CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 24B-2 	Exhibit 10.1


 


Certain confidential portions of this Exhibit, indicated
by [*], have been omitted pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. The omitted materials have been filed
separately with the U.S. Securities and Exchange Commission.


 


 


EXCLUSIVE LICENSE AGREEMENT


 


This Exclusive
License Agreement (“Agreement”) is entered into and effective as of March 5, 2015 (“Effective
Date”), by and between Navidea Biopharmaceuticals, Inc., a company organized and existing under the laws of Delaware,
with its principal place of business located at 5600 Blazer Parkway, Suite 200, Dublin, OH 43017, (“Company”);
SpePharm AG, a company organized and existing under the laws of Switzerland, with offices located at Kapellplatz 1, 6004
Luzern, Switzerland (“SpePharm”) and, solely for the purposes of Section 2.6 and Articles 14, 16 and 17, Norgine
BV, a company organized and existing under the laws of The Netherlands, with offices located at Hogehilweg 7, 1101 CA Amsterdam
Zuid-Oost, The Netherlands (“Norgine”). Company and SpePharm are each referred to herein by name or as a “Party”
or, collectively, as the “Parties.”


 


RECITALS


 


Whereas,
Company is engaged in the development, manufacturing and commercialization of the Product (as defined below);


 


Whereas,
SpePharm and its Affiliates (as defined below) have the capability and resources to develop, market, sell and commercialize the
Product in the Licensed Territory (as defined below) and to fulfill the needs and requirements of customers who purchase the Product
in the Licensed Territory; and


 


Whereas,
Company desires to grant an exclusive license to and appoint SpePharm with the right, and SpePharm desires to accept from Company
such exclusive license and the right, to develop, market, promote, sell, offer for sale, use, distribute and otherwise commercialize
the Product in the Licensed Territory, all on the terms and subject to the conditions stated herein.


 


AGREEMENT


 


Now,
Therefore, in consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency
of which is hereby acknowledged, the Parties agree as follows:


 


ARTICLE I –
DEFINITIONS


 


When used in this Agreement, capitalized
terms will have the meanings as defined below and throughout this Agreement.


 


1.1           “Accounting
Standards” shall mean Generally Accepted Accounting Principles (GAAP) or International Financial Reporting Standards
(IFRS), as designated and used by the applicable Person.


 


[*] - indicates deleted language


 




    	 



    	 



    




 


1.2           “Additional
Indication” shall have the meaning set forth in Section 2.9(a).


 


1.3           “Additional
Products” shall have the meaning set forth in Section 2.8.


 


1.4           “Additional
Product License” shall have the meaning set forth in Section 2.8.


 


1.5           “Affiliate”
shall mean any Person, whether de jure or de facto, that directly or indirectly through one or more intermediaries,
controls, is controlled by or is under common control with a Party, regardless of whether such Affiliate is or becomes an Affiliate
on or after the Effective Date. A Person shall be deemed to “control” another Person if it (a) owns, directly or indirectly,
beneficially or legally, at least fifty percent (50%) of the outstanding voting securities or capital stock (or such lesser percentage
which is the maximum allowed to be owned by a Person in a particular jurisdiction) of such other Person, or has other comparable
ownership interest with respect to any Person other than a corporation; or (b) has the power, whether pursuant to contract, ownership
of securities or otherwise, to direct the management and policies of the Person.


 


1.6           “AI
Notice Period” shall have the meaning set forth in Section 2.9(a).


 


1.7           
“Agreement” shall have the meaning set forth in the introductory paragraph hereof.


 


1.8           “Applicable
Laws” shall mean any and all laws, rules, regulations, directives, and guidance of any governmental authority pertaining
to the development, manufacture, extrusion, packaging, labeling, storage, marketing, sale, distribution or intended use of a Product,
as amended from time-to-time.


