Document:

Exhibit 10.3

 

CONFIDENTIAL TREATMENT REQUESTED
UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

 

[*] INDICATES OMITTED MATERIAL THAT
IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY
WITH THE COMMISSION.

 

License Agreement

 

between

 

Mallinckrodt
Inc.

 

and

 

BioSynthema Inc.

 

    	 

    	 

    

 

TABLE OF CONTENTS

 

	Article 1	 
	 	 
	Definitions	4
	 	 
	Article 2 	 
	 	 
	License	11
	 	 
	Article 3 	 
	 	 
	Development and Commercialization	11
	 	 
	Article 4	 
	 	 
	Manufacture	12
	 	 
	Article 5 	 
	 	 
	Consideration	12
	 	 
	Article 6	 
	 	 
	Commercialization Option	14
	 	 
	Article 7	 
	 	 
	Intellectual Property	14
	 	 
	Article 8	 
	 	 
	Representations and Warranties	17
	 	 
	Article 9	 
	 	 
	Confidentiality	19
	 	 
	Article 10 	 
	 	 
	Announcement and Publicity	20
	 	 
	Article 11	 
	 	 
	Term and Termination	20
	 	 
	Article 12 	 
	 	 
	Indemnification and Insurance	23
	 	 
	Article 13	 
	 	 
	Information on Clinical Safety and Epidemiology	25
	 	 
	Article 14	 
	 	 
	Governing Law and Jurisdiction	25
	 	 
	Article 15	 
	 	 
	Miscellaneous Provisions	25

 

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License Agreement

BioSynthema
Inc. / Mallinckrodt Inc.

 

This License Agreement
dated the 10th day of October, 2007 (the “Effective Date”), is entered into by and between Mallinckrodt
Inc., a corporation organized and existing under the laws of the State of Delaware and having its principal offices at 675 McDonnell
Blvd., Hazelwood, MO 63042 (referred to as “Mallinckrodt”), and BioSynthema Inc., a corporation organized and
existing under the laws of Missouri, with an office at 4041 Forest Park Avenue, Saint Louis, MO 63108, and its Affiliates (BioSynthema
Inc. and its Affiliates are hereafter referred to as “BI”).

 

INTRODUCTION

 

WHEREAS,
BI has entered into an agreement with Dr. [*], referred to as the [*] License Agreement (as defined in Article 1) to obtain certain
rights in and to inventions relating to radiolabeled somatostatin analogues covered in the Generic Patents (as defined in Article
1);

 

WHEREAS,
BI has entered into an agreement with the Erasmus Hospital Medical Centre (hereinafter “Erasmus”) in Rotterdam,
The Netherlands, referred to as the Erasmus License Agreement (as defined in Article 1) providing for the transfer of certain
clinical data to BI;

 

WHEREAS,
BI has accepted delivery of and has certain exclusive rights to the commercial use of clinical data relevant to the Product (as
defined in Article 1) pursuant to the Erasmus License Agreement;

 

WHEREAS,
Mallinckrodt owns certain rights to the Mallinckrodt Patents (as defined in Article 1);

 

WHEREAS,
BI has, prior to the Effective Date, performed Development (as defined in Article 1) work on the Product in an effort toward ultimately
obtaining Marketing Authorization (as defined in Article 1) for the Product; and

 

WHEREAS,
BI wishes to obtain and Mallinckrodt agrees to convey certain licenses to the Mallinckrodt Patents, for the purpose of permitting
BI to Develop, manufacture and Commercialize the Product.

 

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:

 

Certain confidential information has
been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential
basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

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ARTICLE
1

 

DEFINITIONS

 

For purposes of
this Agreement the terms defined in this Article shall have the meanings specified below:

 

	1.1	“Accounting Standards” shall mean
    GAAP (Generally Accepted Accounting Principles), consistently applied by the respective Party so utilizing such Accounting
    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 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 License 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	“Applicable Laws” shall mean all laws, regulations,
    ordinances, rules or standards applicable to the conduct, performance or obligations of either Party hereunder and imposed
    by a governmental, quasi-governmental authority or Regulatory Authority having jurisdiction in the respective portion of the
    Territory, including by way of illustration and not limitation, the U.S. Food, Drug and Cosmetic Act and the Good Manufacturing
    Practices promulgated by FDA or other Regulatory Authorities.
	 	 
	1.5	“BI Early Termination License” shall have the
    meaning as set forth in Section 11.4(c).
	 	 
	1.6	“BI Intellectual Property” shall mean BI’s
    rights (only to the extent they relate to the Product, the Product Components and the Compound) in and to: (1) the Generic
    Patents; (2) any patents licensed or otherwise acquired from a Third Party (including those listed on Exhibit 2)
    necessary or useful in the Development, manufacture or Commercialization of the Product; (3) the Erasmus clinical patient
    data as granted under the Erasmus License Agreement as of the Effective Date; (4) other clinical patient data from medical
    facilities and other non-clinical data under any Other Data Agreements; (5) any BI New Intellectual Property; (6) any BI Know-How;
    and (7) any intellectual property rights licensed or otherwise acquired from any Third Party which include the right to sublicense
    to Mallinckrodt or its Affiliates as set out in Exhibit 2.
	 	 
	1.7	“BI Know-How” shall mean any proprietary or
    non-proprietary information only to the

 

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	 	extent related to the Product, the Product Components
    and the Compound including, but not limited to research, development, manufacture and production methods and processes, use,
    inventions, discoveries, formulation, specifications (including raw material, component and product specifications), processes,
    trade secrets, expertise, developments and regulatory information Controlled by BI, whether or not protected under patent,
    trademark, copyright or other legal principles, to which BI has rights.
	 	 
	1.8	“BioSynthema License Rights” shall have the
    meaning as set forth in Section 2.1 below.
	 	 
	1.9	“BI New Intellectual Property” shall mean: (1)
    any BI Intellectual Property, (2) any BI Know-How, (3) any improvements, enhancements, new discoveries, inventions, applications
    and further know-how conceived, made or acquired by BI and related to the Product, the Product Components and Compound, its
    formulation or the manufacture thereof, (4) any BI rights in the clinical patient data under the Erasmus License Agreement,
    (5) any BI rights to any data arising under the Other Data Agreements and (6) any BI interests in any co-owned intellectual
    property right pertaining to the Product only to the extent that any of the foregoing arises from the Development and/or the
    manufacture of the Product, the Product Components and the Compound from and after the Effective Date hereof. BI New Intellectual
    Property shall include any and all intellectual property rights in the foregoing, including all patents and trademarks, including
    domain names that BI uses in relation to the Compound, the Product Components and/or Product.
	 	 
	1.10	“Calendar Quarter” shall mean any period of
    three consecutive calendar months during a Calendar Year commencing with the first day of any January, April, July or October.
	 	 
	1.11	“Calendar Year” shall mean the calendar year,
    starting on January 1 and ending on December 31, in which the first First Commercial Sale of the Product occurs and each successive
    calendar year.
	 	 
	1.12	“Combination Product” shall mean the Product
    when sold in a finished dosage form containing the Product in combination with one or more other active ingredients.
	 	 
	1.13	“Commercialization” or “Commercialize”
    shall mean all activities conducted by a Party either directly, by its Affiliates or through a Third Party and directed
    to marketing, promoting, distributing, importing, exporting, offering for sale or selling a Product in the Field, which may
    include pre-launch market preparation, whether undertaken by a Party alone or with a partner or a Sublicensee. When used as
    a verb, “Commercialize” means to engage in Commercialization.
	 	 
	1.14	“Commercialization Agreement” shall have the
    meaning as set forth in Section 6.2(c).
	 	 
	1.15	“Commercialization Exercise” shall have the
    meaning as set forth in Section 6.2.
	 	 
	1.16	“Commercialization Option ” shall have the meaning
    as set forth in Section 6.1.

 

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	1.17	“Commercially Reasonable Effort”
    shall mean reasonable efforts and resources customarily used in the nuclear medicine pharmaceutical industry in the United
    States for radiopharmaceutical oncology products with equivalent sales potential to the Product.
	 	 
	1.18	“Compound” shall mean the somatostatin peptide
    analogue, DOTAo-Tyr3-octreotate, as shown in Exhibit 3.
	 	 
	1.19	“Confidential Information” shall mean and include
    any and all know-how, data and information, not in the public domain, including without limitation information relating to
    the Compound, the Product Component and/or the Product, or the business, marketing, research and development activities, results
    of clinical trials, regulatory proceedings, finances, contractual relationships and operations of the Parties or their Affiliates.
	 	 
	1.20	“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 make, have made, use, sell, or offer for sale Compound, the Product Components and/or the Product, or 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: (i) breaching the terms of any agreement with a Third Party; (ii) infringing upon the intellectual
    property rights of a Third Party; or (iii) misappropriating the proprietary or trade secret information of a Third Party.
	 	 
	1.21	“Damages” shall mean any and all losses, costs,
    claims, liabilities, fines, penalties, damages, expenses, court costs, interest, and reasonable fees of counsel, consultants,
    and expert witnesses, but shall not include consequential damages or lost profits of a Party, its Affiliates or its Sublicensees
    or subcontractors.
	 	 
	1.22	“Develop” or “Development” shall
    mean all activities conducted by BI, either directly or through a Sublicensee, as are necessary or useful toward successful
    application for Marketing Authorization.
	 	 
	1.23	“Development Costs” shall mean all costs and
    expenses as solely determined by BI and incurred by BI in connection with the Development of the Product.
	 	 
	1.24	“Dollars” or “USD” shall
    mean the lawful currency of the United States of America.
	 	 
	1.25	“Effective Date” shall mean the date provided
    in the Preamble to this Agreement.
	 	 
	1.26	“EMEA” shall mean the European Medicines Evaluation
    Agency or any successor agency responsible for review and approval of marketing applications for human drugs or diagnostics
    in the EU.
	 	 
	1.27	“Erasmus License Agreement” means the agreement
    between Erasmus Hospital and BI which grants to BI rights in clinical data on approximately five hundred (500) patients treated
    with the Product, including data on safety, efficacy and outcome, for inclusion in

 

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	 	a New Drug Application for submission to Regulatory
    Authorities to obtain Marketing Authorization for the Commercialization of the Product.
	 	 
	1.28	“EU” shall mean the European Union, as it may
    be constituted from time to time.
	 	 
	1.29	“FDA” shall mean the U.S. Food and Drug Administration
    or its successor agency responsible for review and approval of marketing applications for human drugs or diagnostics in the
    US.
	 	 
	1.30	“Field” shall mean human oncology.
	 	 
	1.31	“First Commercial Sale” shall mean the first
    arms’ length sale of a Product to a Third Party in a country in the Territory following applicable Marketing Authorization
    for one or more indication(s) of such Product in such country, excluding for use in a clinical trial.
	 	 
	1.32	“Force Majeure” shall mean failure or delay
    by any Party in fulfilling or performing any term of this Agreement 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), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts, Third Party supplier failures, including
    unscheduled shut down of a reactor which is integral for the performance of BI’s obligations hereunder, or any other
    cause beyond the reasonable control of the affected Party.
	 	 
	1.33	“Generic Patents” shall mean Patent Case 100-7382
    and Patent Case 118-7595 (additional use patent), and any corresponding patent applications or patents including any and all
    substitutions, extensions, re-examination, or supplementary protection certificates, reissues, renewals, divisions, continuations
    or continuations-in-part thereof, provisional patents, patents of addition, or registrations of any kind, including but not
    limited to those set out in Exhibit 1a. For reference purposes, and not by way of limitation, the foregoing
    Generic Patents relate to labeled somatostatin analogues.
	 	 
	1.34	“Good Clinical Practice” or “GCP”
    shall mean the internationally recognized ethical and scientific standard for the design, conduct, performance, monitoring,
    auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results
    are credible and accurate and that the rights, integrity and confidentiality of the trial subjects are protected.
	 	 
