the originally scheduled order of
Compound or Product, or (iii) if the Compound or Product failure is the result
of a manufacturing deviation requested by BIOMEDICA. In the event of a Supply
Breach, BIOMEDICA may terminate this Agreement upon thirty (30) days prior
written notice to MIP provided it gives written notice of termination to MIP
within sixty (60) days of the Supply Breach. Any failure by MIP or MIP’s
designee to supply Compound or Product due to a Force Majeure shall not be a
material breach or Supply Breach under this Agreement.

5.4 If MIP terminates this Agreement, under Articles 5.2 or 5.7, MIP, in
addition to any claim for damages MIP may have, shall be entitled to retain all
amounts paid by BIOMEDICA to MIP prior to such termination. BIOMEDICA shall
further reimburse MIP for all costs and work necessarily and properly incurred
by MIP 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 MIP under this
Agreement.

5.5 If BIOMEDICA terminates this Agreement, under Article 5.2, 5.3 or 5.7, in
addition to any claim for damages BIOMEDICA may have, BIOMEDICA shall be
entitled to within thirty (30) days of such termination at BIOMEDICA’s expense
receive all Compound or Product which have been ordered but not delivered.
BIOMEDICA shall reimburse MIP 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
BIOMEDICA under this Agreement.

5.6 Termination For Insolvency. Either Party may terminate this Agreement
immediately upon delivery of written notice to the other Party (a) upon the
institution by or against the other Party of insolvency, receivership or
bankruptcy proceedings or any other proceedings for the settlement of the other
Party’s debts; provided, however with respect to involuntary proceedings, that
such proceedings are not dismissed within one hundred and twenty (120) days;
(b) upon the other Party’s making an assignment for the benefit of creditors;
(c) upon the other Party’s dissolution or ceasing to do business.

6. CONFIDENTIALITY

6.1. Confidentiality and Exceptions. During the Term of this Agreement and for a
period of ten (10) years thereafter, each party hereto shall maintain in
confidence and not use or disclose to others for any purpose, other than to its
employees or agents (which agents shall enter into a confidentiality agreement
incorporating similar terms as set forth herein

 

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or be otherwise reasonably acceptable to the other party) with a need to know
such information to perform such party’s obligations under this Agreement or
other than as expressly authorized in this Agreement, the content of the
transactions contemplated herein and other information disclosed to such party
by the other party which is identified as “Confidential Information” by the
disclosing party (collectively “Confidential Information”). This obligation of
confidentiality shall not apply to the extent that it can be established by the
party in receipt of such information, that the information:

 

  6.1.1. was already known to the receiving party at the time of disclosure;

 

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

 

  6.1.3. 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;

 

  6.1.4. was disclosed to the receiving party by a third party who was not known
to the receiving party to have obligations restricting disclosure of such
information; or

 

  6.1.5. was independently developed by the receiving party without any use of
Confidential Information of the disclosing party.

6.2 Each party, and its employees and agents shall protect and keep confidential
and shall not use, publish or otherwise disclose to any third party, except as
permitted by this Agreement, or with the other party’s written consent, the
other party’s Confidential Information.

6.3 All Confidential Information supplied by one party to the other to assist in
carrying out the obligations hereunder shall remain the property of such party
and shall be returned to the other party upon termination or expiration of this
Agreement.

7. INDEMNIFICATION AND INSURANCE

7.1 Indemnification by BIOMEDICA. BIOMEDICA agrees to indemnify, defend and hold
MIP 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
claims or suits (“General Claims Against MIP”) arising out of (a) BIOMEDICAS’ or
a third party’s use, handling or shipping of the Compound or Product (including
in the event that MIP or MIP’s designee makes shipping arrangements on behalf of
BIOMEDICA), (b) BIOMEDICAS’ breach of any of its material obligations,
warranties or representations hereunder, (c) BIOMEDICAS’ negligent acts or
omissions or willful misconduct. Notwithstanding the foregoing, BIOMEDICA will
not be required to indemnify, defend and hold MIP and its Affiliates and their
respective directors, officers, employees and

 

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agents harmless from and against any General Claims Against MIP to the extent
that such claims arise out of (i) MIP’s breach of any of its obligations,
warranties or representations hereunder; (ii) MIP’s negligent acts or omissions
or willful misconduct; (iii) any failure of MIP to supply (except to the extent
labels and/or content thereof are provided by BIOMEDICA) or prepare for shipment
of the Compound or Product in accordance with this Agreement, cGMPs or any other
applicable laws, rules, regulations or other requirements of any applicable
governmental entity; or (iv) any failure of MIP to supply Compound or Product
consistent with the Specifications and requirements set forth herein.