 


1.9           “Business
Combination” means with respect to a Party, any of the following events: (i) any Third Party (or group of Third Parties
acting in concert as a “group” within the meaning of Section 13(d) of the U.S. Securities Exchange Act of 1934) acquires
(including by way of a tender or exchange offer or issuance by such Party), directly or indirectly, beneficial ownership or a right
to acquire beneficial ownership of shares of such Party representing fifty percent (50%) or more of the voting shares (where voting
refers to being entitled to vote for the election of directors) then outstanding of such Party, but excluding for such purposes
any transaction or series of transactions with Financial Investors (as defined below) made for bona fide equity financing purposes
in which cash is received by a Party or indebtedness of such Party is cancelled or converted or a combination thereof; (ii) such
Party consolidates with or merges into another corporation or entity which is a Third Party, or any corporation or entity which
is a Third Party consolidates with or merges into such Party, in either event pursuant to a transaction in which more than fifty
percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger
is not held by the holders of the outstanding voting shares of such Party immediately preceding such consolidation or merger; or
(iii) such Party sells, transfers, leases or otherwise disposes of all or substantially all of its assets to a Third Party.


 




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1.10         “Business
Program” shall have the meaning set forth in Section 2.6(c).


 


1.11         
“Calendar Year” shall mean a twelve (12) month period commencing on January 1 and ending on December 31.


 


1.12         “Commercialization”,
with a correlative meaning for “Commercialize” and “Commercializing”, means all activities
undertaken relating specifically to the pre-launch, launch, promotion, market access, detailing, pricing, reimbursement, marketing,
sale, and distribution of the Product in the Licensed Territory, including: (a) strategic marketing, sales force detailing, advertising,
and medical education and liaison; (b) market access studies for use in generating pricing and reimbursement data in the Licensed
Territory; and (c) all Product distribution, importation, exportation, invoicing and sales activities.


 


1.13         “Commercialization
Plan” shall have the meaning set forth in Section 7.2.


 


1.14         “Commercially
Reasonable Efforts” shall mean those efforts and resources that a similarly situated pharmaceutical company would reasonably
devote in the exercise of its commercially reasonable practices relating to a product owned by it or to which it has rights of
the type licensed hereunder, which is of similar market potential at a similar stage in its development or product life, taking
into account the competitiveness of the global and local marketplace, the pricing and launching strategy for the respective product,
the proprietary position of the product, the profitability (but not considering any payments due to either Party pursuant to this
Agreement) and the relative potential safety and efficacy of the product and other relevant factors, including technical, legal,
scientific, regulatory or medical factors. “Commercially Reasonable” as used herein shall be interpreted in a corresponding
manner.


 


1.15         “Company”
shall have the meaning set forth in the introductory paragraph hereof.


 


1.16         “Company
Development Plan” shall have the meaning set forth in Section 4.2.


 


1.17         “Company
Indemnitees” shall have the meaning set forth in Section 13.1.


 




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1.18         “Company
Know-How” shall mean all Information Controlled (subject to Sections 2.9 and 4.6) by Company or any of its Affiliates
as of the Effective Date or thereafter during the Term (as defined below), in each case to the extent related to, or necessary
or useful for, the development, manufacture, use, sale and/or Commercialization of the Product. For clarity, the use of “Affiliate”
in this definition shall exclude any Third Party that becomes an Affiliate after the Effective Date due to a Business Combination
of Company, provided that (a) any Information Controlled by Company or any of its Affiliates immediately prior to the Business
Combination of Company shall continue to be Controlled by Company and its Affiliates after such Business Combination; and (b) any
Information made, developed, conceived, or reduced to practice by, or otherwise owned by, such Third Party or any of its Affiliates
(including Company), whether solely or jointly, in connection with the research, development, use, sale, offer for sale, manufacture,
or other Commercialization of the Product, shall be deemed Controlled by Company and its Affiliates for purposes of this Agreement.


 


1.19         “Company
Marks” shall have the meaning set forth in Section 11.3(b).


 


1.20         “Company
Patents” shall mean any Patent Rights in the Licensed Territory (a) Controlled by Company or any of its Affiliates as
of the Effective Date or thereafter during the Term and (b) that would, but for the licenses granted herein, be infringed by the
development, manufacture, use, sale, offer for sale, keeping (whether for sale or otherwise), importation and/or Commercialization
of the Product. Company Patents existing as of the Effective Date are, without limitation, set forth on Exhibit A.


 


1.21         “Company
Territory” means worldwide except the Licensed Territory.


 


1.22         “Competitive
Infringement” shall have the meaning set forth in Section 11.4(a).


 


1.23         “Confidential
Information” shall have the meaning set forth in Section 14.1.


