Document:

Territory License Agreement

 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

  

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 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 OnaltaTM. 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 OnaltaTM; 
 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

  

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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. 

  

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	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. 

  

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	 	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. 

  

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	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. 

  

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	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. 

  

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	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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	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

  

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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, OnaltaTM, 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, OnaltaTM, 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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	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 31st 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 31st 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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	 	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. 

  

 27 

 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. 

  

 28 
  

  
 *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

  

 29 

	 	 
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. 

  

 30 

	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. 

  

 31 

	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. 

  

 32 

	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. 

  

 33 

	 	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,

  

 34 

	 	 
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.

  

 35 

	 	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,

  

 37 

	 	 
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

  

 38 

	 	 
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. 

  

 39 

	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— 
  

 40 

 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

  

 41Supply Agreement

 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. 
  

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 1.2. “Agreement” shall mean this Agreement together with all schedules, and
appendices attached to this Agreement, all as respectively amended, modified or supplemented by the Parties in accordance with the terms of this Agreement. 
 1.3. “Compound” shall mean a lyophilized kit comprising the DOTA-chelated somatostatin peptide analogue known as edotreotide plus excipients provided. 
 1.4. “Confidential Information” shall mean any information relating to the scientific and business affairs of a Party
disclosed to the other Party in connection with this Agreement, regardless of whether such information is specifically designated as confidential and regardless of whether such information is in written, oral, electronic, or other form. Such
Confidential Information may include, without limitation, trade secrets, know-how, Inventions, non-published Patent Rights, technical data or specifications, materials formulations, compositions, processes, information, testing methods and/or
results, business or financial information and methods, research and development activities, production and marketing plans, and customer and supplier information. 
 1.5. “Dose” shall mean a unit consisting of one patient vial of Compound or Product. 
 1.6. “Effective Date” shall mean the date first above written, which date post-dates the beginning of the Term as such as defined herein. 
 1.7. “Good Clinical Practice” or “GCP” shall mean the generally accepted standard of Good Clinical Practice
within the pharmaceutical industry for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are clinical and accurate and that the
rights, integrity and confidentiality of the trial subjects are protected. 
 1.8. “Good Manufacturing
Practices” or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant governmental authority having jurisdiction over the development, manufacture or sale
of the Compound or the Product in the Territory. 
 1.9. “Inventory” shall mean Compound or Product.

 1.10. “Product” shall mean the yttrium radiolabeled Compound for therapeutic use and indium-111 radiolabeled
Compound for dosimetry purposes, both in a form ready for use in human clinical trials and/or by the ultimate consumer with the trademark of Onalta. 
 1.11. “Purchase Order” shall mean the order form to be completed and issued by BIOMEDICA to MIP or MIP’s designee for the purpose of ordering Compound or Product (Exhibit B).

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

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 1.13. “Specification(s)” shall mean the standards established for the
characteristics, quality, and quality control testing of the Compound or the Product, and its constituents, components, and packaging, as described in the IMPD, Section 2.1 SS.4, 2.1 SK.4 and 2.1.P.5 and MIP product specification and as may be
amended from time to time by the mutual written agreement of the Parties (Exhibit A). 
 1.14. “Term” shall
mean the period commencing on the September 1, 2009 (the effective date of the Territory License Agreement) and continuing for 10 (ten) years thereafter, with a renegotiation of the terms during year five (5) for the second five
(5) years. In no case shall the Term survive termination of the Territory License Agreement. 
 1.15.
“Territory” shall mean those countries as of the Effective Date belonging to the European Union, the European Free Trade Association (Switzerland, Iceland, Lichtenstein and Norway), Eastern Europe, Russia and the other former Commonwealth
of Independent States (CIS), the Middle East and Arabic States, Turkey, and the North Africa region. “Territory” shall specifically exclude the State of Israel unless and until such rights become available. For the sake of clarity, as of
the Effective Date, the Territory shall mean the specifically enumerated countries listed in Exhibit F attached hereto. 
 The
following Exhibits attached to this Agreement are hereby incorporated by reference: 
  