7.2 Indemnification by MIP. MIP agrees to indemnify, defend and hold BIOMEDICA
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
claims or suits (“General Claims Against BIOMEDICA”) arising out of (a) MIP’s
supply (except to the extent that labels and/or content thereof is provided by
BIOMEDICA) or preparation for shipment of the Compound or Product; (b) MIP’s
breach of any of its material obligations, warranties or representations
hereunder; (c) MIP’s negligent acts or omissions or willful misconduct; or
(d) any failure of the Compound or Product to meet the Specifications.
Notwithstanding the foregoing, MIP will not be required to indemnify, defend and
hold BIOMEDICA and its Affiliates and their respective directors, officers,
employees and agents harmless from and against any General Claims Against
BIOMEDICA to the extent that such claims arise out of (i) BIOMEDICAS’ breach of
any of its obligations, warranties or representations hereunder;
(ii) BIOMEDICAS’ negligent acts or omissions or willful misconduct;
(iii) BIOMEDICAS’ or third party’s use, labeling, handling or shipment of the
Compound or Product.

7.3 Conditions of Indemnification. A Party or any of its Affiliates or their
respective employees or agents (the “Indemnitee”) that intends to claim
indemnification under this Article 6 shall promptly notify the other Party (the
“Indemnitor”) of any Liability in respect of which the Indemnitee intends to
claim such indemnification reasonably promptly after the Indemnitee is aware
thereof, and the Indemnitor shall assume the defense of any related third party
action, suit or proceeding with counsel mutually satisfactory to the Parties;
provided, however, that an Indemnitee shall have the right to retain its own
counsel and participate in the defense thereof at its own cost and expense.
Indemnity shall not apply to amounts paid in settlement of any claim, loss,
damage or expense if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld unreasonably. The failure of an
Indemnitee to deliver notice to the Indemnitor within a reasonable time after
becoming aware of any such matter, if prejudicial to the Indemnitor’s ability to
defend such action, shall relieve the Indemnitor of any liability to the
Indemnitee under this Article 6. The Indemnitee under this Article 6 and its
employees and agents shall cooperate fully with the Indemnitor and its legal
representatives in the investigation and defense of any matter covered by this
indemnification.

 

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7.4 Insurance. Each Party shall obtain and maintain insurance reasonably
sufficient to cover its potential liability under this Agreement and shall
provide evidence of such insurance to the other Party upon request.

7.5 Limitation of Damages. Neither Party nor its affiliates shall have any
liability for any special, incidental, or consequential damages, including, but
not limited to the loss of opportunity, revenue or profit, in connection with or
arising out of this Agreement, even if it shall have been advised of the
possibility of such damages.

8. DISPUTE RESOLUTION

8.1 Dispute Resolution. The Parties recognize that disputes as to certain
matters may from time to time arise which relate to either Party’s rights and/or
obligations hereunder. The Parties hereby agree that they will attempt in good
faith to resolve any controversy, claim or dispute (collectively, a “Dispute”)
arising out of or relating to this Agreement promptly by negotiations. Any such
Dispute which is not settled by the Parties within fifteen (15) days after
notice of such Dispute is given by one Party to the other in writing shall be
referred to a senior executive of MIP and of BIOMEDICA who are authorized to
settle such Disputes on behalf of their respective companies (“Senior
Executives”) and who, if possible, are not involved in the Dispute. The Senior
Executives will meet for negotiations within thirty (30) days of the end of the
15-day negotiation period referred to above, at a time and place mutually
acceptable to both Senior Executives. If the Dispute has not been resolved
within thirty (30) days after the end of the 15-day negotiation period referred
to above (which period may be extended by mutual agreement), the other Party can
immediately bring an action relating to the Dispute before a court of competent
jurisdiction in accordance with Article 9.10.

9. GENERAL PROVISIONS

9.1 Notices. All notices given under this Agreement shall be in writing and
shall be personally delivered or mailed by certified first class mail return
receipt requested or a reputable express delivery service to the Party for which
it is intended at its address as set forth below, or at such other address as
the addressee may have designated to the other Party in writing. Any notice
shall be deemed given only upon actual delivery thereof at the proper address.

All notices to MIP shall be addressed to:

If to MIP, at:

Molecular Insight Pharmaceuticals, Inc.