	1.35	“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 Regulatory Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory
    pursuant to its regulations, guidelines or otherwise.
	 	 
	1.36	“Interest” shall mean a rate per annum equal
    to LIBOR (London Interbank Offered Rate) plus one percent (1%) at the time such payment is due, and for the time period until
    payment is received by the Party entitled to receive such Interest

 

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	1.37	“[*]” shall mean Dr. [*] of Rotterdam,
    The Netherlands.
	 	 
	1.38	“[*] License
    Agreement” shall mean the sublicense agreement entered into by and between [*] and BI, dated June 12, 2007 granting
    BI rights to the Generic Patents.
	 	 
	1.39	“MAA”
    shall mean a Marketing Authorization Application filed with the EMEA or any regulatory
    authority in any other country other than the US that is responsible for review and approval of marketing applications for
    human drugs or diagnostics.
	 	 
	1.40	“Mallinckrodt
    Early Termination License” shall have the meaning as set forth in Section
    11.4(a). 
	 	 
	1.41	“Mallinckrodt Milestone Payments” shall mean
    the milestone payments due from BI as set forth under Sections 5.2 and 5.3.
	 	 
	1.42	“Mallinckrodt Patents” shall mean any issued
    patent and any pending patent application owned or Controlled by Mallinckrodt during the Term of this Agreement with a claim
    encompassing the Compound, the Product, or any claims or formulations related to the Product and Compound, processes, uses
    and intermediates for the foregoing and shall include any continuations, continuations-in-part, divisions, provisionals, substitutions,
    patents of addition, reissues, re-examinations, 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, including but not
    limited to those set out in Exhibit 1b.
	 	 
	1.43	“Mallinckrodt Royalties” shall mean the royalty
    payments due from BI as set forth under Section 5.4.
	 	 
	1.44	“Marketing Authorization” shall mean, with respect
    to a country in the Territory, the approval by the appropriate Regulatory Authority necessary for the Commercialization of
    the Product in that country. For the sake of clarity, Marketing Authorization shall not include the reimbursement approval.
	 	 
	1.45	“NDA” or “New Drug Application”
    shall mean a new drug application and all amendments and supplements thereto filed with the FDA (as more fully defined
    in 21 C.F.R. 314.5 et seq.), or the equivalent application filed with any equivalent Regulatory Authority outside the US (including
    any supra-national agency such as EMEA) requiring such filing, including all documents, data and other information concerning
    the Product which are necessary for gaining Marketing Authorization.
	 	 
	1.46	“NDA Acceptance” shall mean the date upon which
    the Product NDA submitted by BI is accepted for filing by FDA or the equivalent dossier is accepted for review by any

 

Certain confidential information has
been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential
basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

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	 	other country’s respective Regulatory Authority,
    such as, for example, a Common Technical Document (“CTD”) submitted to the EMEA.
	 	 
	1.47	“Net Sales” shall mean, with respect to the
    Product, the gross amount invoiced by or on behalf of the relevant Party or its Affiliates or Sublicensees for sales of the
    Product, during the Term hereof as set forth in Article 11, to Third Parties in bona fide, arms’-length transactions,
    less the following customary deductions, each determined in accordance with the Accounting Standards:

 

		(i)	normal
                                         and customary trade and quantity discounts actually allowed and properly taken directly
                                         with respect to sales of the Product; 

 

		(ii)	amounts
                                         actually repaid or credited by reason of defects, rejection, recalls, returns, rebates
                                         and allowances of goods; 

 

		(iii)	chargebacks
                                         and other amounts paid on sale or dispensing of Product; 

 

		(iv)	amounts
                                         payable resulting from governmental mandated rebate programs;

 

		(v)	tariffs,
                                         duties, excise, sales, value- added and other taxes (other than taxes based on income);

 

		(vi)	retroactive
                                         price reductions specifically identifiable to the Product that are actually allowed or
                                         granted;

 

		(vii)	customary
                                         cash discounts for timely payment;

 

		(viii)	delayed ship order credits; all
                                         freight, postage and insurance included in the invoice price;

 

		(ix)	pharmacy service fees for services
                                         such as compounding fees for the preparation of radiopharmaceuticals and fees for the
                                         preparation of unit doses; and

 

		(x)	discounts pursuant to indigent patient
                                         programs and patient discount programs.

 

In the event the Product is
sold as a Combination Product, the Net Sales of the Product, for the purposes of determining royalty payments, shall be determined
by multiplying the Net Sales (as defined above in this Section) 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 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 Product and the other product(s) in combination, Net Sales for
purposes of determining royalty payments shall be negotiated in good faith and agreed upon by the Parties based on the relative
value contributed by each component.

 

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	1.48	“Other Data Agreements” shall mean
    any agreement(s) between a Third Party and BI, other than the Erasmus License Agreement, which grant to BI rights in data
    relating to the Compound, the Product Components or the Product, including without limitation clinical data on patients treated
    with the Product, data on safety, efficacy and outcome, stability or manufacturing data of the Compound, the Product Components
    or the Product for inclusion in a New Drug Application for submission to Regulatory Authorities to obtain Marketing Authorization.
	 	 
	1.49	“Party” or “Parties” shall mean
    BI or Mallinckrodt, or BI and Mallinckrodt, whichever the context admits.
	 	 
	1.50	“Person” shall mean any individual or legal
    entity, including a corporation, partnership, association, joint-stock company, trust, unincorporated organization or government
    or political subdivision thereof.
	 	 
	1.51	“Product” shall mean the lutetium-177 radiolabeled
    Compound for radio-therapeutic and dosimetric use in final therapy dosage form and ready for infusion into the patient by
    the customer.
	 	 
	1.52	“Product Components” shall mean the lutetium
    Lu 177 chloride sterile solution, the Product Reaction Vial and such other elements comprising the Product as defined in the
    NDA which are combined to form the lutetium-177 labeled Compound. As used in the preceding sentence, “lutetium Lu 177
    chloride sterile solution” shall mean the sterile radiochemical solution of the lutetium-177 radioisotope in a hydrochloric
    acid solution.
	 	 
	1.53	“Product Reaction Vial” shall mean the vial
    containing frozen or lyophilized material comprised of the Compound plus other additives necessary for a commercially stable
    formulation to which a lutetium-177 solution is added to make the Product.
	 	 
	1.54	“Regulatory Authority” shall mean the FDA or
any foreign counterpart or additional governmental or regulatory agency in the Territory responsible for applicable Marketing
Authorization pharmacovigilance, reimbursement or other subject matters contemplated in this Agreement.
	 	 
	1.55	[Deleted pursuant to terms of Termination and Amendment attached
    hereto as Annex A.1].
	 	 
	1.56	“Specifications” shall mean the written standards
    for the Product and the Product Components as set forth in the NDA approved by a Regulatory Authority in connection with the
    Marketing Authorization of the Product or as set forth in a separate DMF.
	 	 
	1.57	“Sublicensee” shall mean a Third Party to which
    either Party may grant a right or license to the Product or the Compound under all or part of the BI Intellectual Property
    or the Mallinckrodt Patents in the Territory, or delegate an obligation hereunder.
	 	 
	1.58	“Term” shall have the meaning as set forth in
    Section 11.1.

 

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	1.59	“Territory” shall mean all the countries
    and territories of the world.
	 	 
	1.60	“Third Party” shall mean any Person other than
    BI, Mallinckrodt, their respective Affiliates or permitted Sublicensees hereunder.
	 	 
	1.61	“US” shall mean the United States of America,
    including the District of Columbia, the Commonwealth of Puerto Rico and all other places under the jurisdiction thereof.

 

ARTICLE
2

 

LICENSE

 

	2.1	Grant
    to BI.  In consideration of the payments provided for in this Agreement, and subject to the provisions of this
    Agreement, Mallinckrodt hereby grants to BI an exclusive, worldwide, royalty-bearing license in the Field under the Mallinckrodt
    Patents, with the right to grant sublicenses as provided below to Develop and Commercialize the Product and exercise its rights
    under this Agreement (“BioSynthema License Rights”).  
	 	 
	2.2	Sublicense.
    Under the BioSynthema License Rights, BI shall have the right to grant sublicenses to Third Parties including but not
    limited to sublicenses for the manufacturing of the Product, provided that the terms and conditions of a sublicense agreement
    shall be consistent with the terms of this Agreement. BI shall remain directly liable to Mallinckrodt for its obligations
    hereunder and shall be deemed a guarantor of each Sublicensee’s performance of BI’s obligations under this Agreement.  BI
    shall strictly enforce each Sublicensee’s performance of BI’s obligations under this Agreement.  Any
    sublicense by BI shall not waive any of BI’s obligations to Mallinckrodt, nor waive any of Mallinckrodt’s rights
    under this Agreement.  Any reference to the obligations, performance, requirements or duties of BI hereunder shall
    be deemed applicable to and enforceable by either Party against any BI Sublicensee.  In the event that BI assigns
    any of BI’s rights or obligations under this Agreement to a Sublicensee, then BI shall promptly notify Mallinckrodt
    of that fact and of the extent of the involvement of the Sublicensee with regard to this Agreement.  BI shall provide
    Mallinckrodt with such additional information regarding any such Sublicensee as may be reasonably requested by Mallinckrodt.
    
	 	 
	2.3	Limitations
    of Rights. No license is granted by Mallinckrodt to BI other than the license expressly granted by the provisions of Section
    2.1.  Mallinckrodt retains all other rights under the Mallinckrodt Patents.

 

ARTICLE 3

 

BioSynthema
shall utilize Commercially Reasonable Efforts to Develop and Commercialize the Product.

 

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ARTICLE 4

 

MANUFACTURE

 

	4.1	Manufacturing
    Responsibility. BI shall be responsible, at its expense, for: (i) procuring all necessary materials required to manufacture
    the Compound, the Product Components and the Product; (ii) obtaining all licenses, permits or approvals required to manufacture
    the Compound, the Product Components and the Product; and (iii) manufacturing the Product in accordance with GMP to meet the
    requirements of the Development work hereunder, the requirements for patient use from and after the First Commercial Sale
    and in accordance with the Product Specifications as approved in each country in which the Product has Marketing Authorization.
    

 

ARTICLE 5

 

CONSIDERATION

 

	5.1	[Deleted
    pursuant to terms of Termination and Amendment attached hereto as Annex A.1]
	 	 
	5.2	[Deleted
    pursuant to terms of Termination and Amendment attached hereto as Annex A.1]
	 	 
	5.3	[Deleted
    pursuant to terms of Termination and Amendment attached hereto as Annex A.1]
	 	 
	5.4	[Deleted
    pursuant to terms of Termination and Amendment attached hereto as Annex A.1] 

 

		(a)	[Deleted
                                         pursuant to terms of Termination and Amendment attached hereto as Annex A.1]

 

		(b)	Royalty
                                         Term. Royalties shall be payable within sixty (60) days of the end of each Calendar
                                         Quarter from the First Commercial Sale of the Product until 2020. Notwithstanding the
                                         foregoing, the royalties hereunder shall cease to be payable in a country to the extent
                                         that the Mallinckrodt Patents are held to be invalid by a court of competent jurisdiction
                                         in that country.

 

		(c)	[Deleted
                                         pursuant to terms of Termination and Amendment attached hereto as Annex A.1]

 

	5.5	Sales
    Reports.  After the first First Commercial Sale of Product, BI shall have the following sales report obligations:

 

		(a)	Substance
                                         of Reports. Within sixty (60) days following the close of each Calendar Quarter,
                                         BI shall furnish to Mallinckrodt a written report showing the Net Sales in each country
                                         in the Territory.

 

		(b)	Records.
                                         BI shall keep accurate records in sufficient detail to enable the amounts

 

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	 	 	due hereunder to be determined and to
                              be verified by an independent certified public accountant mutually agreed upon by the Parties pursuant
                              to Section 5.5(d).
	 	 	 