	 	Exhibit A:	Specifications 

	 	Exhibit B:	Purchase Order 

	 	Exhibit C:	Ordering and Fulfillment Process 

	 	Exhibit D:	Monthly Minimum Payment Obligation 

	 	Exhibit E:	Example of Over Achievement /Underachievement Adjustments 

	 	Exhibit F:	Listing of Countries in Territory 

  
 2. SUPPLY OF COMPOUND AND PRODUCT 
 2.1 Engagement. During the Term and after the Effective Date of this Agreement, BIOMEDICA hereby engages MIP and MIP accepts such engagement as BIOMEDICA’s exclusive supplier of Compound and Product
subject to the terms of this Agreement. 
 2.2 Product and Specifications. MIP agrees to supply, directly or through a MIP
designee selected by MIP to be identified to BIOMEDICA immediately upon signing of this Agreement, the Compound or the Product to BIOMEDICA according to the Specifications (Exhibit A), in accordance with current good manufacturing practices
(“GMP”) and in accordance with any other applicable standards imposed by law. 
 2.3 Orders of Compound or Product.
BIOMEDICA shall submit to MIP or MIP’s designee a binding Purchase Order substantially in the form attached hereto as Exhibit B by

  

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

 2.4 Prior to the first shipment of Compound or Product to any third party site, BIOMEDICA or its licensee shall obtain and
forward to MIP from such third Party its license evidencing proper legal authority for the receipt and possession of the Compound or Product. If and to the extent necessary, BIOMEDICA shall further obtain all approvals, licenses and permits required
to import Compound or Product into each country in the Territory as directed by BIOMEDICA. 
 2.5 MIP or MIP’s designee
shall deliver Compound or Product in accordance with the quantities and requested delivery date(s) specified in the relevant order. MIP or MIP’s designee will pack the Compound or Product for shipment and storage in accordance with the
applicable Specifications. 
 2.6 Delivery. MIP or MIP’s designee shall ship the Compound or the Product to
BIOMEDICA’s facility (or as otherwise reasonably directed by BIOMEDICA in writing) using a carrier of BIOMEDICA’s selection, approved by MIP or MIP’s designee. MIP or its designee shall ship the Compound and the Products to BIOMEDICA
or it’s designees in accordance with all appropriate regulations. BIOMEDICA shall be responsible for providing evidence of proper legal authority for the receipt and possession of Compound or Product in each country in the Territory. BIOMEDICA
shall obtain all approvals, licenses appointing any customs brokers, and acquiring any necessary licenses or permits, including but not limited to obtaining the necessary import licenses from the appropriate governmental authorities. Delivery of
Final Product as directed by BIOMEDICA shall be FCA (INCOTERMS) MIP or MIP designee’s facility shipping dock. Title and risk of loss for the goods shall pass to BIOMEDICA at point of delivery by MIP or MIP’s designee to the selected
carrier. All transportation and packaging costs incurred to deliver Compound or Product ordered by BIOMEDICA shall be borne by BIOMEDICA. 
 2.7 Packaging Information. Packages will consist of one Dose per package. The package design for the Product will be IAEA compliant Type A packaging for international transportation. BIOMEDICA is solely
responsible for compliance of the text of the package labels with applicable regulations in the Territory countries for both the Product and the Compound. It is the intent of the Parties that the package label will indicate BIOMEDICA as the Party
for whom the Compound and/or Product is manufactured. 
 2.8 If either Party or its designee discovers that the Compound,
Product and/or Dose does not comply with Specifications, then the discovering Party shall within 1 (one) business day inform the other Party of such non-compliance to determine a mutually agreed course of action. With respect to any such Compound,
Product and/or Dose which do not comply with Specifications as a result of shortcomings in process or parameters under the direct control of

  