 


1.24         “Control”
or “Controlled” shall mean, with respect to any Information, Patent Rights, other intellectual property
rights, or any proprietary or trade secret information, the legal authority or right (whether by ownership, license or otherwise)
of a Party to grant a license or a sublicense under such Information, Patent Rights or intellectual property rights to another
Person, or to otherwise disclose such proprietary or trade secret information to another Person, without breaching the terms of
any agreement with a Third Party, or misappropriating the proprietary or trade secret information of a Third Party.


 


1.25         “Days”
or “days” shall mean calendar days unless otherwise specified.


 


1.26         “Developing
Party” shall have the meaning set forth in Section 2.9(b)(ii).


 


1.27         “Disclosing
Party” shall have the meaning set forth in Section 14.1.


 


1.28         “Divest”
or “Divestiture” means the divestiture of a Business Program through (a) an outright sale or assignment of all
or substantially all rights in such Business Program to a Third Party or (b) an exclusive (even with respect to a Party and its
Affiliates) out-license of all rights and obligations, including all research, development, manufacture and commercialization rights
and obligations, with respect to such Business Program with no further material role, influence or authority of a Party or any
of its Affiliates with respect to such Business Program.


 




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1.29         “Dollar”
or “$” shall mean the legal tender of the United States.


 


1.30         “Effective
Date” shall have the meaning set forth in the introductory paragraph hereof.


 


1.31         “Euro”
or “€”shall mean the currency of participating member states of the European Union.


 


1.32         “Excluded
Information” shall have the meaning set forth in Section 2.9(b)(ii).


 


1.33         “Excluded
Regulatory Materials” shall have the meaning set forth in Section 2.9(b)(iii)


 


1.34         “Expanded
Territory” shall mean those countries and territories listed on Exhibit E attached hereto.


 


1.35         “Field”
shall mean [*].


 


1.36         “Financial
Investor” means any investor or series of Affiliated investors whose primary business is the investment of capital for
financial gain (including venture capital funds, private equity funds, pension funds and so-called “angel investors”),
but in all cases excluding so-called “strategic investors” such as biotechnology companies, specialty pharmaceutical
companies, pharmaceutical companies, generic pharmaceutical companies, and medical device companies and their Affiliates such as
strategic venture arms.


 


1.37         “First
Commercial Sale” means, in a particular country, the first commercial sale for which revenue has been recognized of [*]
by SpePharm, its Affiliates or Sublicensees, to any Third Party for end use in such country in the Licensed Territory, after obtaining
Product Approval (including pricing and reimbursement approvals as applicable), as is required in order to sell such Product in
such country.


 


1.38         “Fiscal
Year” shall mean SpePharm’s fiscal year beginning on January 1 of each year.


 


1.39         “Force
Majeure Events” shall have the meaning set forth in Section 17.1.


 


1.40         “General
IP” shall have the meaning set forth in Section 11.1(b).


 




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1.41         “Generic
Product” means any pharmaceutical product in the same dosage form sold by a Third Party not authorized by or on behalf
of SpePharm, its Affiliates or Sublicensees, that (a) is approved as interchangeable with Product through an abbreviated route
of approval by a Regulatory Authority, which approval references the Product, or (b) is approved for the same indication for use
through a regulatory pathway referencing clinical data first submitted by Company or its Affiliates or licensees or SpePharm or
its Affiliates or Sublicensees for obtaining Product Approval for the Product.


 


1.42         “Improvement”
means any enhancement or modification of the Product’s dose, dosage form, strength, presentation, preparation, packaging
(including volume) or formulation.


 


1.43         “Indemnification
Claim Notice” shall have the meaning set forth in Section 13.3.


 


1.44         “Indemnified
Party” shall have the meaning set forth in Section 13.3.


 


1.45         “Indemnifying
Party” shall have the meaning set forth in Section 13.3.


 


1.46         “Information”
shall mean any and all data, results, technology and information of any type whatsoever, in any tangible or intangible form, including
trade secrets, scientific, technical or regulatory information, processes, methods, techniques, materials, technology, results,
analyses, laboratory, pre-clinical and clinical data, and other know-how, whether or not patentable, including pharmacology, toxicology,
drug stability, manufacturing and formulation data, methodologies and techniques, clinical and non-clinical safety and efficacy
studies, marketing studies, absorption, distribution, metabolism and excretion studies, but excluding any Patent Rights.


 


1.47         “Initial
Indication” means imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients
with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.


 


1.48         “Initial
Territory” shall mean all countries and territories included within Company’s EMA (European Medicines Agency) marketing
authorization as of the Effective Date for Product 1, which are Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.


