10-Q/A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q/A

Amendment No. 1

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2009

OR

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

Commission File Number 001-33284

MOLECULAR INSIGHT PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

Massachusetts	04-0562086
(State or Other Jurisdiction of Incorporation or Organization)	(I.R.S. Employer Identification No.)
160 Second Street, Cambridge, Massachusetts	02142
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (617) 492-5554

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    YES  x    NO  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    YES  ¨    NO  x

The number of shares outstanding of the registrant’s common stock as of November 4, 2009 was 25,268,327.

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    YES  ¨    NO  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer	¨	Accelerated filer	x
Non-accelerated filer	¨  (Do not check if a smaller reporting company)	Smaller reporting company	¨

EXPLANATORY NOTE

Molecular Insight Pharmaceuticals, Inc. (the “Company”) is filing this Amendment No. 1 to its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2009 (the “Original Quarterly Report”) as an exhibit-only filing. The Company is filing this Amendment No. 1 to the Original Quarterly Report (“From 10-Q/A”) for the sole purpose of re-filing Exhibits 10.3, 10.4, 10.5 and 10.6 thereto originally filed on November 9, 2009 by adding exhibits and schedules to those exhibits, in response to a comment received from the Securities and Exchange Commission in connection with a request for confidential treatment of portions of such exhibits and schedules. The Company has made no other changes to the previously filed Original Quarterly Report.

This Amendment does not reflect events occurring after the filing of the Original Quarterly Report or modify or update those disclosures affected by subsequent events. Except as described above, no other modifications or changes have been made to the Original Quarterly Report as originally filed. Other events occurring after the filing of the Original Quarterly Report or other disclosures necessary to reflect subsequent events have been addressed in our reports filed with the Securities and Exchange Commission subsequent to the filing of the Original Quarterly Report.

PART II — OTHER INFORMATION

ITEM 6. EXHIBITS

See Exhibit Index on the page immediately preceding the exhibits for a list of the exhibits filed as a part of this Form 10-Q/A, which is incorporated by reference.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	MOLECULAR INSIGHT PHARMACEUTICALS, INC.
Date: March 10, 2010	By:	/S/ DANIEL L. PETERS
		Daniel L. Peters
		President and Chief Executive Officer
Date: March 10, 2010	By:	/S/ CHARLES H. ABDALIAN, JR.
		Charles H. Abdalian, Jr.
		Senior Vice President and Chief Financial Officer

3

Exhibit Index

Exhibit Number	Description of Exhibit
4.1*	Form of Common Stock
10.1*	Inducement Grant Option Award Agreement, between Molecular Insight Pharmaceuticals, Inc. and Daniel L. Peters, dated August 11, 2009 (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on August 11, 2009)
10.2*	Severance Agreement by and between Molecular Insight Pharmaceuticals, Inc. and Donald E. Wallroth, effective September 2, 2009 (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on September 4, 2009)
10.3†	Azedra Commercial Facility and Supply Agreement, dated August 6, 2009, by and between Molecular Insight Pharmaceuticals, Inc. and MDS Nordion, a division of MDS (Canada), Inc.
10.4†	Territory License Agreement, dated September 1, 2009, by and between Molecular Insight Pharmaceuticals, Inc. and BioMedica Life Sciences, S.A.
10.5†	Supply Agreement, dated October 19, 2009, by and between Molecular Insight Pharmaceuticals, Inc. and BioMedica Life Sciences, S.A.
10.6†	Facility Setup and Contract Manufacturing Agreement, dated October 20, 2009, by and between Molecular Insight Pharmaceuticals, Inc. and Eckert & Ziegler Nuclitec GmbH.
31.1	Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
31.2	Certification of Principal Financial Officer Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
32	Certifications of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

† Portions of this exhibit have been omitted and are being filed separately with the Secretary of the Securities and Exchange Commission pursuant to a confidential treatment request.

* Previously filed with the Original Quarterly Report on November 9, 2009.

EX-10.3

Exhibit 10.3

Azedra Commercial Facility and Supply Agreement

THIS AGREEMENT made in duplicate as of this 6th day of August, 2009

BETWEEN:
	MDS NORDION, a division of MDS (Canada) Inc.
	having a place of business at
	447 March Road
	Ottawa, Ontario, Canada
	(“Nordion”)
AND:
	MOLECULAR INSIGHT
	PHARMACEUTICALS, INC.
	having a place of business at
	160 Second Street
	Cambridge Massachusetts, 02142 USA
	(“Molecular Insight Pharmaceuticals”)

WHEREAS:

I. Molecular Insight Pharmaceuticals is the owner or licensee of a certain compound known as Azedra, a therapeutic radiopharmaceutical agent for the treatment of certain neuroendocrine cancers;

II. MIP has expertise in the production and development of radiopharmaceuticals, processes, and in the radiolabelling of compounds;

III. Nordion has expertise in the production of radiochemicals, in the development of radiopharmaceuticals, processes, and in the radiolabelling of compounds;

IV. Nordion has expertise in designing and overseeing the construction of facilities for the radiolabelling of compounds;

V. Nordion and Molecular Insight Pharmaceuticals agreed to a proposal for the Phase III Clinical Trial and Commercial Supply Facility Agreement dated February 5, 2009 (“Letter of Agreement”) and Molecular Insight Pharmaceuticals paid Nordion a sum of ****** for the Phase 1 inception which was due upon execution of the Letter of Agreement;

* Confidential Treatment Requested *

VI. Nordion and Molecular Insight Pharmaceuticals entered into (i) a Development Agreement dated March 22, 2006 (the “Development Agreement”) for the purpose of undertaking a development program to establish a process permitting Molecular Insight Pharmaceutical’s precursor (unlabelled MIBG Ultrace^™ resin) to be labeled with I-131 to form a radiopharmaceutical (i) a Clinical Supply and Interim Facility Agreement dated July 12, 2007 (“Interim Facility Agreement”) for the purpose of interim clinical supply of Azedra, and (ii) a Scale-up Agreement dated March 18, 2008 (the “Scale-up Agreement”) for the purpose of establishing a process to manufacture a scaled-up batch size of Azedra.

VII. Molecular Insight Pharmaceuticals desires that Nordion establish a Facility at its site in Ottawa, Ontario to accommodate growth and expansion of the process developed under the Development Agreement for the manufacture and supply of Azedra in sufficient quantities for use in the Clinical Trial Phase and the Commercial Phase.

VIII Molecular Insight Pharmaceuticals desires that upon completion of the Facility established under this Agreement that Nordion transition the manufacture of Azedra from the existing facility currently located in room 1215 at Nordion’s site in Ottawa, Ontario to the Facility established under this Agreement.

NOW THEREFORE in consideration of the mutual covenants and agreements herein contained, and subject to the terms and conditions hereinafter set out, the parties hereto agree as follows:

ARTICLE 1 – DEFINITIONS

For the purposes of this Agreement:

1.1 “Affiliate” shall mean an entity or person which controls, is controlled by or is under common control with either party. For purposes of this section 1.1 control shall mean (a) in the case of corporate entities, the direct or indirect ownership of more than one-half of the stock or participating shares entitled to vote for the election of directors, and (b) in the case of a partnership, the power to direct the management and policies of such partnership.

1.2 “Azedra” shall mean Molecular Insight Pharmaceuticals’s proprietary drug product, a high specific activity I-131 labeled meta-iodobenguane in therapeutic (“Tx”) and diagnostic (“Dx”) dosage forms also known as high specific activity I-131 MIBG, for use in treating certain neuroendocrine cancers.

1.3 “Batch” shall mean a production batch of Azedra Manufactured under this Agreement and shall be of the size set forth on Schedule D attached hereto.

1.4 “Batch Production Date” shall mean the date on which Isotope is added to Precursor during the Manufacture of Azedra.

1.5 “Clinical Trials” shall mean human trials for clinical development of Azedra for the purpose of seeking pharmaceutical regulatory approval.

1.6 “Clinical Trial Phase” shall mean human trials for clinical development of Azedra for use in Clinical Trials.

1.7 “Commercial Phase” shall mean the period of supply of Azedra commencing after NDA regulatory approval has been received in the United States from the FDA by Molecular Insight Pharmaceuticals.

1.8 “Current Good Manufacturing Practices” or “cGMP(s)” shall mean the good manufacturing practices required by the FDA and as set forth in the FD&C or FDA rules and regulations for the manufacturing, testing and quality control of pharmaceutical materials as applied to compounds, which practices are current on the Effective Date of this Agreement and may be supplemented, amended or modified from time to time. To the extent that standards in other countries for the manufacture, testing, and quality control of pharmaceutical materials are higher or more stringent than those required by the FDA, the more stringent standards if agreed to between the parties shall be delineated in subsequent Quality Agreements.

1.9 “Data” shall mean Azedra formulation data (under the predecessor agreements), and data summaries, data reports, and results generated under this Agreement, included in the following documents: stability testing reports, Azedra Batch records and validation reports. Data shall exclude Nordion Background Technology and Nordion Confidential Information.

1.10 “Effective Date” shall mean the date first appearing above.

1.11 “Equipment” means any equipment or machinery, and in the case of cGMP manufacturing hereunder, qualified equipment or machinery, used by Nordion in the development and/or Manufacture of Azedra, or the holding, processing, testing, or release of Azedra.

1.12 “FDA” shall mean the United States Food and Drug Administration.

1.13 “FD&C” shall mean the United States Federal Food, Drug and Cosmetic Act, as amended.

1.14 “Facility” shall mean the new facility and Equipment to be established by Nordion at its manufacturing site in Ottawa, Ontario as described in Schedule A and pursuant to cGMPs, to be used for the production of Azedra for Clinical Trials and Commercial Phase supply.

1.15 “Facility Milestone(s)” shall mean the milestones relating to the establishment of the Facility as described in Schedule A.

1.16 “Facility Program” shall mean the program by which Nordion shall establish the Facility in accordance with the Facility Milestones as described in Schedule A.

1.17 “IND” shall mean an Investigational New Drug Application as defined by the rules and regulations promulgated under the FD&C and U.S. Public Health Service Act and any supplements, modifications or amendments thereunder.

1.18 “Isotope” or “I-131” shall mean tellurium derived Iodine 131 (I-131).

1.19 “Manufacture(d)” means any processes and activities necessary to produce Azedra, including without limitation, the manufacturing, processing, packaging, labeling, quality control testing, stability testing, release or storage of Precursor and Azedra, but excluding sterilization.

1.20 “Master Batch Record” or “MBR” shall mean a formal set of instructions for the Manufacture of each Batch, developed and maintained in Nordion’s standard format by Nordion, using Molecular Insight Pharmaceuticals’ master formula and technical support.

1.21 “Master Validation Plan” shall mean the program by which documented evidence provides assurance that the Process will consistently produce Azedra that meets Specifications.

1.22 “Molecular Insight Pharmaceuticals Background Technology” shall mean technology conceived, created, developed or reduced to practice by Molecular Insight Pharmaceuticals prior to or during the Term of this Agreement or independently of this Agreement, and independently of Nordion Background Technology including, without limitation, patents, know-how, techniques, methods, processes, drawings, schematics, procedures, protocols, parameters, engineering details, functional descriptions, data and database content, technical or scientific information, manuals and trade secrets, which Molecular Insight Pharmaceuticals owns, uses, conceives, creates, develops, reduces to practice or provides in performing under this Agreement, or which is licensed to Molecular Insight Pharmaceuticals and which is in existence in the form of a writing, prototype or can otherwise be demonstrated to be the property of Molecular Insight Pharmaceuticals, or to which Molecular Insight Pharmaceuticals has the rights.

1.23 “Nordion Background Technology” shall mean technology, conceived, created, developed or reduced to practice by Nordion prior to or during the Term of this Agreement or independently of this Agreement, including, without limitation, patents, know-how, techniques, methods, processes, drawings, schematics, procedures, protocols, parameters, engineering details, functional descriptions, data and database content, technical or scientific information, manuals and trade secrets, which Nordion owns, uses, conceives, creates, develops, reduces to practice or provides in performing under this Agreement, or which is licensed to Nordion and which is in existence in the form of a writing, prototype or can otherwise be demonstrated to be the property of Nordion or to which Nordion has the rights.

1.24 “NDA” shall mean a new drug application as defined in the rules and regulations promulgated under the FD&C and U.S. Public Health Service Act, as supplemented, modified or amended from time to time.

1.25 “Precursor” shall mean Ultratrace^™resin as specified in Schedule F and produced pursuant to cGMPs.

1.26 “Process” shall mean the method of radiolabeling of Precursor with I-131, formulation, dispensing and testing of Azedra developed pursuant to the Scale-up Agreement and in compliance with cGMPs, which shall be adjusted only to accommodate the physical set up and aseptic conditions of the Facility and shall be documented in the applicable Master Batch Record

1.27 “Quality Agreement” shall mean the agreement set out in Schedule “E”.

1.28 “Regulatory Authority” shall mean the United States Food and Drug Administration, the European Medicinal Evaluation Agency (EMEA), or respective Regulatory Authorities in other countries or any successor entity thereto.

1.29 “Reference Standards” shall mean the cGMP compliant compounds supplied by Molecular Insight Pharmaceuticals as specified in Schedule F.

1.30 “Specification(s)” shall mean those final conditions, characteristics and specifications for Azedra as set out in Schedule B, as amended by mutual written agreement of the parties from time to time.

1.31 “Term” shall mean the Initial Term and each Renewal Term as defined in section 17.1.

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

Schedule A: Description of Facility Program, Facility Milestones, Facility Schedule

Schedule B: Azedra Specifications

Schedule C: Facility Construction Fees

Schedule D: Price of Batches for Clinical Trial and Commercial Phase Supply

Schedule E: Quality Agreement

Schedule F: Specifications for Precursor and Reference Standards

Schedule G: Change in Scope Form

ARTICLE 2 – PURPOSE

2.1 Scope and Object

The scope and object of this Agreement is to establish a new facility at Nordion’s manufacturing site in Ottawa, Ontario in which to perform the Process for the Manufacture and supply of Azedra for Clinical Trials and Commercial Phase supply in accordance with the responsibilities and obligations attributed to each of the parties as set out in this Agreement. Both parties shall use commercially reasonable efforts to meet their respective milestones set out in Schedule A. If either party, acting in good faith, materially fails to satisfy any milestone, such party shall provide written notice thereof to the other party and the parties shall determine a reasonable corrective action plan and revised milestone schedule.

ARTICLE 3 – FACILITY PROGRAM

3.1 Facility Construction

In consideration of Nordion establishing the Facility, Molecular Insight Pharmaceuticals will pay to Nordion the fees as set out in Schedule C, provided that the respective milestone(s) for establishing the Facility as set forth on Schedule A attached hereto are materially met by Nordion. Unless otherwise set out (see Schedule C) amounts owing by Molecular Insight Pharmaceuticals during the Facility program shall be paid within thirty (30) days of receipt of Nordion’s invoice.

Nordion shall establish the Facility in accordance with its obligations described and attributed in Schedule A, it being understood that some activities may be reasonably delayed to the extent that such activity is premised on the work or provision of data, information, equipment or technology by Molecular Insight Pharmaceuticals, and provided that such activities do not materially interfere or could be reasonably expected to interfere with other established Nordion production activities. Molecular Insight Pharmaceuticals acknowledges that there may be risks and/or unforeseen circumstances that are associated with the implementation of Facility Program that may impact Nordion’s overall achievement of the Milestone Schedule and may result in delays and/or increased Facility costs (from those originally estimated). In that the aggressive timeline for implementation of the project was prepared at the request of Molecular Insight Pharmaceuticals, it is acknowledged by Molecular Insight Pharmaceuticals that such timeline may not, in the ordinary course, be achievable. It is understood and acknowledged that due to the nature of the activities to be carried out during the establishment of the Facility, the time for completion and sequence for carrying out the activities as set out in Schedule A shall therefore serve only as a guide.

Subject to the foregoing each party shall use their commercially reasonable efforts in order to carry out their respective obligations and responsibilities set out in Schedule A.

The Process established under the Scale-up Agreement being transferred to the Facility and validated under this Agreement has a 15 Ci starting activity of Isotope. It is assumed this Process and related methods have been fully validated and utilized in the current interim facility established under the Interim Facility Agreement. Yields are as described in Schedule D. Molecular Insight Pharmaceuticals accepts that the success of work detailed in this Agreement is dependant upon the successful completion of the 15 Ci process developed under the Scale-up Agreement.

Nordion shall, in consultation with Molecular Insight Pharmaceuticals, develop and implement a Master Validation Plan that will allow the production of Azedra under cGMPs for Clinical Trial supply and for Commercial Phase supply. Prior to implementation, both parties shall in writing approve the Master Validation Plan, which approval will not be unreasonably or untimely withheld.

3.2 Program Manager

The parties, upon signing this Agreement, shall each designate a program manager, who shall be responsible for coordinating communication and monitoring performance under this Agreement. The program manager for Nordion shall respond to Molecular Insight Pharmaceutical’s reasonable inquiries regarding the status of Nordion’s activities under this Agreement and

shall keep Molecular Insight Pharmaceuticals informed as to interim progress. The program managers shall meet either monthly or more frequently than monthly if agreed to in advance by the parties, in person or by telephone, for the purpose of reviewing the status of the project and assessing progress against the milestones and activities set forth in Schedule A. Minutes of meetings shall be prepared, maintained and provided to each of the parties. Prior to the scheduled monthly meetings, Nordion shall prepare and submit to Molecular Insight Pharmaceuticals a monthly written report that sets forth in reasonable detail the progress of the Facility construction and indicates any problems that are known to Nordion or reasonably anticipated by Nordion to occur that either may impact the program schedule for the Facility or may result in a cost increase to be borne by Molecular Insight Pharmaceuticals.

3.3 Scientific and Technical Dispute Resolution

Except as otherwise set out, in the event that at any time during the Term of this Agreement, a disagreement, dispute, controversy or claim should arise relating to the scientific or technical issues in connection with Nordion or Molecular Insight Pharmaceuticals performance under this Agreement, the Program Managers will attempt, in good faith, to resolve their differences within a period of ten (10) business days. With respect to the scientific or technical issues, if after ten (10) business days the Program Managers are unable to resolve such dispute, the Program Managers shall refer the matter to a joint Steering Committee comprised of three (3) senior members of each party. The Steering Committee shall meet as required to resolve the matter.

3.4 Scope Change

The parties acknowledge and agree that Schedule A may require amendment during the course of establishing the Facility. All such changes to Schedule A shall be made by written agreement of the parties in the form of the attached Change in Scope Form (Schedule G). If any change to Schedule A impacts the scope of work to be provided by Nordion, Nordion will provide a written estimate of the increased cost, which must be approved by Molecular Insight Pharmaceuticals in advance of implementation. Changes in scope shall be charged to Molecular Insight Pharmaceuticals based on the rates set out in Schedule C which rates shall be subject to escalation in accordance with section 4.6. No work on such scope change shall be carried out or implemented by Nordion prior to Nordion’s receipt of Molecular Insight Pharmaceuticals’ written approval of such change.

3.5 Use of the Facility

During the Term of this Agreement after transition of the Process to the Facility, subject to section 9.1, Nordion shall ensure that the Facility is available for the Manufacture of Azedra for supply to Molecular Insight Pharmaceuticals on an exclusive basis and Nordion shall only use the Facility for the Manufacture of Azedra or any other product at the election of Molecular Insight Pharmaceuticals and subject to the mutual agreement of the parties. Nordion further agrees that it shall not (i) use other facilities for the Manufacture of Azedra unless Molecular Insight Pharmaceuticals consents to the use of such other facilities in writing, such consent not to be unreasonably withheld, and (ii) Manufacture Azedra for any third party unless directed to do so in writing by Molecular Insight Pharmaceuticals. For the sake of clarity, it is the intent of the parties that the Facility may be used for the clinical or commercial manufacture of one or more Molecular Insight Pharmaceuticals products the manufacture of which shall be the subject of a separate agreement.

3.6 Additional Compensation for Molecular Insight Pharmaceuticals Audits

During the Facility Program, upon ten (10) days prior written notice to Nordion, Molecular Insight Pharmaceuticals and any third-party consultant or auditor appointed by Molecular Insight Pharmaceuticals, such consultant and/or auditor being subject to a confidentiality agreement with and reasonably acceptable to Nordion, shall have reasonable access to observe and inspect the Facility for the purpose of determining the progress against Facility Milestones.

In the event that Molecular Insight Pharmaceuticals elects to audit Nordion following a warning or similar citation to Nordion with respect to the Facility and Azedra from any applicable Regulatory Authority, Nordion shall not charge Molecular Insight Pharmaceuticals in connection with such an audit unless such warning or similar citation arises from the acts or omissions of Molecular Pharmaceuticals.

Molecular Insight Pharmaceuticals, upon thirty (30) days prior written notice to Nordion shall have the right to conduct one annual surveillance Quality Assurance audit, the duration of which shall not exceed two (2) business days.

Notwithstanding the foregoing, in the event that Molecular Insight Pharmaceuticals requests an audit for any other reason, Molecular Insight Pharmaceuticals will compensate Nordion based on the rate of ****** (subject to escalation in accordance with section 4.6) per required Nordion person per hour for the time spent by Nordion on the following audit activities including but not limited to:

• preparing and hosting Facility audits requested by Molecular Insight Pharmaceuticals including FDA preaudit inspections;

* Confidential Treatment Requested *

• preparing responses to FDA inquiries if requested by Molecular Insight Pharmaceuticals and preparation by Nordion of any other information requested by Molecular Insight Pharmaceuticals necessary to conduct any audit; and

• attending meetings with the FDA at Molecular Insight Pharmaceuticals request.

Molecular Insight Pharmaceuticals shall reimburse Nordion for all reasonable costs incurred for travel incurred by and accommodation for Nordion personnel in carrying out the foregoing activities. Molecular Insight Pharmaceuticals shall not compensate Nordion for any travel time for Nordion employees. Nordion shall provide an estimate of all such activities to Molecular Insight Pharmaceuticals prior to incurring the expenditure.

3.7 Ownership of Physical Assets, Precursor, Reference Standards and Data

At all times (both during the Term and after expiration or termination of this Agreement for any reason) Nordion will retain all right and title in and to the physical assets and real property that comprise and/or are used and/or employed in the Facility.

Molecular Insight Pharmaceuticals shall at all times (both during the Term and after expiration or termination of this Agreement for any reason) retain title to and ownership of Precursor, Reference Standards and Data, provided further, that both during the Term and after termination and/or expiration of this Agreement (i) Nordion may retain an archival copy of the Data for the purpose of management of its obligations and (ii) Nordion may use the Data for the purposes of increasing its general knowledge and experience with respect to its radiopharmaceutical capabilities. Nordion will not use Data in any regulatory submission to any national regulatory authority for the purpose of clinical investigation or licensure of any Nordion produced MIBG dose form. Nordion shall at all times take such reasonable measures as are required to store, in accordance with applicable specifications, the Precursor, Reference Standards and Azedra. Nordion shall ensure that Azedra, and any work in process are free and clear of any liens or encumbrances. Nordion shall immediately notify Molecular Insight Pharmaceuticals if at any time it believes any Precursor, Reference Standards and/or Azedra has been damaged, lost or stolen.

3.8 Repairs and Maintenance

After completion of the Facility Program, Nordion shall, subject to section 14.7, maintain such Facility in satisfactory operating condition as required by the FDA, Specifications, Process and cGMPs, and all other applicable laws, regulations, rules or orders.

The cost of routine repairs, preventive maintenance and service contracts for the Facility and Equipment shall be borne by Nordion. Nordion may periodically require the Facility to be unavailable for Azedra production due to repair or unforeseen maintenance activities. In addition, Nordion may shut down the Facility annually for a two (2) week maintenance period. Such outages shall be made only with eight (8) weeks advance written notice to Molecular Insight Pharmaceuticals and, to the extent possible and reasonable in the circumstance, be planned in conjunction with Molecular Insights Pharmaceuticals so as to minimize the impact on supply capability.

3.9 Alternative Manufacturing Sites - Nordion Obligation to Assist

Nordion shall be the sole manufacturer of Azedra in the initial Azedra NDA filed with the FDA. Molecular Insight Pharmaceuticals may establish additional Azedra manufacturing sites and include such sites in the NDA once it has received regulatory approval from the FDA, provided that:

(a) Nordion shall, during the Term of this Agreement, upon written notification from Molecular Insight Pharmaceuticals of its desire to establish an additional manufacturing site, shall have a right of negotiation for the establishment of any such additional Azedra third party manufacturing site(s) that is not owned directly or indirectly, by Molecular Insight Pharmaceuticals. Molecular Insight Pharmaceuticals shall be entitled to discuss, negotiate and enter into an agreement with third parties for the establishment of additional Azedra manufacturing sites, provided further however, that the terms and conditions of establishment of such site(s) shall not be less favorable to Molecular Insight Pharmaceuticals than those last offered by MDS Nordion, and

(b) the establishment of any new manufacturing site by Molecular Insight Pharmaceuticals shall not reduce the then-current purchase levels (based on the average monthly purchase levels in the preceding four (4) months prior to exercise of the right of negotiation) of Azedra by Molecular Insight Pharmaceuticals as supplied by Nordion under this Agreement.

Molecular Insight Pharmaceuticals recognizes that Nordion has used and employed Nordion Background Technology in the Facility. Such Nordion Background Technology shall remain the exclusive property of Nordion. Molecular Insight Pharmaceuticals shall have no right to adopt or exploit Nordion Background Technology without Nordion’s prior written consent. Nordion’s obligation to assist Molecular Insight Pharmaceuticals (if any) in the establishment of any third party manufacturing site shall be limited to the provision of chemistry manufacturing and controls documents (“CMC”) excluding Nordion specific documents, Nordion Background Technology and Nordion Confidential Information.

ARTICLE 4 – TRANSITION, PRICING, PURCHASE COMMITMENT AND PAYMENT

4.1 Azedra Supply and Transition

Nordion shall notify Molecular Insight Pharmaceuticals in writing of the completion of the Facility. After written notice by Nordion of completion of the Facility pursuant to this Agreement and provided that Nordion is capable of Manufacture of Azedra in the Facility, and subject to Molecular Insight Pharmaceutical’s approval, such approval not to be unreasonably or untimely withheld, Nordion shall transition Manufacture of Azedra to the Facility within thirty (30) days. After transition to the Facility Nordion agrees to (i) use the Process to produce Batches of Azedra (in quantities specified on Schedule D) that meet the Specifications, FDA requirements and are manufactured in conformance with cGMPs and (ii) make arrangements for shipment of Azedra to third parties on behalf of Molecular Insight Pharmaceuticals as directed by Molecular Insight Pharmaceuticals. All Batches shall be shipped in regulatory approved lead shields. Nordion reserves the right to withhold from shipment any Batch, or portion thereof, which does not conform to Specifications. Nordion, at the time of execution of this Agreement, will be supplying Azedra from an alternative facility established under the Interim Facility Agreement.

Azedra production runs will be performed on Mondays and up to two other weekdays each week subject to Nordion staff availability. In the event that the market demand for Azedra attains the level whereby the three production days are fully utilized, and that market demand is reasonably sustained for a period of at least three (3) consecutive months, Nordion will use commercially reasonable efforts to accommodate Azedra production on additional days. If thereafter such market demand is not sustained for any period of two consecutive months, Nordion may reduce the days on which it carries out production runs.

4.2 Clinical Trial and Commercial Phase Orders and Pricing

The purchase price for a Batch (and additional vials) supplied to Molecular Insight Pharmaceuticals for Clinical Trials and during the Commercial Phase shall be as set out in Schedule D and shall be payable as set forth in Section 4.7 herein. All orders for Azedra shall be forwarded by Molecular Insight Pharmaceuticals and received by Nordion a minimum of fourteen (14) business days for Clinical Trials and twenty (20) business days during the Commercial Phase prior to the week in which Azedra is to be Manufactured.

4.3 Minimum Purchase Obligation

Subject to section 4.4, commencing with the first full month after completion of the Facility (as notified by Nordion to Molecular Insight Pharmaceuticals pursuant to section 4.1), Molecular Insight Pharmaceuticals shall, during the remainder of the Term, purchase or otherwise pay Nordion for a minimum of two (2) Batches of Azedra per calendar month. In the event the minimum purchase obligations described in this section 4.3 are not met by Molecular Insight Pharmaceuticals, as averaged over a rolling two (2) month period, Nordion may without liability, in addition to any other remedy available, at its sole option and unfettered discretion, suspend Manufacture of Azedra until full payment is made by Molecular Insight Pharmaceuticals (during which period the minimum purchase commitment shall continue to accrue), or notwithstanding any other remedial or cure provision contained in this Agreement, terminate this Agreement upon ten (10) days prior written notice. The provisions of section 4.5 shall apply to cancellation of a Batch (and additional vials) however section 4.5 shall in no way limit Molecular Insight Pharmaceuticals’ minimum purchase commitment under this Agreement and any cancellation fee due and payable in a given month (and paid) shall be applied against amounts owing by Molecular Insight Pharmaceuticals with respect to its minimum purchase commitment in such month.

In the event that Nordion elects to suspend Manufacture of Azedra due to Molecular Insight Pharmaceuticals failure to meet its minimum purchase obligation pursuant to this Section 4.3 and Molecular Insight Pharmaceuticals subsequently cures such failure, Nordion agrees to resume Manufacture of Azedra within fifteen (15) business days of such cure.

4.4 Facility Reservation Fees

(i) If at the time of completion of the Facility (as notified by Nordion to Molecular Insight Pharmaceuticals pursuant to section 4.1) use of the Facility to Manufacture Azedra be delayed due to a regulatory reason, the commencement of the minimum purchase commitment in section 4.3 shall on a one time basis, be temporarily suspended until such time as the delay preventing such use is resolved by Molecular Insight Pharmaceuticals, provided further however, that if such delay endures for a continuous period of six (6) months (from the date of Nordion’s notification of completion of the Facility pursuant to section 4.1), for the remaining duration of the delay Molecular Insight Pharmaceuticals in lieu of the minimum purchase

commitments set out in section 4.3, shall (subject to the terms and conditions of this Agreement), pay to Nordion a facility reservation fee of ****** per month, which payment shall be due and payable on the first day of each month. This facility reservation fee shall not be refundable or reimbursable. The temporarily suspended minimum purchase commitment shall resume immediately upon resolution of the delay preventing use of the Facility for the Manufacture of Azedra.

(ii) During the period of FDA review of Molecular Insight Pharmaceuticals’ submission of the NDA for Azedra, the minimum purchase commitment in section 4.3 shall be temporarily suspended and the facility reservation fee shall be ****** per month for each full month or part thereof during which the NDA is under review. The temporarily suspended minimum purchase commitment in section 4.3 shall resume immediately upon FDA approval of the NDA. This facility reservation fee shall not be refundable or reimbursable, but shall be credited in a given month only towards amounts owed by Molecular Insight Pharmaceuticals for the purchase of Batches (and additional vials) in such month under this Agreement. Payment of the purchase price for Batches (and additional vials) delivered in excess of this facility reservation fee in a given month shall be invoiced to Molecular Insight Pharmaceuticals. The provisions of section 4.5 shall apply to cancellation of a Batch (and additional vials), and in the event that facility reservations fees are applicable, such cancellation fees payable (and paid) by Molecular Insight Pharmaceuticals in a given month, shall be applied against the facility reservation fees paid in such month.

4.5 Batch Cancellation

(a) Subject to section 4.5 (b) and the terms and conditions of this Agreement, Molecular Insight Pharmaceuticals shall be entitled to cancel any Batch (and additional vials) ordered from Nordion during the Term of this Agreement to be entirely used solely for the purpose of Clinical Trials) at no charge by providing to Nordion at least seven (7) or more business days written notice of cancellation prior to the scheduled Batch Production Date. If an order for a Batch is cancelled with less than seven (7) business days and more than two (2) business days written notice prior to the scheduled Batch production date, ****** of the full purchase price of such Batch (and additional vials) shall be due and payable by Molecular Insight Pharmaceuticals. For a Batch (and additional vials) cancelled upon two (2) or less business days notice prior to the scheduled Batch production date, ****** of the full purchase price of the Batch (and additional vials) shall be due and payable by Molecular Insight Pharmaceuticals.

* Confidential Treatment Requested *

(b) Subject to the terms and conditions of this Agreement, Molecular Insight Pharmaceuticals shall be entitled to cancel any Batch (and additional vials) ordered from Nordion during the Commercial Phase at no charge by providing to Nordion at least fifteen (15) or more business days written notice of cancellation prior to the scheduled Batch Production Date. If an order for a Batch is cancelled with less than fifteen (15) business days and more than two (2) business days written notice prior to the scheduled Batch production date, ****** of the full purchase price of such Batch (and additional vials) shall be due and payable by Molecular Insight Pharmaceuticals. For a Batch (and additional vials) cancelled upon two (2) or less business days notice prior to the scheduled Batch production date, ****** of the full purchase price of the Batch (and additional vials) shall be due and payable by Molecular Insight Pharmaceuticals.

4.6 Price Escalation

During the Term of this Agreement the Batch Fee (including additional vials) (pursuant to Schedule D item A (i)), Waste Disposal Fees (pursuant to Schedule D item A (iii)), facility reservation fees (section 4.4), Scope Change labour rates (Schedule C) and those fees set out in section 3.6, shall be subject to price escalation on January 1^st of each contract year during the Term of this Agreement, in accordance with the increase in the Canadian Consumer Price Index (CPI) as published by the Government of Canada. The CPI will be determined based on the percentage increase in the CPI for the twelve (12) month period ending three (3) months prior to January 1^st of each contract year during the Term of this Agreement.

4.7 Compensation

Molecular Insight Pharmaceuticals has paid Nordion a lump sum of ****** under the terms of the Letter of Agreement, of which payment Nordion hereby acknowledges receipt, and which amount shall be non-refundable as attributed as set out in Schedule C “Advance Payment”.

For the purposes of certainty all sums expressed in this Agreement shall be in Canadian or United States currency, as specified.

Nordion shall invoice Molecular Insight Pharmaceuticals for the purchase price of Batches (and additional vials) of Azedra. All undisputed payments for such Batches (and additional vials) will be paid by Molecular Insight Pharmaceuticals within thirty (30) days of receipt of the invoice or if the invoice is issued by e-mail payment shall be due within (30) days of the date of sending the e-mail. Any undisputed amounts which remain unpaid after the aforementioned thirty (30) day period shall bear annual interest at the rate twelve percent (12%) annually and calculated at the rate of one percent (1%) monthly.

* Confidential Treatment Requested *

In the event Molecular Insight Pharmaceuticals disputes any particular invoiced item or amount, Molecular Insight Pharmaceuticals shall pay the non-disputed portion of the invoice and the parties shall attempt in good faith to resolve the dispute pertaining to the balance within fifteen (15) days of receipt of the notice of dispute issued by either party. In the event that the parties cannot resolve the dispute within the aforementioned fifteen (15) day period either party may pursue any remedy available under this Agreement or available at law.

ARTICLE 5 – PRECURSOR AND REFERENCE STANDARDS

5.1 Precursor and Reference Standards

Molecular Insight Pharmaceuticals or, at Molecular Insight Pharmaceuticals’ discretion, its designee, shall provide to Nordion, at no charge, Precursor and Reference Standards which meet the specifications in Schedule F in sufficient quantities to permit Nordion to meet its obligations hereunder. Nordion shall only use Precursor and Reference Standards provided hereunder for the Manufacture of Azedra pursuant to this Agreement. Molecular Insight Pharmaceuticals shall at all times retain title in and to Precursor and Reference Standards in Nordion’s possession.

5.2 Unavailability or Scarcity of Precursor and/or Reference Standards

Molecular Insight Pharmaceuticals will notify Nordion upon Molecular Insight Pharmaceuticals becoming aware of a shortage of supply of Precursor or Reference Standards if such shortage will impact the manufacture of the Azedra. Molecular Insight Pharmaceuticals shall not be liable for any delays or shortages in the supply of Precursor or Reference Standards; provided, however, that notwithstanding anything to the contrary in this Agreement, that any such shortages or delays for any reason in Precursor or Reference Standards supply, will not affect any amounts payable by Molecular Insight Pharmaceuticals pursuant to sections 4.4 (facility reservation fees), section 4.3 (minimum purchase commitments) and 4.5 (Batch cancellation fees) and shall excuse Nordion’s performance of activities related to such Batch of Azedra to the extent that Nordion’s non-performance was caused by the Precursor or Reference Standards supply delay or shortage and only for a period of time equal to the delay.

5.3 Compliance with Law, Handling

While Precursor, Reference Standards, Isotope and Azedra are in its possession or under its control, Nordion shall be responsible for compliance in all material respects with applicable statutory and regulatory requirements in the United States and Canada.

ARTICLE 6 – AZEDRA SHIPMENTS

6.1 Orders and Shipments

During the Term of this Agreement, Molecular Insight Pharmaceuticals will forward orders to Nordion at its Ottawa, Ontario facility by facsimile or such other method as agreed by the parties. Each order will set forth the quantity of Azedra to be produced and prepared for shipment, the identity of the recipient, delivery destination protocol number, IND/NDA number, applicable USNRC materials license number and IRS number. Delivery of Azedra to Molecular Insight Pharmaceuticals or as otherwise directed by Molecular Insight Pharmaceuticals shall be Ex Works (Incoterms 2000) at Nordion’s facility in Ottawa, Ontario. Risk of loss of Azedra shall pass to Molecular Insight Pharmaceuticals at point of delivery at Nordion’s facility in Ottawa, Ontario.

During the Term of this Agreement Nordion shall use commercially reasonable efforts to meet Molecular Insight Pharmaceuticals’ orders and delivery requirements. Prior to the first shipment of Azedra to any third party site, Molecular Insight Pharmaceuticals shall obtain from such third party and provide to Nordion such third party’s license evidencing proper legal authority for the receipt and possession of Azedra by such third party. Molecular Insight Pharmaceuticals shall obtain all approvals, licenses and permits required to import Azedra into the United States. Nordion shall make shipping arrangements with FedEx or such other carrier designated by Nordion and reasonably approved by Molecular Insight Pharmaceuticals. All Azedra shipping costs incurred from the Ex Works point of delivery shall be borne by Molecular Insight Pharmaceuticals.

ARTICLE 7 – PRODUCT WARRANTY and LIMITED LIABILITY

7.1 Limited Product Warranty

Nordion provides a product warranty, and does warrant for each Batch, that Azedra will (i) conform with the Specifications, and (ii) be Manufactured, and prepared for shipment in accordance with cGMPs.

If either party discovers that a Batch of Azedra does not meet the Specifications, then the discovering party shall promptly communicate with the other party. All warranty obligations of Nordion with respect to a particular Batch shall cease and have no effect to the extent that any defect in such Batch arises from accident, abuse, misuse, alteration or negligence of Molecular Insight Pharmaceuticals or its third party suppliers or customers. If Molecular Insight Pharmaceuticals determines that the failure to meet Specifications results from an act, failure to act or other fault of Nordion, or agent of Nordion, Nordion will promptly:

(i) replace such batch of Azedra; and

(ii) pay for shipping costs of replacement of Azedra.

In the event that Nordion reasonably disputes Molecular Insight Pharmaceuticals’ determination that the fault is due to Nordion and/or its agent, the parties will select a mutually acceptable outside consulting firm which will be instructed to review the applicable information and data and confirm or dissent from Molecular Insight Pharmaceuticals’ determination. If the consulting firm confirms Molecular Insight Pharmaceuticals’ determination, Nordion will have the obligations set out in this section and Nordion will pay the fees of such consulting firm. If the consulting firm dissents from Molecular Insight Pharmaceuticals’ determination or determines that the failure to meet Specifications was due to products, information or services supplied by Molecular Insight Pharmaceuticals, Nordion will not have the obligations set out in this section with respect to the disputed Batch and Molecular Insight Pharmaceuticals will pay the fees for such consulting firm.

7.2 Acknowledgement

MOLECULAR INSIGHT PHARMACEUTICALS ACKNOWLEDGES THAT NORDION IS CARRYING OUT THE MANUFACTURE AND SUPPLY OF AZEDRA TO MEET SPECIFICATIONS. EXCEPT AS EXPRESSLY SET OUT IN THIS AGREEMENT, NORDION HEREBY DISCLAIMS ALL OTHER WARRANTIES OR CONDITIONS, WHETHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

7.3 Disclaimer

EXCEPT IN THE CASE OF THEIR RESPECTIVE INDEMNIFICATION OBLIGATIONS HEREIN, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR INDIRECT, CONTINGENT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, TORT, OR ANY OTHER CAUSE OF ACTION, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

ARTICLE 8 – NONCOMPETE

During the Term of this Agreement, Nordion will not produce or sell I-131 MIBG (Azedra or generic) for any oncology indication in North America except for Molecular Insight Pharmaceuticals. Nordion shall not be restricted in any way from developing, producing or selling generic I-131 MIBG for markets outside North America but is prohibited from using the Facility or any Data for any such production or development. Nordion shall not be restricted in any way from developing, producing or selling I-131 radiochemical or any other I-131 radiopharmaceutical product.

ARTICLE 9 – MARKET ACCESS

In the event that Nordion desires to market and distribute Azedra in a geographic market not actively being developed by Molecular Insight Pharmaceuticals or should Molecular Insight Pharmaceuticals desire that a third party market and distribute Azedra in a geographic market not actively being developed by Molecular Insight Pharmaceuticals, the parties agree to discuss potential access to such markets in good faith.

ARTICLE 10 – LICENSE/OWNERSHIP

10.1 Royalty-Free License

Molecular Insight Pharmaceuticals hereby provides to Nordion a non-exclusive, nontransferable, royalty-free license during the Term of this Agreement to use Molecular Insight Pharmaceuticals Background Technology relating to Azedra and the radiolabelling of Precursor with I-131 for the sole purpose of assisting Nordion in carrying out its obligations set out in this Agreement.

10.2 Ownership

Molecular Insight Pharmaceuticals Background Technology shall remain the sole and exclusive property of Molecular Insight Pharmaceuticals. Nordion Background Technology shall remain the sole and exclusive property of Nordion. The parties acknowledge and agree that if and to the extent that the Process is jointly developed by Nordion and Molecular Insight Pharmaceuticals during the Term of this Agreement then each party may continue to use and exploit such jointly developed technology as their own technology both during and after the Term of this Agreement.

Nothing in this Agreement transfers or licenses any right, title or interest to Molecular Insight Pharmaceuticals Background Technology or Nordion Background Technology, except as expressly set out herein.

ARTICLE 11 – MOLECULAR INSIGHT PHARMACEUTICALS REPRESENTATIONS AND WARRANTIES

11.1 Molecular Insight Pharmaceuticals’ Representations and Warranties

Molecular Insight Pharmaceuticals represents, warrants and covenants that:

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

(ii) it is the owner or has the right of use of the Molecular Insight Pharmaceuticals Background Technology supplied to Nordion by Molecular Insight Pharmaceuticals to assist Nordion in Manufacture of Azedra and in carrying out its obligations hereunder;

(iii) to Molecular Insight Pharmaceuticals’ knowledge, there is no action or proceeding pending or, to its knowledge, threatened against Molecular Insight Pharmaceuticals before any court, administrative agency or other tribunal which would have an adverse material effect on its business or its ability to perform its obligations hereunder;

(iv) it has the right to grant the license in section 10.1 and right to permit Nordion to use Molecular Insight Pharmaceuticals Background Technology to the extent required to assist Nordion in carrying out its obligations under this Agreement;

(v) it has not received any written notice of adverse claim or infringement of any patent or other intellectual property right, or misappropriation of trade secrets in connection with, the Molecular Insight Pharmaceuticals Background Technology or the use and exploitation of the Precursor, Reference Standard or Azedra;

(vi) to Molecular Insight Pharmaceuticals’ best knowledge and belief, making, using, offering for sale or selling of Precursor, Reference Standards and Azedra, and the data, information, technology and know how used in the Process and manufacture of Azedra contributed by Molecular Insight Pharmaceuticals, do not infringe any valid third party patent, pending published patent application or other intellectual property right;

(vii) it is not under any obligations, contractual or otherwise, to any other entity that might conflict, interfere or be inconsistent with any of the provisions of this Agreement;

(viii) it shall obtain and maintain at its expense, all licenses, permits and approvals necessary for it to perform its obligations under this Agreement;

(ix) as of the Effective Date, it is not currently subject to any proceeding pending or, to its knowledge, threatened for reorganization, liquidation or dissolution for the benefit of its creditors or otherwise;

(x) Azedra shall not be misbranded within the meaning of the FD&C as a result of the application of the label content supplied by Molecular Insight Pharmaceuticals to Nordion pursuant to this Agreement, and Azedra is not an article which may not be introduced into interstate commerce under the provisions of section 505 of the FD&C.