160 Second Street

Cambridge, MA 02142 USA

Attn: Paul Granger, General Counsel

If to BIOMEDICA at:

 

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BioMedica Life Sciences, Ltd.

4 Papanikoli Str.,

15232 Halandri, Athens, Greece

Attn: Ioannis Vitsaras, CEO

9.2 Entire Agreement. This Agreement sets forth the entire understanding of the
Parties with respect to the subject matter hereof and supersedes all prior
agreements, written and oral, between the Parties. No modification of any of the
terms of this Agreement shall be deemed to be valid unless it is in writing and
signed by the Party against whom enforcement is sought. No course of dealing or
usage of trade shall be used to modify the terms and conditions herein.

9.3 Force Majeure. “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,
interruption of or delay in transportation, strike or labor disruption. 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.

9.3.1 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.

9.3.2 MIP shall, upon signing of this Agreement, qualify ****** suppliers of
Yttrium-90. All costs and expenses, including but not limited to qualifying and
validating, associated with qualifying a back up supply from the second MIP
qualified supplier shall be borne equally by both MIP and BIOMEDICA.

9.3.3. 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.

9.4 Waiver. No waiver by either Party of any default, right or remedy shall be
effective unless in writing, nor shall any such waiver operate as a waiver of
any other or of the same default, right or remedy, respectively, on a future
occasion.

9.5 Assignment. This Agreement may not be assigned or otherwise transferred by
either Party without the prior written consent of the other Party; provided,
however, that either Party may assign this Agreement, without the consent of the
other Party, (i) to any

 

* Confidential Treatment Required *

 

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of its Affiliates, if the assigning Party guarantees the full performance of its
Affiliates’ obligations hereunder or (ii) in connection with the transfer or
sale of all or substantially all of its assets or business or in the event of
its merger or consolidation with another company. In all cases the assigning
Party shall provide the other Party with prompt notice of any such assignment.
Any purported assignment in contravention of this article shall, at the option
of the non assigning Party, be null and void and of no effect. No assignment
shall release either Party from responsibility for the performance of any
accrued obligation of such Party hereunder.

9.6 Binding Effect. This Agreement shall inure to the benefit of and be binding
on the Parties, their Affiliates and permitted assigns.

9.7 Severability. It is the intention of the Parties to comply with all
applicable laws domestic or foreign in connection with the performance of its
obligations hereunder. In the event that any provision of this Agreement, or any
part hereof, is found invalid or unenforceable, the remainder of this Agreement
will be binding on the Parties hereto, and will be construed as if the invalid
or unenforceable provision or part thereof had been deleted, and the Agreement
shall be deemed modified to the extent necessary to render the surviving
provisions enforceable to the fullest extent permitted by law.

9.8 Headings; Interpretation. The headings used in this Agreement are for
convenience only.

9.9 Independent Parties. This Agreement shall not be deemed to create any
partnership, joint venture, or agency relationship between the Parties.

9.10 Governing Law. The construction, validity and performance of this Agreement
will be governed in all respects by the laws of Switzerland. 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 the
Commonwealth of Massachusetts, U.S.A. if the defendant is MIP, or to the
exclusive jurisdiction of the courts of Athens, Greece, should BIOMEDICA be the
defendant.

9.11 Execution by Counterparts; Exchange by Facsimile. This Agreement may be
executed by the Parties in one or more counterparts. Such counterparts may be
exchanged by facsimile (provided that each executed counterpart is transmitted
in one complete transmission). Where there is an exchange of executed
counterparts, each Party shall be bound by the Agreement notwithstanding that
original copies of the Agreement may not be exchanged immediately. The Parties
shall cooperate after execution of the Agreement and exchange by facsimile to
ensure that each Party obtains an original executed copy of this Agreement.

9.12 Survival. Except where explicitly provided elsewhere herein, termination of
this Agreement for any reason, or expiration of this Agreement, will not affect:
(i) obligations, including the payment of any sums, which have accrued as of the
date of

 

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termination or expiration, and (ii) rights and obligations which, from the
context thereof, are intended to survive termination or expiration of this
Agreement.

—Signature Page to Follow—

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their duly authorized representatives as of the day and year first above
written.

 

BioMedica Life Sciences S.A.   Molecular Insight Pharmaceuticals Inc. Name:  
/s/ Yannis Vitsaras   Name:   /s/ Charles Abdalian Title:   CEO   Title:   Chief
Financial Officer