 


1.49         “Inventions”
shall have the meaning set forth in Section 11.1(a).


 


1.50         “JMC”
shall have the meaning set forth in Section 3.1(a).


 




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1.51         “Joint
IP” shall have the meaning set forth in Section 11.1(b).


 


1.52         “Jointly
Funded Data” shall have the meaning set forth in Section 11.1(e).


 


1.53         “Licensed
Territory” shall mean the Initial Territory and the Expanded Territory.


 


1.54         “Litigation
Conditions” shall have the meaning set forth in Section 13.3.


 


1.55         “Losses”
shall have the meaning set forth in Section 13.1.


 


1.56         “Major
EU Market Countries” means [*].


 


1.57         “Marketing
Materials” shall have the meaning set forth in Section 9.1.


 


1.58         “Negotiation
Period” shall have the meaning set forth in Section 2.9(a).


 


1.59         “Net
Sales” shall mean on a country-by-country and Product-by-Product basis, with respect to any period for each country in
the Licensed Territory, [*];


 


1.60         “Non-Developing
Party” shall have the meaning set forth in Section 2.9(b)(ii).


 


1.61         “Norgine”
shall have the meaning set forth in the introductory paragraph hereof.


 


1.62         “Party”
and “Parties” shall have the meaning set forth in the introductory paragraph hereof.


 


1.63         “Patent
Challenge” shall have the meaning set forth in Section 15.7.


 


1.64         “Patent
Rights” shall mean all patents and patent applications (which for the purpose of this Agreement shall be deemed to include
certificates of invention and applications for certificates of invention), including all divisionals, continuations, substitutions,
continuations-in-part, re-examinations, reissues, additions, renewals, revalidations, extensions, registrations, pediatric exclusivity
periods, supplemental protection certificates and the like of any such patents and patent applications, any and all utility models
and short term patents, and any and all foreign equivalents of the foregoing.


 


1.65         “Person”
shall mean any natural person or any corporation, partnership, limited liability company, business association, joint venture
or other entity.


 


1.66         “PV
Agreement” shall have the meaning specified in Section 5.5.


 


1.67         “PIP
Trials” shall have the meaning set forth in Section 4.2(b).


 




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1.68         “Product”
shall mean [*] (with and without labeling). For clarity, any references in this Agreement to the Product shall always mean [*],
unless otherwise expressly stated to refer to only one of [*].


 


1.69         “Product
1” shall mean any product approved for radiolabeling with technetium 99m, containing Lymphoseek® (or any alternative
or replacement name), with the chemical name tilmanocept, in its current 250μg, multi-dose volume packaging configuration
as of the Effective Date and any other multi-dose volume packaging configuration, and any Improvements thereto or thereof.


 


1.70         [*].


 


1.71         “Product
Approval” shall mean all authorizations, permits and approvals that are issued by a Regulatory Authority and necessary
for the use, distribution, promotion and/or sale of a Product in a particular country or jurisdiction, including pricing and reimbursement
approval.


 


1.72         “Product
IP” shall have the meaning set forth in Section 11.1(a).


 


1.73         “Product
Marks” shall mean the Product -related trademarks used by Company in the Company Territory for the Product, including
those listed in Part II of Exhibit C and as may be updated from time-to-time by the Company.


 


1.74         “RA
Field” shall mean any and all drugs for the diagnosis of rheumatologic conditions in humans, including rheumatoid arthritis,
psoriatic arthritis, osteo-arthritis, ankylosing spondylitis, and further including manifestations of such diseases in the joint,
cartilage, synovium or entheses.


 


1.75         “RA
Field License Agreement” shall mean that certain license agreement by and between Company and TcRA Imaging, Inc. (“TcRA”),
wholly-owned subsidiary of R-NAV, LLC (“R-NAV”), dated June 15, 2014.


 


1.76         “RA
Field Licensee” shall mean TcRA and its affiliates, or any licensee, sublicense, assignee or successor (whether by operation
of law, merger or otherwise) thereof.


 


1.77         [*].


 


1.78         [*]


 


1.79         “RA
Field Rights” shall have the meaning set forth in Section 2.10(a).


 


1.80         “Receiving
Party” shall have the meaning set forth in Section 14.1.