ARTICLE 12 – NORDION’S REPRESENTATIONS AND WARRANTIES

12.1 Representations and Warranties

Nordion represents, warrants and covenants that:

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

(ii) it is the owner or has the right to use the Nordion Background Technology and other Nordion proprietary technology used during the Term of this Agreement;

(iii) the Nordion Background Technology does not, to Nordion’s best information and belief, infringe any patents, copyright or other industrial or intellectual property rights of third parties;

(iv) it has not received any notice of adverse claim of infringement of any patent or other intellectual property right, or of misappropriation of trade secrets, in connection with the use and exploitation of the Nordion Background Technology;

(v) there is no action or proceeding pending or, to its knowledge, threatened against Nordion before any court, administrative agency or other tribunal which would have an adverse material effect on Nordion’s business or its ability to perform its obligations hereunder;

(vi) as of the Effective Date, Nordion is not currently subject to any proceeding pending or, to its knowledge, threatened for reorganization, liquidation or dissolution for the benefit of its creditors or otherwise;

(vii) it shall obtain and maintain, at its expense, all Facility licenses, permits and approvals necessary for it to manufacture Azedra under this Agreement and shall provide Molecular Insight Pharmaceuticals with copies of such licenses, permits and approvals upon request;

(viii) the Azedra delivered pursuant to this Agreement shall, at the time of delivery by Nordion to Molecular Insight Pharmaceuticals, not be misbranded (to the extent branded by Nordion) or adulterated within the meaning of FD&C and effective at the time of delivery of the Azedra.

ARTICLE 13 – INDEMNITY

13.1 Indemnification by Molecular Insight Pharmaceuticals

Molecular Insight Pharmaceuticals agrees to indemnify, defend and hold Nordion 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 Nordion”) arising out of (a) Molecular Insight Pharmaceuticals’ or a third party’s use, handling or shipping of Reference Standards, Precursor or Azedra (including in the event that Nordion makes shipping arrangements on behalf of Molecular Insight Pharmaceuticals), (b) Molecular Insight Pharmaceuticals’ breach of any of its material obligations, warranties or representations hereunder, (c) Molecular Insight Pharmaceuticals’ negligent acts or omissions or willful misconduct, or (d) failure of the Reference Standards or Precursor to meet applicable specification. Notwithstanding the foregoing, Molecular Insight Pharmaceuticals will not be required to indemnify, defend and hold Nordion and its Affiliates and their respective directors, officers, employees and agents harmless from and against any General Claims Against Nordion to the extent that such claims arise out of (i) Nordion’s breach of any of its obligations, warranties or representations hereunder; (ii) Nordion’s negligent acts or omissions or willful misconduct; (iii) any failure of Nordion to Manufacture, (except to the extent labels and/or content thereof are provided by Molecular Insight Pharmaceuticals) or prepare for shipment Azedra 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 Nordion to Manufacture Azedra consistent with the Specifications and requirements set forth herein. Notwithstanding anything in this section 13.1, “General Claims Against Nordion” shall not include “IP Claims Against Nordion” as described in section 13.3.

13.2 Indemnification by Nordion

Nordion agrees to indemnify, defend and hold Molecular Insight Pharmaceuticals 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 Molecular Insight Pharmaceuticals”) arising out of (a) Nordion’s Manufacture (except to the extent that labels and/or content thereof is provided by Molecular Insight Pharmaceuticals) or preparation for shipment of Azedra; (b) Nordion’s breach of any of its material obligations, warranties or representations hereunder; (c) Nordion’s negligent acts or omissions or willful misconduct; or (d) any failure of the Azedra to meet the Specifications. Notwithstanding the foregoing, Nordion will not be required to indemnify, defend and hold Molecular Insight Pharmaceuticals and its Affiliates and their respective directors, officers, employees and agents harmless from and against any General Claims Against Molecular Insight Pharmaceuticals to the extent that such claims arise out of (i) Molecular Insight Pharmaceuticals’ breach of any of its obligations, warranties or representations hereunder; (ii) Molecular Insight Pharmaceuticals’ negligent acts or omissions or willful misconduct; (iii) any

defect or failure of Reference Standards or Precursor to meet applicable specifications or (iv) Molecular Insight Pharmaceuticals’ or third party’s use, labeling, handling or shipment of Reference Standards, Precursor or, Azedra. Notwithstanding anything in this section 13.2, “General Claims Against Molecular Insight Pharmaceuticals” shall not include “IP Claims Against Molecular Insight Pharmaceuticals” as described in section 13.4.

13.3 Intellectual Property Claims Against Nordion

Molecular Insight Pharmaceuticals agrees to indemnify, defend and hold Nordion 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 attorneys’ fees) resulting from any third party claims or suits arising out of any proceeding instituted by or on behalf of a third party based upon a claim that Molecular Insight Pharmaceuticals Background Technology, the Process (only to the extent contributed by Molecular Insight Pharmaceuticals), use or sale of the Reference Standards, Precursors or Azedra infringes a patent or any other intellectual property right of a third party (“IP Claims Against Nordion”). To the extent the Process or method of manufacture is developed or contributed by Nordion, Molecular Insight Pharmaceuticals will not be required to indemnify, defend or hold harmless Nordion or its Affiliates, and their respective directors, officers, employees and agents from and against IP Claims Against Nordion.

13.4 Intellectual Property Claims Against Molecular Insight Pharmaceuticals

Nordion agrees to indemnify, defend and hold harmless Molecular Insight Pharmaceuticals and its Affiliates, and their respective directors, officers, employees and agents from and against any damages, claims, liabilities and expenses (including, but not limited to, reasonable attorney’s fees) resulting from any third party claims or suits arising out of any proceeding instituted by or on behalf of a third party based upon a claim that the Nordion Background Technology, the method of Manufacture of Azedra or the Process to the extent developed or contributed by Nordion, infringes a patent or other intellectual property right of a third party (“IP Claims Against Molecular Insight Pharmaceuticals”).

13.5 Nordion Infringement

In the event that any portion of the Nordion Background Technology, required in the Manufacture of Azedra, in the opinion of independent counsel mutually selected by the parties, becomes the subject of a valid claim for a patent, copyright or other intellectual property right infringement then Nordion shall, for a period of at least sixty (60) days after issuance of the opinion, use its commercially reasonable efforts to:

i) procure the right to continue using the technology, or

ii) modify the Nordion Background Technology to become non-infringing (with all Nordion costs, including any commercially reasonable increase to the cost of the manufacturing of Azedra, to be borne by Nordion).

After expiry of the sixty (60) day period from the issuance of the aforementioned opinion, if Nordion has been unable to remedy the infringement in accordance with subparagraph i) or ii) above, Molecular Insight Pharmaceuticals or Nordion, may upon written notice, suspend the Manufacture of Azedra and/or terminate this Agreement. The provisions of this section 13.5 are in addition to, and do not in any way limit, the indemnification obligations of Nordion set forth in this Article 13.

13.6 Molecular Insight Pharmaceuticals Infringement

In the event that any portion of the Molecular Insight Pharmaceuticals Background Technology required in the Manufacture of Azedra, in the opinion of independent counsel mutually selected by the parties, becomes the subject of a valid claim for a patent, copyright or other intellectual property right infringement, then Molecular Insight Pharmaceuticals shall, for a period of at least sixty (60) days after issuance of the opinion, use its commercially reasonable efforts to:

i) procure the right to continue using the technology, or

ii) modify the Molecular Insight Pharmaceuticals Background Technology to become non-infringing provided such modification does not increase the cost of Manufacture of Azedra by Nordion (with all Molecular Insight Pharmaceuticals’ costs including any increase to the cost of the Manufacture of Azedra by Nordion to be borne by Molecular Insight Pharmaceuticals).

After expiry of the sixty (60) day period from the issuance of the aforementioned opinion, if Molecular Insight Pharmaceuticals has been unable to remedy the infringement in accordance with subparagraph i) or ii) above, Nordion or Molecular Insight Pharmaceuticals may upon written notice, suspend Manufacture activities and/or terminate this Agreement. The provisions of this section 13.6 are in addition to, and do not in any way limit, the indemnification obligations of Molecular Insight Pharmaceuticals set forth in this Article 13.

13.7 Indemnification Procedures

A party (the “indemnitee”) intending to claim indemnification under this Agreement shall promptly notify the other party (the “Indemnitor”) in writing of any action, claim or other matter in respect of which the Indemnitee or any of its directors, officers, employees or agents intend to claim such indemnification; provided, however, the failure to provide such notice within a reasonable period of time shall not relieve the Indemnitor of any of its obligations hereunder except to the extent the Indemnitor is materially prejudiced by such failure. The Indemnitor shall be entitled to control the defense of and/or settle any such action, claim or other matter. The Indemnitee agrees to the complete control of such defense or settlement by the Indemnitor, provided, however, any settlement of such claims shall require the Indemnitee’s prior written consent unless such settlement includes a full release of the Indemnitee, in which case no consent shall be required. The Indemnitee and its directors, officers, employees and agents shall co-operate fully with the Indemnitor and its legal representatives in the investigation and defence of any action, claim or other matter covered by this indemnification. The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and at its own expense.

ARTICLE 14 – REGULATORY MATTERS

14.1 Regulatory Status

Upon Nordion’s reasonable request, Molecular Insight Pharmaceuticals shall provide updates to Nordion on submissions to the FDA and other jurisdictions and regulatory agencies for marketing authorization with respect to Azedra.

14.2 Molecular Insight Pharmaceuticals Responsibilities

It shall be the responsibility of Molecular Insight Pharmaceuticals or its designee to file, obtain and maintain an IND/NDA, registrations, listings, authorizations and approvals as the FDA or any other applicable governmental entity may require to enable use of Azedra in Clinical Trials and the Commercial Phase in the United States. Nordion shall provide directly to Molecular Insight Pharmaceuticals, or at Nordion’s discretion for the purpose of protection of its proprietary technology with respect to the manufacture of the Isotope, directly to the regulatory authority (with a copy to Molecular Insight Pharmaceuticals purged of Nordion proprietary technology) all required information in its possession necessary to assist Molecular Insight Pharmaceuticals in filing, obtaining and maintaining all licenses, registrations, listings, authorizations and approvals of any governmental entities necessary for the use of Azedra in support of Molecular Insight Pharmaceuticals’ Azedra IND/NDA submission. Molecular Insight Pharmaceuticals will provide Nordion with copies of any submissions made describing activities that occur at Nordion.

14.3 Nordion Responsibilities

Nordion shall be responsible for obtaining and maintaining all necessary Facility licenses, registrations, authorizations and approvals which are necessary to Manufacture, and prepare for shipment Azedra under cGMP conditions and other regulatory requirements including, but not limited to, the use and handling of radioactive materials.

At Nordion’s expense, Nordion shall update and maintain its existing I-131 bulk chemical Drug Master File (“DMF”) with the FDA as may be required for Molecular Insight Pharmaceuticals’ IND/NDA for Azedra. Nordion hereby grants Molecular Insight Pharmaceuticals for the purpose of this Agreement, a right of reference to such DMF, and upon request shall provide a letter of access to the DMF allowing regulatory review of the DMF by the FDA in conjunction with Molecular Insight Pharmaceuticals’ Azedra submissions.

14.4 Government Inspections, Compliance Review and Inquiries

Upon request of any governmental entity or any third party entity authorized by a governmental entity, such entity shall, for the purpose of regulatory review, have access to observe and inspect the (i) Facility, (ii) procedures used for the storage of Reference Standards and Precursor and (iii) manufacturing, testing, storage and preparation for shipment of Azedra, including Process development operations, and auditing the Facility for compliance with cGMP and/or other applicable regulatory standards. Nordion shall give Molecular Insight Pharmaceuticals prompt written notice of any upcoming inspections or audits by a governmental entity of the Facility or any of the foregoing and shall allow Molecular Insight Pharmaceuticals to participate in such audits by being present at any FDA close-out meeting and shall provide Molecular Insight Pharmaceuticals with a written summary of such inspection or audit following completion thereof. Notwithstanding the foregoing Molecular Insight Pharmaceuticals shall be entitled to have a representative in attendance at the Facility as an observer for the pre-approval inspection. Nordion agrees to use commercially reasonable efforts promptly to rectify or resolve any deficiencies noted by a government entity in a report or correspondence issued to Nordion. Subject to any specific arrangements agreed upon by the parties, Molecular Insight Pharmaceuticals shall be responsible for communicating with any governmental authority concerning the Azedra or the marketing, distribution or sale of Azedra, and Nordion shall in accordance with the compensation rates set forth in section 3.6 provide Molecular Insight Pharmaceuticals with whatever assistance Molecular Insight Pharmaceuticals may reasonably require to assist it in such communications. Nordion shall have no such communications specifically related to Azedra, except to the extent that they relate to Nordion’s Manufacture of Azedra under this Agreement, in which case Nordion

shall be responsible for such communications. Notwithstanding the foregoing and except to the extent that an immediate communication is necessary under the circumstances or required by law, Nordion in good faith shall consult in advance with Molecular Insight Pharmaceuticals regarding all communications that relate to Azedra or to Nordion’s ability to Manufacture Azedra pursuant to this Agreement.

14.5 Complaints and Adverse Reactions

Nordion or Molecular Insight Pharmaceuticals shall provide to each other prompt notice of any information either of them receives regarding the safety of the Precursor, Reference Standards, Azedra or Isotope, including any confirmed or unconfirmed information regarding adverse, serious or unexpected events associated with Azedra that may implicate the Manufacture of Azedra or one of its components; provided, however, that Molecular Insight Pharmaceuticals shall not be required to provide clinical trial status reporting to Nordion. For serious or adverse events, notice must be given by telephone within one (1) business day after receipt of the information, followed immediately with written notice, advising the other of any adverse reaction or safety issues with respect to Azedra of which it becomes aware, regardless of the origin of such information. Any other complaints shall be reported in writing to the other party on a weekly basis. Nordion agrees to co-operate with Molecular Insight Pharmaceuticals and any governmental entity in evaluating any complaint, claim, safety or adverse use report related to Azedra. Nordion will provide timely assistance in responding to any complaints, including reviews of Batch records and retained samples as well as any necessary testing.

14.6 Recalls

Molecular Insight Pharmaceuticals shall notify Nordion promptly if Azedra is the subject of a recall or correction (a “Recall”), and Molecular Insight Pharmaceuticals and/or its designee shall have sole responsibility for the handling and disposition of such Recall. Molecular Insight Pharmaceuticals and/or its designee shall bear the costs of any Recall of Azedra unless and to the extent such Recall shall have been the result of Nordion’s or its agents or employees negligent acts or omissions or any product defects for which Nordion is responsible in which case Nordion shall to such extent be responsible for all of Molecular Insight Pharmaceuticals’ reasonable out-of-pocket costs incurred for:

(i) notification of recall to Nordion and third parties;

(ii) return shipment of any defective Azedra to Nordion; and

(iii) replacement of Azedra.

In the event that Nordion disputes Molecular Insight Pharmaceuticals’ determination that the fault is due to Nordion and/or to its employees or agents, the parties will select a mutually agreeable outside consulting firm which will be instructed to review the applicable information and data and to confirm or dissent from Molecular Insight Pharmaceuticals’ determination. If the consulting firm confirms Molecular Insight Pharmaceuticals’ determination, Nordion will pay the fees of such consulting firm. If the consulting firm dissents from Molecular Insight Pharmaceuticals’ determination Nordion will not have the obligations set forth herein with respect to the Recall and Molecular Insight Pharmaceuticals will pay the fees of such consulting firm. Molecular Insight Pharmaceuticals and/or its designee shall maintain records of all sales, shipping records of Azedra and customers in sufficient detail to adequately administer a Recall for the period of time as required by applicable regulation.

14.7 New Regulatory Requirements

Each party shall promptly notify the other of new regulatory requirements of which it becomes aware which are relevant to the manufacture of Azedra under this Agreement and which are required by the FDA and other applicable governmental entities. The parties shall confer with each other with respect to the best means to implement and comply with such requirements.

If after a NDA submission is made to the FDA or EMEA, any Facility investment above ****** in aggregate required to maintain cGMP or FDA compliance, and the need for such investment is not due to the negligence or fault of Nordion, such investment shall be treated as a scope change pursuant to Section 3.3, shall be the subject of a Change in Scope Form (Schedule G) and paid for by Molecular Insight Pharmaceuticals.

14.8 Records

Nordion shall maintain all records necessary to evidence compliance in all material respects with (i) all applicable laws, rules, regulations and other requirements of applicable governmental entities in the United States and Canada relating to the Manufacture and supply of Azedra; (ii) the Specifications; and (iii) material obligations under this Agreement. All such records shall be maintained by Nordion for at least two (2) years after termination or expiration of this Agreement. Nordion shall provide to Molecular Insight Pharmaceuticals reasonable access to such records upon request. Prior to destruction of any record after such time, Nordion shall give written notice to Molecular Insight Pharmaceuticals. Molecular Insight Pharmaceuticals shall have the right within thirty (30) days of receipt of such notice to request that Nordion maintain such records in an off site storage facility for such longer periods as Molecular Insight Pharmaceuticals requests, provided that Molecular Insight Pharmaceuticals pays all costs associated with such off site storage.

* Confidential Treatment Requested *

14.9 Labels

Molecular Insight Pharmaceuticals shall be solely responsible for, and shall provide and approve the form and content of, the labels (except lot number and expiry date which shall be the responsibility of Nordion) to be applied to Azedra. Label form and content (other than lot number and expiry date) shall remain the liability and exclusive property of Molecular Insight Pharmaceuticals. Such labels shall not be used by Nordion after termination or expiration of this Agreement and the label provided by Molecular Insight Pharmaceuticals may only be used by Nordion for the purpose of performing its obligations under this Agreement.

14.10 Testing, Documentation, and Quality Assurance

Nordion shall maintain accurate and complete production records with respect to the Process, Batches and shipments, and Molecular Insight Pharmaceuticals shall have access upon not less than three (3) days prior written notice to such records in order to determine that each Batch was produced, tested and prepared for shipment in compliance with all applicable laws, rules, regulations, as well as the Specifications and cGMP requirements.

The tests and analyses provided in the Specifications as well as the nature and form of records may be amended by Nordion from time to time, subject to the consent of Molecular Insight Pharmaceuticals, which shall not be unreasonably or untimely withheld after Nordion shall have delivered to Molecular Insight Pharmaceuticals, in writing, an explanation of such changes and why they are necessary or advisable. The parties agree to execute the Quality Agreement in substantially the form attached as Schedule “E”. Nordion shall Manufacture and prepare for shipment, Azedra in conformance with cGMPs and regulations applicable to the shipment of radioactive materials and subject to the Quality Agreement.

Molecular Insight Pharmaceuticals shall be entitled to audit Nordion’s quality assurance processes in accordance with the Quality Agreement.

ARTICLE 15 – CONFIDENTIALITY

15.1 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 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, all technology including Molecular Insight Pharmaceuticals Background Technology, Nordion Background Technology and improvements thereto, 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:

(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 was not known to the receiving party to have obligations restricting disclosure of such information; or

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

Each party agrees that it will take the same degree of care to protect the confidentiality of the other party’s Confidential Information as it takes to protect its own proprietary and confidential information, which shall in no event be less than commercially reasonable. 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.

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.

ARTICLE 16 – DISCLOSURE OF INFORMATION

16.1 Authorized Disclosure

Notwithstanding section 15.1 each party may disclose Confidential Information to the extent such disclosure is reasonably necessary for prosecuting or defending litigation and/or complying with applicable government laws, rules or regulations, provided that if a party is required by law or regulation to make any such disclosure of the other party’s Confidential Information, except where impracticable for necessary disclosure, for example in the event of medical emergency, it will give reasonable notice to the other party of such disclosure requirement and will use its reasonable efforts to secure a protective order or limit the extent of the information to be disclosed.

ARTICLE 17 – TERM AND TERMINATION

17.1 Term

This Agreement shall commence upon the Effective Date and, unless terminated earlier pursuant to this Agreement or extended upon mutual agreement of the parties, shall expire five (5) years after the Effective Date (the “Initial Term”). Thereafter, this Agreement shall automatically be renewed for successive additional three (3) year terms (each a “Renewal Term”). Either party may terminate this Agreement by providing two (2) years prior written notice to the other party, such termination to be effective upon expiry of the Initial Term or any Renewal Term as is the case.

17.2 Termination for Regulatory Delay

In the event of any of the following:

(i) Molecular Insight Pharmaceuticals has not filed the NDA for regulatory approval with the FDA within one (1) year of the last patient having been treated in the clinical program, or

(ii) the NDA has not received regulatory approval from the FDA within two (2) years from the filing date, or

(iii) FDA regulatory approval is not received within three (3) years after the Effective Date,

whichever is earlier, then Nordion may, without liability at its sole option and unfettered discretion terminate this Agreement. Should Nordion exercise this option, the Exit Fee defined in section 17.6 (v) shall not apply, however all other remedies shall remain in full force and effect.

17.3 Termination for Breach

This Agreement may be terminated by a 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 therefore. 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 cure such breach (or thirty (30) days with respect to a failure by Molecular Insight Pharmaceuticals to pay any amounts hereunder when due other than with respect to amounts which Molecular Insight Pharmaceuticals’ in good faith, disputes are due to Nordion). Notwithstanding the foregoing, if the breaching party does not cure such breach within such cure 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.

17.4 Termination for Nordion Failure To Supply

With respect to the supply of Batches of Azedra by Nordion pursuant to purchase orders placed pursuant to this Agreement, Nordion’s failure to supply Batches in a timely manner and consistent with such orders and the Specifications shall not be considered a material breach by Nordion unless and until Nordion has failed, in any one contract year period, to fulfill more than four (4) Batch orders 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 Molecular Insight Pharmaceuticals, (ii) Nordion is able to supply an additional Batch meeting the Specifications in accordance with this Agreement within one (1) week of the delivery date of the originally scheduled Batch, or (iii) if the Batch failure is the result of conducting the Process under a deviation at the request of Molecular Insight Pharmaceuticals. In the event of a Supply Breach, Molecular Insight Pharmaceuticals may terminate this Agreement upon thirty (30) days prior written notice to Nordion provided it gives written notice of termination to Nordion within sixty (60) days of the Supply Breach. Any failure by Nordion to Manufacture or supply Azedra due to a Force Majeure shall not be a material breach or Supply Breach under this Agreement.

17.5 Bankruptcy

This Agreement may be terminated by a party in the event the other party files a petition in bankruptcy, is adjudicated a bankrupt, makes an assignment for the benefit of its creditors, or otherwise seeks relief under or pursuant to any bankruptcy, insolvency or reorganization statute or proceeding, or if a petition in bankruptcy is filed against it which is not dismissed within ninety (90) days or proceedings are taken to liquidate the assets of such party (each a “Bankruptcy Event”). In the event of a Bankruptcy Event or in the event that it can be reasonably be determined that a party cannot meet its debts and liabilities as they become due or make the required payments under this Agreement, the other party may modify the payment terms hereunder such that payment is required in advance.

17.6 Remedies Upon Termination

In the event of termination or expiration of this Agreement, in addition to any other remedies available to either of the parties:

(i) Nordion shall use reasonable efforts to terminate all activities under this Agreement immediately;

(ii) within forty-five (45) days of such termination, at Molecular Insight Pharmaceuticals’ request and expense (subject to a quotation provided by Nordion and payable in advance at the request of Nordion) Nordion shall deliver to Molecular Insight Pharmaceuticals all data, documentation and other information belonging to Molecular Insight Pharmaceuticals pursuant to the terms of this Agreement;

(iii) all licenses granted by Molecular Insight Pharmaceuticals to Nordion under this Agreement shall immediately terminate,

(iv) within sixty (60) days of such termination all Precursor and Reference Standards remaining in inventory shall at Molecular Insight Pharmaceuticals’ option and expense (subject to a quotation provided by Nordion and payable in advance at the request of Nordion) be disposed of or returned by Nordion to Molecular Insight Pharmaceuticals, and

(v) upon the termination of this Agreement for any reason, except a material breach by Nordion, Molecular Insight Pharmaceuticals shall reimburse Nordion for any reasonable expenses incurred in employee(s) severance as a result of or arising from discontinuation of the Manufacture of Azedra, inventory write-down, facility decommissioning and any related waste disposal costs (the “Exit Fee”). This provision will not apply in the event Molecular Insight Pharmaceuticals meets its minimum purchase obligations during the first three (3) years of the Commercial Phase, , in which case Nordion, as owner of the Facility, shall be responsible for any and all costs, expenses and actions necessary in connection with the reconditioning, dismantling or disposing of the Facility or any parts thereof.

(vi) Molecular Insight Pharmaceuticals shall pay to Nordion any amounts otherwise due within thirty (30) days of the date of termination.

ARTICLE 18 – SURVIVAL

18.1 Consequences or Termination or Expiration

All sections which by their nature must survive in order to give effect to their intent and meaning shall survive termination or expiration of this Agreement, including, without limitation, sections 3.7, 7.1-7.3, 10.2, 11.1, 12.1, 13.1-13.7, 14.8, 15.1, 16.1, 17.6, 18.1, 22.1, 23.1, 24.1, 25.1 and 28.1.

ARTICLE 19 – NOTICES

19.1 Any notice to be sent to a party hereunder shall be forwarded to:

Nordion at:	MDS Nordion
	447 March Road
	Ottawa, ON K2K 1X8
Attention:	Vice President, Marketing and Sales
	Fax: 613-592-0767
with copy to :	Associate General Counsel
Molecular Insight Pharmaceuticals at:
	Molecular Insight Pharmaceuticals, Inc.
	160 Second Street
	Cambridge, MA
Attention:	Chief Executive Officer
	Fax: 617-492-5664

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

ARTICLE 20 – ASSIGNMENT

20.1 No Assignment

This Agreement shall enure to the benefit of and shall be binding upon te heirs, executors, administrators, successors and permitted assigns of the parties. Neither Nordion nor Molecular Insight Pharmaceuticals shall assign this Agreement or any portion of this Agreement without the written approval of the other party, which approval shall not be unreasonably or untimely withheld; provided, however, that Molecular Insight Pharmaceuticals or Nordion may assign this Agreement without the other’s consent in connection with the sale of all or substantially all of its assets or the business to which this Agreement pertains, to a third party (provided such third party has agreed to accept assignment and assume the obligations and liabilities under this Agreement) or in connection with a merger, consolidation or similar transaction.

ARTICLE 21 – COMPLIANCE

21.1 Compliance with Laws

This Agreement and Nordion’s and Molecular Insight Pharmaceuticals’ obligations hereunder shall be carried out in all material respects in compliance with all applicable laws, by-laws, rules, regulations and orders of all applicable Federal, State, Provincial and Municipal governments.

ARTICLE 22 – NON-WAIVER

22.1 Non-Waiver of Rights

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

22.2 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, 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.

In the event that such Force Majeure affects Isotope Nordion shall use commercially reasonable efforts to identify a then existing alternative source of Isotope supply. Any incremental cost incurred by Nordion subsequent to entering into this Agreement in obtaining Isotope from a then existing alternative supplier for Manufacture of Azedra, shall be borne on a pass through basis by Molecular Insight Pharmaceuticals. All costs and expenses, including but not limited to qualifying and validating an existing alternative supplier of Isotope for use in the Process shall be borne by Molecular Insight Pharmaceuticals. If Molecular Insight Pharmaceuticals elects not to bear the incremental cost, Manufacture of Azedra , shall be suspended during the period of Force Majeure, without liability to either party.

Molecular Insight Pharmaceuticals acknowledges and agrees that at the time of entering into this Agreement Nordion’s usual supplier Atomic Energy of Canada Ltd. and as such Nordion, due to Force Majeure (and for reasons beyond its reasonable control), may be unable to supply Isotope to Manufacture Azedra.

ARTICLE 23 – INSURANCE

23.1 Product Liability Insurance

During the Term of this Agreement and for a period of one (1) year thereafter Molecular Insight Pharmaceuticals at its own expense shall provide and maintain a Comprehensive General Liability insurance policy issued by a reputable insurance company with respect to Azedra. Such policy shall add Nordion as an additional insured and shall have a limit of liability of not less than ****** per occurrence and in the aggregate. Molecular Insight Pharmaceuticals shall be solely responsible for any

* Confidential Treatment Requested *

deductible or retention associated with this policy and such deductible or retention amounts shall not affect Nordion’s interests. The policy shall contain a cross liability clause and shall provide for severability of interest such that breach of a policy condition committed by any one insured shall not adversely affect the rights of the other insured and the insurance shall apply to each insured as though a separate policy were issued to each party. Nordion shall be provided thirty (30) days’ prior written notice of any material change to the policy and such change shall be subject to Nordion’s prior written consent, which consent shall not be unreasonably withheld. Nothing contained in this section shall be deemed to limit in any way the indemnification provisions contained in this Agreement.

ARTICLE 24 – PUBLICATION

24.1 Publicity

The parties agree that, except as may otherwise be required by applicable laws, regulations, rules or orders or in connection with obtaining regulatory approvals for Azedra, 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.

A copy of any proposed press release shall be provided to the other party for approval at least three (3) business days prior to any proposed release.

In the event that this Agreement or any portion of its contents is required to be disclosed by Molecular Insight Pharmaceuticals or Nordion pursuant to Security Exchange Commission rules or regulations, the FDA, or other federal or state authorities, Molecular Insight Pharmaceuticals or Nordion, as the case may be, shall provide reasonable notice to the other prior to any such disclosure in order that, to the extent possible permitting such party to purge the Agreement of sensitive or confidential information while enabling the other party to comply with the applicable laws, rules and regulations.

ARTICLE 25 – INDEPENDENT CONTRACTOR

25.1 No Joint Venture

The parties agree that with respect to the transactions contemplated herein that they shall both be acting as independent contractors and nothing herein shall constitute the parties as entering into a joint venture or partnership, nor shall anything herein constitute either party as an agent of the other for any purpose whatsoever.

ARTICLE 26 – SEVERABILITY

26.1 Invalid Provisions

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

ARTICLE 27 – AGREEMENT

27.1 Entire Agreement

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, including, without limitation, the Interim Facility Agreement which is terminated upon transition of the manufacture of Azedra under this Agreement pursuant to section 4.1. This Agreement may not be modified, amended, rescinded, canceled or waived, in whole or in part, except by written amendment signed by both parties hereto. In the event of a conflict between a term of the Agreement and any Schedule or Quality Agreement, the terms of this Agreement shall govern.

ARTICLE 28 – LAW

28.1 Applicable Law

This Agreement shall be governed and construed in accordance with the laws of the Province of Ontario, without reference to its principles on conflict of laws. The application of the United Nations Convention for the International Sale of Goods is expressly excluded.

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

MDS Nordion, a division of MDS (Canada) Inc.
By:	/s/ Chris Wagner
Molecular Insight Pharmaceuticals, Inc.
By:	/s/ Donald Wallroth

SCHEDULE A

Description of Facility Program, Facility Milestones and Facility Schedule

Facility Description:

MDS Nordion will modify an existing facility to establish a dedicated facility suitable for cGMP Manufacture of Molecular Insight Pharmaceuticals’ Azedra (I-131 MIBG) for clinical supply and Commercial Phase supply upon FDA approval. This will involve the deconstruction of some existing facility components, and as Nordion determines and in accordance with the Facility Program reuse of some of the existing components, modifications to the current room layout and construction of new walls and anterooms. The Azedra facility will be located in Room 1531 within Nordion’s Kanata Radiopharmaceutical Manufacturing Facility. The facility is purposely designed to comply with the current FDA and EMEA requirements for the aseptic manufacture of radiopharmaceuticals. The Class 10,000 hot cell will be used for product formulation and the aseptic Azedra cell will house the Class 100 dispensing system. The cells will be capable of safely holding up to 50 Ci of I131 and will be connected to an appropriate nuclear ventilation system including charcoal / HEPA filters.

Key Deliverables:

1. Facility set-up and establishment of a validated 15 Ci process capable of yielding a minimum of 15 shippable vials per Batch of therapeutic, diagnostic or any combination thereof.

2. Commissioning and Validation of Facility and Process Equipment:

a. A qualified Class 10,000 Production Suite Clean room housing the Formulation and Dispensing Cells

b. A qualified Class 100,000 Service area to access to the Formulation and Dispensing Cells from the rear.

c. A class 10,000 Formulation cell and a Class 100 Dispensing cell for related MIBG production

d. A gowning anteroom (class 10,000).

e. Bio-decontamination equipment

f. Environmental Monitoring Equipment

g. Filter Integrity Test Equipment

h. Formulation Equipment

i. Dispensing, Capping and Crimping equipment

j. A dose calibrator.

k. A visual inspection station.

l. A pot loading and extraction system (manual)

3. Note that QC test methods are already validated for the current process and the move of the process to a new manufacturing facility has no impact on their validated state.

4. Validation Summary Reports: Facility, Aseptic Media Fills, Process Equipment, Process and Stability.

Commercial Production Facility Layout:

FACILITY MILESTONES AND SCHEDULE

Phase 1 – Inception

• Creating a detailed project and quality plan

• Validate project schedule and budget

• Identifying and engaging the project team and key Operations Project representatives

• Defining and implementing project management mechanisms

• Identifying and aligning required 3^rd party contractors

• Creating the detailed design drawings for the facility and room and the detailed design specification for the hot cell.

Phase 2 – Construction and Installation

• Hot Cell Factory Acceptance Testing

• Deconstruct and remove all components from the existing facility that are not being reused

• Obtain and install new facility components like hot cells, ventilation components, waste containers

• Engage 3^rd party contractors for civil construction, electrical, ventilation, plumbing etc.

• Complete “As Built” Facilities drawing set

Phase 3 – Process Configuration and Design

1. Adapt existing 15 Ci scale process equipment, flow and layout to a 2 hot cell operation

2. Design updates to process equipment for a 2 cell process

3. Modify process documents and drawings as required

4. Complete set of Standard Operating Procedures

Phase 4 – Facility and Process Equipment Commissioning and Qualification

• Final Master Validation Plan

• Complete Site Acceptance Tests for all major components

• Room and Ventilation Commissioning

• Process Equipment Commissioning

• Two (2) water runs to verify process flow

• One (1) - 15Ci hot commissioning run to verify active process and flow

• Establish routine maintenance / calibration / environmental monitoring programs

• Final Commissioning Report

• IQ / OQ / PQ for Facility and Process Equipment

• Radiation safety verification

• Facility & Process Equipment Validation Summary Report

• Three (3) aseptic media fills to verify process sterility

• Aseptic Media Fills Validation Summary Report

Phase 5 – Process Validations

• Validate any procedures related to the manufacturing, and safety that were changed as a result of the transfer of the existing 15 Ci process to the new facility (the testing parameters and specifications will be mutually agreed upon by both parties)

• Execution of three (3) Process Validation runs with full release as per the product specifications

• Stability Validation Summary Report

• Process Validation Summary Report

Phase 6 – Transition and Project Close

• Complete Operations Training

• Coordinated transition from project team to operations staff

• Establish inventory of critical spare parts

• Set-up of all Facility and Process Equipment into the maintenance and calibration program

• All validation reports and project documents finalized

• Final information for the Chemical, Manufacturing and Controls (CMC) section of the IND/NDA being prepared by Molecular Insight Pharmaceuticals (Molecular Insight Pharmaceuticals) will be available at this time

• Final Safety Analysis Report

• Initiate routine production in the new facility

Timeline

Estimated 13 months based on commercially reasonable efforts, provided that such activities do not materially interfere or could be reasonably anticipated to interfere with established Nordion production activities Should a key element ,such as the delivery of the hot cell differ from the estimated lead time, the schedule will be affected.

SCHEDULE B

Azedra Specifications

	UNCONTROLLED COPY
910700.SPE (4)
Effective Date: 09-05-12 CF 2881	Page 1 of 3
Ultratrace™ lobenguane I-131 Therapeutic Dose

Signatures

Prepared by:	signature on file	Date:
	J. Hewitt, Development		yy/mm/dd
Approved by:	signature on file	Date:
	R. Pickering, Production		yy/mm/dd
Approved by:	signature on file	Date:
	T. Dasgupta, Quality Control		yy/mm/dd
Approved by:	signature on file	Date:
	A. Warbick Cerone, Regulatory Affairs		yy/mm/dd
Approved by:	signature on file	Date:
	A. Martus, Global Sales & Marketing		yy/mm/dd
Approved by:	signature on file	Date:
	J. Cybulski, Quality Assurance		yy/mm/dd

Document History

Effective	Version	Comments	Prepared By	Reviewed By	Approved By
06-12-21	1	CF 61	C. Bensimon		R. Pickering
					F. Francis
					J. Bukovcan
					M. Zaroukian
					J. Cybulski
07-04-26	2	CF 650	N. Baird		R. Pickering
					T. Dasgupta
					J. Bukovcan
					M. Zaroukian
					J. Cybulski
08-05-16	3	CF 1402	S. Oelsner		R. Pickeing
					T. Dasgupta
					A. Warbick Cerone
					M. Zaroukian
					J. Cybulski

NOTE: A vertical line in the margin (tracking bar), denotes change. For complete rewrites, tracking bars are not used.

This document contains information proprietary to MDS Nordion.

Any disclosure or use of this information or any reproduction of this document other than the specified purpose for which it is intended is expressly prohibited except as MDS Nordion may otherwise agree in writing.

910700.SPE (4)

Page 2 of 3

Ultratrace™ lobenguane I-131 Therapeutic Dose

PRODUCT	:  Ultratrace™ lobenguane I-131 (I-131 MIBG) Therapeutic Dose contract manufacturing for    Molecular Insight Pharmaceuticals Inc.
MANUFACTURER	:  Each I-131 MIBG Therapeutic Dose is manufactured by MDS Nordion according to    910700.SOP
pH	:  4.5 - 5.5 per 910803.STM
BACTERIAL ENDOTOXIN	:  £ 3 EU/mL as per 910809.STM
STERILITY	:  Pass USP test for sterility as per 910808.STM
RADIOCHEMICAL IDENTITY OF I131-IOBENGUANE	:  R1 ± 10% of reference MIBG standard as per 910801. STM
UNBOUND IODINE-131	:  £ 5% as per 910801. STM
I131-MIBG	:  ³ 94% as per 910801 .STM
OTHER RADIOCHEMICAL IMPURITIES	:  £ 1% as per 910801.STM
TOTAL VOLUME	:  20 mL - 25 mL as per 910700E.PCR
TOTAL ACTIVITY	:  270 - 405 mCi @ time of calibration as per 910802. STM
ACTIVITY CONCENTRATION	:  13.5 - 16.5 mCi/mL @ time of calibration as per 910805.STM
MIBG CONCENTRATION	:  1 -10 µg/mL as per 910801.STM
ASCORBIC CONCENTRATION (as sodium ascorbate)	:  54 - 66 mg/mL as per 910804.STM

	UNCONTROLLED COPY
910701.SPE (1)
Effective Date: 09-05-12 CF 2484	Page 1 of 3
Ultratrace™ lobenguane I-131 Dosimetry Dose

Signatures

Prepared by:	signature on file	Date:
	J. Hewitt, Development		yy/mm/dd
Approved by:	signature on file	Date:
	R. Pickering, Production		yy/mm/dd
Approved by:	signature on file	Date:
	T. Dasgupta, Quality Control		yy/mm/dd
Approved by:	signature on file	Date:
	A. Warbick Cerone, Regulatory Affairs		yy/mm/dd
Approved by:	signature on file	Date:
	A. Marius, Global Sales & Marketing		yy/mm/dd
Approved by:	signature on file	Date:
	J. Cybulski, Quality Assurance		yy/mm/dd

Document History

Effective Version Comments Prepared By Reviewed By Approved By

NOTE: A vertical line in the margin (tracking bar), denotes change. For complete rewrites, tracking bars are not used.

This document contains information proprietary to MDS Nordion.

Any disclosure or use of this information or any reproduction of this document other than the specified purpose for which it is intended is expressly prohibited except as MDS Nordion may otherwise agree in writing.

910701.SPE (1)

Page 2 of 3

Ultratrace™ lobenguane I-131 Dosimetry Dose

PRODUCT	:  Ultratrace™ lobenguane I-131 (I-131 MIBG) Dosimetry Dose contract manufacturing for    Molecular Insight Pharmaceuticals Inc.
MANUFACTURER	:  Each I-131 MIBG Dosimetry Dose is manufactured by MDS Nordion according to    910700.SOP
pH	:  4.5 - 5.5 per 910803.STM
BACTERIAL ENDOTOXIN	:  £ 3 EU/mL as per 910809.STM
STERILITY	:  Pass USP test for sterility as per 910808.STM
RADIOCHEMICAL IDENTITY OF I131-IOBENGUANE	:  R1 ± 10% of reference MIBG standard as per 910801.STM
UNBOUND IODINE-131	:  £ 5% as per 910801. STM
I131-MIBG	:  ³ 94% as per 910801.STM
OTHER RADIOCHEMICAL IMPURITIES	:  £ 1% as per 910801.STM
TOTAL VOLUME	:  1.5 mL-2.5 mL as per 910700F.PCR
TOTAL ACTIVITY	:  24 - 36 mCi @ time of calibration as per 910802.STM
ACTIVITY CONCENTRATION	:  13.5 - 16.5 mCi/mL @ time of calibration as per 910805.STM
MIBG CONCENTRATION	:  1 - 10 µg/mL as per 910801. STM
ASCORBIC CONCENTRATION (as sodium ascorbate)	:  54 - 66 mg/mL as per 910804.STM

910701.SPE (1)

Page 3 of 3

Ultratrace™ lobenguane I-131 Dosimetry Dose

GENTISATE CONCENTRATION (as sodium gentisate)	:   20 - 25 mg/mL as per 910804.STM
VISUAL INSPECTION	:  Clear solution, free of visible particulates as per 910802.STM
EXPIRY DATE (TOE)	:  8 days post production @ 12:00 ET
CALIBRATION DATE (TOC)	:  2 days post production @ 12:00 ET
STORAGE	:  Frozen at £ -70°C
SHIPPING CONDITIONS	:  On Dry Ice
CATEGORY	:  Reserve
PACKAGING	:  Lead Pot F-517 (910207.SPE)    Shipping Box (900201.SPE)    Box Insert (Lid 900202.SPE/9T900202),    (Bottom 900203.SPE/9T900203)    Dry Ice Pellets (900208.SPE/10010201)    Waxed Cardboard Tubes (900204.SPE/9T900204)

SCHEDULE C – Facility Fees

The total estimated cost of the facility portion of the project is ******. Materials and 3rd party services will be billed at actual Nordion ***** to cover administrative expenses. Costs incurred in currencies other than Canadian dollars will be converted to Canadian dollars based on the Bank of Canada closing rate on the day prior to effecting the purchase commitment. Nordion will provide copies of actual invoices. Nordion will allow Molecular Insight Pharmaceuticals interaction on choices of materials and equipment to be purchased, however the final decisions shall be made by Nordion. Labour has been estimated and is billed in Canadian dollars on a fixed cost basis.