		(c)	Currency
                                         Exchange. All payments shall be made in U.S. Dollars. The U.S. Dollar equivalent
                                         of Net Sales invoiced in a currency other than U.S. Dollars shall be calculated in the
                                         same manner and using the same exchange rate as Mallinckrodt’s ultimate parent
                                         company (Covidien) uses to translate its consolidated income statements into U.S. Dollars.
                                         The methodology employed by Covidien to translate its consolidated income statements
                                         into U.S. Dollars shall be in accordance with Accounting Standards.

 

		(d)	Record
                                         Retention and Inspection.  Royalty payments shall be made to the address and to the
                                         Affiliate as Mallinckrodt may designate from time to time.

 

		(i)	BI shall
                                         keep for two (2) years from the date of each payment of royalties complete and accurate
                                         records of sales by BI of Product in sufficient detail to allow the accruing royalties
                                         to be determined accurately.

 

		(ii)	Mallinckrodt
                                         shall have the right for a period of one (1) year after receiving any report or statement
                                         with respect to royalties due and payable to appoint an independent certified public
                                         accountant reasonably acceptable to BI to inspect the relevant records of BI and/or its
                                         Sublicensees (directly) to verify such report or statement. Mallinckrodt may exercise
                                         this right once with respect to the prior year’s Net Sales. If the right is not
                                         exercised during the one (1) year period described, the report shall be deemed accepted.
                                         Mallinckrodt may exercise this right only once in any Calendar Year.

 

		(iii)	BI shall
                                         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 Mallinckrodt, solely to verify the accuracy of the
                                         reports and payments. The results of each inspection, if any, shall be binding on both
                                         Parties.

 

		(iv)	Mallinckrodt
                                         agrees to hold in strict confidence and use only for the purpose described in this Article
                                         5 all information concerning royalty 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 Mallinckrodt to reveal such information
                                         in order to enforce its rights under this Agreement in a court of competent jurisdiction
                                         or if disclosure is required by law, regulation or judicial order or to Novartis Pharma
                                         AG (“Novartis”) as may be necessary for Mallinckrodt to comply with
                                         any contractual obligations to Novartis. 

 

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		(v)	Mallinckrodt 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 [*] percent ([*]%) of the amount paid,
                                         BI shall pay for such inspection. BI shall immediately pay Mallinckrodt the amount of
                                         any underpayment revealed by the inspection; any overpayments shall be fully creditable
                                         against amounts payable in subsequent payment periods, or fully refunded by Mallinckrodt
                                         to BI in the event there are no further sales of Product.

 

		(vi)	BI shall include in each Sublicense
                                         entered into by it pursuant to this Agreement a provision requiring the Sublicensee to
                                         keep and maintain adequate records of sales made pursuant to such sublicense and to grant
                                         BI access to such records for the purpose of BI inspecting such records for verification
                                         of Net Sales.

 

		5.6	Withholding
                                         Taxes.  In the event BI is required by law to make any deduction or withholding of
                                         taxes from any payment due to Mallinckrodt or its Affiliate under this Agreement, BI
                                         is authorized to withhold such taxes from the payments made under this Agreement at the
                                         applicable rate, taking into account any reduced rate of tax that Mallinckrodt or its
                                         Affiliate may be eligible for under applicable treaty or other applicable tax law; provided,
                                         however, Mallinckrodt shall provide to BI all necessary documentation establishing its
                                         eligibility for either (i) treaty benefits under an applicable treaty, or (ii) a reduction
                                         in or exemption from taxes under other applicable tax law.

 

		5.7	Interest
                                         Due.   All payments due by BI to Mallinckrodt, if
                                         not paid as specified in this Agreement shall accrue Interest until all such payments
                                         and Interest are paid. 

 

ARTICLE 6

 

[Deleted pursuant
to terms of Termination and Amendment attached hereto as Annex A.1]

 

ARTICLE 7

 

INTELLECTUAL
PROPERTY

 

		7.1	Mallinckrodt
                                         Patents During the Term of this Agreement, Mallinckrodt
                                         shall be responsible for the prosecution and maintenance of Mallinckrodt Patents. 

 

		7.2	Infringement
                                         Claims by Third Parties.

 

		(a)	Notice.
                                         If the manufacture, use, marketing, promotion, importation,
                                         offer for sale, distribution or sale of Compound or 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
                                         

 

Certain confidential information has
been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential
basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

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			in writing.
                                                                        The notice shall set forth the facts of the Infringement Claim in reasonable detail. 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.

 

		(b)	Litigation.
                                          The Parties will promptly meet to discuss the lawsuit.
                                         BI shall defend any such infringement suit and will pay all losses, damages, costs, and
                                         expenses, including attorney's fees, that may be incurred by BI in the defense or settlement
                                         of the litigation. Mallinckrodt will cooperate fully, at BI’s expense, with BI
                                         in defending any such litigation for patent infringement. If BI should decide to settle
                                         any such litigation, it will notify Mallinckrodt of the proposed terms of any such proposed
                                         settlement and Mallinckrodt may agree to such proposed settlement or Mallinckrodt will
                                         assume the prosecution of the litigation and assume complete responsibility for all subsequent
                                         expenses, damages and judgments. If any settlement of the litigation results in an obligation
                                         on the part of BI to pay license fees or royalties to a Third Party, BI shall not reduce
                                         the royalty rate otherwise owed to Mallinckrodt. In addition, 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. 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. 

 

		7.3	Infringement
                                         Claims Against Third Parties

 

		(a)	Notice.
                                          If either Party becomes aware that any Third Party is (or is reasonably likely to be)
                                         infringing any Mallinckrodt Patents, or BI Intellectual Property, 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. 

 

		(b)	Institution
                                         of Proceedings. Mallinckrodt shall have the 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
                                         the Mallinckrodt Patents. BI shall have the 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 the BI Intellectual Property. In the event
                                         the respective Party does not take any action with respect to any such infringement within
                                         120 days after receiving notice of such infringement thereof, the other Party may at
                                         its own discretion and at its own expense undertake such prosecution thereof. The Party
                                         undertaking the prosecution shall have the sole charge and direction of the prosecution
                                         of any such suit or action and the other Party shall, at its own expense, have the right,
                                         but not the obligation, to be represented in such action by its own counsel acting in
                                         an advisory but not controlling capacity. 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. The Party controlling any 

 

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such
legal proceedings shall, at the request of the other Party and to the extent permitted by law, direct its counsel to provide the
other Party copies of all pleadings, discovery, and any other filings made or received in such legal proceedings. In addition,
the Party controlling such legal proceedings may name the other Party as a party plaintiff as required by law and, if so required,
shall pay the reasonable costs of representation solely for the purposes of prosecuting the lawsuit.

 

		(c)	Division
                                         of Settlement / 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 or settlement recovery shall be shared equally between
                                         the Parties. 

 

		(d)	Settlement
                                         Status. The Parties shall keep each other informed
                                         of the status of, and of their respective activities regarding, any litigation or settlement
                                         thereof concerning the Compound and/or 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	Patent Term
                                         Extensions. The Parties shall cooperate in good faith
                                         with each other in procuring a patent term extension, wherever applicable, to the Mallinckrodt
                                         Patents. In the event that Mallinckrodt, which is responsible for prosecution and maintenance
                                         of the Mallinckrodt Patents, elects not to file for an extension, Mallinckrodt shall
                                         (i) inform BI of its intention not to file and (ii) cooperate with BI to file for such
                                         extension if the law requires such filing be made by Mallinckrodt or grant BI the right
                                         to file for such extension.

 

		7.5	BI
                                         Intellectual Property. During the Term of this Agreement,
                                         BI New Intellectual Property shall be owned by BI and BI shall at its discretion be responsible
                                         for the filing, prosecution and maintenance of any patents or patent applications granted/filed
                                         on inventions or discoveries made by BI during the Development of the Compound and the
                                         Product. BI will disclose promptly to Mallinckrodt, in writing, all such inventions and
                                         discoveries made or conceived by BI personnel/representatives, and any
                                         such new patent applications filed. Such written
                                         disclosures shall include the names of all inventor(s) and/or developer(s). Such written
                                         disclosures shall be held in confidence by Mallinckrodt and BI. BI shall provide Mallinckrodt
                                         copies of drafts of such patent applications and copies of all prosecution documents
                                         in a timely manner prior to its filing in order to permit Mallinckrodt a reasonable time
                                         period to review such patent applications or prosecution documents and, at Mallinckrodt’s
                                         discretion, provide BI reasonable technical assistance in the preparation and prosecution
                                         of such patent applications.
                                          

 

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ARTICLE 8

 

REPRESENTATIONS
AND WARRANTIES

 

		8.1	Mallinckrodt Representations
and Warranties.  Mallinckrodt represents and warrants to BI as follows with respect to Mallinckrodt’s
performance of its obligations under this Agreement:

 

		(a)	This
                                         Agreement has been duly executed and delivered by Mallinckrodt and constitutes the valid
                                         and binding obligation of Mallinckrodt, enforceable against Mallinckrodt 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 Mallinckrodt,
                                         its officers and directors.

 

		(b)	Mallinckrodt
                                         is the owner of, or Controls, and it will maintain during the Term, the entire right,
                                         title and interest in and to the Mallinckrodt Patents and it has the right to grant the
                                         licenses described in the License Agreement and as described herein and the grant of
                                         such licenses will not result in a breach of any agreement, contract or other understanding
                                         of any nature whatsoever to which Mallinckrodt is a party. 

 

		(c)	Having
                                         no duty to conduct due diligence, Mallinckrodt has no knowledge as of the date of this
                                         Agreement of any patent applications, valid issued patents or other intellectual property
                                         rights owned by any Third Party which adversely affects Mallinckrodt’s obligations
                                         under this Agreement, the licenses granted hereunder, the Mallinckrodt Patents, and specifically,
                                         Mallinckrodt does not have any knowledge that practicing the Mallinckrodt Patents will
                                         constitute an infringement of any Third Party’s valid and enforceable rights.

 

		(d)	Having no duty to conduct due diligence,
                                         Mallinckrodt does not have any knowledge of any prior art, public use, prior offering
                                         for sale, presentation, publication or any other act that would adversely affect the
                                         validity of, or limit the scope of, any pending or issued claims of, the Mallinckrodt
                                         Patents.

 

		(e)	Mallinckrodt 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.

 

		(f)	Mallinckrodt is duly organized and
                                         validly existing under the laws of the State of Delaware and has full legal power and
                                         authority to enter into this Agreement.

 

		(g)	Mallinckrodt 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	BI Representations and Warranties.
                                          BI represents and warrants to Mallinckrodt as follows with respect to the performance
                                         of its obligations under this Agreement:

 

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		(a)	This Agreement has been duly executed
                                         and delivered by BI and constitutes the valid and binding obligation of BI, enforceable
                                         against BI 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 BI, its officers and directors.

 

		(b)	BI 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.

 

		(c)	BI is duly organized and validly
                                         existing under the laws of the State of Missouri and has full legal power and authority
                                         to enter into this Agreement.

 

		(d)	BI
                                         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.

 

		(e)	BI has entered into the [*] License
                                         Agreement and has thereby acquired valid and enforceable rights to the Generic Patents
                                         (listed in Exhibit 1a). A true and correct copy of the [*] License Agreement
                                         has been delivered to Mallinckrodt prior to the Effective Date hereof, with financial
                                         information redacted. BI represents and warrants that it has the right to enforce, or
                                         the right to cause to be enforced, the Generic Patents and the patents licensed under
                                         any Third Party license agreements that are listed in Exhibit 2 against
                                         a Third Party infringer.