 




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1.81         “Regulatory
Authority” shall mean any applicable government regulatory authority involved in granting approvals for the promotion,
sale, distribution, import/export, use, handling, reimbursement and/or pricing of a Product.


 


1.82         “Regulatory
Data” shall mean all regulatory information, data and results relating to the Product which are necessary for Product
Approvals, including in-vitro Product testing data and study data, data queries, data tables reports and case report forms generated
during any pre-clinical or clinical study or registry study, for the Product.


 


1.83         “Regulatory
Materials” shall mean all regulatory applications, submissions, notifications, communications, correspondence, registrations,
Product Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority for the use, distribution,
promotion, importation, exportation, pricing, reimbursement, marketing and sale of the Product in a particular country or jurisdiction.


 


1.84         “Relevant
Executive Member” shall have the meaning set forth in Section 3.1(f).


 


1.85         “Repurchase
Price” shall have the meaning set forth in Section 15.8(b)(xi).


 


1.86         “Right
of Reference” has the meaning assigned to such term in 21 C.F.R. §314.3(b) (or any analogous Applicable Laws recognized
outside the United States).


 


1.87         “ROFN”
shall have the meaning set forth in Section 2.8.


 


1.88         “ROFN
Notice” shall have the meaning set forth in Section 2.8.


 


1.89         “Royalty
Term” shall have the meaning set forth in Section 10.4(b).


 


1.90         “Segregate”
means, with respect to a Business Program, to use Commercially Reasonable Efforts to segregate the development, manufacture and
Commercialization activities relating to such Business Program from development, manufacture and Commercialization activities with
respect to any Products licensed under this Agreement, including ensuring that: (a) personnel involved in performing the development,
manufacture or Commercialization of such Business Program do have access to any material non-public plans or information relating
to the development, manufacture or Commercialization of any Products; (b) personnel involved in materially performing the development,
manufacture or Commercialization of any Products in the Field under this Agreement have access to non-public plans or information
relating to the development, manufacture or Commercialization of such Business Program; provided, that, in either case of (a) or
(b), management personnel may review and evaluate plans and information regarding the development, manufacture and Commercialization
of such Business Program solely in connection with portfolio decision-making among product opportunities; and (c) no Product IP,
General IP or Joint IP is practiced or used in the development, manufacture or commercialization of the Business Program.


 




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1.91         “SpePharm”
shall have the meaning set forth in the introductory paragraph hereof.


 


1.92         “SpePharm
Development Plan” shall have the meaning set forth in Section 4.3.


 


1.93         “SpePharm
Excluded Rights” shall have the meaning set forth in Section 2.10(b)(i).


 


1.94         “SpePharm
Indemnitees” shall have the meaning set forth in Section 13.1.


 


1.95         “SpePharm
IP” means all Patent Rights and Information Controlled by SpePharm, its Affiliates or Sublicensees (to the extent SpePharm
receives rights from its Sublicensees) as of the date of termination of this Agreement, that is necessary, or uniquely specific,
for development, marketing, promotion, importation, use, sale, offer for sale, distribution, manufacture, having manufactured and
otherwise commercializing the Product, but excludes General IP and Joint IP.


 


1.96         “SpePharm
Witholding Tax Action” shall have the meaning set forth in Section 10.8(c).


 


1.97         “Sublicensee”
shall have the meaning set forth in Section 2.2(a).


 


1.98         “Successor
Entity” shall have the meaning set forth in Section 15.9(a)(viii).


 


1.99         “Supply
Agreement” shall have the meaning set forth in Section 6.1.


 


1.100       “Term”
shall have the meaning set forth in Section 15.1.


 


1.101       “Territory”
shall mean, with respect to Company, the Company Territory, and with respect to SpePharm, the Licensed Territory.


 


1.102       “Third
Party” shall mean any entity other than Company, SpePharm, Norgine or their respective Affiliates.


 


1.103       “Third
Party Claims” shall have the meaning set forth in Section 13.1.


 


1.104       “Upstream
Agreements” shall mean (i) that certain License Agreement by and between Company and The Regents of the University of
California effective as of July 14, 2014, and (ii) that certain Amended and Restated License Agreement by and between Company and
The Regents of the University of California effective as of July 14, 2014.


 




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1.105     “U.S.”
shall mean the United States of America, including all possessions and territories thereof.