Any deviation in:

(i) the Canadian dollar exchange rate against the US dollar (or other relevant currency) in excess of ******, or

(ii) final invoice price for purchased materials and services,

between the date of the notification by Nordion to Molecular Insight Pharmaceuticals of a purchase commitment being required and the date of payment by Nordion to the vendor with respect to such purchase, shall be subject to full adjustment between the parties.

Payments will be made in advance of Nordion making a purchase commitment for material, equipment, and third party services. Payment for Nordion labor shall be as set out below. The detailed spend profile will be determined as part of the detailed project planning phase and will then determine the final payment schedule. Based on the preliminary project plan, the payment schedule is as follows:

	Due on:	Firm cost for Nordion labour ($CDN)	Estimated cost for materials & 3rd party contracts ($CDN)	Project Total ($CDN)
Phase 1	Start	******
	During Complete	******	******
Phase 2&3	Start	******
	During Complete	******	******
Phase 4	Start	******
	During Complete	******	******
Phase 5	Start	******
	During Complete	******	******
Phase 6	Start	******
	During Complete	******
Total		******	******	******

The above material and third party contract payments may be broken down and staged for large capital purchases (i.e. payments related to large capital expenditures can be received just before Nordion makes the purchase commitment).

* Confidential Treatment Requested *

Advance Payment

Nordion acknowledges receipt of an advance payment of ****** from Molecular Insight Pharmaceuticals pursuant to the Letter of Agreement dated February 5, 2009, such advance payment to be applied by Nordion as a credit against Nordion labor costs incurred under this Agreement, as such labor charges become due and payable, provided further that notwithstanding anything to the contrary in this Agreement, such advance payment is nonrefundable.

Non-refundable Payments

Once a Phase is commenced:

(i) all amounts payable and to be paid by Molecular Insight Pharmaceuticals for labour with respect to such Phase are payable and non-reimbursable.

(ii) all materials consumed and third party services rendered (and for purchase and service commitments to the extent such commitments cannot be terminated), are payable and non-reimbursable.

* Confidential Treatment Requested *

Scope Change

Scope changes shall be charged to Molecular insight Pharmaceuticals as follows:

(i) ****** for any materials, equipment, third party services obtained via a Nordion purchase order, or Nordion inventory obtained via inventory requisition

(ii) Nordion labour rate is ****** per hour

(iii) Nordion staff travel and accommodation shall be reimbursed to Nordion at cost. Time incurred during travel to destinations shall be paid to Nordion for each person half day or less of travel at the rate of ****** ; and a full day travel at the rate of ******

The price of the Facility includes all equipment, material and labour Nordion deems appropriate and within scope for the proper execution of the project. Should Molecular Insight Pharmaceuticals request additional equipment such as back-up instruments, or additional work such as method development, then additional charges shall apply as scope change under this Agreement.

Third party services and materials were estimated by Nordion based on the available information at the time the estimate was being prepared. Actual costs or exchange rates may vary as against original cost projections as firm quotations are obtained from vendors, favorably or unfavorably affecting the cost thereof.

* Confidential Treatment Requested *

SCHEDULE D

Prices of Batches for Clinical Trial and Commercial Supply

A. Azedra Batch Pricing 2009

The Batch price shall be calculated as follows:

(i) The Batch Fee (excluding Isotope and Waste Disposal Fee): ******

A Batch shall yield a minimum of 15 shippable vials. Nordion shall use commercially reasonable efforts to increase the yield to 22 shippable vials / batch, in any combination of dosimetric or therapeutic doses. In the event a Batch should yield less than 15 shippable vials, the minimum Batch price will be adjusted on a pro rata basis.

Any vials produced above 22 shall be paid for as follows:

• For vials 23-40 in the same batch, ******/ treatment (max 2 Tx vials, 1 Dx vial) (above minimum batch fee).

• For all vials > 40 in the same batch, ******/ treatment (2 Tx vials, 1 Dx vial) (above minimum batch fee).

• There is no charge for additional Dx vials

(ii) Isotope Fee per Batch: ******/ Ci x 15 Ci of activity (as at Batch Production Date): *****

(iii) Waste Disposal Fee per Batch: ******.

Total Batch price: ******

B. Price Increases 2010 and following:

1 The Batch Fee (excluding Isotope and Waste Disposal Fee) will escalate in accordance with Section 4.6.

2. The Isotope Fee will increase each calendar year during the Term of the Agreement by an amount equal to the ***** by Nordion to customers in North America as at November 1 as compared to the average selling price as at October 31 of the previous year.

* Confidential Treatment Requested *

3. The Waste Disposal Fee will increase each calendar year by the greater of CPI as described in Section 4.6, or the increase in Nordion’s actual costs as certified by a duly authorized officer of Nordion.

Price increases under this Item B shall be provided in writing to Molecular Insight Pharmaceuticals on or about December 1 of each calendar year during the Term of this Agreement. Nordion shall provide an Officer’s Certificate with respect to the price increases in B2 and B3.

SCHEDULE E

Quality Agreement

To be reviewed by QA and MIP

INTERCOMPANY QUALITY AGREEMENT

MOLECULAR INSIGHT PHARMACEUTICALS, INC.

having a place of business at

160 Second Street

Cambridge Massachusetts, 02142 USA

(hereinafter called “Molecular Insight Pharmaceuticals”)

AND

MDS Nordion

Ottawa, Ontario, Canada K2K 1X8

(hereafter called “Nordion”)

MIPI / MDS Nordion Azedra Quality Agreement

1. QUALITY AGREEMENT

This Quality Agreement (“Quality Agreement”) is entered into as of             , 20     (“Effective Date”) by and between MDS Nordion (“NORDION”) and Molecular Insight Pharmaceuticals, Inc., (“MIPI”).

This Quality Agreement is entered into pursuant to and is expressly subject to the terms of that certain Azedra Manufacturing and Clinical Supply Agreement entered into as of August 6^th, 2009 by and between NORDION and MIPI (the “Commercial Facility and Supply Agreement”).

Note: In the event of a conflict between the terms and conditions of this Quality Agreement and the terms and conditions of the Commercial Facility and Supply Agreement, the terms and conditions of the Commercial Facility and Supply Agreement shall govern and control.

This Quality Agreement defines the duties of NORDION and MIPI with respect to the contracted clinical supply pharmaceutical formulation, manufacture, labeling, packaging and testing of AZEDRA drug product for the markets identified in the Commercial Facility and Supply Agreement. .

In particular this Quality Agreement clearly states which party is responsible for the cGMP aspects of Product formulation, manufacturing, packaging and testing and specifies the manner in which the party releasing Product ensures that the Product complies with the approved Product Specifications and the Marketing Authorizations.

This Quality Agreement takes the form of a detailed checklist of all the activities associated with pharmaceutical formulation, manufacture, production, packaging and testing, analysis, release, and distribution. Responsibility for each activity is assigned to either NORDION or MIPI in the appropriate box in the Delegation Responsibility Checklist, which follows.

In order to provide better quality assurance, NORDION will perform the activities defined herein in accordance with Standard Operating Procedures (defined below), to the extent that a Standard Operating Procedure is applicable to such activity. In the event of a conflict between the terms and conditions of this Quality Agreement and the terms and conditions of a Standard Operating Procedure, the terms and conditions of such Standard Operating Procedure shall govern and control, <upon mutual agreement between NORDION and MIPI>.

This Quality Agreement is intended to comply with the guidance and directives set forth in

(i) FDA: 21 CFR Parts 210 & 211

(ii) Health Canada guidance documents

Molecular Insight PHARMACEUTICALS, INC. (MIPI)	MDS Nordion
160 Second Ave	447 March Road
Cambridge, MA 02142	Ottawa, Ontario
	K2K 1X8
By:	By:
Name:	Name:
Title:	Title:

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MIPI / MDS Nordion Azedra Quality Agreement

1.	QUALITY AGREEMENT	1
2.	KEY TERMS	3
3.	MANAGEMENT CONTROLS	5
4.	PRODUCTION	6
5.	FACILITIES & EQUIPMENT	8
6.	MATERIALS MANAGEMENT	9
7.	PACKAGING AND LABELING	10
8.	LOT RELEASE	11
9.	VALIDATION	13
10.	ENVIRONMENTAL AND CRITICAL UTILITIES CONTROL	14
11.	TESTING	15
12.	STABILITY	16
13.	DEVIATION MANAGEMENT	16
14.	OUT OF SPECIFICATION ( OOS)	17
15.	CHANGE CONTROL	17
16.	DOCUMENT CONTROL	19
17.	TRAINING	21
18.	REGULATORY	21
19.	RECALLS	24
20.	COMPLAINTS	25
21.	ADVERSE EVENTS	25
22.	AUDITS	26
23.	MANAGEMENT OF RELATIONSHIPS AND COMMUNICATION STRATEGY	26

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MIPI / MDS Nordion Azedra Quality Agreement

2. Key Terms

For purposes of this Quality Agreement, the following definitions shall apply (any capitalized terms not defined below or elsewhere herein shall have the meaning as such term has under the Commercial Facility and Supply Agreement):

A. “ACR” shall mean NORDION analytical control record.

B. “Applicable Laws” means all laws, ordinances, rules and regulations applicable to the Processing of Product and to the obligations of NORDION or MIPI in connection therewith, as the context requires, including, without limitation, (i) all applicable federal, state and local laws and regulations of the Territory; (ii) the U.S. Federal Food, Drug and Cosmetic Act of 1941, as amended; and (iii) cGMP.

C. “Deviations” or “deviation” shall have the meaning as set forth in the Deviation Management Section of this Quality Agreement.

D. “Facilities” means the following NORDION facilities located in Ottawa, Canada.

E. “FDA” shall mean the United States Food and Drug Administration, and any successor entity thereto.

F. “cGMP” shall mean the current Good Manufacturing Practice regulations for finished pharmaceuticals, as promulgated by FDA and EU Regulatory Authorities, both as amended from time to time. cGMP shall also include Good Manufacturing Practice regulations promulgated by a Regulatory Authority in a Territory and internationally accepted standards for current Good Manufacturing Practices.

G. Critical System shall be those equipment, software, facilities, utilities which have a direct impact on product SQUIPP

H. “Marketing Application” shall mean an application for marketing authorization which has not yet been approved by the FDA or other Regulatory Authority, including without limitation, FDA Investigational New Drug Application, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing applications promulgated by Regulatory Authorities.

I. “Marketing Authorizations” shall mean any approved application for marketing authorization, including without limitation, FDA Investigational New Drug Application, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing authorizations promulgated by a Regulatory Authority.

J. “Out of Specifications” or “OOS” shall mean nonconformance with the Specifications, cGMP or Applicable Laws.

K. “Process” or “Processing” means the sterile production, filling, producing and/or packaging of the Raw Materials into Product, in accordance with the Specifications and the terms and conditions set forth in the Commercial Facility and Supply Agreement and this Quality Agreement.

L. “PCR” shall mean NORDION process control records.

M. “Product” shall mean the Azedra, which is further defined in the Commercial Facility and Supply Agreement.

N. “PRF” shall mean NORDION product release form.

O. “Raw Materials” shall mean the materials listed in any Marketing Authorization.

P. “Regulatory Authority” shall mean the FDA and any other regulatory authority, within a Territory, involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

Q. “Specifications” means the specifications for the Product and the procedures, requirements, standards, quality control testing, other data and scope of services, each as set forth in the Commercial Facility and Supply Agreement.

R. “Standard Operating Procedures” or “SOPs” shall mean the standard operating procedures in effect at NORDION, which have been approved by NORDION’s Quality Assurance department and which are applicable to the Processing.

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MIPI / MDS Nordion Azedra Quality Agreement

S. “SQUIPP” shall mean the safety, quality, identity, potency and purity of Product, as required by the Code of Federal Regulations (CFR) and other Applicable Laws.

T. “Territory” shall mean the United States of America and any country in which Product where product is supplied as identified by the Commercial Facility and Supply Agreement.

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MIPI / MDS Nordion Azedra Quality Agreement

DELEGATION RESPONSIBILITY CHECKLIST

3. Management Controls

	MANAGEMENT CONTROLS RESPONSIBILITIES	MIPI	NORDION
1.	Quality System Program •        Assure the quality system is established and functioning properly and in accordance with cGMP requirements. •        Monitor the quality system and make necessary adjustments to maintain substantial compliance with cGMP requirements. •        Perform all obligations in accordance with: •        any applicable Product registrations; •        this Quality Agreement; •        Applicable cGMP guidelines; •        Any conditions registered in the manufacturing authorizations (IND), and •        The validated process as described in applicable approved SOPs, and the manufacturing Batch Records.		X
2.	Debarment Warrant that it is not debarred under the U.S. Generic Drug Enforcement Act of 1992 and to its knowledge, after reasonable inquiry, that it does not employ or use the services of any individual (i) who is debarred or (ii) who has engaged in activities that could lead to being debarred.		X
3.	Quality Assurance Maintain adequate quality assurance presence and oversight in the manufacturing facility during the manufacture of the Products to ensure compliance with cGMP requirements: •        NORDION Quality Assurance (QA) will have the responsibility and authority to approve and reject all components, containers, materials with the manufacture of Product. •        NORDION QA will be responsible for the review of batch documentation, investigating deviations, nonconformances, out of specification results associated with the manufacture of the Product. •        NORDION QA will be responsible for reviewing and approving or rejecting all procedures or specifications that may have adverse impact on the identity, strength, quality or purity of the Product.		X
	MIPI, as outlined in the following sections of this agreement, has the ultimate authority for the dispositioning of Product.	X
	NORDION will notify MIPI regarding any instance that may adversely effect the Product and work with MIPI Quality Assurance to take a mutually agreed upon appropriate action within the mutually agreed upon timeframes outlined in the following sections of this agreement.		X
4.	Audits Perform periodic auditing of all the Quality System to assure compliance with Standard Operating Procedures, cGMP requirements, and MIPI expectations as defined in this quality agreement).	X	X

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MIPI / MDS Nordion Azedra Quality Agreement

	MANAGEMENT CONTROLS RESPONSIBILITIES	MIPI	NORDION
5.	Access •        Provide access to procedures, methods, documentation, data as well as the records for those systems and facilities outlined in this Quality Agreement, supporting the manufacture, testing, storage or control of MIPI Product. •        Given the process is carried out in a highly controlled environment, access to the process will be limited to areas that are not environmentally controlled. MIPI personnel may periodically observe manufacture of the Product, from locations that are not environmentally controlled or by video tape.		X
6.	Revisions to this Quality Agreement Any changes to be made to the this Quality Agreement which encompass the activities and elements contained herein, may only be made upon the mutual written agreement of both MIPI & NORDION.	X	X

4. Production

	PRODUCTION RESPONSIBILITIES	MIPI	NORDION
1.	Production Program •        Ensure that Product is manufactured in accordance with manufacturing to approved instructions that are executed within manufacturing limits, and in accordance with the Quality system requirements in this Quality Agreement as well as regulatory requirements. •        Perform manufacturing tasks so as to not adversely impact the SQUIPP of the Product.		X
2.	Execution of Production Training: •        Ensure personnel are trained per NORDION related procedures and methods. Training documentation will be provided to MIPI upon request during audits or on site visits		X
	Production: •        Perform manufacturing in accordance with preapproved batch documentation and instructions •        Document completion of instructions in accordance with cGMP documentation practices •        Perform in-process sampling, testing, and sample submission per approved instructions •        Perform and respond appropriately to in-process monitoring •        Maintain usage logs in accordance with established procedures and cGMP requirements. •        Materials used in production are approved for manufacturing.
	Facilities & Equipment •        Equipment, systems, instruments, and facilities are maintained, calibrated, qualified, and/or validated per intended use. Use only equipment, facilities, instruments, methods, and materials that are approved for use.
	Deviations •        Report any deviations (e.g., Deviations, Non-Conforming Material) in accordance with the deviation program
	Performance Monitoring •        Perform routine inspection & approval of equipment & processing areas & related documentation.

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MIPI / MDS Nordion Azedra Quality Agreement

	PRODUCTION RESPONSIBILITIES	MIPI	NORDION
3.	Prevention of Contamination and Cross Contamination Establish contamination mitigation program that ensures contamination is mitigated within and between facilities, systems, personnel during production processes applicable to Product manufacture as well as previous / subsequent customer production runs (i.e., contamination is mitigated during Product manufacturing runs and changeover between customer production runs and Product manufacture) •        Maintain equipment and facility cleaning per established procedures. •        Establish and comply with specified materials and personnel flow. •        Maintain, as appropriate, segregation and dedication of equipment, facilities and materials. •        Perform tasks under specified environmental conditions.		X
4.	Lot Numbers Assign unique lot numbers as defined by NORDION procedure.		X
5.	Date of Manufacture Assign the date of Product manufacture and expiry when issuing the batch production document,		X
6.	PRODUCT Expiration Date •        Changes to the expiration date will be handled in accordance with the requirements of this Quality Agreement, entitled Change Control.		X
7.	Certificate of Analysis (i.e., NORDION product release form) NORDION will provide a certificate of analysis with the following information at a minimum: •        Name of the Product; •        Lot or Batch Identification Number; •        Date(s) of manufacture; •        Date of expiration; •        Name of each test method performed; •        Respective test specification; •        Respective test results expressed in numerical value, unless designated as pass/fail or not detectable in the specification limit; •        Identification and the dated signature of the authorized NORDION qualified person; and •        Batch size.		X
8.	Certificate of Compliance The NORDION product release form will serve as a signed certificate of compliance confirming that the Products have been manufactured, tested, and stored in accordance with defined requirements, the Master Production Record, and cGMP criteria.		X

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MIPI / MDS Nordion Azedra Quality Agreement

5. Facilities & Equipment

	FACILITIES AND EQUIPMENT RESPONSIBILITIES	MIPI	NORDION
1.	Facilities and Equipment Program MIPI and NORDION agree that Product facilities, equipment and supporting utilities are of suitable size, design, construction, location, and state to facilitate cleaning and proper operation through review of design of the commercial facility •        NORDION will ensure the same are maintained in a good state of repair to comply with applicable requirements associated with sanitation, housekeeping, pest control, security, and safety. •        Facilities and equipment used for MIPI Product manufacture are identified and are qualified and validated per intended use.	X	X
2.	Facility Access Controlled access to the premises is maintained. •        All visitors shall comply with NORDION’s security and safety requirements. •        NORDION will maintain confidentiality of Product manufacture related activities for visitors to the site.		X
3.	Maintenance, Calibration Maintenance and calibration of the equipment used to manufacture and test and store the components and Products will be performed. •        Periodically evaluate trending data from calibration activities to assuring proper calibration activities and durations •        Ensure that all critical systems within the scope of the facilities and equipment program are calibrated prior to validation and Product manufacture / cGMP use. •        Non-conforming instruments shall be identified by NORDION and addressed via the applicable NORDION quality system		X
4.	Other operations at site •        MIPI will be provided with prior written notice of any addition or expansion of the range of products manufactured in the same facility as the Product, that could affect the SQUIPP of the Product as a Change Control.		X

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MIPI / MDS Nordion Azedra Quality Agreement

6. Materials Management

	MATERIALS MANAGEMENT RESPONSIBILITIES	MIPI	NORDION
1.	Materials Management Program Manufacturing materials will be obtained through a documented program to accurately receive, test, track, inventory and store all manufacturing materials.		X
2.	Scope At a minimum, include materials management of the materials used in the manufacture, testing and storage of MIPI Product and related components. Program elements shall include: •        Supplier qualification; •        Receiving; •        Tracking of usage and distribution; •        Quarantine and; •        Warehousing and storage		X
3.	Material Usage Maintain product specifications.	X	X
	Retain samples of active ingredient(s) and raw materials, including samples for periodic re-tests, for a suitable period of time beyond Product expiry date.		X
	Use only chemical materials, packaging and labeling components approved and tested and/or confirmed in accordance with validated or compendial methods.		X
	Dispose of Product waste and any special waste related to the Processing of the Product in accordance with Applicable Laws.		X
	Non-conforming materials are identified by NORDION, addressed via the applicable NORDION quality system		X
	Non-conforming materials affecting MIPI related Product SQUIPP and/or Product disposition shall be communicated by NORDION to MIPI within 24 hours of NORDION’s observance.		X
4.	Tracking, Inventory and Status Materials shall be tracked using a documented system throughout their receipt and usage lifecycle, encompassing, but not limited to: •        Identity; •        Status (accepted, rejected, quarantine, pending); •        Quantity; •        Location; •        Lot genealogy and traceability; and •        Expiry.		X
5.	Supplier Program Maintain a quality review program for materials vendors/suppliers according to defined policies and procedures, which shall be available for review by MIPI upon request. •        Maintain procedures that are a part of the Materials Management Quality System. •        Define audit requirements for qualifying key suppliers. •        Develop specific acceptance criteria for supplier materials or services. •        Execute audits of key suppliers. •         Monitor corrective actions for suppliers that are conditionally accepted. •         Maintain a list of qualified suppliers.	X	X

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MIPI / MDS Nordion Azedra Quality Agreement

	MATERIALS MANAGEMENT RESPONSIBILITIES	MIPI	NORDION
6.	Suppliers Chosen by NORDION Ensure suppliers chosen by NORDION meet requirements. •       Provide listing of approved NORDION suppliers whose component/materials are used in Product. •       Provide demonstration of approval of NORDION approved suppliers during MIPI audit of NORDION.		X
7.	Suppliers Chosen by MIPI For suppliers designated by MIPI and which are not NORDION approved vendors, MIPI shall be responsible for meeting requirements of section 5 above. MIPI will provide adequate documentation to NORDION to demonstrate the material has been appropriately controlled, tested and released in accordance to approved specifications and procedures. •        Provide details of any labeling requirements, container sealing and integrity, and storage and shipping conditions for the material.	X
8.	Re-Testing Original Results / Specifications •        Re-testing will be performed within defined time intervals for a limited number of customer supplied materials to ensure the chemical, microbiological, and physical stability of the Raw Materials, unless MIPI provides an official expiration date (expired materials may not be re-tested). •        Testing may be conducted by a MIPI approved third-party contract testing laboratory	X X	X
9.	Conformance Verification •        Prior to NORDION’s disposition of Product for release by MIPI, all materials used in the Product shall meet NORDION’s requirements for production use.		X
10.	Storage and Warehouse of Products Materials, components and Products are stored under appropriate environmental conditions.		X
11.	Shipment of PRODUCT The Products will be labeled and packaged for transit pursuant to regulatory filing and requirements. •        Only approved, finished, labeled Products will be shipped by NORDION to MIPI or a MIPI designated site, unless requested in writing by MIPI. •        NORDION will only ship Product according to procedure, which comply with all applicable regulatory requirements		X

7. Packaging and Labeling

	PACKAGING AND LABELING RESPONSIBILITIES	MIPI	NORDION
1.	Packaging and Labeling Program Product will be packaged and labeled according to procedure that meets all applicable requirements.		X

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MIPI / MDS Nordion Azedra Quality Agreement

	PACKAGING AND LABELING RESPONSIBILITIES	MIPI	NORDION
2.	Scope System shall control the acceptance, issuance, use, and reconciliation of labels & labeling to assure that correct & accurate labeling of PRODUCT occurs. •        Ensure that only approved suitable containers and packaging materials are used for PRODUCT in accordance with written specifications.		X
3.	Label Content Provide PRODUCT specific information for development of PRODUCT label copy.	X	X
	Review and approve master label copy and artwork	X	X
	MIPI will perform necessary regulatory applications for introduction or changes in product labeling.	X

8. Lot Release

	LOT RELEASE RESPONSIBILITIES	MIPI	NORDION
1.	Lot Release Program Product will be released to an established program, that ensures conformance to cGMP requirements.	X	X
2.	Batch Record Review Perform review of batch records to assure Product was made in accordance with approved procedures. •        Review batch records & any data, documents or test results that support the batch records for Product acceptance, including but not limited to: •        Laboratory testing records; •        Records of deviations occurring during manufacturing including environmental monitoring deviations; and •        Documentation of quality control testing & inspections conducted during manufacturing. •        Document deviations and out of specifications (“OOS’s”) in accordance with the Deviation Management and OOS Section of this Quality Agreement: •        Review deviations prior to release of Product for commercial distribution, deviations must not have an impact on the SQUIPP of the Product; and •        Ensure batch record issues related to deviations, non-conformances and OOS’s, which will potentially result in changes, are sufficiently linked to the Change Control system as outlined in the Change Control Section of this Quality Agreement. •        Ensure all OOS findings, occurring during manufacture of a given lot are satisfactorily resolved before the material is released. •        Notify MIPI upon observance of deviations or OOS which may affect Product, as outlined in accordance with the Deviations Section		X

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MIPI / MDS Nordion Azedra Quality Agreement

	LOT RELEASE RESPONSIBILITIES	MIPI	NORDION
3.	Product Lot Disposition Note:    Reference Appendix III for MIPI / NORDION Product Lot Release process map Promptly notify MIPI on a timely basis (within 1 day) if any problems are discovered that could impact Product lots previously shipped to MIPI and /or MIPI designated locations, to assure that regulatory reporting guidelines can be met. •         Promptly notify MIPI of the disposition for every batch of rejected Product. •         Provide MIPI’s quality unit with (1) copies of all required batch record documentation •         Batch record documentation to be provided shall be reviewed and approved by NORDION’s Quality unit and shall include batch record documents, test data (analytical, chemistry and environmental), test reports and test records. •         For each lot of Product, NORDION shall provide the required documentation as shown in Appendix IV •         Prior to Product being shipped to Europe, an appropriate BSE / TSE Statement will be provided (pending MIP approval of a scope change to complete the study)		X
	LOT RELEASE RESPONSIBILITIES	MIPI	NORDION
4.	Lot Review & Release MIPI will review and approve Product Master Batch Record prior to release of the product for distribution	X
	MIPI will review and approve the executed Product batch record and subsequent lot disposition. •         MIPI will approve the batch record OR notify NORDION of issues which require clarification, additional information and action by NORDION as soon as possible. MIPI will provide an “on-call” individual during lot disposition activities to ensure rapid communication through the process.	X
	•         Product lot release shall be based on MIPI’s and NORDION internal procedures (i.e., Product that does not meet defined specifications can be rejected by either party)	X	X
	In the event that there is required follow-up by NORDION, NORDION shall perform such actions in a timely manner: •         Complete review and disposition of MIPI issues, where applicable, for Product release as soon as possible •         Provide response and/or additional information to MIPI for lot release		X
	Upon receipt of additional NORDION provided information, MIPI will review the information and notify NORDION of issues which require clarification, additional information and action by NORDION and determine batch disposition (e.g., approve, quarantine, rejection).	X
	•         MIPI shall delay or refuse approval for Product release in the event of unapproved changes and or unacceptable deviations or any other issues that MIPI determines would adversely affect the product quality, purity, identity, integrity or potency. •         NORDION would also reject product that does not meet specification, or from manufacturing or testing deviations that could adversely affect the product quality, purity, identity, integrity or potency .	X	X

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MIPI / MDS Nordion Azedra Quality Agreement

5. Product & Batch Record Documentation Problems   Any problem discovered by MIPI likely to cause rejection of the approved Product will be communicated to NORDION as soon as reasonably possible. X

9. Validation

	VALIDATION RESPONSIBILITIES	MIPI	NORDION
1.	Validation Program Establish, execute and maintain and periodically assess and audit a documented validation program that establishes documented evidence to provide a high degree of assurance that a specific process consistently produces a result meeting its predetermined specifications. •        The validation program must ensure that verification activities are performed in a controlled environment, with trained individuals using approved procedures and protocols, & with approved materials & components.		X
2.	Scope The NORDION validation program will encompass those facilities, equipment, systems, utilities, processes, analytical testing and monitoring activities associated with the manufacturing, storage, testing and control of critical processes/data for MIPI Product. •        Qualifications and validations are to be completed prior to the manufacture of cGMP Product.		X
3.	Specifications and Acceptance Criteria
	NORDION will review and approve executed protocols/protocol amendments and associated reports.		X
	NORDION will provide MIPI specific documented specifications, requirements, and acceptance criteria where applicable		X
	NORDION shall provide MIPI with summaries of all validations and qualifications related to specific Product manufacture. Full validation reports are available for review at NORDION during MIPI audit.		X
	MIPI will review and approve the Master Validation Plan associated with Product manufacture.	X
	NORDION shall make available the executed qualification protocol reports associated with Product manufacture for MIP review on site.	X
4.	Equipment, Computer, Facility, and Utilities Qualification: Generate and execute protocols for qualification to ensure with a high degree of certainty that the protocol subject is installed and operates and performs as specified. •        Computer Qualification: establish and maintain procedures to ensure the integrity of electronic data.	X
5.	Process Validation Process Validation for MIPI Process will be carried out. •        Protocols will be designed and carried out to ensure, with a high degree of certainty, the process can perform effectively and reproducibly to produce Product meeting predetermined specifications and quality attributes.		X

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	VALIDATION RESPONSIBILITIES	MIPI	NORDION
6.	Analytical Method Validation Analytical methods are designed with detection limits to ensure they are able to test the Product to its specification. All methods used in the testing and release of the Product will be validated in accordance with pre-approved protocols. Carry out any methods transferred to NORDION from MIPI to the pre-approved protocol. NORDION will ensure an adequate method transfer protocol is carried out prior to adoption of the method at NORDION MIPI will ensure all methods transferred to NORDION are validated and will provide the validation package to NORDION for purposes of regulatory inspection	X X	X X
7.	Laboratory Qualification Ensure that laboratories at NORDION that perform testing on the Product are in compliance with cGMP guidelines.		X
8.	Validation Maintenance •        Periodically review and assess the validated state of the subjects in the scope of the system. •        Address any deficiencies in the validated state via the supporting quality systems. •        Generate and execute revalidation, requalification and verification protocols and respective reports. •        Provide MIPI updates to validation plan.		X

10. Environmental and Critical Utilities Control

	ENVIRONMENTAL and CRITICAL UTILITIES RESPONSIBILITIES	MIPI	NORDION
1.	Environmental and Critical Utilities Program Establish, execute, maintain and periodically audit a documented program for the control and monitoring of the environment and utilities to ensure that these meet: •        Applicable cGMP guidelines; •        Any conditions registered in the manufacturing authorizations; and •        The validated process as described in applicable approved SOPs, and the manufacturing batch records.		X
2.	Scope •        Critical utilities and associated equipment, systems and instruments are maintained, calibrated, qualified and validated for their intended use.		X
3.	Notification Promptly notify MIPI within twenty-four (24) hours of any environmental and critical utilities data applicable to MIPI Product that may indicate adverse impact.		X
4.	Changes and Corrective Actions •        Ensure the impact of proposed changes on the environmental controls & monitoring are reviewed, mitigated & approved and & that changes which have an adverse impact, that cannot be mitigated, are denied.		X

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11. Testing

	TESTING RESPONSIBILITIES	MIPI	NORDION
1.	Testing Program •         Ensure the testing program conforms to cGMP requirements. •         Establish testing program that includes sampling, sample retention, testing identification, test evaluation, test performance & reporting and testing method validation, OOS/atypical evaluation.		X
2.	Scope Test methods associated with MIPI containers and closures, components, drug substance, in-process materials and packaging and labeling materials shall be available for review by MIPI during an audit.		X
	Review & approve all Standard Operating Procedures, test methods & proficiency testing procedures		X
3.	Analytical methods provided by MIPI	X
	Provide to NORDION approved copies of the current and complete regulatory filed methods relating to the Product, for application by NORDION in the production process.	X
4.	Transfer of Methods
	MIPI will collaborate with NORDION to transfer any methods required by NORDION.	X
5.	Reference Standards Supply qualified reference standards accompanied by a Certificate of Analysis listing the expiration date, storage conditions and any correction factors that need to be applied.	X
	Maintain reference standards in accordance with specifications.		X
6.	Release Testing In the event that MIPI performs, or contracts a MIPI approved supplier to perform any release testing, MIPI will supply NORDION with a certificate of analysis containing the testing data and the specifications.	X
	NORDION shall evaluate all testing data supplied by MIPI in order to assign final disposition of Product.		X
	For any testing which MIPI completes, the results shall be made available to NORDION in a timely manner, not to exceed (30) days, so as not to delay release procedures.	X
7.	PRODUCT Process Samples •         NORDION or a site designated by MIPI will retain PRODUCT process samples for at least 3 months beyond the expiration of the PRODUCT. •         The amount of sample retained will be at least twice the quantity required to carry out the release tests, with the exception of sterility and endotoxin testing.		X
8.	Raw Materials Samples NORDION will retain samples of Raw Materials for a minimum of one (1) year beyond the date of manufacture of the Product.		X

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12. Stability

	STABILITY RESPONSIBILITIES	MIPI	NORDION
1.	Stability System The Product shall undergo stability testing to an established stability program. •        The stability program will include the establishment of written program and stability indicating methodology, the test program and associated documentation. •        MIPI will identify the critical stability indicating parameters for the product & for inclusion into the stability program. •        Establish trending data to identify changes or concerns that can be associated with the Product. •        Review and evaluate any trending data developed from the stability testing program.	X X X	X X X

13. Deviation Management

	DEVIATION MANAGEMENT RESPONSIBILITIES	MIPI	NORDION
1.	Deviation Management Program •        Apply the NORDION deviation system to the manufacture and testing of the Product.		X
2.	Scope Definition of Deviations •        An excursion from approved operating, manufacturing, testing instructions, or procedure., •        A deviation does not permanently change an existing procedure; it is typically a specific or one time excursion. If the corrective action plan includes a permanent change, initiate a change proposal through the change management system. •        Deviations that may affect MIPI’s Product or regulatory status are within the scope.		X
3.	Notification of Deviations •        Notify MIPI immediately, within 24 hours, where those deviations may have an effect on MIPI drug Product and Drug Substance.		X
4.	Investigation Documentation of Deviations The deviation shall be documented and investigated as per the NORDION deviation procedure.		X
	NORDION and MIPI shall work together to determine the impact of the deviation on MIPI Product and associated fillings.	X	X
5.	Resolution of Deviations •        Corrective actions shall be identified as part of the deviation resolution. •        Corrective actions that require changes to approved equipment or documentation shall be governed by the Change Control Section of this Quality Agreement. •        Those batches with deviations will not be released until both parties have evaluated the impact of the deviations and agree that they do not affect the SQUIPP.	X	X

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14. Out of Specification (OOS)

	OUT OF SPECIFICATION RESPONSIBILITIES	MIPI	NORDION
1.	Out of Specification Program Testing results will be subject to the established OOS program, which has been designed to ensure conformance to cGMP requirements.		X
2.	Scope •        Perform investigations to determine the root cause of the OOS result in instances where an analytical result fails to conform to pre-established Specifications. •        NORDION shall provide OOS information related to MIPI Product		X

15. Change Control

	CHANGE CONTROL RESPONSIBILITIES	MIPI	NORDION
1.	Change Control Program Ensure MIPI related activities for the Product occur within the established control program. All changes must be in compliance with cGMP requirements, and MIPI product registrations.		X
2.	Scope The scope of such a change management process includes chemical manufacturing, pharmaceutical manufacturing and packaging processes that may affect the Product SQUIPP or the documentation thereof. The associated changes may relate to: •        Master Production Control Records; •        Standard Operating Procedures, analytical standards and test methods (for Raw Materials and finished Product); •        Material Specifications (for Raw Materials and packaging components); and •        MIPI specific validated/qualified process, equipment, facilities, utilities or computer systems.		X
3.	Prospective Changes •        The change program shall apply to prospective changes approved prior to implementation only. •        Excursions shall be in the scope of the deviation program. MIPI reserves the right to reject any batch when changes have been made without prior approval. •        Notify MIPI of any proposed changes to the Facilities or the Processing that may materially impact the Product. Such proposed changes must be approved by MIPI in writing in advance of their implementation.		X

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	CHANGE CONTROL RESPONSIBILITIES	MIPI	NORDION
4.	Proposal of Changes All proposals shall include a detailed description of the proposed change and the rationale [supporting data, and timeline for implementation].		X
	In the event that proposed change will result in change to established regulatory filing: •        MIPI is responsible for assessing the impact of the change on the filing and supplementing the filing to include the change where required; and •        For any NORDION initiated change, NORDION is responsible for providing detailed description of change, rationale for change and documentation supporting the change.	X	X
5.	Impact Assessment All changes to the Product and related documents shall proceed through both a technical and a cGMP impact assessment by NORDION’s quality and change management personnel. The assessment shall consider impact to: •        Product safety quality identity and purity; •        Specifications; •        Documentation; •        Equipment, facilities, utilities, computerized systems; •        Materials; •        Validation.		X
6.	Implementation Plan The assessment must include a plan for implementing the changes. In the event that additional supporting data is required, the plan must include the agreed upon conditional dispositioning of the Product.		X
7.	Approval and Implementation of Changes All changes must be approved prior to implementation. Implementation can occur after formal or written approval from MIPI.	X	X
8.	Supporting Data for Success of Change In the case where the success of the change is evaluated by subsequent data the completed change package must include or cross-reference this data.		X

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16. Document Control

	DOCUMENTATION CONTROL RESPONSIBILITIES	MIPI	NORDION
1.	Documentation Control Program •       Product shall be manufactured using documentation from an established, documentation control program that ensures that only approved controlled and accurate documentation is used to execute and document regulated activities. •       The program shall provide a consistent document lifecycle, which includes: •        identification of new/changed documentation; •        preparation, review, approval methodology and responsibilities; •        implementation and training; •        version control; •        issuance and accountability; •        regular assessment for adequacy; •        archiving and security; and •        obsolescing and destruction.		X
2.	Scope •       Provide all documents generated specific to MIPI Product, manufacturing, processing, and testing: •        Documents used in the chemical & pharmaceutical, production, manufacturing, packaging, testing, and control of Product; and •        SOP’s, forms, specification and other batch documentation to support the manufacturing process. •       Provide NORDION’s generic and quality system related procedures, at time of on-site visit and/or audit which govern quality system execution.		X
3.	Control Ensure that only authorized, officially issued copies of approved documentation are used for the execution and documentation of any regulated activity.		X
4.	Master Production Records The Master Product Record will have sections to record the summaries of all Product testing data, lot release data, manufacturing data and deviations, as applicable.		X
	MIPI will provide NORDION with sufficient MIPI specific Product and process information to generate the master production record for execution.	X
	MIPI reserves the right to transcribe the manufacturing information into MIPI’s format for MIPIs use	X
	The Master Production Record will be submitted to MIPI for written approval before use in manufacturing. •        Updates of the Master Batch Record will be part of the change control program requiring MIPIs approval for any changes before use in manufacturing		X

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	DOCUMENTATION CONTROL RESPONSIBILITIES	MIPI	NORDION
5.	Protection of Proprietary Information NORDION shall have the right to remove its or its client’s proprietary information from documentation before supplying to MIPI for review.		X
	MIPI shall have the right to remove its or its contractors’ proprietary information from the documentation before supplying to NORDION for review.	X
6.	Changes •        MIPI shall not make any changes to NORDION-owned or NORDION-controlled cGMP documentation without the prior written consent of NORDION, in order to ensure that all cGMP documentation, which is maintained at NORDION and subject to regulatory review, matches or is consistent with information filed with regulatory authorities. •         NORDION shall not make any changes to the manufacturing and non-generic testing documentation directly supporting Product, without the prior written consent of MIPI through the change control program.	X	X
7.	Records Retention Program Responsible for maintaining all records pertaining to the manufacture of the Product in accordance to a documented record retention program.		X
8.	Record Retention Scope and Period •        Records subject to the retention program shall include but not be limited to manufacturing data, incoming, in process and final test data, stability records, labeling, customer complaints, validation records, preventative maintenance and calibration, facility, environmental and equipment monitoring, and customer, vendor and regulatory audits. •        Retain lot records of the clinical trial materials for a maximum of ten (10) year past the stop use date and or in accordance with the mutually agreed upon duration as will be established in a separate document mutually agreed upon by MIPI and NORDION. •        Store the Master Production Record, Master Batch Record, batch records and all other documentation related to the Product for a period of at least ten (10) years; provided, however, that NORDION may maintain such records for a shorter period of no less than two (2) years from the relevant finished Product expiration date if NORDION’s Standard Operating Procedures provide for such a shorter period; provided, further that, notwithstanding the foregoing, in no event shall NORDION retain such records for less than the period of time otherwise required under Applicable Laws. If NORDION plans to discontinue such storage prior to expiration of the ten (10) year period, NORDION shall provide MIPI with sufficient prior written notice so that MIPI can arrange for alternative storage, and NORDION shall cooperate with MIPI to have any such documentation transferred to an alternative storage facility. NORDION shall use best efforts to protect such records from fire, water or any and all other type of damage.		X

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	DOCUMENTATION CONTROL RESPONSIBILITIES	MIPI	NORDION
9.	Record Destruction Notify MIPI prior to the destruction of any of the retained documentation.		X
	Notify NORDION of desire to retain documentation slated for destruction.	X
	Arrange for secure transportation of retained documentation.		X
	Ensure secure destruction of documentation.		X

17. Training

	TRAINING RESPONSIBILITIES	MIPI	NORDION
1.	Training Program Establish, execute and maintain a documented training program.		X
2.	Scope Train all personnel performing the manufacturing, validation, testing, and quality obligations of this Quality Agreement in accordance with a documented training program and the cGMP Authority requirements. •         Training shall be conducted and assessed on a routine basis by qualified personnel. •         Provide a sufficient number of qualified personnel to perform the manufacturing, validation, testing, and quality obligations of this Quality Agreement		X

18. Regulatory

	REGULATORY RESPONSIBILITIES	MIPI	NORDION
1.	Regulatory Program •         Establish regulatory program, Standard Operating Procedures, methods and facilities to include all Drug Substance to ensure conformance to cGMP requirements. •         Establish regulatory program to include Product inventory, submissions to Regulatory Authorities, quality assurance review, government regulatory agency actions (approval, suspension, revocation). •         Review & approve all licensing submission data to assure cGMP compliance. •        Ensure that all submissions to regulatory agencies are approvable, thereby assuring timely permission to distribute Product.	X
2.	Marketing Applications •         Prepare, maintain and update the Marketing Authorizations in accordance with all Applicable Laws. •         Provide NORDION with copies of those portions of the Marketing Applications which are applicable to the Processing or contain any information for activities that are the responsibility of or carried out by NORDION prior to submission of such Marketing Applications to the applicable Regulatory Authority.	X

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MIPI / MDS Nordion Azedra Quality Agreement

	REGULATORY RESPONSIBILITIES	MIPI	NORDION
3.	Filings Ensure all appropriate regulatory filings and import/export documentation are filed with regulatory agencies and that approvals have been granted prior to shipment/human administration.	X
	Review & approve all licensing submission data to assure cGMP compliance (NORDION is responsible for NORDION data only).	X	X
	Identify any cGMP concerns relating to a submission that have a cGMP impact & to approve of any changes or corrective actions to assure cGMP compliance.	X
	Provide point of contact between MIPI’s regulatory affairs staff or consultants regarding issues that impact the Chemistry Manufacturing and Controls (“CMC”) registration information for the Drug Substance and/or drug Product.		X
	Provide MIPI with agreed finalized CMC documentation covered in this Quality Agreement.		X
	Perform a technical/regulatory review of all documentation provided to MIPI to support regulatory submission (NORDION data only).	X	X
	Provide support for MIPI with respect to proposing appropriate CMC regulatory strategies and identifying potential regulatory consequences for issues involving drug products.		X
	MIPI will be responsible for making final decisions regarding CMC regulatory strategy and will document such decisions for NORDION.	X
	MIPI will provide a copy of applicable sections of MIPI’s final regulatory submissions, for reference during inspections.	X
4.	Regulatory Inspections Upon notification to Nordion, Nordion will in turn inform MIP of any regulatory inspections that may involve the Product and permit a representative from MIPI’s quality unit to be present.		X