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MIP or MIP’s designee, then MIP or MIP’s designee promptly will replace such Compound, Product and/or Dose at no additional cost to BIOMEDICA. 
 2.9 BIOMEDICA shall not modify the Compound or the Product, or use alternative radioisotopes with the Compound or Product. Yttrium-90
isotope supply must meet Specifications (Exhibit A) and be qualified and validated for the Product and/ or Compound. MIP will provide BIOMEDICA with two (2) qualified and validated suppliers of Yttrium-90. BIOMEDICA shall not be limited to
these two suppliers to the extent additional suppliers of qualified and validated Ytrrium-90 may also be available. 
 2.10
During the period that precedes availability of the Product, MIP agrees to provide the Compound for purposes of radiolabeling by BIOMEDICA in connection with its Onalta compassionate use and clinical study activities in the Territory subject to
BIOMEDICA first securing and providing MIP with evidence of receipt of all relevant licenses and regulatory approvals required in each relevant country in the Territory. The final formulation and doses of Compound will be compounded at the treatment
center or designated site and coordinated by BIOMEDICA. BIOMEDICA shall be solely responsible for preparing or having prepared any Product and insuring compliance with GMP (Good Manufacturing Practices) and GCP (Good Clinical Practices) standards
required or customary in the Territory. 
 2.10.1 Certificates of Manufacturing Compliance. At the request of BIOMEDICA and at
BIOMEDICA’s expense, MIP shall provide or cause to be provided for such Compounds or Products purchased, a certificate of manufacturing compliance, containing the types of information reasonably agreed upon by BIOMEDICA and MIP. Such
certificate shall certify that the Compounds or Products were manufactured in accordance with the specifications provided by BIOMEDICA and in compliance with all local laws in the country of manufacture. 
 2.10.2 Prior to the initial release and shipment of the Compound or Product in each country in the Territory, BIOMEDICA shall provide MIP or
MIP’s designee with applicable radioactive license(s) and regulatory documentation authorizing the use and administration of the Compound or the Product in humans. 
 2.10.3 Compound Radiolabeling Tech Transfer Support. MIP will provide up to ****** hours for Compound radiolabeling tech transfer support to BIOMEDICA personnel without a labor charge but with
reimbursement for all reasonable expenses incurred. At BIOMEDICA’s request, MIP will provide BIOMEDICA additional tech transfer support, for which support, BIOMEDICA agrees to reimburse MIP for at a daily rate range of ****** depending on the
technical expertise and experience level required for the specific assistance requested by BIOMEDICA, plus reasonable expenses incurred. BIOMEDICA will provide MIP an advance notice of 30 days for requested support. 
  
 * Confidential Treatment Required *

  

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 3. PRICING, PURCHASE COMMITMENT AND PAYMENT 
 3.1 Minimum Purchase Obligation. During the Term of this Agreement BIOMEDICA commits to purchase or otherwise pay MIP certain guaranteed
monthly minimum amounts. Such guaranteed monthly minimum amounts shall commence at the beginning of Q3 2010 and continue through Q4 2013 inclusive. The cumulative guaranteed monthly minimum amount due in any given quarter shall define a target
guaranteed quarterly minimum amount for calculating any underachievement adjustment or overachievement adjustment to be received by BIOMEDICA in an immediately subsequent quarter under the conditions set forth in 3.1.1 and 3.1.2.
 3.1.1 Adjustments Underachievement Associated with Minimum Purchase Obligation. ****** of any payment made by BIOMEDICA to meet a Minimum
Purchase Obligation amount in any particular quarter will be applied by MIP as an Underachievement Adjustment against any overachievement amount in excess of a subsequent quarter’s Guaranteed Quarterly Minimum Purchase Amount. In no case shall
such an underachievement adjustment exceed any payment due by BIOMEDICA to MIP in excess of the minimum payment required in the subsequent quarter. In no case will the underachievement adjustment survive beyond such subsequent quarter. In no event
will the underachievement adjustment reduce the subsequent quarter’s target Guaranteed Quarterly Minimum Amount to less than zero. ****** 
 3.1.2 Adjustments Overachievement Associated with Minimum Purchase Obligation. ****** of any amount paid by BIOMEDICA in excess of the Guaranteed Quarterly Minimum Amount due in any particular quarter for
Compound and/or Product, where such payment has taken into account any overachievement or underachievement adjustments, will be applied by MIP as an Overachievement Adjustment against any underachievement amount that may be owed by BIOMEDICA toward
the subsequent quarter’s target Guaranteed Quarterly Minimum Amount. In no case will the overachievement adjustment survive beyond such subsequent quarter. In no event will the overachievement adjustment reduce the subsequent quarter’s
target Guaranteed Quarterly Minimum Amount to less than zero. ****** 
 3.1.3. For purposes of this section, “Material
Change” shall mean an identifiable event or events that give rise to a significant and material adverse change in demand for Compound and/or Product in any given quarter by more than ****** of projected figures contained in the BIOMEDICA
Business Plan attached and incorporated into the Territory License Agreement between the Parties dated September 1, 2009 for that quarter. A change in demand for either Compound or Product of less than ******, or a change in demand attributed
substantially and directly to conduct within BIOMEDICA’S reasonable control, or where the cause of the event is not identifiable with reasonable certainty, shall not constitute a Material Change. Any increase beyond projections of Compound or
Product shall not constitute a Material Change. BIOMEDICA and MIP 
  