 


1.106     “U.S.
Export Control Laws” shall mean all applicable U.S. laws and regulations relating to the export or re-export of commodities,
technologies, or services, including, but not limited to, the Export Administration Act of 1979, 24 U.S.C. §§ 2401-2420,
the International Emergency Economic Powers Act, 50 U.S.C. §§ 1701-1706, the Trading with the Enemy Act, 50 U.S.C. §§
1 et seq., the Arms Export Control Act, 22 U.S.C. §§ 2778 and 2779, and the International Boycott Provisions of
Section 999 of the U.S. Internal Revenue Code of 1986.


 


1.107     “Valid
Claim” shall mean, with respect to any country, a claim of a pending patent application (which has been pending for five
(5) years or less from the date of filing of the earliest priority patent application to which such pending patent application
is entitled to claim benefit) or issued and unexpired Patent Right (including any supplementary protection certificate or patent
term extension or the like), to the extent such claim has not been (a) rejected, revoked, held invalid or unenforceable by a patent
office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which
no appeal was taken within the allowable time period) or (b) abandoned, surrendered, disclaimed, denied or admitted to be invalid
or unenforceable through reissue, re-examination or disclaimer or otherwise.


 


1.108     “Weighted
Average Price” shall mean total Net Sales of [*] divided by the number of units of [*] sold, in each case across the
referenced set of Major EU Market Countries over the three (3) month period prior to the date of calculation. 


 


1.109     Interpretation.
In this Agreement, unless otherwise specified:


 


(a)          “includes”
and “including” shall mean respectively includes and including without limitation;


 


(b)          unless
the context otherwise requires, the word “or” shall be deemed to include the word “and” (i.e., shall
mean “and/or”);


 


(c)          words
denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders;


 


(d)          words
such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely
to the particular provision in which such words appear; and


 




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(e)          the
Exhibits and other attachments form part of the operative provision of this Agreement and references to this Agreement shall include
references to the Exhibits and attachments.


 


ARTICLE
II – GRANT OF RIGHTS: LICENSE AND EXCLUSIVITY


 


2.1         License
to SpePharm; Retained Rights


 


(a)          License
Grant. Subject to the terms and conditions of this Agreement (including Section 2.9), Company hereby grants to SpePharm and
its Affiliates (i) an exclusive (even as to Company and its Affiliates) right and license, with the right to grant sublicenses
in accordance with Section 2.2, under the Company Patents, Company Know-How, Joint IP and Joint Study Data to develop, market,
promote, import, use, sell, offer for sale, keep (whether for sale or otherwise), distribute and otherwise Commercialize the Product,
in each case in the Field and in the Licensed Territory, and (ii) a co-exclusive (with Company and its Affiliates) right and license
in the Licensed Territory, and non-exclusive right and license outside of the Licensed Territory, with the right to grant sublicenses
in accordance with Section 2.2, under the Company Patents, Company Know-How, Joint IP and Joint Study Data to, manufacture and
have manufactured the Product for the Field for the Licensed Territory. The license granted to SpePharm’s Affiliates under
this Section 2.1(a) shall terminate when and if such entity is no longer an Affiliate of SpePharm.  


 


(b)          Company
Retained Rights. Notwithstanding the rights granted to SpePharm and its Affiliates in Section 2.1(a), Company retains all rights
and interests other than expressly granted under this Agreement, including without limitation, rights to: (i) manufacture and have
manufactured the Product worldwide; (ii) conduct the activities specified in Section 4.2 hereunder; (iii) subject to Section 4.4,
conduct or have conducted clinical trials and other studies in the Licensed Territory for the generation of data in support of
regulatory submissions to the Regulatory Authorities in the Company Territory; and (iv) subject to Section 4.4, conduct activities
in the Licensed Territory with respect to the research, development, and manufacture of the Product, for use and commercialization
in the Company Territory.


 


2.2         Sublicense
Rights. [*].


 


2.3         Negative
Covenant. SpePharm covenants that it will not, and it will not grant a license to or otherwise authorize any of its Affiliates
or Sublicensees to, use or practice any Company Patents and Company Know-How outside the scope of the license granted to it under
Section 2.1(a) above.


 


2.4         No
Implied Rights. Except for the licenses and rights expressly granted under this Agreement, no right, title or interest with
respect to the Product or any other intellectual property interest, by implication or otherwise, under any trademarks, Information
and/or Patent Rights owned or Controlled by Company is granted by Company to SpePharm hereunder.