 

		(f)	BI has
                                         entered the Erasmus License Agreement and the Other Data Agreements and has thereby acquired
                                         valid and enforceable right, title and interest in and to all of the clinical data described
                                         therein. A true and correct copy of the Erasmus License Agreement and the Other Data
                                         Agreements has been delivered to Mallinckrodt prior to the Effective Date hereof, with
                                         financial information redacted.

 

		(g)	BI has
                                         the right, under the [*] License Agreement, the Erasmus License Agreement and any Other
                                         Data Agreements, to sublicense the BI Intellectual Property to Mallinckrodt during the
                                         Term hereof, and shall have the right to sublicense to Mallinckrodt under any BI New
                                         Intellectual Property during the Term.

 

		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, 

 

Certain confidential information has
been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential
basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

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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. 

 

ARTICLE
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 Confidential Information generated under this Agreement as well as
                                         any Confidential Information disclosed by the other Party hereto. 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, Sublicensee(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. Confidential
                                         Information shall not include any information which and to the extent:

 

		(a)	was
                                         already known to the receiving Party, other than under an obligation of confidentiality,
                                         at the time of disclosure by the other Party;

 

		(b)	was
                                         generally available to the public or otherwise part of the public domain at the time
                                         of its disclosure to the other Party;

 

		(c)	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;

 

		(d)	was
                                         disclosed to the receiving Party, by a Third Party who had no obligation to the other
                                         Party not to disclose such information; or

 

		(e)	was
                                         independently developed by the receiving Party without reference to the disclosure by
                                         the other Party.

 

		9.2	The
                                         Parties agree that the financial terms of the Agreement and the reports described in
                                         Section 3.1.2 shall be considered 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

 

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its Affiliates
and to its Sublicensees; provided, however, in connection with any such disclosure the disclosing Party shall secure the same
obligations of confidential treatment of such Confidential Information, as required in this Article 9. BI may disclose all the
terms of this Agreement and the License Agreement to a Third Party for the purpose of seeking financial assistance and investment,
and shall obligate such Third Parties to treat such information as Confidential in accordance with this Article 9.

 

		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	BI
                                         agrees that the terms, including but not limited to the financial terms, may be disclosed
                                         by Mallinckrodt to Novartis without further notice, provided Novartis shall be subject
                                         to the same confidentiality obligations as set forth herein.

 

ARTICLE 10

 

ANNOUNCEMENT
AND PUBLICITY

 

		10.1	Except
                                         upon agreement of both Parties, neither Party hereto shall make any disclosure to any
                                         Third Party, including press releases, concerning the terms of this Agreement. 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 coordinate 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	Except
                                         with Mallinckrodt’s prior written permission, BI shall not use and shall prohibit
                                         its Sublicensees from using Mallinckrodt’s or its Affiliates’ name, symbols
                                         and any other marks in any form of publicity.

 

ARTICLE 11

 

TERM AND TERMINATION

 

		11.1	Term. Unless otherwise
                                         terminated as provided under this Article 11 or under Section 15.2 (Force Majeure), the
                                         term of the Agreement shall commence as of the Effective Date and shall remain in full
                                         force and effect through January 1, 2020 (“Term”).

 

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		11.2	Termination
                                         For Insolvency. Either Party may terminate this Agreement
                                         immediately upon delivery of written notice to the other Party (a) upon a finding of
                                         insolvency, receivership or bankruptcy by a competent court, for the settlement of the
                                         other Party's debts, (b) upon the other Party's making an assignment for the benefit
                                         of creditors, or (c) upon the other Party's dissolution or ceasing to do business. 

 

		11.3	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 ninety (90) 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, with rights to each Party as set forth in Section 11.4 below.

 

		11.4	Effect Of Termination.

		(a)	Termination
                                         by Mallinckrodt. Upon early termination pursuant to Section 11.2, 11.3 or
                                         15.2, if Mallinckrodt is the terminating Party, all of Mallinckrodt’s rights in
                                         the Mallinckrodt Patents shall revert to Mallinckrodt and Mallinckrodt shall automatically
                                         be granted a perpetual, worldwide, royalty-bearing, exclusive license, with the right
                                         to sub-license, in and to the BI Intellectual Property, except expressly excluding the
                                         Generic Patents, to Develop, make, have made, use, offer to sell, import and sell the
                                         Compound, the Product Components and the Product in the Territory in the Field. BI shall
                                         assign to Mallinckrodt all of BI’s rights in and to any Third Party Sublicenses
                                         granted to BI in connection with its performance of the obligations hereunder. At Mallinckrodt’s
                                         election, BI shall transfer to Mallinckrodt upon Mallinckrodt’s request all its
                                         stock of Compound, Product Reaction Vials, Product labeling, package inserts and packaging
                                         at cost, and will immediately transfer ownership of all Marketing Authorizations to Mallinckrodt
                                         and to the extent possible, shall give Mallinckrodt and its Sublicensees an access right
                                         to all clinical development, regulatory and manufacturing data of the Product, as well
                                         as to all other relevant information Controlled by BI regarding the Compound, the Product
                                         Reaction Vials and the Product, as necessary to Develop, manufacture and Commercialize
                                         the Product (the foregoing rights and assets are collectively referred to herein as the
                                         “Mallinckrodt Early Termination License”). In addition, BI
                                         shall provide at Mallinckrodt’s request, the reasonable assistance of appropriate
                                         BI personnel in connection with the transfer therewith. The royalty rate payable
                                         by Mallinckrodt to BI for the Mallinckrodt Early Termination License shall be as follows:

 

		(A)	[*] percent
                                         ([*]%) of the annual Net Sales of the Product for a period of time and upon terms as
                                         set forth in Section 5.4.

 

		(b)	Mallinckrodt’s Right of
                                         First Offer on BI’s Product Manufacturing Assets.

 

Certain confidential information has
been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential
basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

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		(i)	If Mallinckrodt terminates this Agreement
                                         under Article 11 or under Section 15.2, then, in addition to the Mallinckrodt Early Termination
                                         License, Mallinckrodt shall have ninety (90) days after the date of such termination
                                         to provide a written offer to BI (the “Mallinckrodt Proposal”). The
                                         Mallinckrodt Proposal shall contain material terms for a transaction to acquire ownership
                                         of, or a license to, all of the assets of BI used in the manufacture of the Product,
                                         including the BI Intellectual Property related thereto, not otherwise acquired by or
                                         licensed to Mallinckrodt under the Mallinckrodt Early Termination License (the “Product
                                         Manufacture Assets”).

 

		(ii)	If the Mallinckrodt Proposal is not
                                         received within the ninety (90) day response period or if Mallinckrodt notifies BI in
                                         writing that Mallinckrodt declines to extend such an offer, then BI shall have the unrestricted
                                         and irrevocable right thereafter to pursue an option to sell or license the Product Manufacture
                                         Assets to a Third Party.

 

		(iii)	If Mallinckrodt does provide a Mallinckrodt
                                         Proposal within the ninety (90) day response period, then BI and Mallinckrodt shall have
                                         a further sixty (60) days to negotiate exclusively and in good faith the terms of a business
                                         arrangement with respect to the Product Manufacture Assets.

 

		(iv)	If BI and Mallinckrodt are unable
                                         to reach an agreement within such sixty (60) day period, then BI shall so notify Mallinckrodt,
                                         and BI shall have the right thereafter to negotiate with (but not disclose the terms
                                         of the Mallinckrodt Proposal to) any Third Party and consider such proposal from a Third
                                         Party containing the material terms on which the Third Party proposes to enter into a
                                         business arrangement with respect to the Product Manufacture Assets. In the event of
                                         any such Third Party proposal which is acceptable to BI and which is received by BI within
                                         twelve (12) months of the date of termination as provided in subparagraph (i) above (the
                                         “Third Party Proposal”), BI shall give written notice thereof to Mallinckrodt
                                         and Mallinckrodt shall have thirty (30) days thereafter to offer to BI in writing terms
                                         that are in BI’s sole, good faith determination better terms than that offered
                                         in the Third Party Proposal.

 

		(v)	If BI accepts Mallinckrodt’s
                                         offer for the Product Manufacture Assets, then BI and Mallinckrodt shall negotiate in
                                         good faith within thirty (30) days thereafter with the intent of entering into a binding
                                         agreement to execute such transaction and all necessary documents.

 

		(vi)	If BI and Mallinckrodt do not enter
                                         into a binding agreement as provided in subparagraph (v) above, then BI shall have no
                                         further obligation to Mallinckrodt for the sale of the Product Manufacturing Assets under
                                         this Agreement

 

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		(c)	Termination
                                         by BI. Upon early termination by BI pursuant to Section 11.2 or 11.3, BI shall be
                                         granted a perpetual, worldwide, royalty-bearing, exclusive license, with the right to
                                         sub-license in and to the Mallinckrodt Patents existing as of the date of such termination
                                         to make, have made, use, offer to sell, import and sell Product in the Territory in the
                                         Field (the “BI Early Termination License”). The royalty rate
                                         payable by BI for the BI Early Termination License shall be as follows:

 

		(A)	The applicable
                                         percentage as set forth in Section 5.4, reduced by [*] percent ([*]%) and payable upon
                                         the same terms and conditions as set forth in Section 5.4.

 

ARTICLE 12

 

INDEMNIFICATION
AND INSURANCE

 

		12.1	BI will indemnify, defend and
                                         hold Mallinckrodt harmless from and against any and all Damages incurred or suffered
                                         by Mallinckrodt arising out of or resulting from: (i) BI’s breach of a material
                                         term of this Agreement; (ii) BI’s breach of any of its representations or warranties
                                         hereunder; (iii) BI’s performance of its obligations hereunder, including the Development,
                                         manufacture, handling, use, marketing, sale or other disposition, of Compound, Product
                                         Component and/or Product by any of BI, its Sublicensees, and their contractors; (iv)
                                         any actual or alleged bodily injury, illness or death sustained in connection with the
                                         use of the Product; or (v) BI’s breach of any of its obligations under the [*]
                                         License Agreement, the Erasmus License Agreement, any Third Party license agreement(s)
                                         or any Other Data Agreement(s), except to the extent that such Damages are due to Mallinckrodt’s
                                         or Mallinckrodt’s directors’, officers’, or employees’ negligence
                                         or willful misconduct.

 

		12.2	Mallinckrodt will indemnify,
                                         defend and hold BI harmless from and against any and all Damages incurred or suffered
                                         by BI arising out of or resulting from: (i) Mallinckrodt’s breach of a material
                                         term of this Agreement; (ii) Mallinckrodt’s breach of any of its representations
                                         or warranties hereunder, or (iii) Mallinckrodt’s breach of any its obligations
                                         with Novartis; except to the extent that such Damages are due to BI’s or BI’s
                                         directors’, officers’, or employees’ negligence or willful misconduct.

 

		12.3	The Parties agree as follows:

 

		(a)	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 (subject to the terms of this Section 12.3) any such claim
                                         at the indemnifier’s sole expense, with counsel selected by the indemnifier. In
                                         the defense or settlement of any such

 

Certain confidential information has
been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential
basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

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claim, the indemnified Party
shall cooperate 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 cooperation 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.

 

		(b)	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 thirty (30) days
                                         prior written notice of the proposed terms thereof to the indemnifier; provided, however,
                                         that if within said thirty (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.

 

		(c)	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 Damages.

 

		(d)	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 BI, 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. Mallinckrodt may satisfy its obligations under this Article
                                         through self-insurance to the same extent. BI shall, upon request by Mallinckrodt from
                                         time to time, produce a certificate of insurance evidencing such insurance coverage.

 

Certain confidential information has
been omitted from this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential
basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

    	24

    	 

    

 

		12.6	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.

 

ARTICLE
13

 

INFORMATION
ON CLINICAL SAFETY AND EPIDEMIOLOGY

 

		13.1	BI shall be fully responsible
                                         for ensuring compliance with all pharmacovigilance obligations, including the holding
                                         and maintaining of the global safety database for the Product.