 * Confidential Treatment Required * 
  

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agree to account for Material Changes in the demand for Compound and/or Product only during the portion of the Term during which minimum purchase obligations are applicable. 
 3.1.3.1 MIP agrees that if BIOMEDICA can demonstrate that a Material Change outside of BIOMEDICA’s reasonable control has occurred,
such as major regulatory, legal or reimbursement change, the Parties will promptly meet to discuss in good faith an appropriate reforecast of the minimums. During the period of good faith discussions, the Parties agree that the existing minimum
monthly purchase obligations as set forth in this Agreement will continue to be paid by BIOMEDICA. Upon agreement on reforecasted minimums, any overpayment made by BIOMEDICA from the date on which the Material Change was demonstrated will be
refunded to BIOMEDICA. 
 3.2 Pricing Commitment. The agreed upon pricing for the Compound and the Product shall be as follows:

 3.2.1 Pricing ****** 
  

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

  

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

  

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

  

					
	 Price Per Dose*
	  	Transfer
Price	  	Percentage
of Onalta
Price Per
Dose**
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******
	 ******
	  	******	  	******

  

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

	**	Governing equation 

  
 * Confidential Treatment Required * 
  

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

  

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

  

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

  

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

  
 * Confidential Treatment Required * 
  

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

	 	•	 	 Qtr-4 2009 ****** 

	 	•	 	 Qtr-1 2010 ****** 

	 	•	 	 Qtr-2 2010 ****** 

	 	•	 	 Qtr-3 2010 ****** 

	 	•	 	 Qtr-4 2010 ****** 

	 	•	 	 Qtr-1 2011 ****** 

	 	•	 	 Qtr-2 2011 ****** 

 3.3.1 Advance Payment Refund. 
  

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

  

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

  

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

  

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

 3.4 Payment Terms. MIP shall invoice BIOMEDICA as shipped based upon shipments of actual
orders of Compound and Product as well as for any additionally required guaranteed minimum monthly payment amounts owed to MIP as provided for and agreed to in section 3.1 of this Agreement. BIOMEDICA shall pay such invoice(s) within 60 days of date
of shipment with the following terms: ******. All payments for the Compound and Product shall be made in EURO. 
  
 4. EXCLUSIVITY AND NON-COMPETE 
 4.1 During the Term
of the Supply Agreement, MIP is excluded from entering into any other supply agreements with other third parties for ****** therapeutic products that are similar to the Compound or Product within the defined Territory (Exhibit F). 
  
 * Confidential Treatment Required *

  

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 4.2 During the Term of the Supply Agreement, BIOMEDICA is precluded from distributing any
product similar to the Compound or Product in the Territory (Exhibit F), specifically products that are targeted to ****** using a ****** targeting molecule attached to a radionuclide. 
 5. TERM AND TERMINATION 
 5.1 Term. This Agreement
shall commence on the Effective Date, and unless terminated sooner in accordance with its terms and conditions in this Agreement, shall continue in effect until expiration of the Term. 
 5.2 Termination for Breach. This Agreement may be terminated by either Party in the event of breach by the other Party of a material term or
condition hereof; provided, however, the other Party shall first give to the breaching party written notice of the proposed termination of this Agreement (a “Breach Notice”), specifying the grounds of any alleged breach. Upon receipt of
such Breach Notice, the breaching party shall have such time as necessary, but in any event not more than sixty (60) days to (i) cure such alleged breach, or (ii) dispute in writing the grounds of the alleged breach set out in the
Breach Notice in good faith. Upon failure to cure or dispute by the breaching party, the non-breaching party may terminate the Agreement without prejudice to any other rights or remedies which may otherwise be available to the non-breaching party.