 




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2.5         Upstream
Agreement. The Company Patents sublicensed under Section 2.1 are licensed to Company pursuant to the Upstream Agreements. SpePharm
covenants to comply and cause its Sublicensees to comply with the material terms of the Upstream Agreements as applicable to Sublicensees
in all material respects, current copies of which have been provided to SpePharm as of the Effective Date. Company acknowledges
that SpePharm’s and its Sublicensees’ compliance with its diligence obligations expressly set forth in this Agreement
shall satisfy the requirements of the preceding sentence with respect to diligence obligations applicable to Sublicensees under
the Upstream Agreements, if any. SpePharm acknowledges and agrees that its sublicense rights with respect to such Company Patents
under this Agreement are at all times subject to, and limited by, the applicable terms of the Upstream Agreements (including the
scope of the licenses granted to Company) and in the event of any inconsistency between this Agreement and the applicable Upstream
Agreement, the Upstream Agreements shall control (without limitation of the preceding sentence). Company shall not amend or agree
to amend any terms or conditions of the Upstream Agreements in any manner that would adversely affect the rights granted to SpePharm
in the Licensed Territory under this Agreement without the prior written consent of SpePharm. Company further agrees that it shall
not terminate either Upstream Agreement, without the prior written consent of SpePharm. Company shall comply with all material
terms of the Upstream Agreements in all material respects, and shall timely make all payments required to be made thereunder, provided
that Company shall not be in breach of the foregoing obligations to the extent that Company’s failure to comply results from
SpePharm’s non-compliance with the terms of the Upstream Agreements as required under this Section 2.5. For avoidance of
doubt, Company is solely responsible for any payment obligations under the Upstream Agreements. Company shall notify SpePharm when
it has received any notice from any Third Party that is a party to the Upstream Agreements stating that such Third Party intends
to terminate or is terminating any of the Upstream Agreements. Company shall further notify SpePharm of any issue of which Company
is aware that has given or could reasonably be expected to give rise to a material dispute under either Upstream Agreement. [*].


 


2.6         Exclusivity.



 


(a)          During
the Term, SpePharm shall not, and shall cause its Affiliates not to, directly or indirectly, by itself or with a Third Party, develop,
promote, market, import, use, sell, offer for sale, distribute or otherwise commercialize anywhere in the Licensed Territory any
product for [*] (except for any Product under this Agreement).


 




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(b)          During
the Term, Company shall not, and shall cause its Affiliates not to, directly or indirectly, by itself or with a Third Party, develop,
promote, market, import, use, sell, offer for sale, distribute or otherwise commercialize anywhere in the Licensed Territory any
product for [*]; provided that the foregoing restriction shall not apply to any development of the Product under this Agreement
(to the extent permitted hereunder) or product that was offered and not licensed to SpePharm under Section 2.8.


 


(c)          Notwithstanding
this Section 2.6, if a Business Combination occurs with respect to SpePharm or any of its Affiliates, and the Third Party (or any
of such Third Party’s Affiliates or any successors or assigns of such Third Party or such Third Party’s Affiliates
immediately prior to such Business Combination) has a program that existed prior to, or was planned prior to and is demonstrably
to be implemented shortly after, or would be developed independently of any intellectual property licensed hereunder after, the
Business Combination that would otherwise violate this Section 2.6 (a “Business Program”), then such Third Party
or any of such Third Party’s Affiliates or any successors or assigns of such Third Party or such Third Party’s Affiliates,
including SpePharm and its Affiliates as of the Business Combination, as applicable, will be permitted to continue such Business
Program after such Business Combination and such continuation will not constitute a violation of this Section 2.6 so long as such
Third Party acquirer or the Third Party acquirer’s Affiliate Segregates the Business Program. [*].


 


(d)          Notwithstanding
this Section 2.6, if a Business Combination occurs with respect to Company and the Third Party (or any of such Third Party’s
Affiliates or any successors or assigns of such Third Party or such Third Party’s Affiliates immediately prior to such Business
Combination) has a Business Program that existed prior to, or was planned prior to and is demonstrably to be implemented shortly
after the Business Combination, or would be developed independently of any intellectual property licensed hereunder after, then
such Third Party or any of such Third Party’s Affiliates or any successors or assigns of such Third Party or such Third Party’s
Affiliates, including Company and its Affiliates as of the Business Combination, as applicable, will be permitted to continue such
Business Program after such Business Combination and such continuation will not constitute a violation of this Section 2.6 so long
as such Third Party acquirer or the Third Party acquirer’s Affiliate Segregates the Business Program; provided that, at SpePharm’s
election, the JMC shall be dissolved and/or SpePharm shall have final decision making authority with respect to all matters for
which the JMC had review rights or responsibility, provided that the last paragraph of Section 3.1 shall continue to apply.