 

ARTICLE
14

 

GOVERNING
LAW AND JURISDICTION

 

		14.1	The construction, validity and
                                         performance of this Agreement will be governed in all respects by Missouri Law. All disputes
                                         arising out of or affecting this Agreement which cannot be resolved amicably shall be
                                         submitted to the exclusive jurisdiction of the State courts of Missouri (County of St.
                                         Louis) or (at the option of either Party) Federal District Court for the Eastern District
                                         of Missouri.

 

ARTICLE 15

 

MISCELLANEOUS
PROVISIONS

 

		15.1	Waiver.
                                         The failure on the part of BI or Mallinckrodt 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 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 reason of Force
                                         Majeure. If a Force Majeure circumstance persists for more than six (6) consecutive months,
                                         the Party not claiming the delay shall be entitled to terminate this Agreement effective
                                         upon the 

 

    	25

    	 

    

 

expiration
of such six (6) month period, provided that the terminating Party provide at least thirty (30) days prior written notice before
the effective date of such termination.

 

		15.3	Severability. The Parties
                                         shall comply with all Applicable Laws, domestic or foreign in connection with the performance
                                         of their respective 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	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 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 to which this Agreement pertains 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.

 

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

 

		15.6	No Agency. Nothing herein
                                         contained shall be deemed to create an agency, joint venture, amalgamation, partnership
                                         or similar relationship between Mallinckrodt and BI. 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 one Party in connection with or relating to
                                         the Development, manufacture or Commercialization of Compound or Product shall be undertaken,
                                         incurred or paid exclusively by that Party, and not as an agent or representative of
                                         the other Party.

 

		15.7	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:

 

    	26

    	 

    

 

If to Mallinckrodt,
at:

Mallinckrodt
Inc.

675 McDonnell Blvd

St. Louis, MO 63042

Attn: President,
Imaging Solutions

 

With
a copy to:

Mallinckrodt
Inc.

675 McDonnell Blvd.

St. Louis, MO 63042

Attn:
Vice President, Chief Corporate Counsel, Imaging Solutions

 

If to BI at:

Jack L. Erion

President
& CEO

BioSynthema
Inc.

4041 Forest Park
Avenue

St. Louis, MO 63108

Attn: President,
BioSynthema

 

With a copy to:

BioSynthema Inc.

Mary A. Palank, Esq.

Vice President &
General Counsel

BioSynthema Inc.

Palank & Associates
LLC

1034 S. Brentwood
Blvd., Suite 1630

St. Louis, Missouri
63117

 

		15.8	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.

 

		15.9	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.

 

		15.10	Entire Agreement. This
                                         Agreement together with its Exhibits 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 this Agreement shall prevail over any
                                         conflicting terms contained in any of the Exhibits.

 

    	27

    	 

    

 

		15.11	Interpretation.  In this
Agreement unless the context requires otherwise:

 

		(a)	the singular includes the plural
and vice versa;

		 	 

		(b)	a gender includes the other
genders;

 

		(c)	a reference to a document includes
                                         the document as modified from time to time and any document replacing it;

 

		(d)	if something is to be done on a
                                         day which is not a Business Day then that thing must be done on the next or following
                                         Business Day;

 

		(e)	"month" means calendar
                                         month and "year" means 12 months;

 

		(f)	"in writing" includes
                                         any communication sent by letter, facsimile transmission or email;

 

		(g)	a reference to any statute, proclamation,
                                         rule, regulation or ordinance includes any amendment, consolidation, modification, re-enactment
                                         or reprint of it or any statute, proclamation, rule, regulation or ordinance replacing
                                         it. A reference to a specified section, clause, paragraph, schedule or item of any statute,
                                         proclamation, rule, regulation or ordinance means a reference to the equivalent section
                                         of the statute, proclamation, rule, regulation or ordinance which is for the time being
                                         in force;

 

		(h)	"including" and similar
                                         expressions are not words of limitation; and

 

		(h)	a reference to any agency or body,
                                         if that agency or body ceases to exist or is reconstituted, renamed or replaced or has
                                         its powers or functions removed (defunct body), means the agency or body which performs
                                         most closely the functions of the defunct body.

 

ARTICLE 16

 

PAYMENTS

 

All payments due
to a Party hereunder shall be invoiced to the other Party within sixty (60) days following the Calendar Quarter that such payment
is due and owing, and the invoiced Party shall pay all undisputed invoices within sixty (60) days of the date of invoice by wire
transfer pursuant to the instructions on the invoicing Party’s invoice statement. All payments due by either Party under
this Agreement, if not received as specified in this Agreement, shall accrue Interest until all such payments and Interest are
paid.

 

    	28

    	 

    

 

ARTICLE 17

 

SALES AND USE
TAX

 

The payments hereunder
exclude any sales and use or similar taxes imposed by any state or local government in the US which taxes, if any, Mallinckrodt
will bear. BI agrees to collect and remit any such tax, if required to do so under the laws of any state or local jurisdictions.
Each Party shall cooperate with the other Party and take any action reasonably requested (which does not cause such Party to incur
any material cost or inconvenience) in order to minimize any taxes payable, including providing sales and use tax exemption certificates
or other documentation necessary to support sales or use tax exemptions. Mallinckrodt and BI agree to provide each other information
and data that they may from time to time reasonably request and otherwise fully cooperate with each other in connection with (i)
the reporting of any sales or use taxes payable; (ii) any sales or use tax audit; and (iii) any assessment, refund claim or proceeding
relating to taxes payable.

 

ARTICLE 18

 

DISPUTE RESOLUTION

 

If either Party
disagrees with the other Party regarding the adequacy of performance of a Party’s obligations or any payments owing hereunder,
then the Parties agree to meet and negotiate such matter(s) in good faith toward a mutually acceptable resolution.

 

IN WITNESS WHEREOF, the Parties
hereto have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

 

	 	Mallinckrodt
    Inc.	 
	 	 	 	 
	 	By:	/s/
    Steven J. Hanley	 
	 	 	 	 
	 	Name:	Steven
    J. Hanley	 
	 	 	 	 
	 	Title:
    	President,
    Imaging Solutions	 
	 	 	 	 
	 	BioSynthema
    Inc. 	 
	 	 	 	 
	 	By:	/s/
    Jack L. Erion	 
	 	 	 	 
	 	Name:	Jack L.
    Erion	 
	 	 	 	 
	 	Title:	President
    and CEO	 

 

    	29

    	 

    

 

Annex A.1

 

Amending Provisions
from Termination of Commercialization Agreement and Amendment

 to License Agreement, dated March 12, 2010, between BioSynthema
Inc. (“BI”) and

 Mallinckrodt Inc. (“Mallinckrodt”)

 

Section 1.2.

 

Except as expressly
provided herein, the terms of the Commercialization Agreement governing the exercise and effect of early termination shall continue
to apply in full force and effect. Without limiting the generality of the foregoing, the terms of Section 13.2(d) and 13.4(a)
of the Commercialization Agreement shall apply and govern as written (including without limitation the grant of the BI Early Termination
License and BI's corresponding [*] percent ([*]%) royalty obligation through January 1, 2020 as set forth therein). Further, the
following terms of the Commercialization Agreement shall be incorporated in their entirety as additional terms of the License
Agreement:

 

1.2.1   Section
14.1, (Payments), shall be the new Article 16 of the License Agreement, and

 

1.2.2   Section
14.14(a), (Sales and Use Tax), shall be the new Article 17 of the License Agreement, and

 

1.2.3   Section
14.18, (Dispute Resolution), shall be the new Article 18 of the License Agreement, and

 

1.2.4   Section
11.2, (Permitted Disclosures), shall replace Section 9.3 of the License Agreement in its entirety. For clarification, the Parties
agree that BI may disclose all of the terms of the License Agreement to a Third Party for the purpose of seeking financial assistance
and investment subject to and in accordance with the terms, conditions and stipulations of new Section 11.2, of the License Agreement.
Except for disclosures expressly permitted under Article 9 of the License Agreement (e.g., disclosure for the purpose of seeking
financial assistance and investment), the terms of Article 10 of the License Agreement require that both Parties must agree prior
to any disclosure to any Third Party, including press releases, concerning the terms of this Agreement.

 

Section 2.2.

 

The following provisions
of the License Agreement are hereby amended as follows:

 

2.2.1   Articles
1, 2 and 4 of the License Agreement shall remain in full force and effect.

 

2.2.2   Article
3 of the License Agreement is hereby deleted in its entirety and replaced with the following: "BioSynthema shall utilize
Commercially Reasonable Efforts to Develop and Commercialize the Product."

 

Certain confidential
information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been
filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

    	30

    	 

    

 

2.2.3   Article
5, Sections 5.1 through 5.4 (a), (b) and (c) of the License Agreement are hereby deleted in their entirety. Sections 5.5 and 5.6
shall survive and govern as written.

 

2.2.4   New Section
5.4(b) of the License Agreement shall read in its entirety: “Royalties shall be payable within sixty (60) days of the end
of each Calendar Quarter from the First Commercial Sale of the Product until 2020. Notwithstanding the foregoing, the royalties
hereunder shall cease to be payable in a country to the extent that the Mallinckrodt Patents are held to be invalid by a court
of competent jurisdiction in that country.”

 

2.2.5   Article
6 of the License Agreement is hereby deleted.

 

2.2.6   Articles
7 and 8 of the License Agreement shall survive and govern as written.

 

2.2.7   Articles
10 through 15 of the License Agreement along with all exhibits shall remain in full force and effect as written.

 

2.2.8   Section
1.55 of the License Agreement, (Royalty Term) shall be deleted in its entirety.

 

2.2.9   Section
11.1 of the License Agreement (Term) shall be deleted in its entirety and shall be replaced as follows: “11.1 Term. Unless
otherwise terminated as provided under this Article 11 or under Section 15.2 (Force Majeure), the term of the Agreement shall
commence as of the Effective Date and shall remain in full force and effect through January 1, 2020 (“Term”).”

 

Section 3.

 

Except as otherwise
provided for in this Termination and Amendment, the terms and conditions of the License Agreement remains in full force and effect.
To the extent that any of the terms of the License Agreement vary or conflict in any respect with the terms of this Termination
and Amendment, then the terms of this Termination and Amendment shall control.

 

    	31

    	 

    

 

Annex A.2

 

Relevant Provisions
of Commercialization Agreement dated February 5, 2008,

 between Mallinckrodt Inc. and BioSynthema Inc., incorporated into License
Agreement

 

Section 11.2

 

Permitted Disclosures.
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 Sublicensees; provided, however, in connection with any
such disclosure the disclosing Party shall secure the same obligations of confidential treatment of such Confidential Information,
as required in this Article 11. BI may disclose all the terms of this Agreement and the License Agreement to a Third Party for
the purpose of seeking financial assistance and investment, and shall obligate such Third Parties to treat such information as
Confidential in accordance with this Article 11.

 

Section 13.2(d)

 

Termination Without
Cause. Either Party may terminate this Agreement without cause upon twelve (12) months prior written notice to the other Party.
BI may exercise such right only if BI (i) warrants to Mallinckrodt in writing that BI shall discontinue all manufacturing of the
Compound, the Product Components, and the Product, whether for Mallinckrodt or otherwise, and (ii) agrees in writing to terminate
all of the rights of BI under the License Agreement. MI may exercise such right only if Mallinckrodt warrants to BI that, it shall
discontinue all marketing and sales of the Product.