Note: During the regulatory inspection, MIPI will not be involved in the audit room with the regulatory inspection, unless MIPI is requested by NORDION to attend such session,

	Consult and closely cooperate with MIPI prior to making any commitment to any regulatory agency regarding MIPI’s Product.		X
	Upon receipt of an notice of adverse findings Nordion will provide to MIP any regulatory correspondence related to the Product or other system related issues that support manufacturing, packaging or testing of MIPI Product, redacted of or summarized to remove any NORDION commercial confidential information not directly related to the Product.		X
	MIPI, within 24 hours, will inform NORDION in writing of any regulatory issue that impacts NORDION’s ability to manufacture the Product.	X
5.	Regulatory Actions MIPI will notify NORDION of any regulatory actions on the Product that may impact NORDION.	X
	MIPI will promptly forward any regulatory correspondence on the Product to NORDION.	X
	NORDION is responsible for supporting all lot record investigations associated with regulatory actions.		X

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	REGULATORY RESPONSIBILITIES	MIPI	NORDION
	NORDION agrees to supply MIPI with any manufacturing, testing, or storage data relating to the Product within two (2) business days, if requested, as the result of a regulatory inspection, or a potential regulatory exposure, such as a recall or significant Product complaint.		X
	Immediately notify MIPI of any FDA or other Regulatory Authority notice of inspection or inspection of the Facilities directly relating to the Product, and in no event later than 48 hours after the schedule has been established.		X
	Immediately, and in no event longer than 48 hours, notify MIPI of any FDA or other Regulatory Authority investigation that NORDION has a reasonable basis to believe is likely to impact the Processing of the Product.		X
	Provide copies of any FDA Form 483’s, Warning Letters or the like from applicable Regulatory Authorities, no later than 48 hours after receipt, including any subsequent response(s) relating to the Product, either redacted or summarized to remove any NORDION commercial confidential information.		X
	Notify the other party of any Regulatory Authority request for Product samples or Product batch records, no later than 48 hours after receipt of the request.	X	X
	Make available during audit notices of violations or other communication from a Regulatory Authority relating to environmental, occupational health and safety compliance, relating directly to Product. Information of a personnel confidential nature will not be provided.	X	X
6.	Annual Product Review Generation •        Perform an annual product review for the Product, including but not limited to, those CFR requirements encompassing: •        Review critical in-process controls and results; •        Review of batches that failed to meet Specifications; •        Review critical deviations/non conformances and related investigations; •        Review changes carried out to process and/or analytical methods; •        Review of stability monitoring (as applicable); •        Review of adequacy of previous corrective actions; •        List of validated procedures and revalidation dates; and •        List of qualified equipment and requalification dates. •        Issue a report to MIPI. It will contain a review of any changes at NORDION in the manufacturing, testing, storage or validation of the Product in the previous calendar year and a summary of lots made, released, investigated and rejected. •        MDSN will provide data for MIPI to compile their annual product review. •        Control charting or trend analysis of key product parameters will be performed and reported.	X	X
7.	Annual Report MIPI will prepare any annual report as required by applicable regulations and Applicable Laws, including 21 CFR 314.70, 314.81, and/or 601.12.	X
	Provide data and information related to batch records, complaints, recalls, deviations, investigations and non-conforming materials.	X	X

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	REGULATORY RESPONSIBILITIES	MIPI	NORDION
	The annual report cycle will be established at approval, and the specific request for information will be made at least ninety (90) calendar days before the annual report due date, MIPI shall request in writing, the chemistry, manufacturing and controls data required for preparation of the annual report.	X
	NORDION will provide the requested information to MIPI within thirty (30) days of the original request date.		X
8.	Drug Listing MIPI is responsible for drug listing as the manufacturer of the Product for MIPI.	X
	MIPI is responsible for drug listing as the distributor of the Products.	X
	MIPI will provide NORDION with all required information needed to register the Product.	X
	MIPI will notify NORDION of the scheduled Product launches, as applicable.	X

19. Recalls

	RECALL RESPONSIBILITIES	MIPI	NORDION
1.	Recall, Field Alerts, & Product Withdrawal Program Establish documented complaints program and process necessary to assure effective, efficient & reliable management of complaints (other than reports of adverse events) associated with all Drug Substance and Product to ensure conformance to cGMP Authority requirements.	X	X
2.	Scope MIPI, with data and assistance provided by NORDION, is responsible for filing Field Alerts and initiating product recalls due to any defect considered sufficiently serious.	X
	Provide NORDION with a copy of any regulatory correspondence related to field alerts or recalls.	X
	In the event that NORDION has reason to believe that any Product should be recalled or withdrawn from distribution, NORDION shall promptly inform MIPI in writing.		X
	MIPI shall notify the FDA and any foreign regulatory agencies, as required.	X
	MIPI shall be responsible for coordinating all necessary activities regarding the action taken.	X
	MIPI acknowledges and understands that NORDION, as manufacturer of the Product, has significant regulatory obligations if any recall or withdrawal would be necessary.	X
	NORDION and MIPI agree to cooperate fully regarding any proposed recall, product withdrawal, or field correction.	X	X
	Agree to keep each other advised, to exchange copies of documentation as required, and to assure regulatory compliance.	X	X
	Manage any recall or product withdrawal.	X
	Reconcile returned product following recall or product withdrawal.	X
	Issue and follow-up on FDA field alerts.	X

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20. Complaints

	COMPLAINT RESPONSIBILITIES	MIPI	NORDION
1.	Complaint Program Note: MIPI is responsible for complaints related to Product (“Complaints”). This section outlines MIPI expectations that NORDION will have an established Complaint handling program •        All complaints related to the Product will be processed adhering to the NORDION Complaints procedure to assure conformance to cGMP requirements.	X	X
2.	Scope NORDION complaint assessment focuses on possible failure of drug Product to meet any of its Specifications related to product quality & issues associated with manufacturing technique & equipment.	X	X
3.	Receiving & Investigating Product Complaints. Notify NORDION of any problems thought to be due to NORDION manufacturing on receipt of the Complaint (within forty-eight (48) hours).	X
	Promptly perform investigations.	X	X
	Generate investigation report and forward to MIPI within thirty (30) days of receipt by NORDION.		X
	Perform review & approval of any corrective action plans proposed to eliminate the causes of a Complaint.	X	X
	Report any Complaint to the appropriate regulatory authority including adverse drug events reports.	X
	Any Quality Complaint directly related to product received by NORDION from a source other than MIPI will be immediately forwarded to MIPI.		X

21. Adverse Events

	ADVERSE EVENT RESPONSIBILITIES	MIPI	NORDION
1.	Adverse Event System Note: MIPI is responsible for handling of adverse events related to Product (“Adverse Events” or “AE”). This section outlines MIPI expectations that NORDION will have an established Adverse Event handling program •        Reports of adverse events are handled in NORDION complaint system. Any such report will be communicated to MIPI within 48 hours.	X	X
	Establish Adverse Events system to include activities associated with receipt, documentation, investigation, hazard evaluation, reporting and Annual Product Review.	X	X
	Provide support to MIPI in regulatory reporting of Adverse Events where required, providing support in analysis of manufacturing and testing data as it might relate to a reported event.		X

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22. AUDITS

	AUDIT RESPONSIBILITIES	MIPI	NORDION
1.	Internal Auditing Program •        Establish, execute and maintain and internal auditing program for the quality systems identified in this Quality Agreement. •        Perform periodic auditing of facilities, processes, and systems outlined in this Quality Agreement to assure standards are established, NORDION’s performance and compliance to cGMP, and in the event of issues/deviations are observed, NORDION shall establish a corrective action plan to mitigate the outlined issues. NORDION will monitor the execution of the corrective action plan activities and completion thereof.		X
2.	Access Provide access to MIPI quality representatives to manufacturing, warehousing, laboratory premises and program documents and records, relating to MIPI’s Product, for audit purposes.		X
	Escort MIPI representatives at all times.		X
	Give reasonable notice for audits (i.e., 1 month for routine GMP Audits).	X	X
	Schedule audits upon mutual agreement.	X
3.	Periodic Audits Conduct a standard quality cGMP compliance audit at least once every two (2) years.	X
4.	Preparatory Audits Perform a preparatory audit either for initiation of cGMP manufacture of the Products or for pre-approval inspections (PAI).	X
5.	Audit for Cause Product Quality or Safety Audits Perform audits for cause in the event of significant Product quality or safety problems.	X
	For cause audits can be scheduled as required, MIPI will provide at least 10 days notice when scheduling a for cause audit.	X	X
6.	Audit Closeout Conduct audit closeout meeting discuss significant audit observations.	X
	Provide a written audit report to NORDION of all observations within thirty (30) days to NORDION.	X
	Provide a written response and corrective action plan to MIPI within thirty (30) days of the audit report receipt.		X
	As requested, provide status of corrective action plan and written confirmation of completion of corrective actions.		X

23. Management of Relationships and Communication Strategy

MIP and NORDION will designate senior quality staff to act as points of contact for the purpose of this Quality Agreement, Refer to Appendix I

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Appendix I – MIPI / MDS Nordion Quality Agreement Points of Contact.

	MIPI	NORDION
Quality Assurance	Robert Stern Associate Director, Quality Assurance 617.871.6681 Jim Wachholz Vice President, Regulatory and Quality 617-871-6650	Susan Dew Director, Quality Assurance MDS Nordion 613.592.3400 ext 2689 Ron McGregor Senior Vice President, Quality and Regulatory Affairs 613-592-3400 ext 2469
Manufacturing	Jim Kronauge Vice President, Development 617.871.6619
Regulatory Affairs	Tom Class Senior Director, Regulatory Affairs 617.871.6644	Anne Warbick-Cerone Director, Regulatory Affairs 613.592.3400 ext 2033
Program Management	Wendy Graham Coco Vice President, Program Management 617.871.6633	Leena Rawat Director, Project Management Office 613.592.3400 ext 2018

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Appendix II

Azedra Production Documentation & Flow

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To be updated when commercial flow chart is available

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Appendix IV

Lot Release Documentation

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Ultratrace Iobenguane I-131

Documents sent to MIP on release day

910700.PRF – Complete

910700.PCR – Section E & F – Formulation

910210.PCR – Sample Labels Only – Enlarged 155% – Pot & Vial

Copies of pages from ACR’s where values are transcribed to PRF:

910802.ACR – Visual Inspection – Pages 2, 3 & 6 of 8 only

910809.ACR – Complete Document

910804.ACR – HPLC – Page 6 & 7 of 8 only

910803.ACR – pH – Complete document

000036.SOP – Radioactivity Measurement Sheet – Page 1 only

910801.ACR – HPLC – Page 5 & 7 of 10 only

Any applicable deviations/CFs/Lab Investigations

Documents sent within 48 hours of release

C of A – I-131 iodine

910210.PCR – Complete Labelling document

910510.PCR – STERIS VHP 1000 Biodecontamination Unit

910700.PCR – A, B, C and D

MetOne Excursion Log Sheet + Printouts

Accountability Report

910801.ACR – Identity, Radiochemical by HPLC & printouts

910802.ACR – Visual Inspection

910804.ACR – HPLC * printouts

000036.SOP – Radioactivity Measurement Sheet

Documents sent when completed post release

910810.ACR – Bioburden Testing

910808.ACR – Sterility Testing

100014.PCR – Non-Viable – Rooms 1226, 1217

040800.SOP – Product Inventory Sheets – TX and DX

910806.PCR – Shipping Documents

900835.PCR – Room 1226 EM

900834.PCR – Room 1217 EM

900838.PCR – Room 1215 EM

900510.PCR – AMSCO VHP 1000

Product Release Form – When batch is closed out

Completed Deviations, OOSs

All Environmental Notices

Page 32 of 32

SCHEDULE F

Specifications For Precursor and Reference Standards

	UNCONTROLLED COPY
910402.SPE (1)
Effective Date: 06-12-19 CF 61	Page 1 of 2
Polymer 3 Resin

Signatures

Prepared by:	Signature on file	Date:
	C. Bensimon		yy/mm/dd
	Senior Research Chemist
Approved by:	Signature on file	Date
	R. Pickering		yy/mm/dd
	Production
Approved by:	Signature on file	Date:
	F. Francis		yy/mm/dd
	Quality Control
Approved by:	Signature on file	Date:
	J Cybulski		yy/mm/dd
	Quality Assurance

Document History

Effective Version Comments Prepared By Reviewed By Approved By

NOTE: A vertical line in the margin (tracking bar), denotes change. For complete rewrites, tracking bars are not used.

This document contains information proprietary to MDS Nordion.

Any disclosure or use of this information or any reproduction of this document other than the specified purpose for which it is intended is expressly prohibited except as MDS Nordion may otherwise agree in writing.

910402.SPE (1)

Page 2 of 2

Polymer 3 Resin

PRODUCT*	:   Polymer 3 Resin- (Polymer supported 3-benzyl guanidium acetate) (PN# 12920)
MANUFACTURER*	:   Polysciences Inc
EXPIRY DATE*	:   As per Quality Control Incoming Material Testing Specification provided by Molecular Insight Pharmaceuticals (MIP)
STORAGE*	:   Frozen (-20°C)
SAMPLING PLAN	:   Not required- Customer released product
SHIPPING REQUIREMENT	:   Room temperature shipment. Complete 000017.PCR, “Verification, Storage and Maintenance of Customer Supplied Product”
CATEGORY	:   Critical
OTHER*	:   Certificate of Analysis supplied by Polysciences.     Incoming Material Testing Specification supplied by Molecular Insight Pharmaceuticals

* To be verified by QC.

910304.SPE (2)

Page 2 of 2

lobenguane Standard

PRODUCT*	:   m-lodobenzylguanidine hemisulfate salt or iobenguane hemisulfate or MIBG hemisulfate (PN# 700)
MANUFACTURER*	:   ABX advanced biochemical compounds
EXPIRY DATE*	:   As per Incoming Material Testing Specification from MIP
STORAGE*	:   2-8°C
SAMPLING PLAN	:   Not required- Customer released product
SHIPPING REQUIREMENT	:   Room temperature shipment. Complete 000017. PCR, “Verification, Storage and Maintenance of Customer Supplied Product”
CATEGORY	:   Critical
OTHER*	:   Certificate of Analysis supplied by ABX     Incoming Material Testing Specification supplied by MIP

* To be verified by QC.

SCHEDULE G

CHANGE IN SCOPE ORDER

Effective Date:             , 2009

This amendment shall form a change in scope order (“Change in Scope Order”) to the existing (INSERT SCHEDULE WHICH IS BEING MODIFIED) executed on             , 2009 between Molecular Insight Pharmaceuticals, Inc. (“Molecular”) and MDS Nordion, a division of MDS (Canada) Inc. (hereinafter referred to as “Nordion”). All Articles and provisions of the (INSERT SCHEDULE WHICH IS BEING MODIFIED) remain in effect and will apply to all subsequent amendments to that (INSERT SCHEDULE WHICH IS BEING MODIFIED), unless specifically stated as otherwise herein.

The purpose of this Change in Scope Order is set forth below.

Change in Scope Order Description for Azedra           ¡           ¡           Note to draft; Please insert columns
	Total
	Original Project Budget: Change Order No. 1 Value: Revised Project Total:
	See Attachment _ (Revised Schedule _ ) and _ (Revised Project Budget) incorporated herein by reference.

AGREED TO AND ACCEPTED BY:

Molecular Insight Pharmaceuticals, Inc.	MDS Nordion, a division of MDS (Canada) Inc.
By:	By:
Name (Printed):	Name (Printed):
Title:	Title:
Date:	Date:

Attachment A

Amended Schedule

Attachment B

Revised Project Budget

EX-10.4

Exhibit 10.4

Territory License Agreement

between

Molecular Insight Pharmaceuticals, Inc

and

BIOMEDICA Life Sciences, S.A.

TABLE OF CONTENTS

Article I	3
Definitions	3
Article II	9
License	9
Article III	11
Manufacture and Supply	11
Article IV	12
Development and Commercialization	12
Article V	15
Consideration	15
Article VI	21
Call Back Option and Right of First Discussions	21
Article VII	23
Intellectual Property	23
Article VIII	28
Representations and Warranties	28
Article IX	30
Confidentiality	30
Article X	31
Announcement and Publicity	31
Article XI	32
Term and Termination	32
Article XII	34
Indemnification and Insurance	34
Article XIII	36
Information on Clinical Safety and Pharmacovigilance	36
Article XIV	37
Governing Law and Jurisdiction	37
Article XV	37
Miscellaneous Provisions	37

2

TERRITORY LICENSE AGREEMENT

Molecular Insight Pharmaceuticals, Inc. / BIOMEDICA Life Sciences S.A.

This territory license agreement (“Agreement”), dated this 1st day of September, 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 094413470, from the tax office of FAEE Athens; each a “Party” and collectively the “Parties” hereto.

RECITALS

WHEREAS, MIP has experience with and has developed and controls certain intellectual property and technical information with respect to a pharmaceutical product known as Onalta^™. In particular, MIP has licensed exclusive and non-exclusive worldwide rights from Novartis AG to certain intellectual property relating to radiolabeled somatostatin analogues;

WHEREAS, BIOMEDICA has expertise in the health care market, radiopharmaceuticals in particular, and is engaged in the innovation and R&D in the subject areas.

WHEREAS, BioMedica wishes to obtain, and MIP desires to grant, a territory license from MIP for the development, exploitation and commercialization of Onalta^™;

WHEREAS, the Parties have executed a Letter of Intent (LOI) on March 26, 2009, in furtherance of this purpose.

NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements hereinafter set forth, the sufficiency of which is hereby acknowledged, the Parties to this Agreement mutually agree as follows:

1. DEFINITIONS

1.1. “Accounting Standards” shall mean, with respect to MIP, U.S. GAAP (United States Generally Accepted Accounting Principles) and, with respect to BIOMEDICA, IFRS (International Financial Reporting Standards).

1.2. “Affiliate” shall mean any entity that directly or indirectly controls or is controlled by or is under common Control with a Party to this Agreement. For purposes of this definition, “control” or “controlled” means ownership directly or through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a

3

corporation, or fifty percent (50%) or more of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity.

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. “BIOMEDICA Field” shall mean human oncology therapeutic use, and use of the Indium 111 labeled Compound for dosimetry purposes in relation to therapy administration of the Product.

1.5. “BIOMEDICA New Intellectual Property” shall exclude technology developed jointly by the Parties.

1.6. “Calendar Year” shall mean the calendar year, starting on January 1 and ending on December 31, in which the first sale of the Compound or the Product occurs and each successive calendar year.

1.7. “Change of Control” shall mean any of the following events: (a) any Third Party (or group of Third Parties acting in concert) becomes the beneficial owner, directly or indirectly, of fifty percent (50%) or more of the voting power of the stock then outstanding of a Party; (b) a Party consolidates with or merges into another corporation or entity, or any corporation or entity consolidates with or merges into the Party, in either event pursuant to a transaction in which fifty percent (50%) or more of the total voting power of the stock outstanding of the surviving entity normally entitled to vote is not held by the Parties holding more than fifty percent (50%) of the outstanding shares of a Party prior to such consolidation or merger; (c) any Third Party (or group of Third Parties acting in concert) obtains the power to direct or cause the direction of the management and policies of a Party by any lawful means whatsoever; or (d) a Party conveys, transfers or leases all or substantially all of its assets.

1.8. “Commercialization” or “Commercialize” shall mean activities conducted by a Party either by itself or through a Third Party and directed to marketing, promoting, distributing, importing, exporting, offering for sale or selling a Product, which may include pre-launch market preparation, whether undertaken by a Party alone or with a partner or a sub-licensee. When used as a verb, “Commercialize” means to engage in Commercialization.

1.9. “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 Product.

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

1.11. “Confidential Information” shall mean and include any and all Know-How, data and information, not in the public domain. It shall also include, but not be limited to, information relating to the Product and/or Compound, or the business, research and development activities, results of clinical trials, regulatory proceedings, finances, contractual relationships and operations of the Parties.

1.12. “Controlled” or “Controls”, when used in reference to intellectual property, shall mean the legal authority or right of a Party hereto (or any of its Affiliates) to grant a license or sub-license of intellectual property rights to another Party, or to otherwise disclose proprietary or trade secret information to such other Party, without breaching the terms of any agreement with a Third Party, infringing upon the intellectual property rights of a Third Party, or misappropriating the proprietary or trade secret information of a Third Party.

1.13. “Development” shall mean all activities conducted by a Party either by itself or through a Third Party, as are necessary for an application for a Marketing Authorization.

1.14. “Development Costs” shall mean, with respect to the Compound or Product, expenses and other costs, including regulatory expenses, incurred by or on behalf of a Party in connection with the Development of the Compound or Product, including, the costs of clinical trials, the preparation, collation and/or validation of data from such clinical trials and the preparation of medical writing and publishing.

1.15. “Effective Date” shall mean the date first above written.

1.16. “EMEA” shall mean the European Medicines Agency or its successor agency.

1.17. “First Commercial Sale” shall mean the first sale of the Compound or the Product to a Third Party by BIOMEDICA or an Affiliate or sub-licensee of BIOMEDICA in a country in the Territory following applicable EMEA approval for or consent to compassionate use of the Compound or the Product and/or Marketing Authorization in one indication of the Product in the Territory.

1.18. “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.

1.19. “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 Product in the Territory pursuant to its regulations, guidelines or otherwise.

5

1.20. “Initial Period” is the time from the effective date until the filing of a marketing application

1.21. “Interim Period” is the time from the filing of the marketing application to the final action by the EMEA.

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 Product in that country. For the sake of clarity, Marketing Authorization shall not include the reimbursement approval.

1.23. “NDA” or “New Drug Application” shall mean a new drug application and all amendments and supplements thereto filed with the EMEA, or any such Regulatory Authority requiring such filing, including all documents, data and other information concerning a pharmaceutical product that are necessary for gaining Marketing Authorization to market and sell such pharmaceutical product.

1.24. “NDA Acceptance” shall mean the date upon which the Product NDA submitted by BIOMEDICA is deemed filable by the EMEA or the equivalent dossier is accepted for review by any other country’s respective Regulatory Authority.

1.25. “Net Sales” shall mean with respect to the Compound and the Product the gross amount invoiced by or on behalf of BIOMEDICA and its Affiliates and sub-licensees for the Compound or Product sold to Third Parties other than sub-licensees in bona fide, arms-length transactions, less the following customary deductions, determined in accordance with the BIOMEDICA’s Accounting Standards as generally and consistently applied by BIOMEDICA, to the extent included in the gross invoiced sales price of any Compound or Product or otherwise directly paid or incurred by BIOMEDICA, its Affiliates or sub-licensees with respect to the sale of such Compound or Product: i) normal and customary trade and quantity discounts actually allowed and properly taken directly with respect to sales of the Compound or Product; ii) amounts actually repaid or credited by reasons of defects, rejection recalls, returns, rebates and allowances of goods; iii) chargebacks and other amounts paid on sale or dispensing of such Compound or Product; iv) amounts payable resulting from governmental mandated rebate programs; v) tariffs, duties, mandatory transaction or sales related type fees imposed by any governmental entity (even if paid to a third party), excise, sales, value- added and other taxes (other than taxes based on income); vi) retroactive price reductions specifically identifiable to the Compound or Product that are actually allowed or granted; vii) customary cash discounts for timely payment; viii) delayed ship order credits; ix) discounts pursuant to indigent patient programs and patient discount programs and coupon discounts; and x) all freight, postage and insurance included in the invoice price.

1.25.1.  Sales from BIOMEDICA to its Affiliates shall be disregarded for purposes of calculating Net Sales. Any of the items set forth above that would otherwise be deducted from the invoice price in the calculation of Net Sales but which are separately charged to Third Parties shall not be deducted from the invoice price in the calculation of Net Sales.

6

1.25.2.  In the case of any sale or other disposal of the Compound or the Product between or among BIOMEDICA and its Affiliates or sub-licensees, for resale, Net Sales shall be calculated as above only on the value charged or invoiced on the first arm’s-length sale thereafter to a Third Party;

1.25.3.  In the case of any sale which is not invoiced or is delivered before invoice, Net Sales shall be calculated at the time of shipment or when the Compound or the Product is paid for, if paid for before shipment or invoice;

1.25.4.  In the case of any sale or other disposal for value, such as barter or counter-trade, of any Compound or Product, or part thereof, other than in an arm’s length transaction exclusively for money, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the Compound or Product in the country of sale or disposal;

1.25.5.  In the event the Compound and the Product is sold in a finished dosage form containing the Compound in combination with one or more other active ingredients (a “Combination Product”), the Net Sales of the Compound or Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales (as defined above in this Article) of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of the Compound or Product when sold separately in finished form and B is the weighted average sale price in that country of the other product(s) sold separately in finished form. In the event that such average sale price cannot be determined for both the Compound, Product and the other product(s) in combination, Net Sales for purposes of determining royalty payments shall be agreed by the Parties based on the relative value contributed by each component, such agreement shall not be unreasonably delayed or withheld.

1.26. “Know-How” shall mean proprietary or non proprietary information relating to the Compound and/or the Product excluding the regulatory CMC information for the chemical manufacturing process. The information shall include the relevant specifications, technical data, inventions, discoveries, formulation, processes, trade secrets, expertise developments and regulatory information of the Product controlled by MIP as well as, chemical, stability, pharmacological, safety, clinical data, analytical and quality control data, whether or not protected under patent, trademark, copyright or other legal principles, to which MIP has rights at the Effective Date. For the sake of clarity, any information related to the manufacture of the Tyr-3 octreotide will not be disclosed to BIOMEDICA.

7

1.27. “Novartis License Agreement” shall mean the license agreement entered into by and between Novartis and MIP dated November 3, 2006 and any amendments thereto.

1.28. “Novartis” shall mean Novartis Pharma AG, a corporation organized and existing under the laws of Switzerland, and having its principal offices at Lichtstrasse 35, CH-4056 Basel, Switzerland.

1.29. “Novartis Patents” shall mean those patents and patent applications owned or Controlled by MIP during the term of this Agreement with a claim encompassing Compound, Product, or any other formulations of Compound, processes, uses and intermediates for the foregoing and shall include any patents or patent applications and any continuations, continuations-in-part, divisions, provisionals, substitutions, patents of addition, reissues, examination, renewals or extensions thereof (including any supplemental patent certificates) and any confirmation patent or registration patent and all foreign counterparts of any of the foregoing.

1.30. “ Onalta” and “www.onalta.com” shall mean the trademarks owned and selected by MIP for the Product.

1.31. “Peptide” shall mean the DOTA-chelated somatostatin peptide analogue known as edotreotide.

1.32. “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.

1.33. “Regulatory Authority” shall mean the EMEA or additional governmental or regulatory agencies in the Territory responsible for applicable Marketing Authorization.

1.34. “Royalty Term” shall have the meaning as set forth in article 5.6.

1.35. “Sub-licensee” shall mean a Third Party to whom BIOMEDICA may grant a right or license to use Novartis Patents or Know-How to make, use or sell any Product in the Territory.

1.36. “Term” shall have the meaning as set forth in article 11.1.

1.37. “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 pursuant to article 2.4.

8

1.38. “Trademark” shall mean MIP’s “Onalta” related trademarks, logos, and tradenames.

1.39. “Valid Claim” shall mean an issued claim of a Novartis Patent which claim has not been held invalid or unenforceable by final decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which is not admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

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

Exhibit A:         BIOMEDICA Business Plan

Exhibit B:         Intellectual Property

Exhibit C:         Examples of Contingent Milestone Payment Calculations

Exhibit D:         Examples of Permitted Disclosures

2. LICENSE

2.1 Grant to BIOMEDICA. Subject to the terms and conditions of this Agreement, MIP hereby grants to BIOMEDICA exclusively within the Territory, a royalty-bearing license under its rights in the Novartis Patents and Know-How necessary for BIOMEDICA to (i) develop, (ii) market, (iii) advertise, (iv) manufacture, (vi) have manufactured, (vii) import, (viii) export, (ix) distribute, and (x) commercialize the Compound and the Product, including securing all regulatory approvals and performing clinical studies. Such rights granted are expressly conditioned on and subject to the Novartis License Agreement. In addition, MIP hereby grants to BIOMEDICA a non-exclusive, non-transferable license to use the trademark ONALTA in connection with sale or distribution of the Product throughout the Territory subject to the terms and conditions set forth below. For the avoidance of doubt, the rights granted herein are for the Compound when used as a therapeutic Product, and BIOMEDICA shall not be granted any rights to use, sell or otherwise promote the Compound or Product as a diagnostic product.

2.2 MIP agrees that in the event that it grants future sublicenses under the Novartis License Agreement on more favorable terms than the terms set forth in this Agreement, MIP will offer such terms to BIOMEDICA provided such terms are not unfairly discriminatory to BIOMEDICA. More favorable payment terms to a third party licensee which are either not under MIP’s control (such as government imposed terms), or reasonable in light of the size and limited economic opportunity in the subject country or region, shall not constitute unfair discrimination.

9

2.3 Sub-license. BIOMEDICA shall have the right to grant, under the license granted in article 2.1, additional sub-licenses to Third Parties with respect to the Product, provided that the terms and conditions of sub-license agreements shall be consistent with the terms of this agreement. BIOMEDICA shall undertake to enforce the provisions of such sub-license agreements and shall remain responsible for the performance of sub-licensee’s obligations. BIOMEDICA shall cause each sub-licensee to execute any and all additional documents reasonably requested by MIP to reflect the conditions set forth in this agreement.

2.3.1 BIOMEDICA’s right to grant Third Party sublicenses hereunder is expressly conditioned upon prior written notice and approval by MIP and by Novartis, which approval from MIP shall not be unreasonably withheld.

2.4 Limitations of Rights. It is acknowledged and agreed that no other license rights are granted by MIP to BIOMEDICA other than the license expressly granted by the provisions of Article 2.1, and that MIP expressly retains all other rights under any MIP Know-How and MIP Patents.

2.5 MIP-NOVARTIS Change in Payment Terms. To the extent that MIP and NOVARTIS, or in the event of material breach by Novartis enter into a new agreement reducing the payments to be paid to Novartis under the Novartis License Agreement and/or amending the payment structure, MIP agrees to extend the benefit of any such reduction or amendment to BIOMEDICA to the extent fair and reasonable.

2.6 Additional Countries. If exclusive sublicense rights to the Novartis Patents become available in ******, then MIP shall notify BIOMEDICA in writing of the existence of such rights, and the Parties shall undertake to include ****** within the Territory under this Agreement. Other than ******, if after the Effective Date but within the Term of this Agreement, if MIP desires to sublicense rights to the Novartis Patents for any country not included in the Territory, then MIP shall give BIOMEDICA reasonable notice of its intent and an opportunity to participate in negotiations for sublicense rights in such country.

2.7 Transfer of MIP Information and MIP Files. MIP shall use reasonable efforts to transfer to BIOMEDICA within ninety (90) days of the Effective Date or such longer period as reasonably required by MIP, instructions and training manuals for the radiolabeling and patient administration of the Compound, existing as of the Effective Date, on an “as is” basis. For the sake of clarity MIP shall not be requested to perform clinical trials or animal studies with the Compound or Product, and all data and files shall be transferred as is with no further obligations on MIP. The MIP information provided hereunder shall remain the property of MIP, but BIOMEDICA shall be free to use it in connection with the sublicense granted above.

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*Confidential Treatment Requested*

2.8 Liaison. The primary contact persons (the “Contact”) at BIOMEDICA and MIP are set forth in Section 15.8, and these designated persons shall act as liaisons for the purpose of this Agreement, which role shall include but not be limited to receiving the reports set forth in Articles 4.2 and 5.8 and other notices under this Agreement. The Parties may change their respective Contact at any time by providing written notice to the other Party.

3. MANUFACTURE AND SUPPLY

3.1 Purchase of Compound and Product. During the Term of this Agreement BIOMEDICA shall purchase all of its requirements for the Compound and the Product exclusively and solely from MIP, a MIP designated third party manufacturer, and/or a BIOMEDICA designated third party manufacturer approved by MIP. BIOMEDICA shall not, without the written authorization from MIP, supply or otherwise distribute the Compound or Product to any third party outside of the Territory.

3.1.1 Supply agreement. The Parties agree to begin good faith negotiations on a definitive supply agreement for the Compound and the Product immediately upon execution of this Agreement. It is the goal of the Parties to finalize the supply agreement within 14 days of the Effective Date of this Agreement. The Parties acknowledge that the effective date of the supply agreement shall be concurrent with the date MIP enters into a manufacturing agreement with an MIP designated third party, manufacturer. The Parties understand and acknowledge that the supply agreement will include an advance payment by BIOMEDICA for inventory on the following schedule:

• Qtr-4 2009        ******

• Qtr-1 2010        ******

• Qtr-2 2010        ******

• Qtr-3 2010        ******

• Qtr-4 2010        ******

• Qtr-1 2011        ******

• Qtr-2 2011        ******

3.1.2 The acquisition of product from inventory will be at the agreed-to price for both the Compound and the Product (section 3.4). For the sake of clarity, the Parties agree that the supply agreement referenced above in Section 3.1.1 will include a minimum purchase requirement by BioMedica, with the amount(s) and frequency of such minimum purchase to be

11

*Confidential Treatment Requested*

negotiated by the Parties acting in good faith. The inventory payments referred to in section 3.1.1 will be credited against purchases once purchases exceed milestones that will be defined in the supply agreement between MIP and BIOMEDICA.

3.2 Responsibility for Manufacturing Product. MIP, or the MIP designated third party manufacturer shall supply BIOMEDICA’s requirements for the Product for a period of ten years following the Effective Date of this Agreement upon terms to be agreed in the supply agreement.

3.3 Responsibility for Manufacturing Compound. MIP, or the MIP designated third party manufacturer shall supply BIOMEDICA’s requirements for the Compound for a period of five years following the Effective Date of this Agreement upon terms to be agreed in the supply agreement.

3.4 ****** License Termination: Immediately upon execution of this Agreement, MIP and BIOMEDICA jointly agree to develop and implement a Peptide distribution plan to be effective concurrent with MIP’s termination of the ****** Agreement (90 day notice required) in order to be able to seamlessly supply peptide within the Territory.

3.5 Pricing Commitment: MIP will provide the Compound for radiolabeling during the interim period until the Product, Onalta™, is available. BIOMEDICA will purchase the Compound at an agreed upon single unit dose price of ******. BIOMEDICA will be responsible for Y-90 isotope purchase for the production at radiopharmacies until the Product, Onalta™, is available. BIOMEDICA will purchase the Product at an agreed upon unit price of ******.

3.6 Training and Support: MIP will provide reasonable levels of technical support to BIOMEDICA at BIOMEDICA’s request on a time and materials basis. The Parties will enter into good faith discussions regarding the details of such support and associated costs upon request by BIOMEDICA. Such support will take place as soon as reasonably possible and primarily focused on training BIOMEDICA’s personnel.

4. DEVELOPMENT AND COMMERCIALIZATION

4.1 Development Costs. BIOMEDICA shall be solely responsible for all Development and Commercialization activities to be conducted pursuant to this Agreement from the Effective Date and all costs related thereto. BIOMEDICA has developed a Business Plan (the “Business Plan”) attached hereto Exhibit A that describes in detail the Development and Commercialization activities that BIOMEDICA will undertake in connection with the Compound and the Product. BIOMEDICA commits to implement the Development and Commercialization activities substantially in accordance with the “Business Plan” Development milestones and timelines shown on page 20 of Exhibit A.

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*Confidential Treatment Requested*

4.2 Reports: BIOMEDICA shall provide to MIP reports detailing its Development and Commercialization activities as set forth below. If BIOMEDICA should elect a third party manufacturer of the Product pursuant to article 3.3, then the report shall include all manufacturing information, including but not limited to lot numbers, Product specifications, and GMP compliance.

4.2.1 During the Initial Period, no later than thirty (30) days after the end of each calendar quarter, BIOMEDICA shall provide written reports to MIP containing specific and detailed information regarding BIOMEDICA’s performance under each of the Timelines and Milestones set forth in the Business development Plan, including but not limited to (i) a summary of the regulatory activities for the Product, including any material changes in such activities since the prior reporting period, (ii) a summary of the clinical study results for the Compound and the Product, including any material changes in the clinical activities since the prior reporting period, (iii) other development activities for the Licensed Product (which may include material changes in the projected timelines) as deemed appropriate by BIOMEDICA in its reasonable discretion, and (iv) a summary of material planned regulatory and clinical activities for the four (4) calendar quarters following such reporting period; the relevant reporting period shall be the three (3)-month period ending March 31, June 30, September 30 or December 31 of each calendar year preceding such report, as applicable;

4.2.2 During the Interim Period, no later than sixty (60) days after the end of each six (6)-month period ending June 30 and December 31 of each calendar year (semi-annual), BIOMEDICA shall provide written reports to MIP containing the information specified in clause (i) above for the six (6)-month reporting period ending June 30 or December 31 of each calendar year preceding such report and a summary of material planned regulatory and clinical activities for the following two (2) six (6)-month periods ending December 31 and June 30; and

4.2.3 Thereafter, no later than sixty (60) days after the end of each calendar year, BIOMEDICA shall provide written reports to MIP containing the information specified in clause (i) above for each calendar year preceding such report and a summary of material planned regulatory and clinical activities for the following calendar year (each report referred to in clauses (i), (ii) and (iii), a “Development Report”). MIP shall be permitted to disclose summaries of Development Reports provided by BIOMEDICA to MIP.

4.3 Development Efforts. BIOMEDICA shall use Commercially Reasonable Efforts to develop and register the Product and shall be solely responsible for compiling the NDA for each Product in the BIOMEDICA Field at its own expense. BIOMEDICA may request MIP’s involvement with any NDA, and BIOMEDICA shall pay all charges associated with MIP’s assistance on a time and materials basis for any requested involvement by MIP’s personnel.

4.3.1 Medical Symposia, Advisory Boards or other Meetings with Key Opinion Leaders. BIOMEDICA agrees that, if it is planning to hold such a meeting, at least one member of MIP’s management shall have the right to attend (at MIP’s sole expense)

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4.4 Development Committee. The parties shall establish a development committee to review and discuss current material clinical development activities and safety information relating to the Compound and the Product, and review and discuss as appropriate future material clinical development, medical symposia, publications in top peer reviewed journals and regulatory plans for the Compound and the Product. BIOMEDICA and MIP may each appoint up to four (4) members to the development committee.

4.4.1 Development Committee Meetings. Beginning no later than ninety (90) days after the Effective Date, the Development Committee shall meet quarterly through the Initial Period. After the Initial Period the Development Committee will meet semi-annually during the Interim Period. Thereafter, the Development Committee shall meet annually. All meetings of the Development Committee will be timed to follow the receipt of the Reports (as defined in Section 4.2 above) and will be held in person at a mutually agreeable time and location.

4.5 Clinical Trials. BIOMEDICA shall be solely responsible for and shall bear all the costs related to the conduct of clinical trials required to file NDAs in the Territory. BIOMEDICA undertakes to run the clinical trial program in accordance with GCP. MIP retains the right to read and access data from BIOMEDICA’s clinical trial including supporting data for MIP’s NDAs in regions outside the territories.

4.6 Marketing Efforts - Market Launch. BIOMEDICA shall use Commercially Reasonable Efforts to launch and sell the Product in the Territory for as long as this Agreement is in effect. The parties agree to meet and discuss marketing and market launch activities with a post development committee as set forth below in section 4.7.

4.7 Post-Development Committee: Within six (6) months of the Effective Date, the parties shall establish a “Post-Development Committee” to provide information sharing and be a forum for creative discussion and problem solving relating to (i) BIOMEDICA’s pre-launch activities, timelines and pre-commercialization plan ii) sales force development plans and marketing plans (iii) an overview of the market penetration rates by territory and any other relevant issues. Each party shall appoint no more than three (3) members to the Post-Development Committee.

4.7.1 Post-Development Committee Meetings: The first meeting of the Post-Development Committee shall occur within one (1) year of the Effective Date at which meeting time the committee meeting schedule will be determined.

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4.7.2 Post-Development Committee Meeting Expenses. Each party shall bear all expenses of their respective members relating to their participation on the Post-Development Committee.

4.8 Booking Sales. BIOMEDICA shall, at its own expense, book sales of the Compound and the Product as distributed by or on behalf of BIOMEDICA.

4.9 Pricing. BIOMEDICA shall be free to set prices of the Compound and the Product.

4.10 Product Name. Product sold or distributed pursuant to this Agreement shall be sold or distributed under the ONALTA Trademark and all such use shall be governed by the terms provided herein.

4.11 Compound Name. Compound sold or distributed pursuant to this Agreement shall be sold or distributed under the name edotreotide radiolabeling kit for intravenous use and all such use shall be governed by the terms provided herein.

5. CONSIDERATION

5.1 License Fee. Upon execution of this Agreement, in consideration of the exclusivity in negotiations enjoyed by BIOMEDICA prior to execution of this Agreement for the rights granted to BIOMEDICA hereunder, BIOMEDICA shall pay and shall cause to be released to MIP the sum of ****** that the Parties have previously escrowed. In addition, in further consideration of the rights granted herein, BIOMEDICA shall pay to MIP, the additional sum of ****** such payment due upon execution of this Agreement. These initial license payments shall not be credited against any royalty or other payments to be made pursuant to this Agreement, and shall not be refundable.

5.2 Milestone Payments. In consideration of the rights granted to BIOMEDICA by MIP hereunder, BIOMEDICA shall make the following milestone payments to MIP. These milestone payments shall not be credited against any royalty or other payments to be made pursuant to this Agreement, and shall not be refundable unless otherwise indicated. BIOMEDICA shall spontaneously notify MIP of such events upon occurrence thereof, whereupon MIP shall submit an invoice to BIOMEDICA requesting such milestone payment. The payment shall be received by MIP 60 days after the occurrence of such milestone.

5.2.1 ****** shall be due three (3) months after a first sale of the Compound following EMEA approval for or consent to compassionate use of the Compound

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5.2.2 ****** shall be due upon submission of the first NDA by BIOMEDICA in the Territory.

5.2.3 ****** shall be due upon NDA Acceptance in the Territory.

5.2.4 In addition to the amount provided in article 5.2.3, ****** shall be due and payable upon the granting of Marketing Authorization by the EMEA.

5.2.5 The payments under article 5.2.2 and 5.2.3 shall be reduced ****** going forward, or will be retroactively refunded in the amount of ****** of the stated sum if the milestone has already be achieved, upon MIP submitting an NDA or obtaining NDA Acceptance outside of the Territory.

5.2.6 If subsequent to the Effective Date, pursuant to article 2.4 the Parties expand the Territory to include additional countries not specified as part of the Territory as of the Effective Date, and the additional countries generate an incremental increase in Net Sales greater than ****** over the original countries in the Territory, then BIOMEDICA shall not be entitled to the reduction or refund specified in article 5.2.5. In addition, to the extent any refund has been paid by MIP, then BIOMEDICA shall repay the corresponding refunded portion to MIP.

5.3 Additional Milestone Payments. The following milestone payments shall be in addition to those specified in Section 5.2, and shall be payable to MIP in the Calendar Quarter following that in which the milestone is achieved pursuant to article 5.10. The following additional milestones under this article 5.3 shall be cumulative. These additional milestone payments shall not be credited against any royalty or other payments to be made pursuant to this Agreement, and shall not be refundable. The payment shall be received by MIP 60 days after the occurrence of such milestone.

5.3.1 ****** shall be due upon achieving cumulative Net Sales of the Compound and/or the Product in excess of ******;

5.3.2 An additional ****** shall be due and payable upon achieving cumulative Net Sales of the Compound and/or the Product in excess of ******;

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5.3.3 An additional ****** shall be due and payable upon achieving cumulative Net Sales of the Compound and/or the Product in excess of ******; and

5.3.4 An additional ****** shall be due and payable upon achieving cumulative Net Sales of the Compound and/or the Product in excess of ******.