 5.2.1 In the event of termination for Breach by MIP under this section, MIP shall be entitled to retain all
amounts paid by BIOMEDICA to MIP as well as the full value of any Compound or Product ordered (and ready for delivery) by BIOMEDICA at the time of termination. 
 5.2.2 In the event of termination under such section by BIOMEDICA, BIOMEDICA shall be entitled to (i) recover the
available balance of any advance payments under Article 3.3 received by MIP from BIOMEDICA and (ii) receive all Compound and Product which have been ordered but not delivered. 
 5.2.3 In the event of a timely received dispute by the non-breaching party in response to its Breach Notice to the breaching
party, the non-breaching party may not unilaterally terminate this Agreement and shall only seek redress under the terms set out in Articles 8.1 and 9.10 of this Agreement regarding resolution of disputes by the Parties Neither Party may enter into
an agreement with any manufacturer precluding such manufacturer from selling to the other Party at any time during the Term of this Agreement. 
 5.3 Termination for MIP Failure to Supply. With respect to the supply of Compound or Product by MIP or MIP’s designee pursuant to purchase orders placed in accordance with this Agreement, MIP or
MIP’s designee failure to supply Compound or 
  
 * Confidential Treatment Required * 
  

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Product in a timely manner and consistent with such Purchase Orders and the Specifications shall not be considered a material breach by MIP or MIP’s designee unless and until such failure by
MIP or MIP’s designee occurs four (4) times in a consecutive 12 month period (a “Supply Breach”). It shall not be considered a Supply breach, in the event that (i) the failure to supply is attributable, in whole or in part,
directly or indirectly, to BIOMEDICA, (ii) MIP or MIP’s designee is able to supply an additional replacement of Compound or Product meeting the Specifications in accordance with this Agreement within one (1) week of the delivery date
of the originally scheduled order of Compound or Product, or (iii) if the Compound or Product failure is the result of a manufacturing deviation requested by BIOMEDICA. In the event of a Supply Breach, BIOMEDICA may terminate this Agreement
upon thirty (30) days prior written notice to MIP provided it gives written notice of termination to MIP within sixty (60) days of the Supply Breach. Any failure by MIP or MIP’s designee to supply Compound or Product due to a Force
Majeure shall not be a material breach or Supply Breach under this Agreement. 
 5.4 If MIP terminates this Agreement, under
Articles 5.2 or 5.7, MIP, in addition to any claim for damages MIP may have, shall be entitled to retain all amounts paid by BIOMEDICA to MIP prior to such termination. BIOMEDICA shall further reimburse MIP for all costs and work necessarily and
properly incurred by MIP in relation to the orderly cessation of the work and sums owing but not invoiced prior to the effective date of any such termination by MIP under this Agreement. 
 5.5 If BIOMEDICA terminates this Agreement, under Article 5.2, 5.3 or 5.7, in addition to any claim for damages BIOMEDICA may have,
BIOMEDICA shall be entitled to within thirty (30) days of such termination at BIOMEDICA’s expense receive all Compound or Product which have been ordered but not delivered. BIOMEDICA shall reimburse MIP for all reimbursable costs and work
necessarily and properly incurred in relation to the orderly cessation of the work and sums owing but not invoiced prior to the effective date of any such termination by BIOMEDICA under this Agreement. 
 5.6 Termination For Insolvency. Either Party may terminate this Agreement immediately upon delivery of written notice to the other
Party (a) upon the institution by or against the other Party of insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of the other Party’s debts; provided, however with respect to involuntary
proceedings, that such proceedings are not dismissed within one hundred and twenty (120) days; (b) upon the other Party’s making an assignment for the benefit of creditors; (c) upon the other Party’s dissolution or ceasing
to do business. 
 6. CONFIDENTIALITY 
 6.1. Confidentiality and Exceptions. During the Term of this Agreement and for a period of ten (10) years thereafter, each party hereto shall maintain in confidence and not use or disclose to others
for any purpose, other than to its employees or agents (which agents shall enter into a confidentiality agreement incorporating similar terms as set forth herein

  

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

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

  

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

  

	 	6.1.3.	became generally available to the public or otherwise part of the public domain after its disclosure to the receiving party through no act or omission of the receiving
party; 

  

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

  