 

Section 13.4(a)

 

Termination by
Mallinckrodt. Upon early termination of this Agreement by Mallinckrodt pursuant to Section 13.2(d) (Termination Without Cause),
the License Agreement shall nonetheless remain in full force and effect, BI shall automatically be granted the BI Early Termination
License and all obligations of BI to pay Mallinckrodt Milestones and Royalties as set forth in Article 5 of the License Agreement
shall be irrevocably waived. The royalty rate payable by BI for the BI Early Termination License under this paragraph (a) shall
be as follows:

 

(A)     [*] percent ([*]%) of the annual
Net Sales of the Product to be paid in accordance with the terms of Section 14.1 for the stated Term of this Agreement.

 

Certain confidential
information has been omitted from this document, as indicated by the notation “[*]”. The omitted information has been
filed on a confidential basis with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

    	32

    	 

    

 

Annex A.2

 

Section 14.1

 

Payments. All payments
due to a Party hereunder shall be invoiced to the other Party within sixty (60) days following the Calendar Quarter that such
payment is due and owing, and the invoiced Party shall pay all undisputed invoices within sixty (60) days of the date of invoice
by wire transfer pursuant to the instructions on the invoicing Party’s invoice statement. All payments due by either Party
under this Agreement, if not received as specified in this Agreement, shall accrue Interest until all such payments and Interest
are paid.

 

All royalty payments
owing for the sale of Products (as contemplated in Sections 4.8(b), 5.1(b), 5.4, 13.3 and 13.4), whether owing during the Term,
or to be paid after termination of this Agreement, shall be paid (without invoice or notice) by wire transfer by the Party owing
such royalty within sixty (60) days following the Calendar Quarter in which the sales generating such royalty payment occurred.

 

All payments, including
any late payment as set forth in this Section 14.1, shall be made in U.S. Dollars. The U.S. Dollar equivalent of Net Sales invoiced
in a currency other than U.S. Dollars shall be calculated in the same manner and using the same exchange rate as Mallinckrodt’s
ultimate parent company (Covidien) uses to translate its consolidated income statements into U.S. Dollars. The methodology employed
by Covidien to translate its consolidated income statements into U.S. Dollars shall be in accordance with Accounting Standards.

 

Section 14.14(a)

 

Sales and Use Tax.
The payments hereunder exclude any sales and use or similar taxes imposed by any state or local government in the US which taxes,
if any, Mallinckrodt will bear. BI agrees to collect and remit any such tax, if required to do so under the laws of any state
or local jurisdictions. Each Party shall cooperate with the other Party and take any action reasonably requested (which does not
cause such Party to incur any material cost or inconvenience) in order to minimize any taxes payable, including providing sales
and use tax exemption certificates or other documentation necessary to support sales or use tax exemptions. Mallinckrodt and BI
agree to provide each other information and data that they may from time to time reasonably request and otherwise fully cooperate
with each other in connection with (i) the reporting of any sales or use taxes payable; (ii) any sales or use tax audit; and (iii)
any assessment, refund claim or proceeding relating to taxes payable.

 

Section 14.18

 

If either Party
disagrees with the other Party regarding the adequacy of performance of a Party’s obligations or any payments owing hereunder,
then the Parties agree to meet and negotiate such matter(s) in good faith toward a mutually acceptable resolution.

 

    	33Exhibit 10.4

 

CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES
ACT OF 1933, AS AMENDED.

 

[*] INDICATES OMITTED MATERIAL THAT IS THE
SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY
WITH THE COMMISSION.

 

KNOW HOW and TRADEMARK LICENCE AGREEMENT

 

BETWEEN:

 

IASON GmbH a company organised and existing
under the laws of Austria, whose registered office is at Feldkirchner Straße 4, A-8054 Graz-Seiersberg represented
by Mr Mag. Christoph Artner in his capacity of CEO, (hereinafter “LICENSOR”)

 

- on the one hand -

 

AND :

 

Advanced Accelerator Applications S.A.,
a company organised and existing under the laws of France, whose registered office is at 20 rue Diesel 01630 Saint Genis Pouilly
(France), represented by Stefano Buono, in his capacity of President and General Director (hereinafter the “LICENSEE”)

- on the other hand -

 

WHEREAS:

 

		A.	LICENSOR has developed the formulation of the pharmaceutical Product(s) described in Schedule A
hereto (« the Product(s) ») and owns a body of scientific, technical and marketing information and know-how
relating to the Product(s).

 

		B.	LICENSOR is the registered owner of the trademark(s) shown in Schedule B hereto which is/are registered
in different countries as given in Schedule B.

 

		C.	LICENSOR has obtained from the competent authorities the Marketing Authorisation according to pharmaceutical
legal rules to sell and market the Product in the countries given in Schedule C.

 

		D.	LICENSOR as the Marketing Authorisation Holder (MAH), is responsible for all aspects of the Product,
including quality and compliance with the conditions of marketing authorisation.

 

		E.	LICENSOR wishes to grant LICENSEE the right to manufacture the Product(s) by using the LICENSOR’s
know-how and the right to sell and to promote the sales of the Product(s) in France, Spain, Belgium, Luxembourg, The Netherlands,
French Cantons of Switzerland, and the following regions of Italy: Valle d ́Aosta, Piemonte, Liguria, WesternPart of the regions
of Lombardia and Emilia Romagna, including the city of Parma, according to the map attached
hereto as Schedule D (the “Territory”). The city of 

 

    	 

    	 

    

 

Parma is belonging to LICENSEE ́s
region. For Southern Italy, LICENSOR intends to grant LICENSEE this right under a special agreement to be defined within the year
2009.

 

		F.	Except for the equipments mentioned under letter G below, LICENSEE has all necessary industrial
equipment and commercial resources for manufacturing and selling the Product(s) in the Territory and is willing to do so in its
own name and on its own account.

 

		G.	LICENSOR will supply and install all necessary technical equipments (Technical Equipment as specified
in Schedule H) as better specified in this agreement and upon the terms and conditions set forth under paragraph 3.1. and Schedule
E of this contract.

 

IT WAS THEREFORE AGREED AS FOLLOWS:

 

		1.	DEFINITIONS

 

In this Agreement:

 

« Affiliate »
means any company, firm, partnership or other legal entity which (a) directly or indirectly owns or controls, or (b) is owned or
controlled by, or (c) is under common control or ownership with, either party.

 

« Authorities »
means the competent authorities which authorise the importation and/or sale of the Product(s) in the Territory.

 

« Effective Date »
means the date of first production of LICENSOR ́s Product on LICENSEE ́s site after having accomplished Variation Type
II for LICENSEE ́s site for first Product under this agreement.

 

« Execution Date »
means the date of signature of this Agreement by both parties as set out at the top of page 1.

 

« Force Majeure »
means any circumstances beyond the reasonable control of either party including, without limitation, any decision of the Authorities
or other governemental bodies, strike, lock-out or other form of industrial action.

 

«Improvement» means any
development or enhancement of the Know-How which would make the Product(s) cheaper, more effective, more useful or more valuable,
or which would in any other way render the Product(s) preferable in commerce when compared to other competitive Product(s).

 

«Inventing Party» has the
meaning set out in clause 6.1(a).

 

«Know-How» means any methods,
techniques, processes, discoveries or inventions, whether patentable or not, specifications, recipes, formulae, designs, plans,
drawings, data or other technical, scientific or marketing information.

 

«LICENSOR’s Know-How »
means any Know-How relating to the Product(s), their manufacture and their marketing, which has been developed or acquired by the
LICENSOR

 

    	2

    	 

    

 

on or before the date of this Agreement, or
which shall be developed or acquired by the LICENSOR after such date, including but not limited to :

		-	the methods of manufacturing,

		-	the technical specifications and formula,

		-	the methods of quality control,

		-	the design and get-up of the packaging and labelling including the LICENSOR’s logo,

		-	the methods of marketing, advertising and sales promotion,

		-	all scientific and medical data, including all data contained in the Registration Dossier.

 

«LICENSOR’s Corporate Design
Guidelines» means the LICENSOR’s guidelines relating to the use of LICENSOR’s corporate Logo and Trademark
on packagings and advertising materials.

 

“Module 3”is the section
of any Marketing Authorisation concerning the industrial process for production of the Product to which the Marketing Authorisation
refers.

 

« Product(s)» means
the pharmaceutical Product(s) in its/their finished form as described in Schedule A.

 

« Production Sites»
are the sites within the Territory, where the LICENSEE envisages to manufacture the Products as listed in Schedule A, and any further
production site that the LICENSEE may add to the attached list from time to time (“New Production Sites”), by
written notice to the LICENSOR.

 

« Product Licence(s) »
means the authorisation(s) issued by the Authorities to manufacture and/or import and/or market the Product(s) in the Territory,
including any Variation Type II filed by the LICENSOR with reference to any of the LICENSEE’s Production Sites.

 

« Territory »
has the meaning ascribed to it in letter E of the premises..

 

« Trademark(s) »
means the LICENSOR’s registered and not registered trademark(s) as set out in Schedule B hereto and, except where the context
otherwise requires, any copyright or other intellectual property rights of the LICENSOR in respect of the get-up of the Product(s)
and the design of the packaging and labelling of the Product(s).

 

“Variation Type II” means
the authorisation by the Authorities of the “variation” of the Marketing Authorisation, which is necessary in order
to include a new production site in the Marketing Authorisation and, thus, produce and market the Product(s) from such production
site.

 

		2.	LICENCE AND ROYALTIES

 

		2.1.	Under the terms and conditions hereinafter set out, the LICENSOR hereby grants LICENSEE and LICENSEE
hereby accepts the grant of :

 

		(a)	an exclusive licence to use the LICENSOR’s Know-How for the purpose of manufacturing and
selling the Product(s) in the Territory and

 

		(b)	an exclusive licence to use the Trademark(s) in relation thereto.

 

    	3

    	 

    

 

		2.2.	As a result of the rights granted under clause 2.1, the LICENSOR shall not, during the term of
this Agreement, grant any third party the right to use the LICENSOR’s Know How and/or the Trademark(s), neither for manufacturing
the Product(s) for sale in the Territory nor for selling or promoting the sales of the Product(s) in the Territory.

 

		2.3.	As a result of the rights granted under clause 2.1, LICENSEE shall not, during the term of this
Agreement, except with the LICENSOR’s prior written consent:

 

		(a)	assign, transfer or sub-license any of its rights or sub-contract or otherwise delegate any of
its obligations under this Agreement to any third party ;

 

		(b)	manufacture the Product for sale outside the Territory or sell the Product(s) outside the Territory.

 

		2.4.	As remuneration of the rights granted under clause 2.1 above, in full consideration of all benefits afforded under this Agreement,
LICENSEE shall pay the LICENSOR a royalty according to Schedule E.

		2.5.	Royalty payments shall be made every 3 months. LICENSEE shall provide the LICENSOR by the 30th
day after each three-month period with a written report showing all necessary data, mainly production amounts (no. of batches performed)
of the Product(s) during the immediately preceding three-month period and calculation of the due royalties according to paragraph
2.4 above. LICENSOR will then issue an invoice to LICENSEE for the amount of said royalties and LICENSEE will then pay the invoice
within 30 days of receipt. Payment shall be made to LICENSOR to the following bank account, or any other bank account subsequently
and timely communicated from LICENSOR to LICENSEE in writing.

 

Steiermärkische Bank und Sparkassen
AG

BIC: [•]

IBAN : [•]

 

		2.6.	LICENSEE shall give LICENSOR access to the LICENSEE’s production records and pharmaceutical
documentation concerning the Products under this agreement, in order to verify the declared no. of batches produced.

 

		2.7.	In case of a disagreement between the parties as to the no. of batches produced, the LICENSOR will
also have access to all sale records of the Product(s), in order to be able to verify correlation between net sales figures of
Product(s) and no of batches declared.

 

		2.8.	The rights under 2.6. and 2.7. can be exercised on a quarterly basis.

 

		3.	PRODUCT LICENCE(S)

 

		3.1	As soon as possible after the Execution Date, the LICENSOR shall, at its own cost provide LICENSEE
with:

 

    	4

    	 

    

 

(a) one copy of the Marketing Authorisation
for each Product, together with all necessary pharmaceutical and technical information and documentation, which is necessary for
the LICENSEE to start the production under this contract. The Qualified persons of both parties have agreed upon such documentation
as described in Schedule F.