5.4 Contingent Milestone Payments. MIP’s rights under the Novartis Patents, and by extension BIOMEDICA’s license rights thereto, are subject to a one-time Call-Back Option as defined by the Novartis and MIP License Agreement and as essentially set forth below in article 6 herein. The Call Back Option is triggered when aggregate worldwide Net Sales of Product in a Calendar Year first reach ******.

5.4.1 BIOMEDICA shall provide MIP with reasonable advance notice if its sales forecasts project potential Net Sales of the Compound and/or the Product could reach ****** in a Calendar Year.

5.4.2 If worldwide Net Sales of the Compound or the Product reach ****** in a Calendar Year, then BIOMEDICA agrees to fully cooperate with MIP as part of any Novartis due diligence inquiry. BIOMEDICA shall assume all costs associated with its involvement in such due diligence.

5.4.3 Should Novartis decide not to exercise its Call Back Option, then BIOMEDICA shall pay the following contingent milestone payments to MIP on a pro-rata basis as determined by BIOMEDICA Net Sales as a proportion of worldwide Net Sales. Where a previously-triggered contingent milestone payment is triggered in a future year, then ****** shall govern an equitable contribution and credit back to any sublicensee having earlier contributed to such previously triggered contingent milestone payment.

5.4.3.1 ****** once an annual worldwide Net Sales amount of ****** is achieved, payable in two equal installments, the first payment due by January 31 ^st of the Calendar Year following the year in which the milestone is achieved and the second payment 12 months later.

5.4.3.2 An additional ****** once an annual worldwide Net Sales of ****** is achieved, payable in two equal installments, the first payment due by January 31^st of the Calendar Year following the year in which the milestone is achieved and the second payment 12 months later.

5.4.3.3 An additional ****** once an annual worldwide Net Sales amount to ****** is achieved, payable in two equal installments, the first payment by January 31^st of the Calendar Year following the year in which the milestone is achieved and the second payment 12 months later.

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5.5 Royalties. In addition to the license fees set forth in article 5.1 and the milestone payments set forth in articles 5.2, 5.3 and 5.4, and as further consideration for the license rights granted to BIOMEDICA hereunder, BIOMEDICA further agrees to pay to MIP royalties on BIOMEDICA’s and/or its Sub-licensee’s aggregate Net Sales for both the Compound and/or the Product in the Territory, during the Royalty Term at a rate calculated according to the following:

5.5.1 ****** of the annual Net Sales of the Compound and/or the Product for Net Sales amounting to less than ****** annually.

5.5.2 ****** of the Net Sales of the Compound and/or the Product on the incremental sales between ****** and ****** annually.

5.5.3 ****** of the Net sales of the Compound and/or the Product on the incremental sales over ******.

5.6 Royalty Term: Royalties shall be payable quarterly on a country-by-country basis from the First Commercial Sale of the Product until the occurrence of the later of: (i) the expiration of the latest to expire Novartis Patent including any extensions in each such country or (ii) 10 years from First Commercial Sale. Royalty payments shall be received by MIP no later than 30 days from the close of the quarter.

5.7 The Combination Royalty: In the event that the Peptide, Compound and / or Product (“MIP Component”) is formulated with a different or other active ingredient or a second product to comprise a fixed Combination Product, the “net sales” of the MIP Component, for purposes of determining royalty payments to Novartis and MIP, shall be determined by multiplying the Net Sales of the Combination Product by the fraction, A/(A+B), whereas A is the weighted average sales price of the Product (by sales volume) when sold independently and B is the weighted average sales price (by sales volume) of the other product-component when sold independently. In the event the weighted average sales price cannot be determined for either “A” or “B”, the Parties hereto shall agree on an alternative method for calculating “net sales” of the MIP Component of the Combination Product for purposes of calculating royalties to Novartis and MIP. In such event, the Parties shall agree on the methodology prior to submitting the registration dossier for the Combination Product, taking into account relevant factors such as, but not limited to, the relative cost and value contributed by each component weighted proportionally.

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5.8 Equity/Option Rights. In addition to the license fees set forth in article 5.1, the milestone payments set forth in articles 5.2, 5.3 and 5.4, and the royalty payments in article 5.5, and as further consideration for the license rights granted to BIOMEDICA hereunder, MIP is entitled to the following stock option grant and conditions:

5.8.1 BIOMEDICA grants MIP an option to have BIOMEDICA assign, transfer and convey a minority shareholder interest in BIOMEDICA to MIP upon conclusion of and execution of the Comprehensive Agreement:

5.8.2 BIOMEDICA grants MIP an option to have BIOMEDICA assign, transfer and convey a minority shareholder interest in BIOMEDICA to MIP upon EMEA approval.

5.8.3 The amount in equivalent shares which MIP shall have the right to exercise under the option grant in (i) and (ii) above, is exactly ****** of the total, non-diluted interest, in all classes of any issued and authorized shares outstanding in BIOMEDICA at the time of each exercise, assuming a fair market valuation of BIOMEDICA at ****** on the Effective Date of this Agreement;

5.8.4 To the extent B BIOMEDICA’s grant of the option grant in (i) and (ii) above is subject to Board or shareholder approval, BIOMEDICA agrees to, in good faith, seek to secure all necessary approvals, or alternatively, to secure a commitment by a major shareholder for the transfer of its shares to MIP.

5.8.5. BIOMEDICA represents that it believes that it has the legal right to make the above commitments. In the event that such commitments violate applicable Greek or E.U. securities laws or rules, then the above grants may, to the extent possible, be rewritten or amended, consistent with the intent of the parties, to cure any deficiencies therein, and if this is not possible, the commitments are automatically null and void.

5.8.6 In the event of a change of control, bankruptcy or dissolution by MIP, or in the event that MIP desires to transfer or assign any equity interest that it may hold in BIOMEDICA, BIOMEDICA shall have a right of first refusal to buy back all or a portion of MIP’s interest in BIOMEDICA’s equity.

5.9 Sales Reports. After the First Commercial Sale of the Compound or the Product and during the Term of this Agreement, BIOMEDICA shall furnish or cause to be furnished to MIP on a quarterly basis a written report showing the Net Sales of Product in each country in the Territory.

5.9.1 Timing. Each quarterly report shall be due within thirty (30) days following the close of each quarter.

5.9.2 Records. BIOMEDICA shall keep accurate records in sufficient detail to enable the amounts due hereunder to be determined and to be verified by an independent certified public accountant mutually agreed upon by the Parties.

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5.10 Currency Exchange. All royalty payments shall be made in United States Dollars (“USD”). With respect to sales or other dispositions of the Compound or the Product invoiced in a currency other than USD, the Net Sales and amounts due to MIP hereunder will be expressed in USD equivalent calculated on a monthly basis in the currency of the country of sale and converted to their dollar equivalent using the Daily Spot Rate on the last day of the period, published in the Reuters System - Reuters Daily Rates between 09:00 a.m. and 10 a.m. CET.

5.11 Payment Due Date; Accrual. Payments shall be made by wire transfer as directed by the receiving Party or to the address designated herein. Milestones and Royalties which have accrued during any Calendar Year and are required to be shown on a sales report provided under this Article 5 of the Agreement shall be due and payable as set forth in the relevant sections in this Article 5 pertaining to such Milestones and Royalties.

5.11.1 BIOMEDICA and Sub-licensees shall keep for three (3) years from the date of each payment of milestones and royalties, complete and accurate records of sales by BIOMEDICA and Sub-licensees of the Compound and the Product in sufficient detail to allow the accruing payments to be determined accurately.

5.11.2 MIP shall have the right for a period of three (3) years after receiving any report or statement with respect to royalties or milestones due and payable to appoint an independent certified public accountant reasonably acceptable to BIOMEDICA to inspect the relevant records of BIOMEDICA and its Affiliates and Sub-licensees to verify such report or statement. MIP may exercise this right once with respect to each year’s Net Sales. If the right is not exercised during the three (3) year period described, the report shall be deemed accepted. MIP may exercise this right only once in any year.

5.11.3 BIOMEDICA and Sub-licensees shall each make its records available for inspection by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from MIP, solely to verify the accuracy of the reports and payments. Such inspection right shall not be exercised more than once in any Calendar Year.

5.11.4 MIP agrees to hold in strict confidence and use only for the purpose described in this Article 5 all information concerning payments and reports, and all information learned in the course of any audit or inspection (and not to make copies of such reports and information), except to the extent necessary for MIP to reveal such information in order to enforce its rights under this Agreement or if disclosure is required by law, regulation or judicial order. The results of each inspection, if any, shall be binding on both Parties.

5.11.5 MIP shall pay for such inspections, except that in the event there is any upward adjustment in aggregate royalties payable for any year shown by such inspection of more than ****** of the amount paid, BIOMEDICA shall pay for such inspection. Any overpayments shall be fully creditable against amounts payable in subsequent payment periods.

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5.11.6  Any upward adjustment in aggregate royalties payable for any year shown by such inspection of not more than ****** of the amount paid shall not be deemed a Material Breach according to article 11.4, but shall be repayable by BIOMEDICA in full with interest as set forth in article 5.12 and promptly be paid upon MIP’s request.

5.11.7  BIOMEDICA shall include in each sub-license or commercialization agreement entered into by it pursuant to this Agreement a provision requiring the Sub-licensee or commercialization partner to keep and maintain adequate records of sales made pursuant to such sub-license or commercialization agreement and to grant access to such records by the aforementioned independent public accountant for the reasons specified in this article.

5.12 Tax Withholding. All payments pursuant to this Agreement are exclusive of any applicable Value Added Tax. Withholding tax applied by a government of any country of the Territory on payments made by BIOMEDICA to MIP hereunder shall be borne by MIP. BIOMEDICA, its Affiliates and Sub-licensees, shall cooperate with MIP to enable MIP to claim exemption therefore under any double taxation or similar agreement in force and shall provide to MIP proper evidence of payments of withholding tax and assist MIP by obtaining or providing in as far as reasonably possible the required documentation for the purpose of MIP’s returns. BIOMEDICA undertakes to make all payments due under this Agreement that are subject to a withholding tax treatment, including double taxation or similar agreement, from the USA.

5.13 Interest Due. In case of any delay in payment (including underpayment) by BIOMEDICA to MIP not occasioned by Force Majeure, interest on the overdue payment shall accrue at an annual interest rate, compounded monthly, equal to the ******, as determined for each month on the last day of that month, assessed from the day payment was initially due. The foregoing interest shall be due from BIOMEDICA without any special notice.

6. CALL BACK OPTION AND

RIGHT OF FIRST DISCUSSIONS.

6.1 Call Back Option. Subject to the provisions of this article 6, Novartis shall have a one time call back option to re-acquire the rights to the Compound and Product in the event that worldwide Net Sales of the Product first reaches ****** in a calendar year (“Call Back Option”).

6.2 Information. In order to enable Novartis to determine whether it wishes to exercise the Call Back Option, MIP and/or Novartis shall be entitled to perform a full due diligence of all the information reasonably available to BIOMEDICA, at MIP’s and/or

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Novartis’ expense, such information shall include, but not be limited to all relevant clinical data, manufacturing data, marketing data, and other data reasonably needed by MIP for reviewing its interest in exercising the Call Back Option. BIOMEDICA shall give access to MIP or Novartis to all information necessary to complete the due diligence.

6.3 Exercise of Call-Back Option. If Novartis exercises the Call-Back Option (“Call Back Exercise”), the following rights and obligations shall apply as between the Parties:

6.3.1 MIP shall immediately notify BIOMEDICA in writing that Novartis has initiated the Call-Back Exercise.

6.3.2 This Agreement, including the licenses and rights granted by MIP to BIOMEDICA shall terminate and BIOMEDICA shall grant to MIP an exclusive, worldwide license in the BIOMEDICA Field under all BIOMEDICA Know-How and BIOMEDICA’s interest in any Third Party intellectual property if such interest may be conveyed, as necessary for MIP or Novartis to develop, make, use, sell, offer for sale and import the Compound and/or Products, and MIP or Novartis shall conduct (or have conducted) under its control the Commercialization of the Product. BIOMEDICA undertakes to use Commercially Reasonable Efforts to secure sub-license rights under any Third Party intellectual property.

6.3.3 In return for the termination of this Agreement and for the grant of the license in article 6.3.2, following MIP’s receipt of payment by Novartis, MIP shall pay to BIOMEDICA a portion of such Novartis payment in an amount equal to BIOMEDICA’s percent of worldwide Net Sales contribution generated, such payment to BIOMEDICA not to exceed a maximum amount of ****** of the total Novartis payment to MIP. MIP acknowledges and agrees that should a portion of the Novartis payment is due to an additional sublicense of MIP such payment will be owed and paid by MIP.

6.3.4 In the event that Novartis at its sole discretion, decides to involve BIOMEDICA in the further Development of the Compound after Novartis has exercised the Call Back Option, BIOMEDICA and Novartis may discuss the nature and scope of such BIOMEDICA involvement and agree in writing the nature of any further BIOMEDICA involvement, but there shall be no obligation on MIP to do so.

6.3.5 All obligations on BIOMEDICA to pay Milestones as set forth in article 5 which at the time of the Call Back Exercise, are not already due and payable pursuant to article 5, shall lapse.

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6.3.6 For the sake of clarity MIP will not pay BIOMEDICA any other payments or royalties.

6.3.7 Any Third Party sub-licenses granted by BIOMEDICA will be transferred to Novartis.

6.4 Non-Exercise of Call Back Option. If Novartis does not exercise the Call Back Option, this Agreement shall continue but the Contingent Milestones shall be thereafter be due as set forth in article 5.4.

7. INTELLECTUAL PROPERTY

7.1 Inventions and Know-How.

7.1.1 MIP Patent Prosecution. MIP agrees it will not abandon, to the extent under MIP control, any Novartis Patent in any country or region of the Territory.

7.2 Infringement Claims by Third Parties

7.2.1 Notice. If the manufacture, use or sale of Product results in a claim or a threatened claim by a Third Party against a Party hereto for patent infringement or for inducing or contributing to patent infringement (“Infringement Claim”), the Party first having notice of an Infringement Claim shall promptly notify the other in writing. The notice shall set forth the facts of the Infringement Claim in reasonable detail.

7.2.2 Third Party Licenses. In the event the Parties agree that practicing under the Novartis Patents in connection with manufacture, use or sale of the Compound or the Product in a country would infringe a Third Party Patent and a license to such Third Party Patent is available and BIOMEDICA in its sole discretion determines that it requires such a license, the Parties agree that:

7.2.2.1  BIOMEDICA will use commercially reasonable efforts to obtain any such required licenses under the Third Party’s Patents; and

7.2.2.2  In the event that BIOMEDICA obtain any such required licenses from Third Party under which BIOMEDICA shall pay the Third Party certain royalties, BIOMEDICA may deduct such Third Party payment from its royalty payments to MIP under article 5 but in no event will such deductions reduce the Royalty payments in any quarter to MIP by greater than ******.

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7.2.3 Litigation. If a Third Party asserts that a patent, trademark or other intellectual properties owned by it is infringed by the importation, manufacture, offer for sale, use or sale of Compound or Product, or if either Party learns of a claim or assertion that the manufacture, use, marketing, promotion, importation, offer for sale, distribution or sale of Compound or Product infringes or otherwise violates the intellectual property rights of any Third Party, then such Party will promptly notify the other Party in writing. MIP and/or Novartis will have the first right, but not the obligation, to control such defense at their own expense. If MIP/Novartis does not assume control of such defense within 120 days of the notice described above, then BIOMEDICA shall have the right to control such defense at its own expense. In any event, the Party not controlling such defense will have the right to be represented in any such action by counsel of its choosing at its own expense; this includes Novartis. The Party controlling such defense shall keep the other Party advised of the status of such action and shall consider recommendations made by the other Party in respect thereto. The Party not controlling such defense will assist and cooperate in any such infringement litigation at the defending Party’s reasonable request and expense. The costs and expenses (including attorneys’ fees) of any suit brought in accordance with this Article shall be borne by the Party controlling the prosecution of such suit. Any costs borne by BIOMEDICA in accordance with this article shall however be entirely off-set against any payments due to MIP under Article 5.

7.3 Infringement Claims Against Third Parties

7.3.1 Notice. If any Novartis Patents are infringed by a Third Party, the Party to this Agreement first having knowledge of such infringement, or knowledge of a reasonable probability of such infringement, shall promptly notify the other in writing. The notice shall set forth the facts of such infringement in reasonable detail.

7.3.2 Institution of Proceedings. MIP and/or Novartis shall have the primary right, but not the obligation, to institute, prosecute, and control with its own counsel at its own expense any action or proceeding with respect to infringement of the claims of such Novartis Patents. In the event MIP/Novartis does not take any action with respect to any such infringement within 120 days after receiving notice of such infringement thereof, BIOMEDICA may request in writing permission to undertake such defense thereof, at its own expense. The Party undertaking the defense shall have the sole charge and direction of the defense of any such suit or action and the other Party including Novartis shall have the right,

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but not the obligation and at its own expense, to be represented in such action by its own counsel action. Each Party agrees to cooperate fully in the prosecution of any such suit or action undertaken hereunder by the other Party and to provide all evidence in its reasonable control.

7.3.3 Division of Damages Award. Each Party shall recover their respective actual out-of-pocket expenses, or equitable proportions thereof, associated with any litigation or settlement thereof from any recovery made by any Party. Any excess amount allocated as a damage award shall be shared between the Parties as follows: MIP shall be allocated an amount equal to its royalty loss and BIOMEDICA shall be allocated the remainder of damages; any amount allocated as a penalty shall be shared equally between the Parties.

7.3.4 Settlement. The Parties shall keep each other informed of the status of and of their respective activities regarding any litigation or settlement thereof concerning Product; provided, however, that no settlement or consent judgment or other voluntary final disposition of a suit under this article 7 may be undertaken without the consent of the other Party if such settlement would require the other Party to be subject to an injunction or to make a monetary payment or would otherwise adversely affect the other Party’s rights under this Agreement.

7.4 Notice of Certification. MIP and BIOMEDICA each shall immediately give notice to the other of any certification filed under the “U.S. Drug Price Competition and Patent Term Restoration Act of 1984” (or its foreign equivalent) claiming that a Novartis Patent is invalid or that infringement will not arise from the manufacture, use or sale of any Product by a Third Party.

7.4.1 If MIP decides not to bring infringement proceedings against the entity making such a certification, MIP shall give notice to BIOMEDICA of its decision not to bring suit within twenty-one (21) days after receipt of notice of such certification.

7.4.2 BIOMEDICA may then, but is not required to, bring suit against the Party that filed the certification at its own expense.

7.4.3 Any suit by BIOMEDICA or MIP shall either be in the name of BIOMEDICA or in the name of MIP, or jointly in the name of BIOMEDICA and MIP, and further including Novartis as may be required by law.

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7.4.4 For this purpose, the Party not bringing suit shall execute such legal papers necessary for the prosecution of such suit as may be reasonably requested by the Party bringing suit.

7.5 Patent Term Extensions. The Parties shall cooperate in good faith with each other in gaining patent term extension wherever applicable to the Compound or Product. All filings for such extension shall be made by MIP, provided, however, that in the event that if MIP elects not to file for an extension, it shall (i) inform BIOMEDICA of its intention not to file and (ii) BIOMEDICA shall have the right to file for such extension.

7.6 BIOMEDICA New Intellectual Property.

7.6.1 Ownership of BIOMEDICA New Intellectual Property. During the Term of the Agreement, New Intellectual Property shall be owned by BIOMEDICA. BIOMEDICA shall inform MIP of new patent applications and action on them in the report provided by BIOMEDICA to MIP pursuant to section 4.2.

7.6.2 BIOMEDICA shall have the sole right to file, prosecute, and maintain all of the patents within the BIOMEDICA New Intellectual Property included herein, and shall have the right to determine whether or not, and where, to file a patent application, to abandon the prosecution of any patent or patent application, or to discontinue the maintenance of any patent application.

7.6.3 Should MIP terminate this Agreement due to a breach by BIOMEDICA of its obligation hereunder, BIOMEDICA shall grant to MIP a perpetual, world-wide, royalty-bearing, exclusive license to such BIOMEDICA New Intellectual Property, with the right to grant sublicenses, to use any BIOMEDICA New Intellectual Property invented or generated by persons obliged to assign their rights to BIOMEDICA in the BIOMEDICA Field. The royalty rate on the MIPs’ Net Sales of the product shall be determined by the Parties upon termination of the Agreement, shall be based on reasonable commercial terms and in no event shall exceed ****** of the royalty rates payable by BIOMEDICA under section 5.5 of this Agreement.

7.6.4 BIOMEDICA New Intellectual Product that relates to the Product or the Compound may be subject to rights by Novartis, during the Term of this Agreement.

7.7 Trademark.

7.7.1 Generalities. MIP is the owner of all right and title in and to the ONALTA Trademark throughout the Territory including but not limited to all applications therefore and registrations thereof and all goodwill associated therewith.

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*Confidential Treatment Requested*

7.7.2 Use of the Trademarks. BIOMEDICA and/or its Sub-licensee shall promote, market, sell and distribute the Product in the Territory under the Trademark during the Term.

7.7.3 Quality Control Standards; Compliance with Laws: Upon MIP prior written request, BIOMEDICA shall furnish to MIP a sample of products and materials bearing the TRADEMARK. If MIP reasonably and in good faith believes the samples bearing the TRADEMARK do not meet a Minimum Quality Threshold (as defined below), MIP shall notify BIOMEDICA in writing, and MIP shall have a reasonable period of time (but in no event more than 30 days from the date of receipt of notice) to make the changes and/or corrections that the parties mutually agree are necessary to protect the TRADEMARK. For purposes of this Agreement, “Minimum Quality Threshold” shall mean, with respect to each product or advertising material bearing the TRADEMARK, the level of quality necessary to comply: (a) in all material respects, with the respective specifications and technical requirements of MIP’s customers applicable to such product; and (b) in all respects, with all statutory and regulatory standards applicable to such product or product advertising.

7.7.4 BIOMEDICA agrees to cooperate with MIP in facilitating MIP’s control of such nature and quality, to permit reasonable inspection of BIOMEDICA operations, and to supply MIP with specimens of all uses of the ONALTA mark upon request. BIOMEDICA shall comply with all applicable laws and regulations and obtain all appropriate government approvals pertaining to the sale, distribution and advertising of goods and services covered by this license.

7.7.5 BIOMEDICA agrees to use the ONALTA mark only in the form and manner and with appropriate legends as prescribed from time to time by MIP, and not to use any other trademark or service mark in combination with the ONALTA mark without prior written approval of MIP.

7.7.6 Domain Name and Website Agreement provision. The Parties shall enter into a separate Domain name and website agreement within 120 days of the Effective Date I connection with the Onalta domain name.

7.7.7 BIOMEDICA agrees to notify MIP of any unauthorized use of the ONALTA mark by others promptly as it comes to BIOMEDICA’s attention. MIP shall have the sole right and discretion to bring infringement or other proceedings involving the ONALTA mark. BIOMEDICA agrees to cooperate in any investigation or suit in the Territory relating to the ONALTA mark at the expense of MIP.

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8. REPRESENTATIONS AND WARRANTIES

8.1 MIP Representations and Warranties

8.1.1 This Agreement has been duly executed and delivered by MIP and constitutes the valid and binding obligation of MIP, enforceable against MIP in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of MIP, its officers and directors.

8.1.2 As of the Effective Date MIP owns or Controls or otherwise possesses adequate licenses or other rights necessary to make, use and sell the Compound and the Product covered by the Novartis Patents and to grant the sublicenses provided herein; and the granting of the license to BIOMEDICA hereunder does not violate any right known to MIP of a Third Party.

8.1.3 The execution, delivery and performance of this Agreement by MIP does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, and to the best of its knowledge, does not violate any material law or regulation of any court, governmental body or administrative or other agency having authority over it.

8.1.4 MIP has disclosed to BIOMEDICA any and all material information in its Control pertaining to the suitability of Compound as a pharmaceutical candidate.

8.1.5 MIP is not currently a Party to, and during the term of this Agreement will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement. MIP has disclosed to BIOMEDICA that ****** is currently unavailable. Should ****** become available, BIOMEDICA shall have the right, at its option, to expand its Territory to include ******. No upfront payments will be required for BIOMEDICA to exercise this option.

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*Confidential Treatment Requested*

8.1.6 MIP is duly organized and validly existing under the laws of the country of the United States and has full legal power and authority to enter into this Agreement.

8.1.7 MIP is not subject to any order, decree or injunction by a court of competent jurisdiction which prevents or materially delays the consummation of the transactions contemplated by this Agreement.

8.2 BIOMEDICA Representations and Warranties

8.2.1 This Agreement has been duly executed and delivered by BIOMEDICA and constitutes the valid and binding obligation of BIOMEDICA, enforceable against BIOMEDICA in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on the part of BIOMEDICA, its officers and directors;

8.2.2 BIOMEDICA is not currently a Party to, and during the term of this Agreement will not enter into, any agreements, oral or written, that are inconsistent with its obligations under this Agreement;

8.2.3 BIOMEDICA is duly organized and validly existing under the laws of Greece and has full legal power and authority to enter into this Agreement; and

8.2.4 BIOMEDICA is not subject to any order, decree or injunction by a court of competent jurisdiction which prevents or materially delays the consummation of the transactions contemplated by this Agreement.

8.2.5 BIOMEDICA has sufficient credit commitments and/or capital commitments, such that it will be able to develop and commercialize Products within all countries in the Territory, consistent with the scope of and pursuant to the license granted herein.

8.2.6 BIOMEDICA has obtained any approval or consent needed from BIOMEDICA’s shareholders or its Board of Directors, to execute this Agreement and perform the activities specified herein.

8.2.7 BIOMEDICA acknowledges and agrees that MIP is the owner of the ONALTA mark and further agrees that it will do nothing inconsistent with such ownership and that all use of the ONALTA mark by BIOMEDICA shall inure to the benefit of and be on behalf of MIP. BIOMEDICA will not apply to register the ONALTA mark in its own name but shall assist MIP in filing any applications to register the ONALTA mark in the name of MIP or its designated agents, to

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the extent the same have not already been filed, and in recording this Agreement with appropriate government authorities. BIOMEDICA agrees that nothing in this Trademark License or any related document shall give BIOMEDICA any right, title or interest in the ONALTA mark other than the right to use the ONALTA mark in the Territory and consistent with this Trademark License and BIOMEDICA agrees that it will not attack the title of MIP in the ONALTA mark or the validity of this Trademark License.

8.3 THE LIMITED WARRANTIES CONTAINED IN THIS ARTICLE ARE THE SOLE WARRANTIES GIVEN BY THE PARTIES AND ARE MADE EXPRESSLY IN LIEU OF AND EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, INFRINGEMENT OR OTHERWISE, AND ALL OTHER EXPRESS OR IMPLIED REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW, STATUTE OR OTHERWISE ARE HEREBY DISCLAIMED BY BOTH PARTIES.

9. CONFIDENTIALITY

9.1 Confidentiality. Subject to the exercise of the licenses granted in Article 2, during the Term of this Agreement, and for a period of five (5) years thereafter, each Party hereto will maintain in confidence all information generated under this Agreement as well as any information disclosed by the other Party hereto (“Confidential Information”). Neither Party shall use, disclose or grant use of such Confidential Information except as required under this Agreement. Each Party shall use the same standard of care as it uses to protect its own Confidential Information to ensure that its and its Affiliates’ employees, agents, consultants, Sub-licensee(s) and clinical investigators only make use of Confidential Information for the purpose of this Agreement and do not disclose or make any unauthorized use of such Confidential Information. Each Party shall promptly notify the other upon discovery of any unauthorized use or disclosure of Confidential Information.

9.1.1 Confidential Information shall not include any information which and to the extent: was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party; was generally available to the public or otherwise part of the public domain at the time of its disclosure to the other Party; becomes generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; was disclosed to the receiving Party, by a Third Party who had no obligation to the other Party not to disclose such information; or was independently developed by the receiving Party without reference to the disclosure by the other Party.

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9.2 The Parties agree that the material financial terms of the Agreement and the reports described in article 4.2 shall be considered the Confidential Information of both Parties.

9.3 Each Party may disclose the Confidential Information to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, or complying with any applicable statute or governmental regulation provided such Party has given the disclosing Party prompt written notice allowing it to limit such disclosure. In addition, either Party may disclose Confidential Information to its Affiliates and to its Sub-licensees; provided, however, in connection with any such disclosure the disclosing Party shall secure confidential treatment of such Confidential Information.

9.4 The Parties shall undertake to ensure that all their employees who have access to Confidential Information of the other Party are under obligations of confidentiality fully consistent with those provided in this article.

9.5 BIOMEDICA agrees that the Confidential Information it receives, including but not limited to the financial information, may be disclosed by MIP to Novartis without further notice, provided that Novartis shall be subject to the same confidential obligations as MIP, as set forth herein.

10. ANNOUNCEMENT, PUBLICITY AND PUBLICATIONS

10.1 Except with the prior written consent of the other Party not to be unreasonably withheld, neither Party hereto shall make any disclosure to any third Party except Affiliates concerning the terms of this Agreement. Each Party will inform the other prior to the disclosure of this Agreement or any of its terms to any government authorities or agencies and will observe all reasonable requirements of the other in regard to any such disclosure. In addition, MIP may make a public statement, including in analyst meetings, concerning this Agreement or the progress of the Product, at MIP’s discretion including but not limited to the events described in Exhibit D. The restrictions on disclosure specified herein shall not apply to announcements required by law or regulations or stock exchange rules, including announcements required by law, regulations or stock exchange rules to be made by either Party to their respective shareholders. It is, however, the Parties’ intent that they will co-ordinate to such extent as may be reasonably possible with respect to the wording of any such announcements and that the financial terms of this Agreement shall not be made public.

10.2 BIOMEDICA will, and will cause its Sub-licensees to obtain MIP’s prior written permission to use MIP’s name, symbols and any other marks in any form of publicity.

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10.3 None of BIOMEDICA, its Affiliates, or any of its or its Affiliates’ or present any information, including, without limitation, the results of any work performed under the Agreement, or preclinical or clinical studies with respect to the Compound or Product, without MIP’s prior written consent. Neither party shall have the right to publish or present Confidential Information of the other party.

11. TERM AND TERMINATION

11.1 Term. Unless earlier terminated as provided under article 6, 11.2 or 11.3 the term of this Agreement shall commence as of the Effective Date and shall remain in full force and effect on a country-by-country basis until the end of the last to expire payment obligations of BIOMEDICA under article 5.6 (“Term”).

11.2 Accrued Obligations. Except where explicitly provided elsewhere herein or in any applicable laws, termination of this Agreement for any reason, or expiration of this Agreement, will not affect: (i) obligations, including the payment of any royalties or other sums which have accrued as of the date of termination or expiration, and (ii) rights and obligations which, from the context thereof, are intended to survive termination or expiration of this Agreement.

11.3 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.

11.4 Material Breach. If either Party is in breach of any material obligation hereunder and, in the case of a breach capable of remedy, it shall not have been remedied by the defaulting Party within sixty (60) days of written notice specifying the breach and requiring its remedy, the Party not in breach of the material obligation may forthwith terminate this Agreement by notice without prejudice to the accrued rights of either Party.

11.5 Change of Control. MIP may be forced to terminate this Agreement in the event that Novartis exercises its right in the MIP_NOVARTIS License Agreement to terminate caused by change of control of MIP by a Direct Competitor of Novartis. MIP shall upon signing of this Agreement use its best efforts to seek to obtain a commitment from NOVARTIS that this Sub-license Agreement and any similar sub-license agreements related to the Compound and the Product shall survive any termination of the MIP-NOVARTIS Agreement under this section so as to reasonably protect the investment and expectations of all sub-licensees.

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11.6 Effect Of Termination.

11.6.1  Effect On License. Upon the expiration or earlier termination of this Agreement, the rights licensed under this Agreement shall be treated as follows:

11.6.1.1  Upon expiration of the Term, BIOMEDICA shall have a fully paid-up, perpetual, irrevocable, royalty-free, transferable, worldwide, non-exclusive right and license under the Novartis Patents and Know-How existing as of the date of such expiration to make, use, offer to sell, import and sell Product in the Territory.

11.6.1.2  Upon early termination pursuant to article 6, 11.2, 11.3 or 11.4, all rights to the Compound and Product shall revert to MIP, including but not limited to the licenses granted under article 2.1 and 2.2.

11.6.2  Effect On Trademark.

11.6.2.1  Upon expiration of the Term, BIOMEDICA and/or its Sub-licensee may continue to use the Trademark in connection with the sale of the Product.

11.6.2.2  Upon early termination of this Agreement by MIP pursuant to article 11.2, 11.3 or 11.4, all the rights to use the Trademark(s) shall revert to MIP. BIOMEDICA agrees to immediately discontinue all use of the ONALTA mark and any term confusingly similar thereto, and to delete the same from its corporate or business name, to cooperate with MIP or its appointed agent to apply to the appropriate authorities to cancel recording of any trademark license from all government records, to destroy all printed materials bearing the ONALTA mark or return the same to MIP at MIP’s sole discretion, and that all rights in the ONALTA mark and the good will connected therewith shall remain the property of MIP.

11.6.3  Ongoing Obligations.

11.6.3.1  Upon expiration or termination of this Agreement for any reason, each Party shall immediately return to the other Party or destroy any Confidential Information disclosed by the other Party, except for one copy which may be retained to determine its continuing obligations pursuant to this Agreement.

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11.6.3.2  Upon early termination by MIP pursuant to article 11.2, 11.3 or 11.4 above, BIOMEDICA shall have no further right to use or refer to the Know-How, and BIOMEDICA shall transfer to MIP all documentation embodying or referring to the Know-How.

11.6.3.3  Upon early termination by MIP pursuant to articles 11.2, 11.3 or 11.4 above and at MIP’ election, BIOMEDICA will immediately transfer ownership of all Marketing Authorizations and shall give an access right to all clinical development, regulatory and manufacturing data, as well as to all other relevant information to MIP, which shall be free to use it.

11.6.3.4  Upon early termination by MIP pursuant to article 11.2, 11.3 or 11.4 above, BIOMEDICA shall transfer to MIP upon MIP’ request all its stock of Compound and Product at cost.

11.6.3.5  Upon early termination of this Agreement by MIP pursuant to article 11.2, 11.3 or 11.4 above and at MIP’s election, BIOMEDICA shall grant and hereby grants to MIP, the right to use any BIOMEDICA pre-clinical and clinical trial results, regulatory files and filings related to Product and Compound. In addition, BIOMEDICA shall provide at MIP’ request, the reasonable assistance of appropriate BIOMEDICA personnel in connection with the transfer therewith.

11.6.3.6  Inventory. Notwithstanding the foregoing, upon early termination of this Agreement pursuant to articles 11.2 or 11.3 but not under article 6, BIOMEDICA shall have the right to sell all remaining Product in its inventory within six (6) months after the date of termination, subject to the payment to MIP of the amounts specified in article 5. Thereafter, BIOMEDICA agrees to destroy any remaining supply of Product at MIP’s request.

12. INDEMNIFICATION AND INSURANCE

12.1 BIOMEDICA will indemnify, defend and hold MIP and Novartis harmless from and against any and all costs, losses, claims, liabilities, fines, penalties, damages, expenses, court costs, interest, and reasonable fees and disbursements of counsel,

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consultants, and expert witnesses (“Damages”) incurred or suffered by MIP arising out of or resulting from: (i) BIOMEDICA’s breach of a material term if this Agreement; (ii) BIOMEDICA’s breach of any of its representations or warranties hereunder; or (iii) the development, handling, use, marketing, sale or other disposition, of Compound and/or Product by any of BIOMEDICA, its Affiliates, Sub-licensees, and their contractors in the BIOMEDICA Field except to the extent that such Damages are due to MIP’s or MIP’s directors, officers, employees, or Affiliates negligence or willful misconduct.

12.2 MIP will indemnify, defend and hold BIOMEDICA harmless from and against any and all Damages incurred or suffered by BIOMEDICA arising out of or resulting from: (i) MIP’ breach of a material term if this Agreement; (ii) MIP’s breach of any of its representations or warranties hereunder or failure to perform duly and punctually any of its covenants, agreements, or undertakings contained in this Agreement; except to the extent that such Damages are due to BIOMEDICA’s or BIOMEDICA’s directors, officers, employees, or Affiliates negligence or willful misconduct.

12.3 The Parties agree as follows:

12.3.1  Each Party shall give the other Party prompt written notice of any claim or threat of claim it receives with respect to any matter for which it may be entitled to indemnification, and the indemnifier shall thereafter defend or settle any such claim at the indemnifier’s sole expense, with counsel selected by the indemnifier. In the defense or settlement of any such claim, the indemnified Party shall co-operate with and assist the indemnifier to the extent reasonably possible, but the indemnifier shall bear and pay any and all expenses incurred by the indemnified Party in providing such co-operation and assistance, either directly or upon request of the indemnified Party who has incurred such expense. Failure to give notice shall not constitute a defense, in whole or in part, to any claim by any indemnified person hereunder except to the extent the rights of the indemnifier are materially prejudiced by such failure to give notice.

12.3.2  Notwithstanding the foregoing, upon any claim being made by a person not a Party to this Agreement (and not an Affiliate of a Party) with respect to any matter to which the foregoing indemnities relate, the indemnified Party may make settlement of such claim on not less than 30 days prior written notice of the proposed terms thereof to the indemnifier; provided, however, that if within said 30-day period the indemnifier shall have requested the indemnified Party not to settle such claim and to deny such claim, the indemnified Party will promptly comply and the indemnifier shall have the right to defend the claim at the indemnifier’s sole expense and with counsel reasonably acceptable to the indemnified Party. In the event that the indemnifier has not responded to such notice within such 30-day period, such absence of response shall be deemed a written consent to the proposed settlement.

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12.3.3  Notwithstanding that the indemnifier has assumed the defense of any claim with counsel selected by the indemnifier, the indemnified Party shall have the right to employ its own counsel, at its sole expense. If, in good faith, an indemnified Party concludes that there are specific defenses available to the indemnified Party which are different from or in addition to those available to the indemnifier with respect to the scope of the foregoing indemnities, then such indemnified Party shall have the right to direct the defense of any such defense of any such claim and each Party shall pay all its own costs, fees and damages.

12.3.4  Neither Party will conduct itself in a way that could prejudice the defense of any such claims or threats.

12.4 References in this Article 12 to a Party that may be entitled to indemnification shall also include its Affiliates and its and their officers, directors, employees and agents.

12.5 The Parties agree to maintain insurance, including but not limited to product liability insurance and Clinical Trial insurance in the case of BIOMEDICA, with respect to their activities hereunder. Such insurance shall be in such amounts and subject to such deductibles based upon standards prevailing in the industry at the time. The Parties may satisfy its obligations under this article through self-insurance to the same extent.

12.6 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.

12.6.1  In the event of a material breach by MIP of this Agreement then BIOMEDICA’s royalty rate under this Agreement to MIP is reduced by ******.

13. INFORMATION ON CLINICAL SAFETY

AND PHARMACOVIGILANCE

13. BIOMEDICA shall be fully responsible for ensuring regulatory compliance with all pharmacovigilance obligations, including the holding and maintaining of a safety database for the Compound and the Product including post marketing surveillance. Within thirty days (30) of the Effective date, MIP will provide a copy of any existing global safety database relating to the

36

*Confidential Treatment Requested*

Product to BIOMEDICA. BIOMEDICA will be responsible to communicate and forward all drug safety information including those events which require expedited reporting under FDA and EMEA regulations, relating to both the Compound and the Product to MIP and to the relevant regulatory authorities as dictated by their safety report regulations. BIOMEDICA will provide on an annual basis commencing one year from the Effective Date a summary report of the clinical and non-clinical safety experience, format to be provided by MIP. Conversely, MIP will provide reciprocate communication of all ongoing and future drug safety data.

14. GOVERNING LAW AND JURISDICTION

14.1 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. If Novartis is joined or is otherwise named as a defendant in any suit under this Agreement, then the Parties agree to waive their rights to defend such suit in the above venues, and instead submit to exclusive jurisdiction in the courts of Basel-Stadt, Switzerland and further agree that Swiss Law shall control interpretation of this Agreement in such proceeding.

15. MISCELLANEOUS PROVISIONS

15.1 Waiver. The failure on the part of BIOMEDICA or MIP to exercise or enforce any rights conferred upon it hereunder shall not be deemed to be a waiver of any such rights nor operate to bar the exercise or enforcement thereof at any time or times thereafter. The observance of any term of this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) by the Party entitled to enforce such term, but any such waiver shall be effective only if in writing signed by the non-waiving Party.

15.2 Force Majeure. Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement, other than an obligation to make a payment, when such failure or delay is caused by or results from fire, floods, embargoes, government regulations, prohibitions or interventions, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes,

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lockouts, or any other cause beyond the reasonable control of the affected Party. If a force majeure circumstance persists for more than 12 months, the Parties shall discuss in good faith about termination of this Agreement.

15.3 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.

15.4 Government Acts. In the event that any act, regulation, directive, or law of a government, including its departments, agencies or courts, should make impossible or prohibit, restrain, modify or limit any material act or obligation of BIOMEDICA or MIP under this Agreement, the Party, if any, not so affected shall have the right, at its option, to suspend or terminate this Agreement as to such country, if good faith negotiations between the Parties to make such modifications to this Agreement as may be necessary to fairly address the impact thereof, after a reasonable period of time are not successful in producing mutually acceptable modifications to this Agreement.

15.5 Assignment. This Agreement and any NDA or Marketing Authorization described herein 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 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.

15.6 Counterparts. This Agreement may be executed in two copies, both of which shall be deemed to be originals, and all of which shall constitute one and the same Agreement.

15.7 No Agency. Nothing herein contained shall be deemed to create an agency, joint venture, amalgamation, partnership or similar relationship between MIP and BIOMEDICA. Notwithstanding any of the provisions of this Agreement, neither Party shall at any time enter into, incur, or hold itself out to third Parties as having authority to enter into or incur, on behalf of the other Party, any commitment, expense, or liability whatsoever, and all contracts, expenses and liabilities undertaken or incurred by

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one Party in connection with or relating to the development, manufacture or sale Compound or Product shall be undertaken, incurred or paid exclusively by that Party, and not as an agent or representative of the other Party.

15.8 Notice. All communications between the Parties with respect to any of the provisions of this Agreement will be sent to the addresses set out below, or to other addresses as designated by one Party to the other by notice pursuant hereto, by internationally recognized courier or by prepaid certified, air mail (which shall be deemed received by the other Party on the seventh Day following deposit in the mails), or by facsimile transmission or other electronic means of communication (which shall be deemed received when transmitted), with confirmation by letter given by the close of business on or before the next following day.

15.8.1  If to MIP, at:

Molecular Insight Pharmaceuticals, Inc.

160 Second Street

Cambridge, MA 02142 USA

Attn: Paul Granger, General Counsel

15.8.2  If to BIOMEDICA at:

BioMedica Life Sciences, Ltd.

4 Papanikoli Str.,

15232 Halandri, Athens, Greece

Attn: Ioannis Vitsaras, CEO

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

15.10 Headings. The paragraph headings are for convenience only and will not be deemed to affect in any way the language of the provisions to which they refer.

15.11 Costs. Each Party shall be responsible for its own costs and expenses incurred in connection with negotiation and execution of this Agreement. Unless otherwise specifically provided for herein, each Party shall bear all costs and expenses it incurs in its’ performance of this Agreement.

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15.12 Entire Agreement. This Agreement shall supersede any prior agreement between the Parties and constitutes the entire understanding of the Parties relating to the matters referred to herein, and may only be amended by a written document, duly executed on behalf of the respective Parties. However the terms of the Novartis License Agreement shall prevail over any conflicting terms contained in this territory license Agreement or the LOI.