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

 6.2 Each party, and its employees and agents shall protect and keep confidential and shall not use, publish or otherwise disclose to any
third party, except as permitted by this Agreement, or with the other party’s written consent, the other party’s Confidential Information. 
 6.3 All Confidential Information supplied by one party to the other to assist in carrying out the obligations hereunder shall remain the property of such party and shall be returned to the other party
upon termination or expiration of this Agreement. 
 7. INDEMNIFICATION AND INSURANCE 
 7.1 Indemnification by BIOMEDICA. BIOMEDICA agrees to indemnify, defend and hold MIP and its Affiliates and their respective directors,
officers, employees and agents, harmless from and against any damages, claims, liabilities and expenses (including, but not limited to, reasonable attorney’s fees) resulting from claims or suits (“General Claims Against MIP”) arising
out of (a) BIOMEDICAS’ or a third party’s use, handling or shipping of the Compound or Product (including in the event that MIP or MIP’s designee makes shipping arrangements on behalf of BIOMEDICA), (b) BIOMEDICAS’
breach of any of its material obligations, warranties or representations hereunder, (c) BIOMEDICAS’ negligent acts or omissions or willful misconduct. Notwithstanding the foregoing, BIOMEDICA will not be required to indemnify, defend and
hold MIP and its Affiliates and their respective directors, officers, employees and

  

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agents harmless from and against any General Claims Against MIP to the extent that such claims arise out of (i) MIP’s breach of any of its obligations, warranties or representations
hereunder; (ii) MIP’s negligent acts or omissions or willful misconduct; (iii) any failure of MIP to supply (except to the extent labels and/or content thereof are provided by BIOMEDICA) or prepare for shipment of the Compound or
Product in accordance with this Agreement, cGMPs or any other applicable laws, rules, regulations or other requirements of any applicable governmental entity; or (iv) any failure of MIP to supply Compound or Product consistent with the
Specifications and requirements set forth herein. 
 7.2 Indemnification by MIP. MIP agrees to indemnify, defend and hold
BIOMEDICA and its Affiliates and their respective directors, officers, employees and agents, harmless from and against any damages, claims, liabilities and expenses (including, but not limited to, reasonable attorney’s fees) resulting from
claims or suits (“General Claims Against BIOMEDICA”) arising out of (a) MIP’s supply (except to the extent that labels and/or content thereof is provided by BIOMEDICA) or preparation for shipment of the Compound or Product;
(b) MIP’s breach of any of its material obligations, warranties or representations hereunder; (c) MIP’s negligent acts or omissions or willful misconduct; or (d) any failure of the Compound or Product to meet the
Specifications. Notwithstanding the foregoing, MIP will not be required to indemnify, defend and hold BIOMEDICA and its Affiliates and their respective directors, officers, employees and agents harmless from and against any General Claims Against
BIOMEDICA to the extent that such claims arise out of (i) BIOMEDICAS’ breach of any of its obligations, warranties or representations hereunder; (ii) BIOMEDICAS’ negligent acts or omissions or willful misconduct;
(iii) BIOMEDICAS’ or third party’s use, labeling, handling or shipment of the Compound or Product. 
 7.3
Conditions of Indemnification. A Party or any of its Affiliates or their respective employees or agents (the “Indemnitee”) that intends to claim indemnification under this Article 6 shall promptly notify the other Party (the
“Indemnitor”) of any Liability in respect of which the Indemnitee intends to claim such indemnification reasonably promptly after the Indemnitee is aware thereof, and the Indemnitor shall assume the defense of any related third party
action, suit or proceeding with counsel mutually satisfactory to the Parties; provided, however, that an Indemnitee shall have the right to retain its own counsel and participate in the defense thereof at its own cost and expense. Indemnity shall
not apply to amounts paid in settlement of any claim, loss, damage or expense if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld unreasonably. The failure of an Indemnitee to deliver notice to
the Indemnitor within a reasonable time after becoming aware of any such matter, if prejudicial to the Indemnitor’s ability to defend such action, shall relieve the Indemnitor of any liability to the Indemnitee under this Article 6. The
Indemnitee under this Article 6 and its employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any matter covered by this indemnification. 
  