 

(b) any and all LICENSOR’s
Know-How in order to enable LICENSEE to prepare and finalise in due time and under the LICENSOR ́s guidance all documents,
forms, reports, records, studies, protocols, product information and any other information required or useful to file and or obtain
LICENSOR ́s Variation Type II for each of the LICENSEE’S Production Site in relation to each Product and any other Product
Licence(s) possibly required in order for the LICENSEE to manufacture, import and/or market the Products in the Territory.

 

(c) installation of the necessary
technical equipment for production of the Products under this agreement, as specifically identified in Schedule H to this agreement
(the “Technical Equipment”). The Technical equipment shall comply with the specifications detailed in Schedule
H and shall be supplied and installed at each Production Site according to the time schedule shown in Schedule H. The LICENSOR
shall also provide the LICENSEE with the after sale service in relation to the Technical Equipment supplied to LICENSEE, as provided
in Schedule H. Supply, installation and after sale service of the Technical Equipment shall be entirely remunerated by the LICENSEE
with the “basis fee” provided in Schedule E, per each Production Site. LICENSEE has to provide the necessary
technical installation to produce the needed nuclide in the target (see schedule H). If additional equipment has to be ordered
from a third party, LICENSOR will do that on the account of LICENSEE after prior consensus of the latter about the items and services
to be ordered. LICENSEE will in no case order equipment from a third party to avoid disagreement between the parties as to the
responsibility for the quality of the technical equipment installed by LICENSOR.

 

		3.2	LICENSOR shall in its name and at its own cost:

 

(a) Perform all necessary validation
works on the site of the LICENSEE, which are basis for production of the necessary site specific documents as described in 3.1.a.
under responsibility of the LICENSOR on the LICENSEE ́s production site.

 

(b) file an application for obtaining
the Variation Type II for each Product and for each LICENSEE’S Production Site and any other Product Licence(s) with the
Authorities as soon as practically possible after signing this Agreement or, in case of New Production Sites, as soon as practically
possible after the reception of the GMP authorisation delivered by the competent Authorities;

 

(c) take any other action that may
be required by the Authorities for granting the Variation Type II or other Product Licences possibly required in order for
the LICENSEE to manufacture, import and/or market the Products in the Territory.

 

    	5

    	 

    

 

		3.3	As soon as the Variation Type II or any other Product Licence(s) is/are issued by the Authorities,
LICENSOR shall inform LICENSEE in writing and shall provide the LICENCEE with one copy thereof.

 

		4.	CONFIDENTIALITY

 

		4.1.	During the term of this Agreement and after its termination, LICENSEE shall not, except as provided
by sub-clause 4.2, disclose to any third party or use for any purpose other than contemplated by this Agreement, any part of the
LICENSOR’s Know-How or any other information which has been or will be disclosed by the LICENSOR to LICENSEE under or pursuant
to this Agreement, which is marked in writing as confidential (“LICENSOR’s Confidential Information”).

 

		4.2.	Any LICENSOR’s Confidential Information may be :

 

		(a)	disclosed by LICENSEE to (i) the Authorities or (ii) any other person, to the extent required by
applicable laws; or

 

		(b)	disclosed by LICENSEE to any of its own employees or to employees of its own Affiliates to the
extent necessary for the manufacture and sale of the Product(s), subject to LICENSEE imposing upon such employees a written undertaking
to comply with obligations identical to those set out in sub-clause 4.1.

 

		4.3.	The obligation of secrecy and non-use shall not apply to such LICENSOR’s Confidential Information
which the LICENSEE has provided to the LICENSOR in writing that:

 

		(a)	is or becomes in the public domain without violation of
this Agreement, or

		 	 

		(b)	has been legitimally received from a third party, without
violation of this Agreement.

 

		4.4.	Upon termination of this Agreement the LICENSEE shall be
obliged to promptly return to the LICENSOR, without being requested to do so, all samples, documents, electronic records, data
carriers and other storage media which the LICENSOR hands over to the LICENSEE within the scope of the cooperation under this
Agreement or makes available to the LICENSEE in any other way. With respect to this obligation, the LICENSEE hereby waives any
right of retention irrespective of ots legal basis. Furthermore, the LICENSEE undertakes not to make any copies, electronic storage
or any other records of the documents handed over and to promptly and completely destroy and/or delete any that have necessarily
been made, and to confirm this in writing at the LICENSOR’s request.

 

		5.	DISCLOSURE OF THE LICENSOR’s KNOW-HOW and TECHNICAL ASSISTANCE

 

		5.1.	As soon as practicable after the Execution Date, the LICENSOR shall disclose the LICENSOR’s
Know-How to LICENSEE in sufficient detail to enable LICENSEE to manufacture the Product(s) on an industrial basis. Thereafter,
the LICENSOR shall,

 

    	6

    	 

    

 

during the term of this Agreement,
disclose to LICENSEE any modification to the LICENSOR’s Know-How.

 

		5.2.	The LICENSOR represents and warrants to the LICENSEE that:

 

		-	the LICENSOR is the owner of the LICENSOR’s Know-How and of the Trademark(s) and has full
right and authority to give and grant all rights and licences for the use of the LICENSOR’s Know-How and Trademark(s) in
the Territory in connection with the manufacture and sale of the Product(s);

 

		-	the use by the LICENSEE of the LICENSOR’s Know-How and of the Trademark(s) in the Territory
does not infringe any third party’s right;

 

		-	the performance by LICENSOR of its obligations under this Agreement does not contravene any provision
of law, regulation, judgment, order, certificate of incorporation, by-laws, agreement or other instruments to which the LICENSOR
or any of its property is subject.

 

		5.3.	Nothing in this Agreement shall be construed as imposing any obligation upon the LICENSOR to engage
in any scientific or technical study relating to the Product(s).

 

		5.4.	During a period of 2 months from the Execution Date:

 

		(a)	LICENSEE shall be entitled, at its own cost, to send to the LICENSOR’s premises where the
Product(s) is/are manufactured suitably qualified employees of LICENSEE for training in the manufacture of the Product(s) and use
of the LICENSOR’s Know-How;

 

		(b)	the LICENSOR shall, if so requested by LICENSEE, make available to LICENSEE, at LICENSEE’s
cost and for a period not exceeding 5 man days in any quarter, the services of suitably qualified employees of the LICENSOR to
provide technical assistance at LICENSEE’s premises in relation to the manufacture of the Product(s) and the use of the LICENSOR’s
Know-How in relation thereto;

 

		(c)	the number of employees of each party who shall visit the other party’s premises pursuant
to paragraphs (a) and (b) above and the time and duration of such visits shall be agreed in advance by mutual consent of both parties ;

 

		(d)	Any employees of either party who shall visit the other party’s premises pursuant to paragraphs
(a) and (b) above shall remain employed by the party which sends them and this party shall :

 

		(i)	ensure that each such employee complies with all security, health and safety and other regulations
in force at the premises visited and

 

		(ii)	Indemnify the other party against any damage to this other party’s property or any personal
injury to any individual which is caused by the negligent act or omission of any such employee at the other party’s premises.

 

    	7

    	 

    

 

		6.	IMPROVEMENTS

 

		6.1.	If any time during the term of this Agreement, either party makes, devises or otherwise acquires
any Improvement, it shall, as soon as reasonably practicable, disclose the Improvement to the other party in the same conditions
as those set out in sub-clause 5.1 and 5.2 above, provided however that such obligation shall not apply to the extent that or for
so long as :

 

		(a)	the party which makes or acquires the Improvement (« the Inventing Party »)
is precluded from doing so by law or any obligation owed to any third party, or

 

		(b)	the disclosure of the Improvement would prejudice the ability of the Inventing Party to obtain
a patent or any other intellectual property protection in respect of the Improvement.

 

		6.2.	Whenever the LICENSOR is the Inventing Party, any Improvement
which is disclosed by the LICENSOR to LICENSEE pursuant to sub-clause 6.1 shall be deemed to be included in the definition
of the LICENSOR’s Know-How and LICENSEE shall have the same rights upon such Improvement as those granted by the LICENSOR
upon the LICENSOR’s Know-How under this Agreement.

 

		6.3.	Whenever LICENSEE is the Inventing Party, any Improvement which is disclosed by LICENSEE to the
LICENSOR pursuant to sub-clause 6.1 (« LICENSEE’s Improvement ») shall belong to LICENSEE and shall
be subject to the following conditions :

 

		(a)	LICENSEE shall be entitled, without the LICENSOR’s prior consent, to:

 

		-	apply at its own cost for any patent upon any LICENSEE’s
Improvement;

		-	use any LICENSEE’s Improvement for manufacturing or selling the Product(s) or for any other
purpose, including granting any license thereupon to any third party; provided that such LICENSEE’s
Improvement is separable from, and not dependent upon, the LICENSOR’s Know-How.

 

		(b)	LICENSEE shall be entitled, without the LICENSOR’s prior consent, to use any LICENSEE’s
Improvement for manufacturing or selling the Product(s) or for any other purpose, including granting any license thereupon to any
third party provided however that (i) such LICENSEE’s Improvement is separable from, and not dependent upon, the LICENSOR’s
Know-How and (ii) such license does not involve any disclosure of THE LICENSOR’s Know-How ;

 

		(c)	In any case the LICENSOR shall be entitled to manufacture, use, sell or otherwise deal in any Product(s)
manufactured through the use of any LICENSEE’s Improvement by way of a non-exclusive, worldwide, perpetual and royalty-free
licence;

 

		7.	MANUFACTURE AND PACKAGING of the PRODUCT(S) 

 

During the term of this Agreement, LICENSEE
shall:

 

    	8

    	 

    

 

		(a)	manufacture and pack the Product(s) in conformity with :

 

		(i)	the LICENSOR’s Know-How and all other written instructions from THE LICENSOR, in conformity
with the Registration Dossier and/or the Product Licence, and

 

		(ii)	all applicable legal and regulatory requirements ;

 

		(b)	ensure that all packagings and labellings for the Product(s) comply with all applicable legal and
regulatory requirements in the Territory and with the LICENSOR’s Corporate Design Guidelines

 

		(c)	permit the LICENSOR’s authorised representatives, at any time during normal working hours
and on reasonable advance notice (not shorter than two weeks) to enter the premises of LICENSEE where the Product(s) is/are manufactured,
packed or stored, in order to check exclusively their conformity with the above provisions, provided a date for the visit is agreed
at least 2 weeks in advance;

 

		(d)	permit the LICENSOR ́s authorised persons to perform regular audits in the following fields:

compliance with GMP-rules

production files of Products under
this contract

provided that a date for the audit
is agreed at least 2 weeks in advance;

 

		(e)	permit the LICENSOR ́s authorised persons to perform Audits on emergency occasion in the following fields, with a prior
notice of at least 3 working days:

fields listed under (d)

radiation protection

packing and shipping in compliance with ADR and IATA.

  

		8.	MARKETING and SALE of the PRODUCT(S)

 

		8.1.	During the term of this Agreement, LICENSEE shall:

 

		(a)	Use its best commercial endeavours to promote the sales of the Product(s) throughout the Territory;

 

		(b)	sell and market the Product(s) in the Territory only in packagings and labellings conforming with
the provisions of sub-clause 7 (b) ;

 

		(c)	refrain from (i) using the Trademark(s) for any other purpose than as permitted under this Agreement;

 

		(d)	notify the LICENSOR in writing of any serious adverse reaction to the Product(s).