—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/ Daniel Peters
Title:	President & CEO	Title:	President & CEO

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EXHIBIT A

BIOMEDICA BUSINESS PLAN

CONFIDENTIAL-UNAUTHORIZED

DUPLICATION PROHIBITED

Onalta™ Europe Business Plan

Prepared For

Biomedica Life Sciences S.A.

4, Papanikoli Str

15232, Halandri

Athens, Greece

Phone: +30.210.689.9801

Fax: +30.210.689.9809

Contact:

Yannis Vitsaras, CEO

Phone: +30.210.689.9807

Vitsaras@biomedica.gr

BioMedica Onalta^™ Business Plan© 29.07.09 Page 1 of 31 CONFIDENTIAL

Table of Contents

Overview of BioMedica Life Sciences S.A.	4
Company Profile	4
Key Products	4
Radiopharmaceutical Products	4
Cold Kits	5
Radioimmunoassay (RIA) Products	5
Precursors for Medical Imaging	5
Crystal Probe 2000	5
Current R&D Programs	5
Corporate Structure	6
BioGenomica S.A.	6
BioRP	6
Demokritos National Scientific Research Center	6
Management Team	7
Key Financials	8
Projected 2009 Sales & EBIT (without Onalta™)	8
Current Debt Structure	8
Cash Position	8
Cash Flow	8
Historical Financials	9
Projected Cash Flows (pre-Onalta™)	10
BioMedica’s Five Year Business Plan	11
Vision Statement	11
Tactics to be Employed by BioMedica	11
Role of Onalta™ in Five Year Business Plan	12
Role of Demogastrin™ and Other Products in BioMedica’s Five Year Business Plan	13
Demogastrin™	13
BioGenomica	13
Onalta™ Revenue Projections	14
Source of Funds Required for Development and Commercialization of Onalta™	17
Primary Immediate Source of Funds	18
Secondary Near-term Source of Funds	18
Tertiary, Longer-term Source of Funds	19
Onalta™ Development and Commercialization Plan	20
Onalta™ Development Plan	20
Timeline & Budget	20
Phase 3 Clinical Study	21
Proposed Phase 3 Study Sites	21
Commencement of Development Activities	22
Organizational Structure & Staffing	22
MIP involvement in the European Phase 3 Clinical Development of Onalta™	23
Named Patient Program	23
Overview and Responsibilities	23
Pricing	24
Timing	25
MIP Involvement	25
Regulatory Affairs	25
Manufacturing and Distribution	26
Sales and Marketing	27
Reimbursement Strategy	30
Consolidated Cash Flow	31

BioMedica Onalta^™ Business Plan© 29.07.09 Page 2 of 31 CONFIDENTIAL

Table of Figures:

Figure 1. BioMedica Historical Financials	9
Figure 2. Cash & Cash Equivalents at end of Period	10
Figure 3. Onalta™ Revenue Projections	16
Figure 4. Forecasted Cash Requirements	17
Figure 5. Cash Requirements vs. Secured Financing	19
Figure 6. Onalta™ Clinical Development Timeline and Costs	20
Figure 7. Proposed Phase 3 Clinical Trial Centers	21
Figure 8. Named Patient Program Pricing	24
Figure 9. Named Patient Program Event Timeline	25
Figure 10. Manufacturing & Distribution Timeline	27
Figure 11. Designated Hub Countries in Europe and Middle East	28
Figure 12. Type-2 Hub Countries and their Respective Spoke Countries	28
Figure 13. Type-1 Hub Countries and their Respective Spoke Countries	29
Figure 14. Sales and Marketing Critical Event Timeline	29
Figure 15. Onalta™ Product Pricing	30
Figure 16. BioMedica Consolidated Cash Flows (w/ Onalta™)	31

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Overview of BioMedica Life Sciences S.A.

Company Profile

Established in 1987 in Athens, Greece, BioMedica Life Sciences S.A. is a privately held research, early and late stage development focused company in the emerging field of nuclear medicine. Since its inception over two decades ago, BioMedica has grown to become Hellenic market leader in diagnostic and therapeutic radiopharmaceutical products and services.

Three strategic imperatives drive BioMedica’s business efforts:

• Development and commercialization of innovative radiopharmaceutical products and services through internal R&D efforts

• Sourcing late stage radiopharmaceutical diagnostics and therapies for development and commercialization in Europe and The Middle East

• Strengthening research partnerships with Greek academic institutions and research centers

Key Products

BioMedica is the Greek license holder of Octreoscan^™ (Covidien), an ¹¹¹In molecular imaging agent for scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors. BioMedica is also sole EU license holder of Rebone^™ (MDS-Nordion) ¹⁸⁶Re, indicated for palliative treatment of painful bone metastases.

Radiopharmaceutical Products

• ¹²³I

• ¹³¹I

• ¹¹¹In

• ²⁰¹TI

• ⁹⁹Mo and ^99MTc

• Octreoscan^™

• Rebone^™

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Cold Kits

• TechneScan^™ DMSA : Renal cortex scintigraphy

• TechneScan^™ DTPA : Nephrological and urological disorders scintigraphy

• TechneScan^™ HDP : Bone scintigraphy

• TechneScan^™ LyoMAA :Lung perfusion scintigraphy

• TechneScan^™ MAG3: Renal scintigraphy

• TechneScan^™ PYP : Gastrointestinal bleeding scintigraphy

Radioimmunoassay (RIA) Products

• OR 68713 Cortisol

• BC 19000 Free Testosterone

• BC 1012 Human Growth Hormone

Precursors for Medical Imaging

• Cyclic 57Co

• MARKERS

• Flood sources 57Co

Crystal Probe 2000

• Laparoscopic – Intra-Operational Gamma-Ray Detection Probe

Current R&D Programs

BioMedica has a proven track record in radiopharmaceutical product and clinical development as demonstrated by its successful, ongoing, clinical programs:

• Demogastrin^™: Minigastrin analog labeled with ^99MTc

• First Greek company to file a successful EMEA submission

• Granted EMEA orphan drug designation in 2006

• Initiating Phase II clinical trials in Europe

• Demobesin-6: 99mTc-labeled bombesin analogs (antagonists)

• In Phase I clinical trials in Europe

• RASP^™: Retinoid conjugates

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• In pre-clinical evaluation

• Development of novel resins for solid phase peptide synthesis

Corporate Structure

In addition to its core radiopharmaceuticals business, BioMedica is actively involved in the development and commercialization of complementary products and services through its subsidiaries, as well as strategic alliances with Hellenic academic and research centers.

BioGenomica S.A.

BioMedica is majority shareholder of BioGenomica, a biotechnology company established in 2004 as a spin-off from The National Scientific Research Center (Demokritos) to provide a wide range of highly specialized genetic testing services:

• Molecular analysis of disease predisposing genes

• Genotyping

• Molecular cytogenetic analysis

BioRP

BioMedica is the majority shareholder of BioRP, a biotechnology company established in 2007 as a spin-off from The National Scientific Research Center (Demokritos). It is engaged in development and production of novel radiopharmaceutical imaging and therapeutic products based on innovative peptide derivative research.

Demokritos National Scientific Research Center

Strategic alliance with BioMedica since 2001 focuses on research and development of novel peptides with commercial applications in nuclear medicine. Demokritos is the oldest and largest scientific research center in Greece and operates the country’s single nuclear reactor.

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Management Team

BioMedica has a highly experienced and seasoned senior management team with a successful track record in nuclear medicine.

• Yannis Vitsaras: CEO

• Major share holder of Biomedica. Previously Sales Manager of Medgenix Greece. Studied mathematics and trained in radiopharmacy

• Dr. S. Georgopoulou MD: CSO

• Medical pathologist with over 12 years experience. Previously Medical Director of Roche Greece

• Mr. D. Protogirou MSc Eng. MBA: CFO

• Over 10 years experience as CFO in several telecommunication companies

• Dr. N. Tsiakkas MD: Regulatory

• Previously Regulatory Director at Astra Zeneca. Founded Medworks, leading CRO in Greece

• Ms. M. Anagnou: Marketing

• Has held management positions in marketing at Roche prior to joining BioMedica

• Dr. D. Psimadas: Radiopharmacist

• Post Doctoral Fellow at Demokritos National Scientific Research Center

• Prof. P. Kordopatis: Peptide Chemistry

• Full Professor of Pharmacology at Patras University. Specialized in Peptide Chemistry

• Dr. P. Kaldrimides: Endocrinologist

• Director of Endocrinology Clinic of METAXA Anticancer Hospital of Athens

• Prof. V. Georgiou: Nuclear Medicine

• Full Professor of Medical Physics at Athens University

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Key Financials

BioMedica has grown into a high-growth, sustainable, and profitable business in the two decades since its formation in 1987. BioMedica has increased annual sales turnover by ****** over this period has been driven by improved sales and marketing efforts for existing radiopharmaceutical products and services, as well as a growing contribution from BioGenomica’s high-growth, high-margin, genetic testing business. This business is expected to contribute ****** of revenue in 2009.

Projected 2009 Sales & EBIT (without Onalta™)

BioMedica forecasts ****** in 2009 sales delivering an estimated EBIT of ******.

Current Debt Structure

• Long-term debt of ****** loan to complete construction of BioMedica’s new headquarters in Athens, Greece

• Short-term debt of ****** to “factor” payables: owed to banks unconditionally backed by receivables from the Government of Greece (see cash flow)

Cash Position

On July 27, 2009 BioMedica had ****** in cash & cash equivalents with an additional ****** in available credit.

Cash Flow

The Government of Greece is the sole payer of healthcare product and service reimbursements in Greece. It is an accepted, albeit burdensome, cost of doing business in the Greek healthcare sector that providers of products and services are required to factor receivables from the Government of Greece through banks at an historic rate of approximately 5%-6% per annum.

This arrangement creates an apparent negative cash flow according to GAAP accounting principles since receivables are all factored under this arrangement which appears in financial statements as short term debt.

* Confidential Treatment Requested *

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Historical Financials

Figure 1. BioMedica Historical Financials

*****

BioMedica has demonstrated consistent growth in turnover and gross operating income over the past five years. Net results have been positive throughout the period.

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Projected Cash Flows (pre-Onalta™)

Figure 2. Cash & Cash Equivalents at end of Period

*****

The growth trajectory of BioMedica’s existing product portfolio will drive an increasing availability of cash to fund operations and drive expansion through in-licensing, acquisition and internally driven innovation.

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BioMedica’s Five Year Business Plan

Vision Statement

BioMedica is committed to transformation, within the next five years, from the leading radiopharmaceutical sales and distribution company in the Southern European/Hellenic region to the leading Pan-European, radiopharmaceutical development, sales & marketing, and distribution company, focused in PET, SPECT, and therapeutic products delivered by targeting molecules

Tactics to be Employed by BioMedica

1. Successful launch and commercialization of Onalta™ in the targeted territories in Europe, Middle East and Mediterranean Rim

2. Completion of Demogastrin™ clinical development and successful European launch *****

3. Ongoing external sourcing of products, both by in-licensing and acquisition, to expand BioMedica’s radiopharmaceutical portfolio and contribute to increasing credibility in development and commercialization capabilities

4. Leveraging its current domain-knowledge and extensive participation in radiopharmaceuticals associated with fourteen medical specialties

5. Initiation of internal development programs for radiopharmaceutical products for European markets

6. Continued growth and expansion of BioGenomica, its current high margin genomic testing subsidiary business, in key European territories to provide funds for investment in the radiopharmaceutical business

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Role of Onalta™ in Five Year Business Plan

Pan-European growth in its business resulting from the successful development and commercialization of Onalta™ is a critical component in BioMedica’s strategy to transform from a Southern European/Hellenic centric company to a Pan European leader in its markets. Onalta’s success will be dependent upon a flawless execution by Biomedica of three critical objectives:

1. Roll-out of compassionate use program throughout the targeted territories

a. Complete shut-down of existing DOTATOC supply channels and strict ongoing enforcement of such closure, through enforcement of patents and supply agreements

b. Smooth transfer of all current DOTATOC users to purchase of product from BioMedica as the sole source supplier

c. Consistent and timely supply of DOTATOC through named patient programs in the licensed territories

2. Excellence and detailed compliance to protocol in clinical development

a. Execution of Phase 3 Clinical Trial in Europe in compliance with protocol(s), endpoints and guidelines through tight management of experienced radiopharmaceutical CRO(s). This program will be coordinated with MIP as part of a global development effort

b. EMEA MAA submission coordinated with MIP and the global development objectives for Onalta™. This submissions will meet or exceed the guidelines set forth for the Onalta™ study

c. Secure market approval

3. Effective, phased, coordinated commercialization throughout the targeted territories upon approval by respective European regulatory agencies

a. Expansion of distribution capabilities

b. Successful negotiation of country by country reimbursement, utilizing leaders in the filed and advancing reimbursement from “high price” to “lower priced” markets

Biomedica projects that the successful execution of these key elements will result in near-term, longer-term, and sustainable value to BioMedica and will result in the phased roll-out of critical resources and competencies necessary for the planned expansion of Biomedica in Europe:

1. Specific clinical development expertise and the demonstrated ability to manage development stage products through the development process, leading to European marketing approval of radiopharmaceutical products

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2. Regulatory expertise, and the demonstrated ability to navigate European regulatory approval processes successfully, confirming the ability to manage an expanding product development and commercialization effort

3. Product sourcing and distribution capabilities for radiopharmaceuticals throughout Europe and rest of world

By building upon the success of Onalta™, BioMedica plans to exploit its experience to target new diseases, develop novel treatment options for these diseases, and commercialize new products for patients on a pan-European scale.

Role of Demogastrin™ and Other Products in BioMedica’s Five Year Business Plan

Demogastrin™

Demogastrin™, BioMedica’s radiopharmaceutical product directed at the diagnosis of medullary thyroid carcinoma, is entering phase II/III clinical trials. Marketing approval and commercialization in Europe is expected within *****, at which point Demogastrin™ will utilize the operational sales, marketing and distribution channels created for Onalta™ to improve the operating margins of Demogastrin™ and Onalta™. Commercialization of Demogastrin™ will significantly enrich BioMedica’s product portfolio, further confirm the clinical development and regulatory skills and experience of the company, and establish BioMedica’s position as an innovator in radiopharmaceuticals.

BioGenomica

BioMedica currently enjoys a leading position in the genomic testing market in Southern Europe, with strong growth expected from BioGenomica, the company’s high margin genetic testing subsidiary. Revenue growth is expected to reach *****, enjoying operating profit margins of *****, and contributing ***** to BioMedica’s overall EBIT each year. BioGenomica’s cash contributions will be utilized to support BioMedica’s growth in radiopharmaceuticals business in Europe.

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Onalta™ Revenue Projections

BioMedica projects Onalta™ sales will reach *****. The following assumptions underpin these projections:

Assumptions

1. Revenue:

a. *****

b. *****

c. *****

d. *****

2. COGs: Projections have utilized the higher end of the acceptable sector benchmark of ***** of sales across all markets, and all products

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3. Administrative Expenses:

a. *****: Limited resources are required to achieve sales objectives. BioMedica will establish European presence by opening an office in Germany and begin recruitment of key management

b. ***** administrative offices and facilities will be fully-recruited, with costs covered from operating revenues and capital commitments secured for Onalta™ development and commercialization. Sales and marketing staff will be hired as growth objectives dictate, with payroll costs reflecting usual and customary market rates

4. Sales and Distribution Expenses

a. *****

b. *****

5. Clinical Development Expenses: Established as highest priority for Biomedica and is fully funded by dedicated funds raised

a. *****

b. *****

c. *****

d. *****

6. Other Expenses

a. *****

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b. ******

Figure 3. Onalta™ Revenue Projections

******

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Source of Funds Required for Development and Commercialization of Onalta™

Forecasted capital expenditures upon execution of the Onalta™ comprehensive agreement total ***** over the initial *****. Cash requirements in 2009 are projected to be ***** and includes the payment additional upfront obligations to Molecular Insight Pharmaceuticals, compassionate use licensing fees, clinical development payments as well as costs associated with salaries, facilities and marketing. Cash requirements for 2010 are projected to be ***** and include payment for clinical development, and costs associated with marketing, salaries and facilities.

Figure 4. Forecasted Cash Requirements

*****

Funding to meet forecasted cash requirements has been secured through multiple sources and provides cash in immediate, near-term and intermediate-term time frames. Expenses will be covered by the secured funding and interest payments will be covered from BioMedica operating revenues from its core business (projected 2010 EBIT of ***** excluding contributions from Onalta™ sales for the initial period of *****.

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Primary Immediate Source of Funds

BioMedica has secured immediate funding from three institutions to cover the cash requirements for Onalta™ development. These funds will become available upon execution of the Onalta™ comprehensive agreement with MIP.

1. ***** of Greece has committed to provide *****

a. Letter of commitment will be issued by July 31, 2009

i. ***** is earmarked to pay Licensee fees due upon signature of final agreement with MIP

ii. ***** is earmarked to cover first quarter cash requirements for Onalta™ development.

2. ***** of Greece has committed to provide ***** to BioMedica to support Onalta™ development

3. ***** of Greece has committed to provide ***** to BioMedica to support Onalta™ development

Secondary Near-term Source of Funds

BioMedica has secured additional sources of funding which will become available upon the execution of the Onalta™ Comprehensive Agreement and will accessed to supplement primary sources of funds as circumstances demand. The committed institutions include:

1. ***** - available by early November 2009 (commitment expected in early September)

2. ***** in additional funding upon request (commitment in place)

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3. BioMedica EBIT: BioMedica has committed to utilize its free-cash flow from its projected annual *****

Tertiary, Longer-term Source of Funds

An additional ***** will be available to BioMedica upon execution of Onalta™ comprehensive agreement, and as needed in the longer term, from leading private and institutional banks in Europe and Greece. These commitments will be announced in late 2009 and 2010.

1. *****

2. Other Leading Institutional Banks in Greece and Europe

Figure 5. Cash Requirements vs. Secured Financing

*****

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Onalta™ Development and Commercialization Plan

Onalta™ Development Plan

The successful clinical development and regulatory approval strategy elements for Onalta™ in the EU involve completion of a pivotal Phase 3 clinical trial utilizing oversight by a clinical research organization (CRO such as ABX) that specializes in execution of radiopharmaceutical clinical development programs in Europe. The organization selected will assist in completion of any additional non-clinical studies required for MAA approval.

Timeline & Budget

Figure 6. Onalta™ Clinical Development Timeline and Costs

*****

The Phase 3 clinical trial is scheduled to commence Q1, 2010, will have a 19 month enrollment plan (approximately 10 patients/month), with last patient enrollment projected to take place in Q3, 2011. The study protocol requires a 10 month follow-up period and is projected to complete in Q2, 2012. The projected overall cost for the Phase 3 trial is *****, including drug supply costs. Preparation of the non-clinical regulatory package is planned to begin Q4, 2010 and complete in Q2, 2012. This activity is budgeted at a total cost of *****. Within eight months of study completion, all CSRs will be complete. MAA filing with EMEA is projected to occur in Q4, 2012, and EMEA approval is expected in late 2013.

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Although patent expiry occurs in 2015, orphan drug status grants EU market exclusivity for Onalta™ for 10 years post approval. It is therefore expected that market exclusivity for Onalta™ will continue through late 2023.

Phase 3 Clinical Study

BioMedica intends to follow MIP’s Phase 3 study protocol (ON-C301), a protocol that has been submitted to, and approved by EMEA (see Appendix for protocol details)

Proposed Phase 3 Study Sites

BioMedica will execute the proposed Phase 3 trial at 18-28 centers in 10 European countries with the goal to recruit 255 patients within the 19 month recruiting timeframe described above. A sample of proposed centers is identified in figure 7.

Figure 7. Proposed Phase 3 Clinical Trial Centers

Proposed Clinical Trial Centers	Location
University Hospital of Basel	Basel, Switzerland
Royal Marsden Hospital NHS Foundation Trust	Sutton (Surrey), United Kingdom
Erasmus Medical Center	Rotterdam, The Netherlands
Universitätsklinikum Innsbruck	Innsbruck, Austria
Central Hospital of Bad Berka GmbH:	Berka, Germany
University Hospital of Heidelberg	Heidelberg, Germany
European Institute of Oncological Research	Milan, Italy
University of Louvain Medical School	Brussels, Belgium
University of Mainz Johannes Gutenberg	Mainz, Germany
University of Bonn	Bonn, Germany

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Commencement of Development Activities

BioMedica will immediately start Onalta™ development activities upon execution of the comprehensive Onalta™ agreement. BioMedica will expedite the initial development program activities to ensure timely completion of the Phase 3 clinical program in Europe on time and in compliance with the protocol. Activities that have been identified include:

1. Identification and recruitment of study centres:

a. Submit protocol summary

b. Distribute feasibility questionnaires

c. Select initial study centres

d. Contract selected centres

e. Continue expansion of study centre enrolment until full complement is reached

2. Identification and recruitment of independent review committee

3. Identification, qualification and selection of electronic data capture vendor

4. Appointment of CRO for study monitoring (European CRO with oncology expertise – see below for examples)

5. Set up and validate pharmacovigilance systems

6. Initiate manufacture of investigational Onalta™ drug and establish distribution and compliance programs

7. Finalize drug packaging and labelling for investigational drug

8. Establish and test drug distribution logistics and finalize logistics program

Organizational Structure & Staffing

BioMedica will initiate staffing of its Onalta™ development organization immediately following completion of the definitive Onalta™ license agreement with MIP. It will plan commencing with the recruitment of a qualified, industry experienced, Head of clinical development. BioMedica intends its clinical development function for Onalta™ to be located in Germany and staffed by professionals located in Germany. Subsequent to the recruitment of the head of clinical development, BioMedica will recruit a clinical development manager and a clinical research associates (CRAs). Final selection of the clinical research organization (CRO) will be done by the head of clinical development, in close association with MIP. At present, BioMedica has identified two companies with the appropriate credentials and experience to successfully manage the Onalta™ Phase 3 program: IBIS and ABX.

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MIP involvement in the European Phase 3 Clinical Development of Onalta™

BioMedica considers MIP’s support in the development of Onalta™ in Europe as critical to its success, and as the means to fully coordinate the global development of the product. BioMedica intends to utilize relevant MIP staff to assist in setting up, training and executing critical components of the Phase 3 trial at the selected study centers. The expenses and costs associated with MIP assistance will be fully funded by BioMedica, and have been included in the Phase 3 budget. It is expected that the comprehensive agreement between BioMedica and MIP will include the mechanisms for defining and quantifying the elements of the services and resources provided by MIP, the terms of reference for their use, and their cost.

Moreover, BioMedica intends to inform and seek advice from MIP throughout the Phase 3 trial and intends to incorporate MIP input in the final trial design, primary endpoint confirmation, and patient recruitment, as the clinical program progresses.

Named Patient Program

Overview and Responsibilities

BioMedica has initiated negotiations with IDIS Limited (“IDIS”) for exclusive distribution of pre-approved Onalta™ through a named patient program in Europe. IDIS, based in the United Kingdom, is widely accepted as having unique capabilities and significant experience in the initiation, management and execution of pre-approval, named patient programs, and the distribution of un-licensed products on a named patient supply basis within the territories that have been targeted for Onalta™ distribution, which include:

• UK

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• France

• Italy

• Germany

• Switzerland

• Austria

• France

• Netherlands

As the sole distributor of pre-approved Onalta™, IDIS will be responsible for:

1. Distribution of Onalta™ “kits” and Onalta™ final product in all targeted territories to approved patients

2. Compliance with all applicable regulations and laws that apply to the distribution of Onalta™ to indentified and approved patients

3. Compliance with the cGDP guidelines and the maintenance of an inclusive and compliant quality management system to monitor the performance of the distribution

4. Training of all staff with valid standard operation procedures and further regulations of BioMedica

5. Management and execution of invoicing for drugs supplied to approved patients, and the reimbursement for their use within each country

6. Management of product storage, and storage facilities in accordance with cGDP

7. Maintenance of all applicable regulatory files and treatment records as required by law

Pricing

Fixed prices governing the sale of the Onalta™ “kits” and the Onalta™ finished product to IDIS have been determined and are as shown in figure 8:

Figure 8. Named Patient Program Pricing

Product	Service Fee Paid to IDIS by BioMedica	Patient Price per Dose
Onalta™ “kits” (ready to infuse excluding 90Y)	*****	*****
Onalta™ finished product	*****	*****

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BioMedica will pay a one time set up fee of ***** for the program following agreement sign-off. In addition, a management fee of ***** per month will be charged by IDIS during the period that Onalta™ “kits” are distributed. This fee will decline to ***** per month when Onalta™ finished product is distributed through this program.

Timing

The proposed named patient program will be operational within eight weeks of execution of the distribution agreement, with roll-out to 15-18 key treatment centers by the end of 2009. Within 24 months, IDIS intends to target >100 centers throughout Europe.

Figure 9. Named Patient Program Event Timeline

Event	Timeline
Signing of Named Patient Program Distribution Agreement	August ‘09
Roll-out of Named Patient Program	October ‘09
Target key European Centers (15-18)	December ‘09
Roll-out to include >100 centers in Europe	October ‘11

MIP Involvement

As part of its continuing relationship with MIP, BioMedica intends to access the technical expertise resident at MIP, and utilize specific MIP resources to prepare training materials for physicians and pharmacists governing the administration and dosing of Onalta™, as well as to provide pharmacovigilance support during the initial roll-out period.

BioMedica intends, and has budgeted for, payments of all approved expenses and costs associated with MIP assistance. BioMedica expects that the comprehensive agreement with MIP will include the mechanisms for defining and quantifying these payments, and the means to approve and pay for such resource use.

Regulatory Affairs

Building upon the experience gained from its successful EMEA Phase 1 filing of Demogastrin™, BioMedica will recruit a world-class Head of regulatory affairs with a proven track record of radiopharmaceutical filing with EMEA, to lead the regulatory program for Onalta™. BioMedica intends to complete recruit this key executive by Q4, 2010. In the interim, BioMedica intends to actively utilize, MedWorks, its long-standing regulatory affairs consultant, in addition to seeking the guidance, support and recommendations from MIP.

* Confidential Treatment Requested *

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MIP Involvement

As part of its continuing relationship with MIP, BioMedica intends to utilize the Regulatory Affairs expertise resident at MIP and views this resource as a critical component to the success of securing Onalta™ EMEA MAA.

BioMedica intends, and has budgeted for, payments of all approved expenses and costs associated with MIP assistance in regards to regulatory affairs. BioMedica expects that the comprehensive agreement with MIP will include the mechanisms for defining and quantifying these payments, and the means to approve and pay for such resource use.

Manufacturing and Distribution

Under the final terms to be agreed upon at the execution of the final comprehensive agreement MIP will retain the rights and obligations to manufacture and distribute Onalta™ for a period of at least three years, with an automatic extension of this obligation of two years granted to BioMedica. Upon expiry of the three/five year manufacturing and distribution contract, BioMedica may opt to assume the rights and obligations to manufacture and distribute Onalta™, or negotiate further extension to its agreement with MIP. Provision for these matters will be incorporated into in the manufacturing and distribution section of the definitive Onalta™ license agreement with MIP.

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With the execution of a manufacturing and distribution agreement with MIP, the following critical activities are to be carried out by BioMedica, IDIS Pharma, and MIP:

Figure 10. Manufacturing & Distribution Timeline

Activity	Timeline	Responsibility
Terminate Bachem peptide distribution	Upon Contract Signing	MIP
Begin supply of 90Y kits to IDIS Pharma	Upon Contract Signing	MIP
Convert kits to lyophilized “ready to infuse” vial form to be labeled with 90Y by radiopharmacists at treatment centers	September-October ‘09	MIP
Enforce the purchase and use of “ready to infuse” kits from IDIS Pharma at treatment centers	October ‘09-Until EMEA Compassionate Use Approval	IDIS Pharma & BioMedica
Enforce use of Onalta™ finished product at Treatment Centers	Upon Compassionate Use Approval	IDIS Pharma & BioMedica

Sales and Marketing

Overview

Upon completion of a detailed sales and marketing study in Q1, 2009, and after further interaction with external consultants knowledgeable of the field and specific attributes of its proposed commercialization strategy, BioMedica has created a sales and marketing plan it believes will deliver the revenues and cash flows detailed in this business plan, and which are based on the following assumptions:

• Economics and pricing based on a luxury goods pricing model/paradigm

• BioMedica will price Onalta™ at ***** per dose in all sublicensed territories, aligning Onalta™ pricing in Europe reasonably in line with MIP’s suggested price of ***** per dose

• Market penetration assumptions are based on the following parameters

• Population distribution and probabilities to access market at suggested price per dose price

• Market penetrations based on social and economic criteria

• Targeted sales approaches based on hub and spoke model

• Intensive pre-marketing activities to develop the markets

• Onalta™ sales regions will be divided into two broad categories that represent probable sales penetration rates

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• Type-2: High sales penetration countries

• Type-1: Low sales penetration countries

• Sales and Marketing effort will concentrate on hub countries in Europe and the Middle East that will have oversight over spoke countries in respective European and Middle Eastern countries/regions

Figure 11. Designated Hub Countries in Europe and Middle East

Hub Countries in Europe	Type	Hub Countries in Middle East	Type
GERMANY	2	U.A.E.	1
U.K.	2	EGYPT	1
FRANCE	2	IRAN	1
ITALY	2
SPAIN	1
POLAND	1
GREECE	1
RUSSIA	1
TURKEY	1

Figure 12. Type-2 Hub Countries and their Respective Spoke Countries

TYPE-2 Hub Countries & Respective Oversight of Spoke Countries (red text)
France	Germany	Italy	U.K.
Monaco	Austria	Bosnia & Herzegovina	Iceland
San Mar.	Hungary	Croatia	Ireland
	Czech Republic	Malta
	Denmark	Montenegro
	Finland	Serbia
	Norway	Slovakia
	Sweden	Slovenia
	Switzerland

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Figure 13. Type-1 Hub Countries and their Respective Spoke Countries

TYPE-1 Hub Countries & Respective Oversight of Spoke Countries (red text)
Belgium	Greece	Poland	Russia	Spain Turkey
Luxembourg	Albania	Estonia	Armenia	Portugal
Netherlands	Bulgaria	Georgia	Azerbaijan
	Cyprus	Latvia	Belarus
	Republic of Macedonia	Lithuania	Kazakhstan
	Romania	Ukraine
	MIDDLE EAST

Timeline of Critical Sales, Marketing and Commercialization Activities

Critical to the success of BioMedica’s Onalta™ “kit” business, its named patient program, and Onalta™ final product penetration and sales is the ability to initiate a comprehensive sales, marketing and commercialization effort.

In planning the sales and marketing effort for Onalta™ BioMedica has identified critical activities that will be executed upon completion of the comprehensive license agreement with MIP:

Figure 14. Sales and Marketing Critical Event Timeline

Event	Target Completion Date
Hire Head of Sales & Marketing	Q1. 2010
Hire and train six initial sales reps. targeted at core EU clinical centers	Q2. 2010
Establish Onalta™ KOL Advisory Board	Q3. 2010
Hire and train 16 additional sales reps. targeted at remaining territories	Q4. 2011
Enter into exclusive distribution agreements for Israel and Turkey	Q2. 2010
Hire and train additional 25-28 sales reps (50 total)	Upon EMEA MAA

BioMedica Onalta^™ Business Plan© 29.07.09 Page 29 of 31 CONFIDENTIAL

Onalta™ Product Pricing

BioMedica has completed an exhaustive pricing analysis for Onalta™ and will deploy product pricing at launch according to the schedule outlined in figure 14:

Figure 15. Onalta™ Product Pricing

Product	Single Dose Price	Treatment Price (three doses)
Onalta™ Kit (ready to infuse excluding 90Y)	*****	*****
Onalta™ Final Product	*****	*****

Reimbursement Strategy

• Named Patient Program

• As part of its contractual agreement with BioMedica, IDIS Pharma will assume responsibility for reimbursement strategy and implementation during the period from license and through EMEA MAA approval

• EMEA MAA

• BioMedica intends to retain IDIS and other external reimbursement consultants to aggressively secure approval for reimbursement of Onalta™ final product at the targeted price of ***** per dose

MIP Involvement

Although all significant sales and marketing activities will be executed by BioMedica and its Onalta™ team, it is BioMedica’s intention of to seek MIP’s counsel, in relationship to pricing so as to maintain a coherent global pricing platform for Onalta™.

* Confidential Treatment Requested *

BioMedica Onalta^™ Business Plan© 29.07.09 Page 30 of 31 CONFIDENTIAL

Consolidated Cash Flow

Figure 16. BioMedica Consolidated Cash Flows (w/ Onalta™)

*****

* Confidential Treatment Requested*

BioMedica Onalta^™ Business Plan© 29.07.09 Page 31 of 31 CONFIDENTIAL

Onalta™ Europe Business Plan

APPENDIX

July 29, 2009

BioMedica Onalta^™ Appendix 29.07.09 - 1 - CONFIDENTIAL

Appendix

Index of Figures

Figure 1. BioMedica Historical Growth	3
Figure 2. BioMedica Project Cash Flow (w/out Onalta)	3
Figure 3. Project Onalta Revenues	4
Figure 4. BioMedica Projected Consolidated Cash Flow (w Onalta)	5
Figure 5. Clinical Development Activities Descriptions	6
Figure 6. Plan for ON-C301 (Phase 3)	7
Figure 7. Normalized Development Plan Activities Time Table	8
Figure 8. NAMED PATIENT SUPPLY AND DISTRIBUTION AGREEMENT	9
Figure 9. Technical Agreement for Distribution Services	32

BioMedica Onalta^™ Appendix 29.07.09 - 2 - CONFIDENTIAL

Figure 1. BioMedica Historical Growth

******

Figure 2. BioMedica Project Cash Flow (w/out Onalta)

******

BioMedica Onalta^™ Appendix 29.07.09 - 3 - CONFIDENTIAL

*  Confidential Treatment Requested  *

Figure 3. Project Onalta Revenues

******

BioMedica Onalta^™ Appendix 29.07.09 - 4 - CONFIDENTIAL

*  Confidential Treatment Requested  *

Figure 4. BioMedica Projected Consolidated Cash Flow (w Onalta)

******

BioMedica Onalta^TM Appendix 29.07.09 - 5 - CONFIDENTIAL

*  Confidential Treatment Requested  *

Figure 5. Clinical Development Activities Descriptions

1. Study Protocol and Informed Consent

Study protocol writing/development, review and approval

Development of subject information sheet and informed consent form

Translation of subject information sheet and informed consent form

Prepare info package w feasibility questionnaire. Communicate to centers

2. Case Report Form

CRF development, review, approval and send to sites

Select electronic CRF vendor

3. Selection of Study Sites

Proposal of study sites

Pre-Study site evaluation visits

Study site approval based upon due diligence information

4. Submission to Authorities & IRB/ECs

Arrange for insurance

Prepare Master CTA - general part

Collection of regulatory documents for to CA and EC

Submission to ECs

Receive all approvals for study start (CA, EC, CTX etc)

5. Study Set-up Activities

Set up of the study tracking system

Development/Update of study Manual of Operations (MOP)

Hospital & Investigator grant/case fee negotiation

Hospital & Investigator contract preparation and signature

Selection of Independent Review Committee

Selection of various other vendors, incl. contract preparation

Selection/Definition of committees and board members

6. Study Drug and Supplies

Labeling and packaging of study drug and supplies

Arrange logistics of drug shipment

Distribution of study drug and supplies to study sites

Waste management

7. Central Patient Randomisation (IVRS)

Contract IVRS provider

8. Investigator/Team Meeting

Organization and conduct of investigator meetings

Organization of CRA training meetings

9. Monitoring

Conduct of site initiation visits

DCF generation and clearance

Conduct of Study close down visits

10. Drug Safety / SAE Reporting

Establish PV System

11. Data Management

Ongoing data clean

Final review of all data

Data base freeze

12. Medical and Statistical Report Writing

Identify study Statistician

Interim analysis

Statistical analysis

Issuance of statistical report

Medical writing

13. Submission to EMEA review process

MAA dossier submission

Review time

Granting of MAA

National CA submission

Granting of national authorization

14. Quality Assurance

Set-up of audit plan with CQA

Set-up of audit action plan

Audit of study sites

Audit of CRO (if applicable)

15. CRO Surveillance

Contracting CRO

Overseeing if milestones are reached/expectations met

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Figure 6. Plan for ON-C301 (Phase 3)

Plan for ON-C301 (Phase 3)

Study Title. A Phase 3 randomized, controlled, open label, multi-center study evaluating the efficacy of ⁹⁰Y-edotreotide administered by intravenous infusion to adults with metastatic, progressive somatostatin-receptor positive carcinoid tumors versus Octreotide acetate (Sandostatin LAR^®)

ON-C301 is a two-arm, randomized, controlled, open label, multi-center study to evaluate the efficacy and safety of ⁹⁰Y-edotreotide versus octreotide acetate (Sandostatin LAR^®) in subjects with metastatic, progressive, somatostatin-receptor positive carcinoid cancer. The proposed study is composed of a screening period followed by randomization into one of two arms: Either (three cycles of ⁹⁰Y-edotreotide given approximately eight weeks apart) or octreotide acetate (40 mg, intramuscularly (i.m.), depot formulation; Sandostatin LAR^®). Subject follow up will continue until documented disease progression, start of an alternative therapy or 36 months post enrollment. Subjects will be assessed for tumor burden every other month for the first six months of the study. Thereafter, responding or stable subjects will be assessed every four months (16 weeks) until documented disease progression or 36 months post enrollment. If a subject randomized to the octreotide acetate (Sandostatin LAR^®) arm experiences progressive disease, based on RECIST criteria and confirmed by blinded independent readers, they may receive three cycles of ⁹⁰Y-edotreotide given approximately eight weeks apart following the procedures stipulated in this protocol. Progression-free survival will be assessed via measurement of tumor response (determined via RECIST criteria). Secondary efficacy assessments include overall survival, overall tumor response, change of biomarkers, quality of life assessed with EORTC QLQ-C30 and GI.NET21 and safety of the treatment regimens.

The primary endpoint is the improvement in the period of progression free survival observed in patients receiving ⁹⁰Y-edotreotide or Octreotide acetate (Sandostatin LAR^®). Approximately 194 subjects will receive ⁹⁰Y-edotreotide or Octreotide acetate (Sandostatin LAR^®). At enrollment, subjects will be randomized in a 1:1 ratio to receive either investigational drug or control. Only subjects determined to be eligible will be randomized. There is no blinding for this study. The sample size estimate assumes a hazard ratio of 0.625 with 90% power to detect a 37.5% effect size.

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Figure 7. Normalized Development Plan Activities Time Table

BioMedica Onalta^™ Appendix 29.07.09 - 8 - CONFIDENTIAL

Figure 8. NAMED PATIENT SUPPLY AND DISTRIBUTION AGREEMENT

Dated	2009
(1)	BioMedica Life Sciences S.A.
(2)	IDIS LIMITED

NAMED PATIENT SUPPLY AND DISTRIBUTION AGREEMENT

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Contents

1	DEFINITIONS AND INTERPRETATION	11
2	APPOINTMENT AND RESTRICTIONS	13
3	TERM	13
4	SUPPLY OF THE PRODUCTS	14
5	PRICING	14
6	PURCHASE ORDERS	14
7	DELIVERY	15
8	REJECTION	16
9	PAYMENT	16
10	RISK AND PROPERTY	17
11	RIGHTS AND DUTIES OF IDIS	17
12	RIGHTS AND DUTIES OF THE MANUFACTURER	18
13	WARRANTIES	19
14	INDEMNITIES	19
15	INTELLECTUAL PROPERTY	20
16	TERMINATION	21
17	CONSEQUENCES OF TERMINATION	22
18	CONFIDENTIAL INFORMATION	22
19	FORCE MAJEURE	23
20	NOTICE	23
21	GENERAL	24
22	DISPUTES	25
23	GOVERNING LAW AND JURISDICTION	25

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DATE 2009

PARTIES

(1) BioMedica Life Sciences S.A. (registered number 094413470) whose registered office is at 4 Papanikoli Str., Chalandri, Attica, Greece

(“the Manufacturer”)

(2) IDIS LIMITED, a company incorporated in England (registered number 2143039), whose registered office is at IDIS House, Churchfield Road, Weybridge, Surrey, KT13 8DB, United Kingdom

(“IDIS”)

INTRODUCTION

A) The Manufacturer wishes to supply the Products in the Territory through an entity with experience in the distribution of unlicensed products on a Named Patient Supply basis.

B) IDIS has capability in the distribution of unlicensed products on a Named Patient Supply basis, within each country in the Territory and wishes to act as the Manufacturer’s distributor of the Products in the Territory.

C) The Manufacturer appoints IDIS as its Exclusive distributor of the Products in the Territory on a Named Patient Supply basis on the terms set out in this Agreement.

OPERATIVE PROVISIONS

Definitions and interpretation

In this Agreement the following words have the following meanings:

“Business Day” means any day other than a Saturday or Sunday or a public or bank holiday in England;

“Commencement Date” means the date of signature of this Agreement by both parties;

“Confidential Agreements” means any and all confidentiality agreements entered into between the parties either before or after the Commencement Date relating to the subject matter of this Agreement;

“Confidential Information” means all information which is commercially sensitive or of a secret nature, or information which is marked confidential, or which is orally stated to be confidential, relating to any and all aspects of the business of either party, including any confidential information set out in Confidentiality Agreements. Such information may be expressed in any form including orally, as an idea, as prices, price lists, plans, customer lists or details or information concerning either party’s relationships with actual or potential clients or customers and the needs and requirements of such persons;

“Contract” has the meaning set out in Clause 6.2;

“Exclusive” means a right granted under this Agreement which the Manufacturer will not itself exercise and will not authorise any other person to exercise;

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“Fax Address” means the fax address of the relevant party given in Schedule 4;

“Force Majeure” means any circumstances beyond the reasonable control of the relevant party (including, without limitation, any strike, lock-out or other form of industrial action, acts of God, war or national emergency, an act of terrorism, riot, civil commotion, malicious damage, compliance with any law or government order, rule, regulation or direction, accident, fire, flood or storm) which prevents that party from complying with any or all of its obligations under this Agreement;

“Indication” means the symptoms, condition, or disease for which the Product has been prescribed for a particular Named Patient;

“Initial Period” means the period of three Years commencing on the Commencement Date;

“Intellectual Property Rights” means all intellectual and industrial property rights including patents, know-how, registered trade marks, registered designs, utility models, applications for and rights to apply for any of the foregoing, unregistered design rights, unregistered trade marks, rights to prevent passing off for unfair competition and copyright, database rights, topography rights and any other rights in any invention, discovery or process, in each case in the United Kingdom and all other countries in the world and together with all renewals and extensions;

“Marketing Authorisation” means an authorisation for the sale and placing on the market of a Product within the Territory;

“Named Patient” means the patient for whom the Product(s) have been prescribed;

“Named Patient Supply” means the supply of Products which do not have a Marketing Authorisation for the Indication in the country of destination and are supplied to meet the special needs of a specific patient or patients under the order of a medical practitioner or other person lawfully permitted to prescribe such Products to a specific patient or patients in the Territory or relevant part of it;

“Orders” has the meaning set out in Clause 6.1;

“Prices” means the price to be paid by IDIS to the Manufacturer for the Products as set out in Schedule 1 of this Agreement, or as varied in accordance with Clause 5.1;

“Products” means the product or products listed in Schedule 1 and additionally any further products of the Manufacturer offered to be supplied to IDIS by the Manufacturer in writing from to time to time after the Commencement Date and accepted in writing by IDIS;

“Service Address” means the address for service of the relevant party given in Schedule 4 of this Agreement;

“Technical Agreement” means the technical agreement set out in Schedule 5;

“Territory” means those countries set out in Schedule 2 of this Agreement and additionally any further countries agreed between the parties in writing from time to time after the Commencement Date;

“Trade Marks” means the trade marks and trade names of the Manufacturer listed in Schedule 3 and such other trade marks as the Manufacturer notifies to IDIS in writing from time to time after the Commencement Date;

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“Year” means the period of 12 (twelve) months beginning on the Commencement Date and each subsequent period of 12 (twelve) months commencing on the anniversary of the Commencement Date during the continuance of this Agreement.