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 7.4 Insurance. Each Party shall obtain and maintain insurance reasonably sufficient to cover
its potential liability under this Agreement and shall provide evidence of such insurance to the other Party upon request. 
 7.5 Limitation of Damages. Neither Party nor its affiliates shall have any liability for any special, incidental, or consequential damages, including, but not limited to the loss of opportunity, revenue or profit, in connection with or
arising out of this Agreement, even if it shall have been advised of the possibility of such damages. 
 8. DISPUTE RESOLUTION

 8.1 Dispute Resolution. The Parties recognize that disputes as to certain matters may from time to time arise which
relate to either Party’s rights and/or obligations hereunder. The Parties hereby agree that they will attempt in good faith to resolve any controversy, claim or dispute (collectively, a “Dispute”) arising out of or relating to this
Agreement promptly by negotiations. Any such Dispute which is not settled by the Parties within fifteen (15) days after notice of such Dispute is given by one Party to the other in writing shall be referred to a senior executive of MIP and of
BIOMEDICA who are authorized to settle such Disputes on behalf of their respective companies (“Senior Executives”) and who, if possible, are not involved in the Dispute. The Senior Executives will meet for negotiations within thirty
(30) days of the end of the 15-day negotiation period referred to above, at a time and place mutually acceptable to both Senior Executives. If the Dispute has not been resolved within thirty (30) days after the end of the 15-day
negotiation period referred to above (which period may be extended by mutual agreement), the other Party can immediately bring an action relating to the Dispute before a court of competent jurisdiction in accordance with Article 9.10. 
 9. GENERAL PROVISIONS 
 9.1 Notices. All notices given under this Agreement shall be in writing and shall be personally delivered or mailed by certified first class mail return receipt requested or a reputable express delivery
service to the Party for which it is intended at its address as set forth below, or at such other address as the addressee may have designated to the other Party in writing. Any notice shall be deemed given only upon actual delivery thereof at the
proper address. 
 All notices to MIP shall be addressed to: 
 If to MIP, at: 
 Molecular Insight Pharmaceuticals, Inc.

 160 Second Street 
 Cambridge, MA 02142 USA 
 Attn: Paul Granger, General Counsel 
 If to BIOMEDICA at: 
  

 16 

 BioMedica Life Sciences, Ltd. 
 4 Papanikoli Str., 
 15232 Halandri, Athens, Greece 
 Attn: Ioannis Vitsaras, CEO

 9.2 Entire Agreement. This Agreement sets forth the entire understanding of the Parties with respect to the subject matter
hereof and supersedes all prior agreements, written and oral, between the Parties. No modification of any of the terms of this Agreement shall be deemed to be valid unless it is in writing and signed by the Party against whom enforcement is sought.
No course of dealing or usage of trade shall be used to modify the terms and conditions herein. 
 9.3 Force Majeure.
“Force Majeure” shall mean an occurrence arising from unforeseen circumstances beyond a party’s reasonable control which prevents, delays or interferes with the performance by such party of any of its obligations hereunder including
without limitation an event that occurs by reason of any act of God, flood, power failure, fire, explosion, casualty or accident, failure of suppliers or usual suppliers to have available for supply sufficient raw materials, equipment or machinery,
or war, revolution, civil commotion, acts of public enemies, act of terrorism, blockage or embargo, interruption of or delay in transportation, strike or labor disruption. Neither party shall be liable to the other for failure to perform or delay in
performing its obligations under this Agreement by virtue of the occurrence of an event of Force Majeure. 
 9.3.1 In the event of Force Majeure, the party affected shall promptly notify the other and shall exert commercially reasonable efforts to eliminate, cure or overcome such event and to resume performance of its obligations. 
 9.3.2 MIP shall, upon signing of this Agreement, qualify ****** suppliers of Yttrium-90. All costs and expenses, including
but not limited to qualifying and validating, associated with qualifying a back up supply from the second MIP qualified supplier shall be borne equally by both MIP and BIOMEDICA. 
 9.3.3. In the event such Force Majeure affecting either party continues for more than ninety (90) days the party not
subject of the Force Majeure may, upon thirty (30) days written notice, terminate this Agreement. 
 9.4
Waiver. No waiver by either Party of any default, right or remedy shall be effective unless in writing, nor shall any such waiver operate as a waiver of any other or of the same default, right or remedy, respectively, on a future occasion.

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

  

 17 

 
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— 

 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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