For the purpose of this paragraph,
a serious adverse reaction shall mean any medical occurrence following the use of the Product(s) which (i) results in patient’s
death or (ii) requires the patient to be hospitalised or to prolong hospitalisation or (iii) results in a

 

    	9

    	 

    

 

persistent or significant disability
or incapacity or (iv) is life threatening or (v) involves a malignancy or congenital anomaly;

 

Install a Documentation Management
for all type of customer claims, starting from low-level complaints upon delivery delays, logistic failures, etc. on a quarterly
base.

 

		(e)	inform the LICENSOR as soon as it becomes aware of (i) the introduction in the Territory of any
Competitive Product or (ii) any infringement to the Trademark(s) or (iii) any decision from the Authorities to suspend or discontinue
the sale of the Product (s) in the Territory and/or to recall from the Customers the Product(s) already delivered to them;

 

		8.2.	Any production and distribution of Products under this contract as free samples for the customers
and/or members of the medical profession in the Territory can be done by LICENSEE on his own decision and costs. Nevertheless LICENSEE
shall pay to LICENSOR the royalty according to Schedule E without any reduction.

 

		9.	PROTECTION OF THE LICENSOR’s KNOW-HOW and OF THE TRADEMARK

 

		9.1.	LICENSOR shall, at its own cost :

 

		(a)	obtain, maintain and renew all existing and future registrations of the Trademark(s) in the Territory,

 

		(b)	take all actions which the LICENSOR shall deem advisable to protect and defend the Trademark(s)
against illicit copy, imitation or infringement by any third party in the Territory.

 

		9.2.	LICENSEE shall inform the LICENSOR of:

 

		(a)	any claim threatened or made against LICENSEE by any person alleging that the use of the LICENSOR’s
Know-How or the Trademark(s) infringes any intellectual property right or other rights of third parties,

 

		(b)	any illicit copy, imitation or infringement by any person in the Territory of the Trademark(s)
or the get-up of the Product(s) or the packaging or labelling thereof of which LICENSEE officially becomes aware;

 

provided however that LICENSEE shall
take no action in relation thereto except as LICENSOR may reasonably require pursuant to sub-clauses 9.4.

 

		9.3	LICENSEE shall take all such steps as LICENSOR may reasonably require to assist the LICENSOR in:

 

		(a)	maintaining the validity or enforceability of LICENSOR’s rights on LICENSOR’s Know-How
or the Trademark(s) in the Territory or

 

    	10

    	 

    

 

		(b)	taking actions for illicit copy, imitation or infringement of the Trademark(s) in the Territory.

 

		9.4	LICENSEE shall be obliged, to provide the contractual Product’s manufactured by the LICENSEE
or by order of the LICENSEE with serial numbers and mark them as given in the SPC (Summary of Product Characteristics) after having
achieved the Variation Type II under French authorithies guidance. A proposal for the labelling to be proposed at Variation Type
II application is attached as Schedule G.

 

    	11

    	 

    

 

		10.	TERM and TERMINATION

 

		10.1	This Agreement shall enter into force on the Execution Date and shall continue for an initial period
of [*] from the Effective Date and thereafter for successive periods of [*] each, until and unless terminated by either party pursuant
to any of the following clauses.

 

		10.2	Either party may terminate this Agreement by the end of the initial period or of any subsequent
period, subject to giving the other party notice to that effect not less than 9 months in advance. In case of termination of this
contract by the LICENSOR prior to the initial period of [*], the LICENSOR is obliged to buy back the equipment (schedule H) bought
by the LICENSEE at book value. The equipment will be depreciated by the LICENSEE in a linear way over [*]. For compensation of
its investments in the contract period, the LICENSOR will pay an additional fee representing [*]% of the total license fee (this
excludes the basis fee as defined in schedule A). Beyond [*] (i.e. the initial period), the LICENSOR will pay [*]% of the latest
annual license fees.

 

		10.3	Without prejudice to any claim for damages against the breaching party, either party shall be entitled
to terminate this Agreement forthwith upon giving notice to the other party if this other party commits any breach of this Agreement
and fails to remedy such breach at the end of a period of 30 (thirty) days after being given a notice containing full particulars
of the breach and requiring it to be remedied.

 

		10.4	Upon termination of this Agreement for any reason, LICENSEE shall :

 

		(a)	be entitled, for a period not exceeding a maximum of 6 months after
the date of expiry of this Agreement (“the Expiry Date”), (i) to manufacture the Product(s) to the extent necessary
to satisfy contractual obligations as given by contracts or orders with customers and accepted by LICENSEE prior to the Expiry
Date.

 

		(b)	subject to paragrph (a) above, cease forthwith (i) to use the Trademark(s) and the Product Licence(s)
and (ii) to use or otherwise exploit in any way, directly or indirectly, LICENSOR’s Know-How, except to the extent that LICENSOR’s
Know-How is, at the date of termination or at any time thereafter becomes public knowledge, otherwise than through any fault or
negligence of LICENSEE;

 

		(c)	ensure that, as soon as practically possible after termination, any reference to the Trademark(s)
and/or LICENSOR’s Logo on its premises, vehicles, business documents and advertising materials is removed and that any of
its advertisements and advertising materials containing such reference ceases to be used;

 

		10.5	After the Expiry Date, neither party shall be under any obligation to the other under this Agreement,
except that the provisions of clauses 3.5, 4, 6.3 and 11 shall continue in force in accordance with their terms, notwithstanding
termination of this Agreement.

 

Certain confidential information has been omitted from
this document, as indicated by the notation “[*]”. The omitted information has been filed on a confidential basis with
the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

    	12

    	 

    

 

Furthermore the LICENSOR shall be entitled
to terminate this Agreement forthwith, by serving written notice, with immediate effect (without giving any prior notice period)
if the LICENSEE

 

		10.5.1	files a nullity suit against a contractual Property Right.

 

		10.5.2	does not achieve the agreed minimum quantities, as provided in paragraph 12.2 below;

 

		10.5.3	has lost the legal basis for pharmaceutical production, e.g. loss of production licence, GMP/certification;

 

		10.5.4	does not fullfill essential obligations of this Agreement despite a warning in writing, as provided
in paragraph 10.3 above; or

 

		10.5.5	if insolvency proceedings have been initiated against the LICENSEE assets.

 

		11.	GOVERNING LAW and SETTLEMENT OF DISPUTES

 

		11.1	This Agreement shall be governed exclusively by the substantive laws of the Republic of Austria
excluding any conflict of law provisons. This shall also apply to the ssue of the Conclusion of this Agreement as well as to the
legal consequences of its after-effet.

 

		11.2	All disputes arising out of this contract or related to its violation, termination or nullity shall
be, unless it is settled amicably within 60 (sixty) days from the date of either party’s claim against the other, finally
settled under the Rules of Arbitration and Conciliation of the International Arbitral Centre of the Austrian Federal Economic Chamber
in Vienna (Vienna Rules) by one or more arbitrators appointed in accordance with these Rules. The number of arbitrators shall be
three. The language to be used in the arbitral proceedings shall be English. The place of arbitration shall be Vienna/Austria.

 

		12.	OBLIGATION TO USE

 

		12.1.	The LICENSEE shall use its best efforts to exercise the license right, to start production without
delay and to carry out the appropriate advertising and marketing activities to promote the sales of the contracutal Product(s).

 

		12.2.	Unless the LICENSEE produces the quantities shown in Schedule E (in the line “no Batches”)
per each solar year - to be considered as minimum quantities – the LICENSOR shall be entitled to terminate this Agreement
forthwith, by serving written notice, with immediate effect (without giving any prior notice period), within [90] days after the
end of the solar year in which the relevant minimum quantities have not been achieved.

 

“It
is hereby agreed and understood that the above right of the LICENSOR to terminate this agreement shall exhaust any and all LICENSOR’s
remedies against the LICENSEE in case the latter does not reach the agreed minimum quantities and the LICENSOR shall not be entitled
to any compensation for damages.”

 

    	13

    	 

    

 

		13.	NO-CONTEST CLAUSE

 

The LICENSEE undertakes not to contest the
LICENSOR’s Know-How either by an invalidity suit, opposition or otherwise, not to assist Third Parties directly or indirectly
in contesting the LICENSOR’s Know-How. The scope of protection of this provision sall also cover the contracutal Know-How.

 

		14.	MISCELLANEOUS

 

		14.1	This Agreement and its Schedules constitute the entire agreement between the parties in relation
to the manufacture and sale of the Product(s) and the use of the Trademark(s) in the Territory and supersede all prior verbal or
written agreements between the parties, if any, relating to the same subject matter. No change to this Agreement and/or any of
its Schedules shall be binding upon the parties unless it is made in a written document signed by authorised representatives of
both parties or of their legal successors.

 

		14.2	Any notice required or permitted under this Agreement may be sent aither by certified mail, return
receipt requested, or by fax or by mail to the following addresses and numbers of the Parties:

 

If to LICENSOR:

Feldkirchnerstraße 4

A -8054 Seiersberg

Fax +43 316 28 43 00 14

Email: christoph.artner@iason.eu

 

If to LICENSEE:

20 rue Diesel

01630 Saint Genis Pouilly, France

Fax: +33-4-50 99 30 71

email: gerard.ber@adacap.com

 

		14.3	Any notice required or permitted to be given concerning this Agreement shall be effective upon
receipt by the Party to whom it is addressed as certified by the return recipt (in case of certified mail) or by confirmation of
dispatch (in case of fax) or by the massage from the adress confirming receipt (in case of email).

 

		14.4	Should any provision of this Agreement become unvalid or unenforceable under applicable laws, this
shall not invalidate or render any other provision unenforceable. The invalidated or unenforceable provision shall be deleted and
replaced, by mutual consent of both parties, by a valid or enforceable provision having an objective or similar to the objective
of the deleted provision.

 

		14.5	Neither party shall be deemed to be in breach of this Agreement, or otherwise liable to the other,
by reason of the non-performance or of any delay in the performace, of any of its obligations hereunder, to the extent that such
delay or non-performance is due to any Force Majeure, provided that the party which is so prevented from, or delayed in,

 

    	14

    	 

    

 

the performance of any of its obligations
under this Agreement shall (a) notify forthwith the other party of the occurrence and likely duration and effect of any such Force
Majeure, (b) use its best endeavours to resolve promptly or cure any matter under its own control and (c) resume performance as
soon as the Force Majeure has ceased or has been removed.

 

		14.6	Failure by either party, either permanently or temporarily, to enforce any of its rights hereunder
or to require performance by the other party of any of its obligations hereunder shall not constitute, or be deemed to constitute,
any waiver of this party’s rights under this Agreement.

 

		14.7	This Agreement is a licence agreement and nothing in this Agreement shall create, or be deemed
to create, any partnership, or any relationship of principal and agent, between the parties.

 

		14.8	Except as otherwise provided in this Agreement, each party shall bear its own costs relating to
the preparation, execution and implementation of this Agreement and all taxes relating thereto.

 

		14.9	Except with the other Party’s prior written consent, Paties shall not disclose to any third
party (except to the Authorities if required by applicable laws) or make any public announcement concerning the existence or content
of this Agreement.

 

		14.10	Both parties agree that this Agreement complies with the provisions EU Regulation 772/2004 of April
27, 2004 on technology transfer agreements and is therefore exempted from prior notification to the EU Commission.

 

Made in 2 copies, January 14,
2009

 

	LICENSOR	LICENSEE
	/s/ Christoph Artner	/s/ Gérard Ber
	Christoph Artner	Gérard Ber 
	 	for Stefano Buono

 

List of the Schedules:

 

A.: The Products

 

B.: Trade Marks

 

C.: C2 Marketing Authorization; C2 projected
Marketing Authorization

 

D.: The Terrritory; Details on Italy

 

E.: Royalties, Base Fees, After-Sales Service

 

F.: Lists of Documents according to 3.1.a

 

    	15

    	 

    

 

G.: Proposal for Labelling

 

H.: Technical Equipment

 

    	16

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