Headings to the Clauses of and Schedules to this Agreement are for convenience only and shall not affect its construction or interpretation.

References to Clauses and Schedules are to the Clauses of and Schedules of this Agreement.

The Schedules are deemed to be incorporated and form part of this Agreement and the term “Agreement” shall be construed accordingly. In the event of conflict between any of the terms of this main part of the Agreement and the Schedules, the former shall prevail.

The word “indemnify” in this Agreement will mean to indemnify, keep indemnified and hold harmless the indemnified party from and against all costs (including the cost of enforcement), expenses, liabilities (including any tax liability), injuries, damages, claims, demands, proceedings or legal costs (on a full indemnity basis) and judgements which the indemnified party incurs or suffers and “indemnity”, “indemnities” and “indemnifies” have a corresponding meaning.

Any reference to a “month” is a reference to the period of a calendar month.

Any reference to “person” means a natural or legal person, firm or unincorporated association.

Words importing the singular include the plural and vice versa.

Appointment and Restrictions

The Manufacturer hereby grants to IDIS the Exclusive right to distribute on its own account the Products in the Territory and IDIS agrees to act in this capacity subject to the terms of this Agreement.

During the continuance of this Agreement, the Manufacturer undertakes not to market or sell the Products directly or indirectly to any other person in the Territory without first obtaining IDIS’s express written consent (such consent not to be unreasonably withheld or delayed).

During the continuance of this Agreement, IDIS undertakes not to seek customers or promote sales of the Products outside the Territory.

IDIS undertakes that it shall not unless otherwise approved in writing by the Manufacturer and for 5 (five) Years from the Commencement Date:

manufacture any goods that compete with the Products in the Territory;

obtain its supplies of the Products for distribution within the Territory other than from the Manufacturer; provided that the Manufacturer is able and willing to supply the same on the terms of this Agreement.

Term

This Agreement shall commence on the Commencement Date and subject to early termination in accordance with its terms shall continue in force in respect of each Product until that Product have been granted a Marketing Authorisation for the Indication within the Territory.

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Supply of the Products

The Manufacturer shall supply the Products to IDIS in accordance with the terms and conditions of this Agreement to the exclusion of any terms and conditions of sale submitted at any time by the Manufacturer and whether printed or sent with any order form, delivery note, invoice or otherwise.

The Manufacturer shall not supply IDIS with any Products with a remaining shelf life of less than 12 (twelve) months or 75% of the full shelf life, whichever is greater. If the Manufacturer is unable to comply with this Clause 4.2 it shall notify IDIS immediately providing details of the remaining unexpired shelf lives of the available Products and, in such event, the Manufacturer shall not proceed with the Order until it has received written confirmation from IDIS that the Order may proceed at which time the Contract shall be formed.

Pricing

The Products will be supplied on a consignment basis and shall be sold by the Manufacturer to IDIS at the Prices. The Prices shall remain fixed for the duration of the Agreement but may be varied by the Manufacturer by giving IDIS not less than 60 (sixty) days notice; save that nothing in this Clause 5.1 shall give the Manufacturer the right to vary Prices in respect of Orders of Products placed by IDIS with the Manufacturer prior to the date of receipt of any notice of Price variation.

All Prices are inclusive of packaging but exclusive of any applicable value added or any other sales tax for which IDIS shall be additionally liable.

The Manufacturer may recommend in writing to IDIS a sale price for each of the Products or impose a maximum selling price at any time; provided that that price does not amount to a minimum selling price or retail price maintenance. For the avoidance of doubt:

where the Manufacturer has recommended a selling price to IDIS, IDIS shall be free to distribute the Products at any price it so chooses; and

where the Manufacturer has set a maximum price, IDIS shall be obliged to distribute the Products at no more than that price; provided that does not amount to a minimum selling price or retail price maintenance.

Without prejudice to any other provision of this Agreement, the Manufacturer shall advise IDIS immediately if any Price given for Products in an Order is incorrect and, in such event where the Price is incorrect the Manufacturer shall not proceed with the Order until it has notified IDIS of that fact and received written confirmation from IDIS that the Order may proceed, at which time the Contract shall be formed.

Purchase Orders

IDIS shall submit, from time to time, written purchase orders (“Orders”) to the Manufacturer for the supply of the Products. Each Order shall stipulate the Products’ names, the Products’ codes, the quantity required and the total price of the Order (excluding VAT).

The receipt by the Manufacturer of an Order during the term of this Agreement shall constitute a contract (“Contract”), subject to the terms and conditions of this Agreement.

Notwithstanding Clause 6.2 and Clause 21.4, before delivery IDIS may vary, add or omit any or all of the Products in an Order by notice in writing to the Manufacturer. The Manufacturer shall not vary, add or omit any of the Products or any part of them from an Order without the express consent of IDIS.

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An update of all outstanding Orders placed by IDIS with the Manufacturer shall be provided by the Manufacturer at least once a week or as often as reasonably requested by IDIS.

Delivery

Within 1 (one) Business Day of the receipt of an Order the Manufacturer shall provide IDIS with an estimated date for delivery. The Manufacturer will in any event give IDIS reasonable notice of the date of delivery.

The Manufacturer shall use all commercially reasonable endeavours to meet delivery dates and shall:

notify IDIS as soon as reasonably practicable of any anticipated or actual delays it experiences or anticipates experiencing in meeting an estimated delivery date;

provide IDIS with such details of the causes of such delays as IDIS reasonably requires; and

update IDIS at least once a week until the causes of such delays are rectified or lapse.

IDIS may, but is not obliged to, grant such extension of time as it considers in its sole opinion is appropriate for the Manufacturer to deliver the Products on time without breaching the Contract or this Agreement. Subject to the foregoing and without prejudice to any other rights or remedies available to IDIS, failure to meet the estimated delivery date or any subsequently agreed date or notify IDIS of any actual or anticipated delay shall entitle IDIS to terminate the Contract and/or the Agreement immediately.

Unless otherwise agreed, delivery of the Products shall take place at IDIS’ premises DDP (ICC Incoterms 2000) at Unit 3 Canada Road, Byfleet, Surrey, KT14 7JL (or such other premises as IDIS may notify to the Manufacturer from time to time) and the Manufacturer shall at its cost arrange for suitable transport to IDIS’ premises at Unit 3 Canada Road, Byfleet, Surrey, KT14 7JL (or such other premises as have been notified by IDIS to Manufacturer) and arrange insurance therefore.

Where the Products are to be delivered in instalments, without prejudice to Clause 6.2, each instalment shall constitute a separate Contract and without prejudice to any other rights or remedies available to IDIS, failure by the Manufacturer to deliver any one or more of the instalments in accordance with the terms and conditions of the Agreement shall entitle IDIS to treat the Contract as a whole as repudiated and terminate the Contract as a whole immediately.

The Manufacturer shall:

fax to IDIS at its Fax Address a copy of the delivery note for each delivery or instalment on the day of delivery and supply a copy of the delivery note with the delivered Products;

inform IDIS if an Order for Products exceeds 30kg by weight when providing IDIS with the estimated date for delivery under Clause 7.1.

On delivery the Products shall be marked in accordance with IDIS’s instructions and properly packed and secured so as to reach their destination in an undamaged condition in the ordinary course of events.

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Rejection

Notwithstanding any other provision of this Agreement, acceptance of Products shall not occur until IDIS or its agent or representative has been given a reasonable time to inspect the Products for compliance with the terms and conditions of this Agreement following delivery or, if later, within a reasonable time after any latent defect in any of the Products has become apparent; provided that latent defect has become apparent before the expiry of the warranty period set out in Clause 13.1.

In the event of a breach of the Manufacturer’s warranties in Clauses 13.1 or 13.2, or where IDIS becomes aware of a defect or latent defect pursuant to Clause 8.1, IDIS may, within a reasonable time of becoming aware of such breach or defect, reject such Products by notice to the Manufacturer specifying the nature and quantity of the defective Products. Within 30 (thirty) days of receipt of such notice the Manufacturer, shall, collect the defective Products from IDIS at the Manufacturer’s expense (including, without limitation, costs of carriage, insurance, export/import duties), and:

where such Products have not yet been distributed by IDIS, replace the defective Products with Products that meet the warranties in Clauses 13.1 and 13.2 at its own expense; or

where such Products have been distributed by IDIS, as the case may be, deduct the relevant amount from the invoice to be raised for such distribution or credit to IDIS’s account the purchase price invoiced and any applicable value added or other sales tax (where these have been paid) for such defective Products plus costs of carriage, insurance and other fees incurred by IDIS (including, without limitation, export/import duties) plus such amounts equal to the profit IDIS would have made on those Products.

Where the Manufacturer fails to collect defective Products pursuant to Clause 8.2 within 14 (fourteen) days, IDIS may store defective Products on its premises or with a third party at the Manufacture’s risk and expense. Where the Manufacturer fails to collect defective Products pursuant to Clause 8.2 within 30 (thirty) days IDIS may destroy the defective Products with the consent of the Manufacturer.

Payment

Within the first 5 (five) Business Days of each month IDIS shall provide the Manufacturer with a monthly sales report for the just concluded month which shall set out the quantity of Products sold by IDIS in that just concluded month and such other information as the Manufacturer may reasonably request.

Upon receipt of a monthly sales report the Manufacturer may invoice IDIS within 90 (ninety) days for the Price of the Products sold by IDIS as stated in the sales report.

Upon delivery of a monthly sales report IDIS may invoice the Manufacturer at any time for the monthly service fee and variable service fee as stated in the sales report. The amount due for both service fees shall be paid by the Manufacturer to IDIS within 30 (thirty) days from the date of the invoice.

Unless otherwise agreed, undisputed invoices shall be paid within 90 (ninety) days of the date of the Manufacturer’s invoice (in the currency stated on the Manufacturer’s invoice) by transfer to such bank account as the Manufacturer may from time to time notify in writing to IDIS.

If an invoice is disputed by IDIS, IDIS shall pay the undisputed amount in accordance with Clause 9.4 and the parties shall attempt to settle the disputed part of that invoice in accordance with Clause 22. Once the dispute is resolved, and if payment is due by IDIS to the Manufacturer the payment shall be made within 30 (thirty) days of the date of resolution.

BioMedica Onalta^™ Appendix 29.07.09 - 16 - CONFIDENTIAL

IDIS reserves the right to decide appropriate credit terms for it’s customers or to invoice customers on a pro-forma basis, if it deems that these customers pose a high credit risk. In the event that a customer is deemed a high credit risk and cannot pay on a pro-forma basis or has an account in arrears, IDIS reserves the right not to fulfil orders for that customer unless a specific agreement is reached with the Manufacturer in accordance with Clause 9.7.

Where agreed by both Parties and for specific customer orders, IDIS will not pay the Manufacturer the Price until IDIS has received payment from the customer. Where agreement is reached under this Clause 9.7, IDIS shall separately identify in the monthly sales report the customer orders to which this Clause 9.7 applies and shall promptly inform the Manufacturer of receipt of payment in respect of the relevant customer orders. Invoices issued by the Manufacturer for the Price of Products sold pursuant to the specific customer orders that are subject to Clause 9.7 shall be paid by IDIS within thirty (30) days of the date of payment.

Risk and Property

Risk of damage to or loss of the Products shall pass to IDIS on delivery. Title will pass to IDIS on receipt of an order from a customer.

Rights and duties of IDIS

During the continuance of this Agreement IDIS shall:

hold and maintain all relevant wholesale dealers and import licences and comply with all applicable legal and regulatory requirements in relation to each of the Products and in particular those relating to the storage and distribution of the Products in the Territory on a Named Patient Supply basis;

unless otherwise prohibited by the applicable legal and regulatory requirements, maintain at all times a minimum stock of Products as it shall reasonably require (such minimum to be agreed between the parties from time to time);

inform the Manufacturer of customer complaints, requirements and suggestions regarding the Products and any information which comes into its possession which IDIS reasonably considers may prejudice or enhance sales of the Products in the Territory;

inform the Manufacturer of any adverse reaction(s) to the Products reported to them by customers or any other person;

if the Manufacturer or a competent regulatory authority recalls a Product, notify all customers who have purchased the relevant Product and in such circumstances and at the Manufacturer’s expense (including price and carriage charge actually and reasonably reimbursed by IDIS to the customer and any transport, an additional fixed charge of €400 per recall and €250 per Order will be charged to coveradministration and handling costs actually and reasonably incurred by IDIS), IDIS shall implement a recall and arrange for the return of the recalled Products from all relevant customers and at the Manufacturer’s option either return the same to the Manufacturer or destroy them;

not remove the Products from the packages designed for delivery to customers without the Manufacturer’s prior written approval;

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be entitled to describe itself as the Manufacturer’s authorised distributor of the Products in the Territory but shall not hold itself out as the Manufacturer’s agent.

Rights and duties of the Manufacturer

During the continuance of this Agreement the Manufacturer shall:

hold and maintain all relevant licences to manufacture, assemble, package and label, export from the country of manufacture (if relevant) and/or supply the Products to IDIS pursuant to this Agreement, including, without limitation, on a Named Patient Supply basis, and will comply with all relevant legal and regulatory requirements in relation to the manufacture, assembly, packaging, packing, labelling, export from the country of manufacture (if applicable) and/or supply of each of the Products;

notify and identify to IDIS any Product which becomes the subject of a Marketing Authorisation for the Indication after the Commencement Date;

reply to requests for information by IDIS regarding the Products, whether related to a technical query or otherwise, as soon as practicable but in any event no later than one Business Day after the request was received;

from time to time provide IDIS with such samples, catalogues, brochures and up to date information (including Prices) concerning the Products as IDIS may reasonably require to assist IDIS with the distribution and sale of the Products in the Territory;

shall ensure that any quotation regarding Products shall always contain its brand name, generic name, form, strength, pack size, availability and any other information reasonably requested by IDIS.

If the Manufacturer wishes to or a competent authority requires the recall of any Product, the Manufacturer shall immediately notify IDIS by telephone, fax or email (with confirmation in writing) of the recall, its urgency, providing details of the specific problem known to it, the batch number of the Products concerned and the details of any alternative Products and their prices that are available from the Manufacturer.

In the event IDIS notifies the Manufacturer of a reported adverse reaction(s) to a Product received from a customer or any other person, the Manufacturer will henceforth assume responsibility for taking any and all actions relating to such adverse reaction(s) including, without limitation, dealing with (i) all reporting aspects of pharmacovigilance to the relevant competent authority, and (ii) allegations or findings of product and/or strict liability that may be required or result from an adverse reaction(s), and shall confirm to IDIS in writing that it has done so.

The Manufacturer shall at all times supply IDIS with the minimum stock agreed by the parties pursuant to Clause 11.1.2 of this Agreement. Notwithstanding the above, the Manufacturer shall use its best endeavours to supply Products to IDIS in respect of orders submitted above that agreed threshold.

The Manufacturer shall upon 60 (sixty) days written notice to IDIS be entitled to:

discontinue or vary the manufacture and assembly and/or supply of any of the Products or any substance or ingredient included in the Products;

BioMedica Onalta^™ Appendix 29.07.09 - 18 - CONFIDENTIAL

make changes in the formulation and/or composition of the Products, provided the Manufacturer is able to supply any Orders of affected Products made by IDIS prior to the date of receipt by IDIS of the notice of any such discontinuation or variation, in their unvaried form and prior to discontinuation.

Warranties

The Manufacturer accepts complete responsibility for the manufacture and assembly of the Products and their packaging and labelling, and represents and warrants to IDIS that for a period of at least 12 (twelve) months after the supply of any Products to IDIS and, if longer, up to the expiry date of any Products, the Products shall be of merchantable quality, free from defects in composition, formulation, material and workmanship.

The Manufacturer represents and warrants that:

it has title to the Products;

the Products shall conform to their description, specification and data sheet or summary of product characteristics (if any);

the Products, their manufacture, assembly, packaging and labelling, export from the country of manufacture (if relevant), use, supply to IDIS and sale, supply or distribution of the Products in the Territory by IDIS will not infringe the Intellectual Property Rights of any third party;

it is authorised to manufacture, assemble, package and label, export from the country of manufacture (if applicable) and supply the Products to IDIS for IDIS to distribute on a Named Patient Supply basis within the Territory.

IDIS represents and warrants to the Manufacturer that it is authorised to sell, supply and distribute the Products in the Territory on a Named Patient Supply basis, where permitted, in each country within the Territory as set out in Schedule 2.

Each party represents and warrants to the other that it will comply with its obligations set out in this Agreement and associated Schedules.

Indemnities

The Manufacturer shall indemnify IDIS in respect of:

the manufacture and assembly, packaging and labelling of the Products;

the sale, supply or distribution of the Products in the Territory;

failure to provide any information required to be provided by the Manufacturer to IDIS under the terms of this Agreement within the applicable time frame.

The Manufacturer shall indemnify IDIS in respect of any allegation or finding that the sale of Products by IDIS in the Territory infringes the Intellectual Property Rights of any third party or any rights of any third party unless such allegation or finding is attributable to any mark or method of packaging or get up of the Product or written material or directions relating to the Product applied, used or given by IDIS otherwise than as directed by the Manufacturer.

Each party shall indemnify the other party in respect of any breach by it of that party’s representations and warranties given in this Agreement.

The indemnities contained in Clauses 14.1, 14.2 and 14.3 above shall be conditional in each case upon the indemnified party:

promptly giving written notice of any claim to be indemnified to the indemnifying party;

BioMedica Onalta^™ Appendix 29.07.09 - 19 - CONFIDENTIAL

providing the indemnifying party with the absolute discretion to conduct, take or resist any proceedings as it sees fit at its own expense;

providing the indemnifying party on request with such information and assistance in relation to such proceedings as it may reasonably require, subject to the indemnifying party indemnifying the other party against all costs reasonably incurred by it in the provision of such information or assistance; and

does not make any settlement, compromise or prejudicial admission in relation to such claim without the prior consent of the indemnifying party (such consent not to be unreasonably withheld or delayed).

Intellectual Property

The Manufacturer grants IDIS a royalty free licence to use the Trade Marks in the Territory on or in relation to the Products for the purposes only of exercising its rights and performing its obligations under this Agreement (including, without limitation, distributing and selling the Products).

IDIS shall not without the prior written consent of the Manufacturer:

make any modifications to the Products or their packaging or labelling;

alter, remove or tamper with any Trade Marks, numbers, or other means of identification used on or in relation to the Products;

use any of the Trade Marks in any way which might prejudice their distinctiveness or validity or the goodwill of the Manufacturer therein; or

use in relation to the Products any trade marks other than the Trade Marks without obtaining the prior written consent of the Manufacturer.

Except as provided in this Agreement IDIS shall have no rights in respect of any trade names or Trade Marks used by the Manufacturer in relation to the Products or of the goodwill associated therewith, and IDIS hereby acknowledges that, except as expressly provided in this agreement, it shall not acquire any rights in respect of any trade names or Trade Marks and that all such rights and goodwill are, and shall remain, vested in the Manufacturer.

IDIS shall, at the expense of the Manufacturer, take all such steps as the Manufacturer may reasonably require to assist the Manufacturer in maintaining the validity and enforceability of the Intellectual Property Rights of the Manufacturer during the continuance of this Agreement.

Without prejudice to the rights of IDIS or any third party to challenge the validity of any Intellectual Property Rights of the Manufacturer, IDIS shall not knowingly do or authorise any third party to do any act which would invalidate or be inconsistent with any Intellectual Property Rights of the Manufacturer and shall not knowingly omit or authorise any third party to omit to do any act which, by its omission, would have that effect or character.

Without prejudice to Clause 14.4, IDIS shall notify the Manufacturer of any actual or threatened infringement in the Territory of any Intellectual Property Rights of the Manufacturer which comes to IDIS’s notice, and of any claim by any third party so coming to its notice that the importation of the Products into the Territory, or their sale in the Territory, infringes any rights of any other person, and IDIS shall at the request and expense of the Manufacturer do all such things as may be reasonably required to assist the Manufacturer in taking or resisting any proceedings in relation to any such infringement or claim.

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Termination

Subject to Clause 3.1, after the Initial Period, either party may terminate this Agreement in respect of any or all Products for any reason by giving not less than 90 (ninety) days written notice to the other to that effect, such notice to expire at or any time after the end of the Initial Period.

Before or after the expiry of the Initial Period, as the case may be, either party shall have the right to terminate this Agreement immediately by notice to the other if the other party:

commits any material or persistent breach of any of the provisions of this Agreement and, in the case of a breach capable of remedy, that party fails to remedy such breach within 30 (thirty) days after receipt of a notice giving full particulars of the breach and requiring it to be remedied;

being a company, summons a meeting of its creditors, makes a proposal for a voluntary arrangement, becomes subject to any voluntary arrangement, is unable to pay its debts within the meaning of section 123 Insolvency Act 1986, has a receiver, manager or administrative receiver appointed over any of its assets, undertakings or income, has passed a resolution for its winding-up (save for the purpose of a voluntary reconstruction or amalgamation previously approved in writing by the party serving notice), is subject to a petition presented to any Court for its winding-up (save for the purpose of a voluntary reconstruction or amalgamation previously approved in writing by the party serving notice), has a provisional liquidator appointed, has a proposal made for a scheme of arrangement under section 425 Companies Act 1985, has an administrator appointed in respect of it or is the subject of an application for administration filed at any court or a notice of appointment of an administrator filed at any court or a notice of intention to appoint an administrator given by any person or is the subject of a notice to strike off the register at Companies House or any of the foregoing ;

the other party has any distrait, execution or other process levied or enforced on any of its property;

the other party ceases, or threatens to cease to carry on business;

has any proceedings analogous to those referred to in Clauses 16.2.2 to 16.2.4 occurs in relation to the other party or its assets in accordance with the jurisdiction to which the other party or its assets are subject;

in the circumstances contemplated by Clause 19.3 there is no agreement reached by the parties within 30 (thirty) days after discussions for that purpose began or ought to have begun.

For the purposes of Clause 16.2.1 a breach shall be considered capable of remedy if the party in breach can comply with the provision in question in all respects save as to the time of performance (provided that time of performance is not of the essence).

The rights to terminate this Agreement given by this Clause 16.2 shall be without prejudice to any other right or remedy of either party in respect of the breach concerned (if any) or any other breach.

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Consequences of termination

Upon termination of this Agreement for any reason:

save as otherwise agreed, including, without limitation, to effect Clause 17.1.3, IDIS shall immediately cease to make use of the Trade Marks;

IDIS shall be entitled to complete all Orders placed with the Manufacturer prior to the date of termination;

at the request of a party and at that party’s expense, the other party shall return or destroy any Confidential Information provided by the first party;

IDIS shall have no claim against the Manufacturer for loss of distribution rights, goodwill or other similar loss.

In the event of termination by either party under Clause 16.1 or the Manufacturer under Clause 16.2.1:

IDIS shall, if the Manufacturer so requests, within 10 (ten) days of the date of termination of this Agreement return all or any part of the stocks of the Products then held by IDIS to the Manufacturer at the Manufacturer’s cost of transportation and insurance, and risk. IDIS shall be responsible for arranging transportation and insurance;

IDIS shall be entitled to sell all remaining stocks that the Manufacturer does not wish to reclaim under Clause 17.2.1 and for those purposes and to that extent, the provisions of this Agreement shall continue in full force and effect.

In the event of termination by IDIS under Clause 16.2.1 IDIS may at its option:

within 10 (ten) days of the date of termination of this Agreement require the Manufacturer to collect all or any part of the stocks of the Products then held by IDIS at the Manufacturer’s cost of transportation and insurance and risk. IDIS shall be responsible for arranging transportation and insurance;

sell all or any remaining stocks the Manufacturer is not required to collect under Clause 17.3.1 and for those purposes and to that extent, the provisions of this Agreement shall continue in full force and effect.

Clauses 13.1, 13.2, 14, 17, 18 and 21 shall survive termination of this Agreement.

Confidential Information

Except as provided by Clauses 18.2 and 18.3, each party shall at all times during the continuance of this Agreement and after its termination:

use its best endeavours to keep all Confidential Information of the other party secret and confidential and accordingly not disclose any Confidential Information of the other party to any other person; and

not use any Confidential Information of the other party for any purpose other than for the performance of its obligations under this Agreement.

Any Confidential Information may be disclosed by a party to:

any governmental or relevant competent authority pursuant to a statutory or regulatory requirement but then only to the extent of such required disclosure;

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its professional advisers, lawyers, auditors and bankers; or

any of its directors or employees or of any of the aforementioned persons, to such extent only as is necessary for the purposes contemplated by this Agreement, or as is required by law and subject in each case to that party ensuring that the person in question keeps the same confidential and does not use the same except for the purposes for which the disclosure is made.

Any Confidential Information may be used by a party for any purpose, or disclosed to any other person, to the extent only that:

it is on the Commencement Date, or later becomes, public knowledge through no fault of that party (provided that in doing so that party shall not disclose any Confidential Information which is not public knowledge); or

it can be shown by that party, to the reasonable satisfaction of the other party, to have been known to the first party other than as a result of a breach of this Clause 18 prior to the same being disclosed by the other party to the first party;

that information has been lawfully obtained after the Commencement Date free of any duty of confidentiality otherwise than directly or indirectly from the other party;

the other party has given its prior written consent to such use and/or disclosure.

Force Majeure

If either party is affected by Force Majeure it shall forthwith notify the other party of the nature and extent thereof.

Neither party shall be deemed to be in breach of this Agreement, or otherwise be liable to the other, by reason of any delay in performance, or non-performance, of any of its obligations under this Agreement to the extent that such delay or non-performance is due to any Force Majeure of which it has notified the other party, and the time for performance of that obligation shall be extended accordingly.

If the Force Majeure in question prevails for a continuous period in excess of three months, the parties shall enter into bona fide discussions with a view to alleviating its effects, or to agreeing upon such alternative arrangements as may be fair and reasonable in the circumstances.

Notice

Any notice to be served by one party on the other shall be in writing and shall be served by sending it by pre-paid recorded delivery (or by pre-paid registered air mail where appropriate) to the Service Address or by fax to the Fax Address or to such other address as is notified by that party to the other from time to time in accordance with this Clause 20.

Notice shall be deemed received in the case of pre-paid recorded delivery, two days from the date of posting, in the case of registered airmail, five days from the date of posting, and in the case of fax, at the time of transmission.

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In proving service it shall be sufficient to prove that the envelope containing such notice was correctly addressed and delivered or the notice was transmitted by fax to the Fax Address and a successful transmission sheet exists.

General

Neither party shall without the prior written consent of the other sub-contract, assign or transfer, or purport to sub-contract, assign or transfer to any other person any of its rights or obligations under this Agreement without the prior written consent of the other party, save that this Agreement will be binding upon and inure to any successor(s) to the business of either party.

Neither party nor its agents or employees shall be deemed to be an agent of the other for any purpose whatsoever, and neither party shall have, nor shall it represent itself as having, any authority to make contracts or obligations in the name of or binding upon the other party, to pledge the other party’s credit, or to extend credit to anyone in the other party’s name.

This Agreement and the documents referred to in it, including Confidentiality Agreements, contains the entire agreement between the parties in respect of the subject matter of the Agreement, and supersede all prior written or oral agreements, representations or understandings between the parties in respect thereto. The parties acknowledge that this Agreement has not been entered into wholly or partly in reliance on, nor has either party been given any warranty, statement, promise or representation made by or on their behalf other than as expressly set out in this Agreement. To the extent that any such warranties, statements, promises or representations have been given the recipient party unconditionally and irrevocably waives any claims, rights or remedies which it might otherwise have had in relation to them. Nothing in this Clause 21.3 will exclude any liability which one party would otherwise have to the other party in respect of any statements made fraudulently.

This Agreement may not be modified except in writing signed by the duly authorised representatives of each party.

In the event that any of the provisions of this Agreement or the application of any such provisions to the parties shall be held by a court of competent jurisdiction to be contrary to law, the remaining portions of this Agreement shall remain in full force and effect.

The failure or delay by either party to this Agreement in exercising any right, power or remedy of that party under this Agreement will not in any circumstances impair such right, power or remedy nor operate as a waiver of it. The single or partial exercise by either party to this Agreement of any right, power or remedy under this Agreement will not in any circumstances preclude any other or further exercise of it or the exercise of any other right, power or remedy.

Subject as expressly provided in this Agreement, the rights, powers and remedies provided in this Agreement are cumulative and not exclusive of any rights, powers and remedies provided by law.

No waiver by either party of any breach of this Agreement by the other shall be considered as a waiver of any subsequent breach of the same or any other provisions.

The parties to this Agreement do not intend that any of its terms will be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999 by any person not a party to it.

This Agreement may be executed in any number of counterparts, each of which when executed shall be construed as an original, but together will constitute one and the same instrument.

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Disputes

Subject to Clause 23, if any dispute arises out of this Agreement, in the first instance, the parties’ account managers shall attempt to resolve the dispute amicably within 30 (thirty) days.

If a dispute cannot be resolved by the parties’ account managers, the parties shall promptly refer the matter to their respective Chief Executive Officers. If either party refuses to make such referral or participate in good faith in this dispute resolution procedure and in any event, if the dispute is not resolved within 30 (thirty) days of such referral or the date such referral could have been made, then either party may commence proceedings in accordance with Clause 23.

Where either party reasonably believes that a dispute relates to a material breach or potential breach of this Agreement or a Contract, that party shall notify its and the other party’s account managers and each party shall then refer the dispute directly to their Chief Executive Officers and the provisions of Clause 22.2 shall apply.

Governing Law and Jurisdiction

This Agreement shall be governed by, and construed in all respects in accordance with the laws of England.

Subject to Clause 22, the courts of England will have exclusive jurisdiction to settle any disputes which may arise out of or in connection with this Agreement. The parties irrevocably agree to submit to that jurisdiction except that either party may seek injunctive relief in any court of competent jurisdiction.

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IN WITNESS of which the parties have signed this Agreement on the date set out above.

SIGNED for and on behalf of

MANUFACTURER

[signature]

[printed name]

[position in company]

[date]

SIGNED for and on behalf of

IDIS LIMITED

[signature]

[printed name]

[position in company]

[date]

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SCHEDULE 1

Products

PRODUCT	IDIS SERVICE FEE**	SELLING PRICE TO TERRITORY***
Onalta Kit*	******	******
Onalta Radiopharmaceutical	******	******

* Onalta kit to be sent in minimum order quantities of 3

** This service fee does not include carriage and packaging which will be charged at cost to the customer.

** If the parties agree to include countries in the Territory that are non-Euro (€) countries, the sales price will be quoted in $ (US) or £ sterling and will be converted from Euros at the exchange rate published in the Financial Times on the first day of the calendar month of customer invoice. These sales will then be identified in the monthly sales report provided by IDIS to the Manufacturer and invoiced by the Manufacturer to IDIS in the same currency and at the same exchange rate relative to the Euro as invoiced to the customer.

Initial Set Up Fee

IDIS will invoice the manufacturer a one off set up fee to encompass the set up of the Onalta Kit and of the Onalta Radiopharmacuetical of ****** following agreement sign-off.

Monthly Management Fee

IDIS will invoice the Manufacturer a management fee of ****** per month whilst providing access to the Onalta kit reducing to a management fee of ****** per month when it is only the Onalta Radiopharmaceutical that is being provided access via this programme. The services provided would include consultancy, provision of information and similar services and will commence at point of agreement sign off. This fee will be incorporated into the reporting as referenced in Clause 9.1.

Annual Escalation

All IDIS costs (either monthly management fees or service fees) will be subject to an annual inflationary increase up to a maximum of ******. This increase will be applied on the 1st January on an annual basis throughout the duration of this Agreement.

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*  Confidential Treatment Requested  *

SCHEDULE 2

Territory

UK

France

Italy

Germany

Switzerland

Austria

France

Netherlands

BioMedica Onalta^™ Appendix 29.07.09 - 28 - CONFIDENTIAL

SCHEDULE 3

Trade Marks

Onalta

BioMedica Onalta^™ Appendix 29.07.09 - 29 - CONFIDENTIAL

SCHEDULE 4

Service

Manufacturer’s Service Address
Manufacturer’s Telephone Number(s)
Manufacturers Fax Address
IDIS’s Service Address	IDIS House
	Churchfield Road
	Weybridge
	Surrey
	KT13 8DB
	United Kingdom
IDIS’ Telephone Number(s)	[+44 1932 824000]
IDIS’ Fax Address	[+44 1932 824200]

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SCHEDULE 5

Technical Agreement

BioMedica Onalta^™ Appendix 29.07.09 - 31 - CONFIDENTIAL

Figure 9. Technical Agreement for Distribution Services

Technical Agreement for Distribution Services

1. Contracting Parties

Contract Giver:	Biomedica Life Sciences S.A
Name and Address:	Biomedica Life Sciences S.A
	4 Papanikoli Str
	Chalandri
	Attica
	Greece
(Hereafter referred to as “Biomedica”)
Contract Acceptor:	IDIS Limited
Name and Address:	IDIS House
	Churchfield Road
	Weybridge
	Surrey
	KT13 8DB
	United Kingdom
(Hereafter referred to as “IDIS”)

2. Changes to this Agreement

2.1. All changes to this agreement must be agreed by both parties following written submission by the requesting party.

No	Details of changes / Reason	Date
1.
2.
3.

3. Purpose of the Agreement

3.1. The purpose of this agreement is to describe the technical aspects of the storage and the distribution of certain finished products of Biomedica carried out by IDIS.

3.2. The regulations of this agreement apply to all orders referring to the product list (see Schedule 1), which have been agreed upon signing the Technical Agreement and before the notice has taken effect. They also apply to orders, which have already been given to IDIS on behalf of Biomedica, as long as they have not yet been carried out.

3.3. Biomedica is responsible for marketing the product.

4. Basis

4.1. IDIS shall comply with the legal regulations that apply to its area of responsibility.

4.2. IDIS is in the possession of a valid wholesale dealer’s licence issued by the UK Medicines and Healthcare Products Regulatory Agency. IDIS shall maintain its systems to support its licence.

4.3. Biomedica and IDIS appoint responsible contact persons (refer to Schedule 2).

Both must inform each other of every amendment to the agreement in writing. Amendments are also part of this agreement.

4.4. IDIS shall implement and update an effective Quality Management System (QMS), including the performance of internal audits and the implementation of the resulting corrective actions.

Biomedica Technical Agreement - 32 - 29/7/2009

4.5. IDIS shall ensure that all staff affected by this agreement shall be appropriately trained with the valid standard operating procedures (SOP) and further regulations of Biomedica and incorporating any necessary amendments into IDIS SOPs which are validated by Biomedica.

4.6. IDIS shall allow the responsible persons of Biomedica to carry out quality assurance audits providing reasonable notice has been given.

4.6.1. These audits shall be limited in scope to the area’s and systems covered by this agreement

5. Responsibilities

5.1. Biomedica is responsible for:

5.1.1. Ensuring product and packaging elements meet the appropriate regulatory requirements.

5.1.2. Placing all relevant information at the disposal of IDIS as well as requirements of the authorities which are necessary for the correct product handling

5.1.2.1.    All packaging shall reflect Biomedica livery.

5.1.3. Making sure that the site of manufacturer is appropriately licensed.

5.2. IDIS is responsible for:

5.2.1. Complying with the cGDP (current Good Distribution Practices) guidelines and ensuring that the correct products are delivered to the consignee at the right time

5.2.2. A cGDP compliant handling of the returned products

5.2.3. Implementing an effective system for Recall

5.2.4. Performing visual inspection on received goods (e.g. integrity of shipment containers, completeness of shipment against shipment documents etc.)

5.2.5. IDIS shall inform Biomedica of any negative quality or safety issues regarding Biomedica products should they become aware of any.

5.2.6. Additional activities/requirements as defined in the ‘Supply and Distribution Agreement’: maintenance of the named patient program database, processes of a controlled distribution, and aspects with regard to drug

5.2.7. Managing product in line with the process flow in schedule 4

5.2.8. Reporting any received adverse events notifications to Biomedica in accordance with the process detailed in schedule 6

6. Facilities

6.1. IDIS shall manage the warehouse in accordance with cGDP as well as storing the Biomedica products delivered on behalf of Biomedica duly.

6.2. IDIS shall protect the Biomedica products from damaging impacts and from access by unauthorized persons.

Damaging impacts are in particular:

• damaging variations in temperature

• dust and smell

• animals, insects

6.3. IDIS shall inform Biomedica immediately if Biomedica products become visibly damaged or risk getting visibly damaged.

6.4. IDIS shall maintain the storage rooms and facilities in accordance with GDP and to calibrating measuring instruments (e.g. temperature loggers) on a regular basis in accordance with cGDP.

6.5. IDIS shall keep the storage rooms in an orderly and tidy condition. Cleaning is done following a written cleaning program.

6.6. IDIS shall appoint reliable personnel for the distribution orders, having the required theoretical and technical qualifications.

6.7. IDIS shall obtain approval from Biomedica if the stored goods are transferred into another warehouse other than the one in Unit 3, Canada Road, Byfleet, Surrey, United Kingdom. The same applies to changes of locations or any change within the warehouse, which may affect the storage, and handling of the products.

Biomedica Technical Agreement - 33 - 29/7/2009

7. Product Data

7.1. Biomedica shall forward IDIS the relevant product data necessary for carrying out the tasks well in advance and for keeping IDIS updated with current product information should there be any changes or amendments

7.2. IDIS shall maintain product related data in line with regulatory requirements.

8. Storage, Delivery and Transportation

8.1. The handling of processes is defined in the existing QMS of IDIS based on SOPs. These are:

8.1.1. Incoming goods: Quarantine, release, documentation

8.1.2. Handling of quality deficiencies

8.1.3. Incoming and outgoing of goods: According to the FEFO principle (first expiry - first out), or the FIFO principle (first in - first out), respectively

8.1.4. Commissioning and distribution of products

8.1.5. Recall procedures

8.1.6. Destruction of damaged or expired goods

8.1.7. Drug safety procedures

8.1.8. Complaint handling

9. Duty of Information

9.1. IDIS must immediately inform Biomedica if:

9.1.1. An inspection by an authority regarding the contracting products is announced

9.1.2. Measures are taken by competent authorities regarding Biomedica products

9.1.3. IDIS learns about a serious product safety, quality of efficacy problem/issue

9.2. Biomedica must inform IDIS of the supply chain details e.g. site of manufacturer, packaging/assembly, storage prior to product arriving at IDIS. This shall be listed in Schedule 4

9.3. Biomedica shall provide IDIS with copies of licenses held by Biomedica nominated manufacturer, packaging/assembly site or storage site.

10. Confidentiality

10.1 Information shared by either party concerning the Products will remain confidential between the parties even after the termination of this Agreement. Refer to the Confidentiality Agreement.

11. Quality Control

11.1. Biomedica shall be responsible for full product testing in accordance with their internal procedures, specifications, methods of analysis and any relevant Marketing Authorisation of the Products detailed in Schedule 1.

11.2. Biomedica shall be responsible for forwarding a Certificate of Analysis for each batch to IDIS.

11.3. Biomedica shall be responsible for forwarding a Certificate of Compliance for each batch to IDIS.

12. Sub Contracting

12.1. With the exception of courier services, IDIS shall not subcontract any activities effecting quality, safety and efficacy of the product without prior consent of Biomedica.

13. Table of Responsibilities

13.1.	Responsibilities	Biomedica	IDIS
1	Adverse event notification to pharmaceutical company		X
2	Adverse event notification to local competent authority	X

Biomedica Technical Agreement - 34 - 29/7/2009

13.2.	Product Data & Quality Control	Biomedica	IDIS
1	Transmission of product-related logistic	X
2	Correct handover and maintenance of product data	X	X
3	Provide TSE Certification regarding product status to IDIS	X
4	Provide Certificate of Analysis for each product batch	X
5	Provide Certificate of Compliance for each product batch	X
13.3.	Storage, Delivery and Transportation	Biomedica	IDIS
1	Delivery of products in conformity with the local market as nominated by Biomedica		X
2	Determination of the storage conditions and way of shipment	X
3	Adherence to storage conditions and way of shipment to user		X
4	Compliance with cGDP guidelines		X
5	Handling of returned goods		X
6	Handling of technical product complaints	X	X
7	Recall procedures	X	X
8	Incoming goods, control, inventory update	X	X
9	Adherence to FEFO principle		X
10	Shipments of products		X
11	Destruction of damaged, returned and expired goods		X

Biomedica Technical Agreement - 35 - 29/7/2009

IN WITNESS whereof this Agreement has been entered into the day and year written.

SIGNED for and on behalf of
Biomedica
Name:	[                    ]
Title:	[                    ]
Date:
SIGNED for and on behalf of
IDIS (TRADING AS IDIS LIMITED)
Name:	Maria Kempshall
Title:	Responsible Person
Date:
Name:	Tony Dutta
Title:	General Manager
Date:

Biomedica Technical Agreement - 36 - 29/7/2009

Schedule 1 – Product List

Brand Name:	Onalta Kit
Generic Name:
Strength:
Presentation:
Form:
Storage:
Pack size:
Therapeutic Area:
Product codes:
Brand Name:	Onalta
Generic Name:	90Y-edotreotide
Strength:	100 ml glass vial containing 80 mL of stabilized aqueous solution.
	Radioactivity concentration: 1.2-1.8 mCi / mL (TOC)
Presentation:	Liquid in Vial
Form:	Aqueous solution
Storage:	90Y-edotreotide is shipped at ambient temperature, should be stored at room temperature (25 ± 2°C), and should be used by the expiration date and time printed on the label. It is Radioactive. DGR.
	The 90Y-edotreotide vial will be labelled and packaged within a lead shield to reduce radiation emission and in accordance with radioactive pharmaceutical requirements.
Pack size:	One Vial
Therapeutic Area:	Oncology
Product codes:

Biomedica Technical Agreement - 37 - 29/7/2009

Schedule 2 – Contact Persons

Contract Acceptor		Contract Giver
Tony Dutta
General Manager
IDIS House
Churchfield Road
Weybridge
Surrey
KT13 8DB
United Kingdom
Telephone No: 01932 824000
Fax No: 01932 824200
Maria Kempshall
Responsible Person
At above address
Direct Telephone No: 01932 824031
Email address: mkempshall@idispharma.com
Alliance Development
Colleen Grant
Alliance Manager
At above address
Tel:	01932 824 147
E-mail:	cgrant@idispharma.com
Alliance Management
Maxine Hamilton
Global Alliance Manager
At above address
Tel:	01932 824 105
Mobile:	07740 720 233
E-mail:	mhamilton@idispharma.com

Biomedica Technical Agreement - 38 - 29/7/2009

Schedule 3 – Supply Chain Details

Onalta Kit

Site of manufacturer:	(require full postal address)
Site of packaging/assembly:	(require full postal address)

Site of storage prior to product arriving at IDIS: (Please enter details)

Contact for placement of purchase orders:

Product lead-time from placement of purchase order:	please advise
Contact for Invoicing:	please advise
Contact for provision of monthly sales report:	Please advise of further names

Onalta

Site of manufacturer:	(require full postal address)
Site of packaging/assembly:	(require full postal address)

Site of storage prior to dispatch to hospitals:	(Please enter details)
Contact for placement of purchase orders:

Product lead-time from placement of purchase order:	please advise
Contact for Invoicing:	please advise
Contact for provision of monthly sales report:	Please advise of further names

Biomedica Technical Agreement - 39 - 29/7/2009

Schedule 4

Order Management Process Flow Onalta Kit

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Biomedica Technical Agreement - 41 - 29/7/2009

Order Management Process Flow Onalta

Biomedica Technical Agreement - 42 - 29/7/2009

Biomedica Technical Agreement - 43 - 29/7/2009

Schedule 5

Process Map: Product Management Onalta Kit

Biomedica Technical Agreement - 44 - 29/7/2009

Process Map: Product Management Onalta

Biomedica Technical Agreement - 45 - 29/7/2009

Schedule 6 – Pharmacovigilance

Biomedica Technical Agreement - 46 - 29/7/2009

Biomedica Pharmacovigilance Representatives
Contacts:	(TBC – please complete)
Address:
Telephone No:	+
Fax No:	+
Email:
IDIS Pharmacovigilance Representatives
Telephone :	+44 (0) 1932 824 026
Fax :	+44 (0) 1932 824 226 - FAO Technical Enquiries
Email :	ps@idispharma.com

Biomedica Technical Agreement - 47 - 29/7/2009

EXHIBIT B

INTELLECTUAL PROPERTY

Generic Patent (100-7382)

Country	Grant. Date	Patent No.	Exp. Date
Australia	04.06.93	633859	04.12.09
Austria	09.12.97	403476	30.11.09
Belgium	20.11.90	1002296	05.12.09
Canada	22.02.00	2004532	04.12.09
Cyprus	01.12.95	1893	01.12.09
Denmark	30.08.04	175338	05.12.09
Finland	30.09.98	101967	11.07.14
Finland	31.12.98	102540	04.12.09
France	21.04.95	8915993	04.12.09
Germany	20.04.06	3991505	30.11.09
Great Britain	20.01.93	2225579	01.12.09
Greece	26.11.96	1002475	05.12.09
Hong Kong	21.12.95	1899/95	01.12.09
Hungary	20.09.95	211468	01.12.09
Ireland	05.12.94	62091	04.12.09
Israel	25.09.94	92534	04.12.09
Italy	19.10.93	1239285	05.12.09
Japan	10.06.05	3686503	04.12.09
Japan	05.12.97	2726320	04.12.09
Korea-South	22.07.98	156541	22.07.13
Luxemburg	18.09.91	87633	05.12.09
Malaysia	31.03.95	106120	31.03.10
Netherlands	03.04.03	194828	04.12.09
New Zealand	20.01.94	231623	04.12.09
Nigeria	13.04.93	10732	05.12.09
Pakistan	21.03.92	132014	05.12.00
Philippines	07.05.96	29649	07.05.13
Poland	28.09.93	163432	04.12.09
Portugal	20.10.95	92487	20.10.10
Saudi Arabia*			01.01.09
Singapore	15.04.97	38709	01.12.09
South Africa	28.08.91	89/9285	05.12.09
Spain	22.11.91	2023533	05.12.09
Sweden	09.11.98	8904087-7	04.12.09
Switzerland	30.08.91	678329-6	30.11.09
Tanganyika	30.09.97	2533	01.12.09
Trinidad+Tobago	14.11.95	78/95	01.12.09
USA	19.05.98	5753627	06.06.15
USA	07.07.98	5776894	07.07.15

* Saudi Arabia: patent application still pending, filing number 95160495

- 1 -

Additional Use Patent (118-7595)

Country	Grant. Date	Patent No.	Exp. Date
Belgium	05.01.93	1004645	19.02.11
France	20.01.95	9101993	18.02.11
Germany*			13.02.11
Great Britain	20.04.94	2241167	18.02.11
Hong Kong	10.04.97	434/97	18.02.11
Italy	15.07.94	1244496	19.02.11
Japan	15.03.02	3288055	21.02.11
Switzerland	28.02.94	683318-4	19.02.11
USA	26.09.00	6123916	26.09.17

* Germany: patent application still pending. Filing number: P4104308.1

Novartis Specific Patents

Country	Appl. Date	Appl. No.	Grant. Date	Patent No.	Exp. Date
Argentina	05.09.95	333413	22.03.04	AR256010M	05.09.15
Australia	04.09.95	30414/95	24.06.99	703057	04.09.15
Austria	04.09.95	95810545.4	07.03.01	714911	04.09.15
Belgium	04.09.95	95810545.4	07.03.01	714911	04.09.15
Brazil	05.09.95	PI9503936-8	22.06.04	PI9503936-8	05.09.15
Canada	05.09.95	2157530			05.09.15
Chile	05.09.95	1351/95	10.10.00	40732	10.10.15
China	05.09.95	115610/95	19.01.05	ZL95115610.1	05.09.15
Colombia	05.09.95	95040393	30.07.01	27134	05.09.15
Czech Republic	04.09.95	PV1995-2263	14.06.00	287012	04.09.15
Denmark	04.09.95	95810545.4	07.03.01	714911	04.09.15
Ecuador	05.09.95	SP 95-1528	20.06.97	PI 97-1158	05.09.15
Europe	04.09.95	95810545.4	07.03.01	714911	04.09.15
Finland	04.09.95	4147/95	13.10.06	117424	04.09.15
France	04.09.95	95810545.4	07.03.01	714911	04.09.15
Germany	04.09.95	69520256.1	07.03.01	714911	04.09.15
Great Britain	04.09.95	95810545.4	07.03.01	714911	04.09.15
Greece	04.09.95	95810545.4	07.03.01	714911	04.09.15
Hungary	04.09.95	2577/95	10.05.00	218284	04.09.15
India	24.08.95	1092/MAS/95			24.08.15
Ireland	04.09.95	95810545.4	07.03.01	714911	04.09.15

- 2 -

Country	Appl. Date	Appl. No.	Grant. Date	Patent No.	Exp. Date
Israel	04.09.95	115154	14.11.00	115154	04.09.15
Italy	04.09.95	95810545.4	07.03.01	714911	04.09.15
Japan	05.09.95	227906/95	07.04.00	3054346	05.09.15
Korea-South	05.09.95	28905/95	27.11.02	364111	05.09.15
Luxemburg	04.09.95	95810545.4	07.03.01	714911	04.09.15
Malaysia	05.09.95	PI95002626			05.09.15
Mexico	04.09.95	9503785	29.03.00	195731	04.09.15
Netherlands	04.09.95	95810545.4	07.03.01	714911	04.09.15
New Zealand	04.09.95	272919	17.04.97	272919	04.09.15
Norway	04.09.95	19953457	23.02.04	316569	04.09.15
Pakistan	03.09.95	467/95	03.09.97	134791	06.09.10
Peru	04.09.95	277844	28.02.01	001736	04.09.15
Philippines	04.09.95	51237	29.10.04	1-1995-51237	29.10.21
Poland	04.09.95	P310274	10.05.01	182434	04.09.15
Portugal	04.09.95	95810545.4	07.03.01	714911	04.09.15
Russia	04.09.95	95114740	13.04.00	2156774	04.09.15
Singapore	04.09.95	9501282-9	16.11.01	50356	04.09.15
Slovak Republic	04.09.95	1088/95	04.11.03	283774	04.09.15
Slovenia	04.09.95	P9530491	07.03.01	714911	04.09.15
South Africa	06.09.95	95/7475	28.05.97	7475/95	06.09.15
Spain	04.09.95	95810545.4	07.03.01	714911	04.09.15
Sweden	04.09.95	95810545.4	07.03.01	714911	04.09.15
Switzerland	04.09.95	95810545.4	07.03.01	714911	04.09.15
Taiwan	08.09.95	84-109395	16.08.00	114095	08.09.15
Thailand	04.09.95	27824/95	08.01.02	11623	04.09.15
Turkey	06.09.95	1094/95	22.04.02	TR199501094B	06.09.15
USA	23.04.97	09/609844	21.08.01	6277356	01.09.15
USA	23.04.97	08/842125	06.02.01	6183721	01.09.15
Venezuela	06.09.95	1572-95	08.01.99		06.09.15

- 3 -

EXHIBIT C

FORMULAIC DISTRIBUTION OF CONTIGENT MILESTONE PAYMENT

CALCULATIONS

The apportionment of the payments, should they become due, will be as follows:

Milestone payment A (5.4.3.1): Proportionately paid by all companies contributing to the generation of ***** in annual revenue. If only one company has generated revenue then the entire ***** will be due from that company. If two or more companies have generated the revenue then the payment will be divided in direct proportion to the revenues generated by that company, in that year.

EXAMPLE: Company A generates ***** revenue and Company B generates ***** revenue.

Milestone payment due from Company A: *****

Milestone payment due from Company B: *****

Milestone payment B (5.4.3.2): Proportionately paid by all companies contributing to the generation of ***** in revenue. If only one company has generated revenue then the entire ***** will be due from that company. If two or more companies have generated the revenue then the payment will be divided in direct proportion to the revenues generated by that company, in that year.

EXAMPLE: Company A generated ***** revenue and Company B generated ***** revenue, Company C *****

Payment due from Company A: *****

Payment due from Company B: *****

Payment due from Company C: *****

Since Company C did not participate in the payment of Milestone Payment (A) it will be required to contribute funds back to Companies A & B to compensate them for their initial development of the market, thus enabling the growth to *****. The amount that will be contributed is equal to the proportion generated by Company C in generating ***** multiplied by Milestone (A).

Total required payment to Companies A & B from Company C: *****

* Confidential Treatment Requested *

- 1 -

Distribution of Payment from Company C will be in the same proportion that Milestone Payment (A) was paid.

Funds paid to Company A: *****

Funds paid to Company B: *****

Milestone payment C (5.4.3.3): Proportionately paid by all companies contributing to the generation of ***** in revenue. If only one company has generated revenue then the entire ***** will be due from that company. If two or more companies have generated the revenue then the payment will be divided in direct proportion to the revenues generated by that company, in that year.

EXAMPLE 1: Company A generated ***** revenue and Company B generated ***** revenue, Company C *****

Payment due from Company A: *****

Payment due from Company B: *****

Payment due from Company C: *****

Since all three companies have paid for both Milestone (A) and Milestone (B) no further payment would be due in this example.

EXAMPLE 2: If a fourth company had contributed to the achievement of the milestone, it would be required to make a market development payment to the other three companies for its share of both Milestone (A) and Milestone (B). The methodology for determining the payment due, for each milestone, would be the same as that employed in the Milestone (B) example. The methodology for distribution of the payment would be as follows:

Milestone (A) Distribution

To Company A :*****

To Company B: *****

To Company C: *****

Milestone (B) Distribution

To Company A: *****

To Company B: *****

To Company C: *****

* Confidential Treatment Requested *

- 2 -

EXHIBIT D

EXAMPLES OF PERMITTED DISCLOSURES

1) Phase 3 Study:

• First patient dosed

• Last patient out

2) Acceptance by EMEA of the MAA application

3) EMEA approval of the MAA

4) Any presentation or publication of data from the clinical development of Onalta™ by BIOMEDICA.

5) Any public disclosure of trial results (e.g. safety, efficacy, primary or secondary endpoints) by BIOMEDICA

6) Final approval by any EU Regulatory Authority subsequent to EMEA approval.

7) Commencement of commercialization of Onalta.

- 3 -

EX-10.5

Exhibit 10.5

SUPPLY AGREEMENT

BETWEEN

BIOMEDICA Life Sciences, S.A.

AND

MOLECULAR INSIGHT PHARMACEUTICALS, INC.

dated as of

October 19, 2009

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

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.

3

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.

4

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

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

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 Requested *

7

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 Requested *

8

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 Requested *

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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 ******.

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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).

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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

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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 Requested *

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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

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EXHIBIT A:Specifications

Specifications for radiolabeling cold carrier kits

OnaltaTM Active Ingredient: [90Y] Yttrium DOTA-Tyr3-Octreotide (90Y Yttrium Edotreotide) ([90Y] Yttrium DOTA-TOC)

ACCEPTANCE CRITERIA

TEST METHOD

Time of Calibration (TOC)

1:00 PM EST at 2 days post production

Time of Expiration (Expiry Date)

3 days post production

Based on stability data

Primary Unit Dose Container

86 mL Dose in 100 mL Sterile Glass Vial

Visual Inspection

Appearance

Clear, colorless solution free of visible foreign matter.

Visual Inspection

Radioactivity Concentration

1.35 – 1.65mCi/mL(TOC

Radiometric assay of quantitative aliquot.

Radiochemical Identity

Radiometric Retention Time (Rt) corresponds with reference standard

HPLC-UV/RAD

Radiochemical Purity

> 90 Area % as [90Y] Yttrium DOTA-TOC

HPLC-RAD

[90Y] Incorporation

> 99.3%

HPLC-RAD or Radiometric TLC

Radionuclidic Identity

Emax = 2.283 MeV (T1/2 = 64.1 hours)

Beta-spectroscopy or Vendor CofA or Dose Calibrator

Specific Activity

>500 mCi/mg @ TOC

Vendor CofA

Radionuclidic Purity

< 2.5 Bq 90Sr / MBq 90Y (2.5uCi 90Sr / Ci 90Y)

Vendor ([90Y]Yttrium Chloride CofA

pH

4.0 – 5.0

pH meter or paper

Bacterial Endotoxin

< 1 EU/mL

USP <85>

Sterility

No growth

USP <71>

Storage

Store between 15-30°C

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PerkinElmer*

precisely.

PerkinElmer Life and Analytical Sciences 549 Albany Street Boston, MA 02118

TechnicaI Data

Caution: For Labortatory Use. A research chemical for research purposes only.

YTTRIUM-90

LOT SPECIFIC INFORMATION

Catalog # NEZ-306

Order# 1505466587 2

Lot# C11082207

Production date/time: 22-Aug-07/Noon ET

Activity. 301 mCi

Volume: 614 µL

Acid: 0.05 M HCl

Vial: P-2 glass vial

Product Specifications (as of Production date)

Sr-90/Y-90 Activity Ratio

Chemical Purity Ca Zn Al Cu Fe Cr Pb P

Zn+Fe+Cu+Pb Specific Activity

Product Release:

as of

Calibration date/time: 27-Aug-07/Noon ET Expiration date/time: l-Sep-07/Noon ET

Value at Prod.

No carrier added

Date:

0.7E-07 Ci/Ci

1-5 µg/Ci

PHYSICAL DATA

Half Life:

Maximum Beta Energy: Maximum Range of Beta in Air: Maximum Range of Beta in water

64.0 Hours 2.28MeV(100%)(1)) 9m(30reet)(2) 11 mm(0.43 inch)(2)

STORAGE CONDITIONS 20°-25° C; excursions permitted to 15°-30° C Warning: This product contains a chemical known to the state of California to cause cancer.

This document contains general Information designed to provide a basic understanding of radiation safely. While we believe the Information to be accurate, regulatory requirements may change and Information contained herein Is not tailored to Individual needs. A radiation protection specialist should be consulted for specific applications.

Certificate of Analysis

Parameter

Value at Cal.

<1.8E-07 Ci/Ci

<100 µg/Ci

<20 µg/Ci

<20 µg/Ci

<20 µg/Ci

<20 µg/Ci

<20 µg/Ci

<20 µg/Ci

<100 µg/Ci

<20 µg/Ci

<1.0E-07 Ci/Ci

0.4 µg/Ci

<0.3 µg/Ci

<0.8 µg/Ci

<0.3 µg/Ci

<0.2 µg/Ci

<2.0 µg/Ci

<10 µg/Ci

<20 µg/Ci

<3.7E-07 Ci/Ci

1.5 µg/Ci

8-27-07

RECEIVED

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EXHIBIT B FORM OF PURCHASE ORDER

Eckert & Ziegler Nuclitec GimbH

Gieselweg 1

38110 Braunschweig, Germany

Tel +49 5307 932-120

Mobile +49 177 9227266

Fax +49 5307 932-272

Attn: Rainer Schneider

Product and Sales Manager

rainer.schneider@ezag.com

BIOMED1CA Life Sciences 4 Papanikoli Str.,

15232 Halandri, Athens, Greece

hereinafter referred to as “Purchaser”.

DESCRIPTION OF ORDER: Compound and Product

SALE OF Compound and Product

Purchaser hereby agrees to purchase from Manufacturer, and Manufacturer agrees

to sell to Purchaser [specify quantity] of the compound and/or Product.

The Compound or Product shall be delivered to

(the “Place of Destination”).

Manufacturer shall provide all compound and Product FCA (INCOTERMS 2000) to Place of

Destination unless otherwise specified

Manufacturer shall use commercially reasonable efforts to ensure the Compound and/or Product are

received by the Purchaser by [insert delivery date] .

EZN

By: Name: Title: Date:

By: Name: Title: Date:

BIOMED1CA

hereinafter referred to as “Manufacturer”;

EXHIBIT C: Ordering and Fulfillment Process

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EXHIBIT D: Monthly Minimum Payment Obligation

******

* Confidential Treatment Requested *

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EXHIBIT E: Example of Over Achievement / Under Achievement Adjustment

******

* Confidential Treatment Requested *

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Exhibit F: Listing of Countries in Territory

Table of Countries by Territory

European     Union	1	Albania	European     Free     Trade     Assoc.	35	Lichtenstein	Middle East     &     Arabic States	62	Mauritania
	2	Andorra		36	Norway		63	Morocco
	3	Austria	Eastern     Europe	37	Belarus		64	Oman
	4	Belgium		N/A	Estonia*		65	Qatar
	5	Boznia and Herzegovina		N/A	Latvia*		66	Saudi Arabia
	6	Bulgaria		N/A	Lithuania*
	7	Croatia		38	Moldova		67	Somalia
	8	Cyprus		39	Ukraine		68	Sudan
	9	Czech Republic	Russia     & CIS	40	Russia		69	Syria
	10	Denmark		41	Armenia		70	Tunisia
	11	Estonia		42	Azerbaijan		71	UAE
	12	Finland		N/A	Belarus*		72	Western Sahara
	13	France		43	Georgia
	14	Germany		44	Kazakhstan		73	Yemen
	15	Greece		45	Krygyzstan	Turkey	74	Turkey
	16	Hungary		N/A	Moldova*	North     Africa	N/A	Algeria*
	17	Ireland		46	Tajikistan		N/A	Egypt*
	18	Italy		47	Turkmenistan		N/A	Libya*
	19	Latvia		N/A	Ukraine*		N/A	Morocco*
	20	Lithuania		48	Uzbekistan		N/A	Sudan*
	21	Luxembourg	Middle East     &     Arabic     States	49	Algeria		N/A	Tunisia*
	22	Malta		50	Bahrain		N/A	Western Sahara*
	23	Netherlands		51	Chad	Europe:     Non-Sovereign     Locations	75	Åland
	24	Poland		52	Comoros		76	Akrotiri and Dhekelia
	25	Portugal		53	Dijibouti		77	Faroe Islands
	26	Romania		54	Egypt		78	Gibraltar
	27	Slovakia		55	Eritrea		79	Guernsey
	28	Slovenia		56	Iran		80	Isle of Man
	29	Spain					81	Jersey
	30	Sweden		57	Iraq	Europe:     Partially     Recognized     Locations	82	Abkhazia
	31	United Kingdom		58	Jordan		83	Kosovo
	32	Vatican City		59	Kuwait		84	Northern Cyprus
European Free Trade Assoc.	33	Switzerland		60	Lebanon		85	South Ossetia
	34	Iceland		61	Libya	Europe:     Unrecognized     Locations	86	Nagorno-Karabakh
							87	Transnistria

* Countries are represented twice in two different territories, only counted once

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EX-10.6

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 -

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 ******,

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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.

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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 20^th 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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Exhibit A—Listing of Countries in Territory

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European     Union	1	Albania	European     Free     Trade     Assoc.	35	Lichtenstein	Middle East     &     Arabic States	62	Mauritania
	2	Andorra		36	Norway		63	Morocco
	3	Austria	Eastern     Europe	37	Belarus		64	Oman
	4	Belgium		N/A	Estonia*		65	Qatar
	5	Boznia and Herzegovina		N/A	Latvia*		66	Saudi Arabia
	6	Bulgaria		N/A	Lithuania*
	7	Croatia		38	Moldova		67	Somalia
	8	Cyprus		39	Ukraine		68	Sudan
	9	Czech Republic	Russia     & CIS	40	Russia		69	Syria
	10	Denmark		41	Armenia		70	Tunisia
	11	Estonia		42	Azerbaijan		71	UAE
	12	Finland		N/A	Belarus*		72	Western Sahara
	13	France		43	Georgia
	14	Germany		44	Kazakhstan		73	Yemen
	15	Greece		45	Krygyzstan	Turkey	74	Turkey
	16	Hungary		N/A	Moldova*	North     Africa	N/A	Algeria*
	17	Ireland		46	Tajikistan		N/A	Egypt*
	18	Italy		47	Turkmenistan		N/A	Libya*
	19	Latvia		N/A	Ukraine*		N/A	Morocco*
	20	Lithuania		48	Uzbekistan		N/A	Sudan*
	21	Luxembourg	Middle     East     &     Arabic     States	49	Algeria		N/A	Tunisia*
	22	Malta		50	Bahrain		N/A	Western Sahara*
	23	Netherlands		51	Chad	Europe:     Non-Sovereign     Locations	75	Åland
	24	Poland		52	Comoros		76	Akrotiri and Dhekelia
	25	Portugal		53	Dijibouti		77	Faroe Islands
	26	Romania		54	Egypt		78	Gibraltar
	27	Slovakia		55	Eritrea		79	Guernsey
	28	Slovenia		56	Iran		80	Isle of Man
	29	Spain					81	Jersey
	30	Sweden		57	Iraq	Europe:     Partially     Recognized     Locations	82	Abkhazia
	31	United Kingdom		58	Jordan		83	Kosovo
	32	Vatican City		59	Kuwait		84	Northern Cyprus
European Free Trade Assoc.	33	Switzerland		60	Lebanon		85	South Ossetia
	34	Iceland		61	Libya	Europe:     Unrecognized     Locations	86	Nagorno-Karabakh
							87	Transnistria

* Countries are represented twice in two different territories, only counted once

27

EXHIBIT B – PROJECT PLAN

28

29

EXHIBIT C - SPECIFICATIONS

30

31

EXHIBIT D – QUALITY AGREEMENT

32

CHANGE CONTROL HISTORY

TO THE

QUALITY (GMP AND GDP) AGREEMENT

between

MIPI

and

EZN

[Not a part of the Agreement]

Rev. Change Date

Date:

Number of pages:

Copies:

Name and number of Appendices:

QUALITY (GMP and GDP) 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 MIPI -

TABLE OF CONTENTS

1	LEGAL REQUIREMENTS	3
2	ACTIVE PHARMACEUTICAL INGREDIENTS, EXCIPIENTS AND PACKAGING MATERIALS	4
3	MANUFACTURE	4
4	QUALITY CONTROLS DURING AND AFTER MANUFACTURE	4
5	REFERENCE AND RETENTION SAMPLES	5
6	DOCUMENTATION	5
7	CERTIFICATION/CONFIRMATION (RELEASE)	5
8	STORAGE, PACKAGING AND TRANSPORTATION	5
9	NOTIFICATION AND APPROVAL OF DEVIATIONS	5
10	CHANGE CONTROL	6
11	PRODUCT DEFECTS	6
12	CONTACT DEPARTMENTS AND INDIVIDUALS	6
13	CONFIDENTIALITY	6
14	FINAL CLAUSES	7
APPENDIX 1		9
APPENDIX 2		10
APPENDIX 3		14
APPENDIX 4		15
APPENDIX 5		16
APPENDIX 6		17

Page 2 of 18

QUALITY AGREEMENT

THIS AGREEMENT (the “Quality Agreement”) is made on

between

Molecular Insight Pharmaceuticals, Inc whose registered office is at 160 Second Street, Cambridge, MA 02142, USA hereinafter referred to as “MIPI”,

and

Eckert & Ziegler Nuclitec whose registered office is at Gieselweg 1, 38110 Braunschweig, Germany hereinafter referred to as “EZN”,

each hereinafter referred to also as “a Party” and together as “the Parties”.

WITNESSETH

WHEREAS MIPI and EZN on the              have entered into a Facility Setup and Contract Manufacturing Agreement (hereinafter the “Commercial Agreement”).

WHEREAS this Quality Agreement covers production and/or packaging and/or analysis and/or distribution of the product listed in the appendices; and

WHEREAS the main roles and responsibilities of the Parties are set out in Appendix 2 hereto;

Now THEREFORE, the Parties hereto have adopted and are bound by the following conditions of this Quality Agreement:

1 LEGAL REQUIREMENTS

1.1 EZN affirms that it will be responsible for the application and issuance of the required Manufacturing Authorisation pursuant to the local legal requirements for the production and/or packaging and/or analysis and/or release of the product listed in Appendix 1 (herein referred to as “the Product”).

1.2 The Parties shall be obliged to immediately advise each other’s Contact Department and Individuals (cf. Article 12) of any changes in the Manufacturing Authorisation with regard to the Product. EZN shall be obliged to forward to MIPI a copy of the Manufacturing Authorisation (cf. Article 1.1).

1.3 EZN warrants that the Product from the first batch and onwards will be manufactured according to the documents agreed upon and as specified in Appendix 2. The manufacture will take place at EZN’s plant at Braunschweig, Germany.

1.4 EZN warrants that all activities related to the Product will be in accordance with (i) all current international rules and regulations according to ICH guidelines and (ii) with rules and regulations of the European Union, including but not limited to the EU-Guide to Good Manufacturing Practice for Medicinal Products, (iii) as well as the agreed directives of MIPI as specified in this Quality Agreement, and (iv) all rules and regulations as defined in the Commercial Agreement (collectively hereinafter called the “Provisions”).

Page 3 of 18

1.5 EZN will allow MIPI and the competent authorities in the Territories where Product is being marketed, after prior agreement and during normal working hours, to perform all the audits and inspections necessary in connection with the manufacture and supply of the Product covered by the Agreement.

1.6 MIPI will be responsible for compliance with the legal requirements and recommendations applicable to the Product and the manufacture hereof in the countries in which the Product is sold, and shall inform EZN of any changes hereto which could require changes at EZN. Implementation of any such changes must be agreed upon separately unless otherwise agreed upon in the Commercial Agreement.

1.7 EZN agrees not to assign or move the performance of any tasks or obligations covered by this Quality Agreement to any other site, any affiliate or any third party without having obtained the prior written consent of MIPI.

2 ACTIVE PHARMACEUTICAL INGREDIENTS, EXCIPIENTS AND PACKAGING MATERIALS

2.1 The active pharmaceutical ingredients, excipients and packaging materials listed in Appendix 3 shall be provided by EZN, checked for accordance with the specifications contained in the said Appendix, and tested and released for use in manufacturing the product by EZN.

2.2 The active pharmaceutical ingredients, excipients and packaging materials indicated in Appendix 4 shall be provided by MIPI, received, identity confirmed, approved and stored in accordance with the specifications in the said Appendix, and released for manufacturing of the product by EZN.

3 MANUFACTURE

3.1 The Product shall be manufactured in batches, ensuring adherence to the manufacturing instructions agreed upon between the Parties following the Scaled up Process as defined in the Commercial Agreement, as well as ensuring the quality in accordance with the Product specifications listed in Exhibit C of the Commercial Agreement. Manufacturing instructions shall be approved by MIPI in writing prior to routine manufacturing. Final definition of batches applying for this Quality Agreement will be subject to separate mutual definition of EZN and MIPI.

4 QUALITY CONTROLS DURING AND AFTER MANUFACTURE

4.1 EZN shall conduct in-process controls according to agreed upon manufacturing instructions.

4.2 EZN shall conduct final quality controls according to Exhibit C of the Commercial Agreement and any additional testing required for current European GMP guidelines or marketing authorization.

Page 4 of 18

5 REFERENCE AND RETENTION SAMPLES

5.1 EZN shall retain reference samples of all starting materials to the Product, including but not limited to active pharmaceutical ingredients, excipients (except for gases, solvents and water) and packaging materials (the “Starting Materials”) until expiry date of the last batch of Final Product it was used for or in compliance with current GMP guidelines. Retention samples of the manufactured Final Product must be taken in a quantity sufficient for two full analytic controls, and they must be kept for twenty-four (24) months past the expiry date.

6 DOCUMENTATION

6.1 EZN shall keep records on all manufacturing and control steps on the basis of GMP-guidelines and keep same for a minimum of five (5) years. All documentation will be in German.

6.2 EZN will issue an annual Product review on the manufacture, analytical testing and summarizing all changes implemented and deviations and submit such review to MIPI, in English and German.

7 BATCH RELEASE

7.1 MIPI shall receive the Confirmation by a Qualified Person (EU GMP Annex 16) of batch release as set forth in Appendix 5.

8 STORAGE, PACKAGING AND TRANSPORTATION

8.1 EZN shall be responsible for appropriate storage of the Starting Materials and the Product, as well as for packaging the Product for transportation in suitable and well-closed containers.

8.2 MIPI is responsible for the transportation of the Product in accordance with the Commercial agreement? International Hazardous material regulations? at all times governing European Guidelines for Good Distribution Practices and local legal requirements.

9 NOTIFICATION AND APPROVAL OF DEVIATIONS

9.1 EZN will investigate and document all deviations, out-of-specification results, non-compliance with Good Manufacturing Practices, production failures or product complaints or any other matter that may affect the quality, safety or efficacy of the Product. Documentation will be retained as part of the batch documentation for the batch affected.

9.2 EZN shall notify MIPI within forty-eight (48) hours of all significant deviations from agreed procedures or specifications, which might have an impact on Product quality and/or affect specifications and process compliance.

Page 5 of 18

10 CHANGE CONTROL

10.1 EZN will utilise a documented system of procedures for control of changes to raw materials, packaging materials, suppliers, equipment, facilities, utilities, manufacturing methods, product and material specifications and requirements, sampling, test methods and release requirements.

10.2 EZN shall inform the MIPI well in advance about any technical changes (e.g. in component sourcing or quality, utilities or environmental conditions), which could affect the regulatory documentation of the Product.

10.3 The Parties shall agree upon documentation necessary for the variation application and timeline of implementation, including necessary validation activities prior to such implementation.

10.4 MIPI will inform EZN in writing about the variation approval promptly after receipt of such approval from the competent authorities. Additionally, MIPI will inform EZN of any changes required in the process for receiving marketing authorization.

11 PRODUCT DEFECTS

11.1 EZN shall assist MIPI in investigating all Product complaints by reviewing Product and materials to determine the cause, if any. In addition, all appropriate documentation shall be reviewed by EZN. EZN shall diligently work to provide a written report of its determination within thirty (30) days from receipt of MIPI’s written request.

11.2 If a deviation or a product defect is discovered, e.g. during stability monitoring or out of customer complaints, which has an impact on the quality of the product after the product has been released; MIPI must be notified immediately.

12 CONTACT DEPARTMENTS AND INDIVIDUALS

12.1 EZN agrees to provide answers as soon as possible to all enquiries and complaints from MIPI.

12.2 Any communication between MIPI and EZN regarding the Quality Agreement shall be addressed to the Individuals mentioned in Appendix 6.

13 CONFIDENTIALITY

13.1 The Parties agree that information exchanged between them under the present Quality Agreement is of a proprietary and confidential nature Both Parties agree to keep confidential any and all information exchanged under the present Quality Agreement and any other information they acquire about each other during the term of the present Quality Agreement. Both Parties warrant to each other to do their utmost in order to ensure that their respective employees respect this confidentiality obligation.

13.2 This obligation does not extend to information for which the receiving Party can prove that:

13.2.1 it had the information prior to the time of disclosure; or

Page 6 of 18

13.2.2 the information has become generally available to the public domain after the date hereof through no fault of the receiving Party.

13.2.3 it has received the information from a third party whose direct or indirect source is not the disclosing Party.

13.3 The receiving Party shall further be entitled to disclose to the competent regulatory or legal authorities such part of the information received from the disclosing Party that is required by law to be disclosed to such authorities. In this event, the receiving Party shall ask the receiving regulatory or legal authority to maintain confidentiality.

14 FINAL CLAUSES

14.1 This Quality Agreement shall become effective upon signature by both Parties.

14.2 Supplements and amendments to this Quality Agreement shall be in writing and signed by the Parties.

14.3 This Quality Agreement shall remain in effect for the term of the Commercial Agreement. The termination or expiration of this Quality Agreement for any reason whatsoever shall be without prejudice to any obligations or rights on the part of either Party which have accrued prior to such termination, and shall not affect or prejudice any provision of this Agreement which is expressly (e.g. Retention of Samples in Article 5.1) or by implication provided to come into effect on, or continue in effect after such termination.

14.4 The Parties shall renegotiate the terms of this Quality Agreement if necessary due to major legal or regulatory changes.

14.5 Upon termination of this Quality Agreement and the corresponding Commercial Agreement, all documents provided by MIPI to EZN and all reference samples as well as the batch manufacturing and control documents archived according to Article 5 and 6 shall be returned to MIPI.

14.6 In the event that any provision in this Quality Agreement is held to be unlawful or invalid in any jurisdiction, the meaning of such provision will be construed to the greatest extent possible so as to render it enforceable. If no such construction can render such provision enforceable, it will be severed. The remainder of this Agreement will remain in full force and effect, and the Parties will negotiate in good faith a reasonable substitute provision that is valid and enforceable in such jurisdiction.

14.7 In case of discrepancy between any provision of the Commercial Agreement and the Quality Agreement, special terms shall prevail over general terms, and new terms prevail over old terms.

14.8 German law shall apply.

MIPI EZN

Page 7 of 18

Name:	Name:
Title:	Title:
Date:	Date

Page 8 of 18

APPENDIX 1

TO THE

QUALITY (GMP AND GDP) AGREEMENT

between

MIPI

and

EZN

Product

Onalta™

Page 9 of 18

APPENDIX 2

TO THE

QUALITY (GMP AND GDP) AGREEMENT

between

MIPI

and

EZN

	MIPI	EZN	corresponding flies / documentation / remarks (e.g. title, No., enclosure, etc.)
Accordance with the registration documents	¨	X
sterile pre-dispensed Iyophilized preparation of DOTA-TOC “KIT”:
Specification	X	¨
Supplier qualification	X	¨
Supplier review	X	¨
Supply/ Procurement	X	¨
Testing	X	¨
Reference samples	X	¨
Release	X	¨
Storage Conditions	X	¨
Shelf Life	X	¨
Certain excipients:
Specification	X	¨
Supplier qualification	¨	X
Supplier review	¨	X
Supply / Procurement	¨	X
Testing	¨	X
Reference samples	¨	X
Release	¨	X
Other excipients: Not Applicable
Specification	¨	¨
Supplier qualification	¨	¨
Supplier review	¨	¨
Supply/Procurement	¨	¨
Testing	¨	¨
Reference samples	¨	¨
Release	¨	¨

Page 10 of 18

	MlPI	EZN	corresponding files / documentation / remarks (e.g. title, No., enclosure, etc.)
Primary packaging:
Specification	X	¨
Supplier qualification	¨	X
Supplier review	¨	X
Clearance for printing	X	¨
Supply/Procurement	¨	X
Testing	X	¨
Retention samples	¨	X
Release	¨	X
Printed secondary packaging:
Label
Specification	X	¨
Supplier qualification	¨	X
Supplier review	¨	X
Clearance for printing	¨	X
Supply/Procurement	¨	X
Testing	X	¨
Retention samples	¨	X
Release	X	¨
Secondary packaging
Specification	¨	X
Supplier qualification	¨	X
Supplier review	¨	X
Clearance for printing	¨	X
Supply/Procurement	¨	X
Testing	X	¨
Retention samples	¨	X
Release	X	¨

Page 11 of 18

	MlPI	EZN	corresponding files / documentation / remarks (e.g. title, No., enclosure, etc.)
Package leaflet:
Specification	X	¨
Supplier qualification	X	¨
Supplier review	X	¨
Clearance for printing	X	¨
Supply/Procurement	X	¨
Testing/Readibility	X	¨
Retention samples	X	¨
Release	X	¨
Finished product:
Specification	X	¨
Assignment of batch no.	¨	X
Determination of shelf life	X	¨
Packaging procedures	X	¨
In-process-control	¨	X
Packaging record	¨	X
Testing procedure	X	¨
Testing record	¨	X
Certificate of analysis	¨	X
Release for shipment	¨	X
Final testing	¨	X
Retention samples	¨	X
Final release for market	¨	X
On-going stability	¨	X
On-going stability Procedure	¨	X

EZN will perform the stability study based on MIPI protocol!

MIPI receives the following documentation:

	Every consignment	On request
Finished product:
Packaging record, complete	¨	X
Packaging record, extract	¨	X
In-process control records	¨	X
Cert. of analysis for finished product	¨	X
Confirmation of proper manufacture/ testing	¨	X

Page 12 of 18

Product Quality Review:

EZN submits documents / data for the activities performed by EZN.

The final evaluation of PQR is the responsibility of MIPI.

Other agreements / Special arrangements

(e.g. specific quality tests, shelf life tests, storage conditions, transport conditions)

On-going stability studies shall be limited to a maximum of analyses of 30 samples consisting at a maximum of tests conducted for a batch release.

Done by (Signature / Date):
MIPI        (Signature/ Date) Q.P.:	EZN        (Signature/ Date) Q.P.:
Head of Production:	Head of Production:
Head of QC:	Head of QC:

Page 13 of 18

APPENDIX 3

TO THE

QUALITY (GMP AND GDP) AGREEMENT

between

MIPI

and

EZN

[Edotreotide Y 90

And edotreotide In 111]

ACTIVE PHARMACEUTICAL INGREDIENTS, EXCIPIENTS AND PACKAGING MATERIALS TO BE PROVIDED BY EZN

Yttrium-90 as yttrium chloride

Indium-111 as indium chloride

Final primary container closure system (clean, sterile, pyrogen freel00 mL glass vial with rubber serum cap and aluminium seal)

Qualify of Active Pharmaceutical Ingredients:

[Please include name and address of manufacturer of active pharmaceutical ingredient]

Quality of Excipients: Certificate of Analysis confirming the identity, purity and strength of the Y-90 and In-111 component isotopes.

Quality of Packaging Material:

Page 14 of 18

APPENDIX 4

TO THE

QUALITY (GMP AND GDP) AGREEMENT

between

MIPI

and

EZN

Edotreotide Y 90 and

Edotreotide In 111

ACTIVE PHARMACEUTICAL INGREDIENTS, EXCIPIENTS AND PACKAGING MATERIALS TO BE PROVIDED BY MIPI

Edotreotide reference standard

Kits for the production of edotreotide Y 90 and edotreotide In 111

Quality of Active Pharmaceutical Ingredients:

Bachem AG- GMP Edotreotide

Rentschler: GMP- freeze dried kits to product edotreotide

Quality of Excipients:

Excipients contained in GMP manufactured kits containing API

Quality of Packaging Material:

Page 15 of 18

APPENDIX 5

Form

Batch Release

Product:

Batch no.:

Packaging size:

Date of manufacture:

Date of expiry:

Quantity

Name and address
of manufacturing site:

Herewith we confirm that the above described batch has been produced incl. packaging and quality control (QC) within a.m. manufacturing site and in compliance with national pharmaceutical law and GMP requirements and in conformance with the manufacturing procedures and testing instructions released by CG.

The batch processing, packaging and analysis records were reviewed. That means, inter alia, that possible deviations (concerning the product covered by the Agreement and the starting materials) are listed and evaluated.

During the course of manufacturing, packaging and testing there were

[    ] no deviation / no OOS result

[    ] deviation / OOS result (deviation / OOS report attached)

[    ] additional relevant information regarding the quality of the product is attached

Date:
Sign:
	(Qualified Person CA

Page 16 of 18

APPENDIX 6

CONTACT DEPARTMENT AND INDIVIDUALS

MIPI

Name Task Address, Phone, Fax, E-mail

EZN

Name Task Address, Phone, Fax, E-mail

Page 17 of 18

EXHIBIT E – PRODUCT PRICE TABLE

Final Product Price (in € per 120mCi dose)

Item	Year 1 (*	Year 2	Year 3	Year 4	Year 5 to 10
Y90-DOTATOC	*****	*****	*****	*****	*****

(* Year 1 will commence upon completion of Facility and receipt of manufacturing authorization. For any dose of Final Product delivered during the Interims Phase, prices of Year 1 shall apply.

All prices in addition to the Monthly Payments and Milestone Payments.

Y-90 Price (in € per 120mCi dose)

EZN will deliver Y-90 for the price of ***** per 120mCi dose.

All prices in addition to the Monthly Payments and Milestone Payments.

Kit Storage and Handling Fee

EZN will store and handle Kits for the price of ***** per patient dose/Kit (exclusive packaging and transportation costs).

All prices in addition to the Monthly Payments and Milestone Payments.

Preliminary non-binding volume forecast (Number of 120 mCi patient doses)

Item	Year 1 (*	Year 2	Year 3	Year 4	Year 5
Y90-DOTATOC	*****	*****	*****	*****	*****

(* Year 1 will commence upon completion of Facility and receipt of manufacturing authorization.

Projected Expected Volume Will Be Provided to EZN On An Agreed Upon Schedule

* Confidential Treatment Requested *

EXHIBIT F – MILESTONE SCHEDULE

Milestone schedule:

1. Upon Effective date /signature of agreement *****

2. Upon reaching the following milestones: *****

• technical readiness of Provisional Facility for Interim Supply, which shall mean three (3) consecutive production runs at the Provisional Facility that meet the product specifications to be proven to MIPI by EZN by means of signed respective batch release reports

• design clearance for the Facility (high throughput supply capability), which shall mean submission of technical design specifications of the Facility (high throughput supply capability) by EZN to MIPI

3. Upon reaching the following milestones: *****

• regulatory clearance of Provisional Facility for Interim Supply, which shall mean the submission of a copy of a document by local authorities by EZN to MIPI

4. Upon reaching the following milestones: *****

• factory acceptance for the Hot Cell(s) for Facility (high throughput supply capability), which shall mean submission of the final report of FAT signed by EZN to MIPI

5. Upon reaching the following milestones: *****

• technical and regulatory clearance for the Facility (high throughput supply capability), which shall mean the submission of the final validation report for the Facility (high throughput supply capability) and a copy of a document by local authorities by EZN to MIPI

A copy of the respective documents send by facsimile or via e-mail to the MIPI contact mentioned in Article 20 of the Facility Setup and Contract Manufacturing Agreement shall be sufficient for due submission.

* Confidential Treatment Requested *

EX-31.1

Exhibit 31.1

CERTIFICATION

I, Daniel L. Peters, certify that:

1. I have reviewed this quarterly report on Form 10-Q/A of Molecular Insight Pharmaceuticals, Inc. for the fiscal quarter ended September 30, 2009;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15a-15(f)) for the registrant and have:

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b. Designed such internal control over financial reporting or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: March 10, 2010	/S/ DANIEL L. PETERS
	Daniel L. Peters
	President and Chief Executive Officer
	(Principal executive officer)

EX-31.2

Exhibit 31.2

CERTIFICATION

I, Charles H. Abdalian, Jr., certify that:

1. I have reviewed this quarterly report on Form 10-Q/A of Molecular Insight Pharmaceuticals, Inc. for the fiscal quarter ended September 30, 2009;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15a-15(f)) for the registrant and have:

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b. Designed such internal control over financial reporting or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation and

d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: March 10, 2010	/S/ CHARLES H. ABDALIAN, JR.
	Charles H. Abdalian, Jr.
	Senior Vice President and Chief Financial Officer
	(Principal financial officer)

EX-32

Exhibit 32

Certification

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Molecular Insight Pharmaceuticals, Inc., a Massachusetts corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:

The Quarterly Report for the quarter ended September 30, 2009 on Form 10-Q/A (the “Quarterly Report”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and the information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the end of the period covered by this Quarterly Report.

Dated: March 10, 2010	/S/ DANIEL L. PETERS
	Daniel L. Peters
	President and Chief Executive Officer
	(Principal Executive Officer)
Dated: March 10, 2010	/S/ CHARLES H. ABDALIAN, JR.
	Charles H. Abdalian, Jr.
	Senior Vice President and Chief Financial Officer
	(Principal Financial Officer)

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.