 


(e)          If
SpePharm or any of its Affiliates acquires a Third Party (including by merger or consolidation) so that such Third Party becomes
an Affiliate over which SpePharm or such Affiliate has control (as defined in Section 1.5), or SpePharm or any of its Affiliates
acquires all or substantially all of the assets of a Third Party (including any subsidiaries or divisions thereof), and the Third
Party (or any of such Third Party’s Affiliates or any successors or assigns of such Third Party or such Third Party’s
Affiliates immediately prior to such Business Combination) has, or the acquired assets contain, as applicable, a Business Program,
then SpePharm shall promptly notify Company of such Business Program within five (5) days after such Business Combination and SpePharm
and/or such Third Party (or any of such Third Party’s Affiliates or any successors or assigns of such Third Party or such
Third Party’s Affiliates), as applicable, will [*].


 




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(f)          If
Company or any of its Affiliates acquires a Third Party (including by merger or consolidation) so that such Third Party becomes
an Affiliate over which Company or such Affiliate has control (as defined in Section 1.5), or Company or any of its Affiliates
acquires all or substantially all of the assets of a Third Party (including any subsidiaries or divisions thereof), and the Third
Party (or any of such Third Party’s Affiliates or any successors or assigns of such Third Party or such Third Party’s
Affiliates immediately prior to such Business Combination) has, or the acquired assets contain, as applicable, a Business Program,
then Company shall promptly notify SpePharm of such Business Program within five (5) days after such Business Combination and Company
and/or such Third Party (or any of such Third Party’s Affiliates or any successors or assigns of such Third Party or such
Third Party’s Affiliates) will [*].


 


(g)          Each
Party acknowledges and agrees that the restrictions set forth in this Section 2.6 are considered by the Parties to be reasonable
for the purposes of protecting the goodwill and value of the other Party’s business. Each Party acknowledges that the other
Party may be irreparably harmed and that monetary damages may not provide an adequate remedy to the other Party in the event the
covenants contained in this Section 2.6 were not complied with in accordance with their terms. Accordingly, each Party agrees that
any breach by it of any provision of this Section 2.6 shall entitle the other Party to, without limit any other rights it may have,
injunctive and other equitable relief to secure the enforcement of these provisions, in addition to any other remedies (including
damages) which may be available to the other Party.


 


(h)          It
is the desire and intent of the Parties that the provisions of this Section 2.6 be enforced to the fullest extent permissible under
the laws and public policies of each jurisdiction in which enforcement is sought. If any provisions of this Section 2.6 relating
to the time period, scope of activities or geographic area of restrictions is declared by a court of competent jurisdiction to
exceed the maximum permissible time period, scope of activities or geographic area, as the case may be, the time period, scope
of activities or geographic area shall be reduced to the maximum which such court deems enforceable. If any provisions of this
Section 2.6 other than those described in the preceding sentence are adjudicated to be invalid or unenforceable, the invalid or
unenforceable provisions shall be deemed amended (with respect only to the jurisdiction in which such adjudication is made) in
such manner as to render them enforceable and to effectuate as nearly as possible the original intentions and agreement of the
Parties.


 




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2.7         Cross-Territorial
Restrictions.


 


(a)          Unless
otherwise expressly authorized by Company in writing, SpePharm shall not (i) actively seek prospective purchasers for the Product
for use in the Company Territory; (ii) engage in any advertising or promotional activities relating to the Product directed primarily
to prospective purchasers for use in the Company Territory; or (iii) solicit orders from any prospective purchaser for sale and
use in the Company Territory. If SpePharm receives any order from a prospective purchaser in the Company Territory, SpePharm shall
promptly refer that order to Company and shall not accept any such orders. SpePharm shall not sell any Product to a purchaser if
SpePharm knows that such purchaser intends to resell or otherwise distribute or provide such Product to a prospective purchaser
for use in the Company Territory.


 


(b)          Unless
otherwise expressly authorized by SpePharm in writing, Company shall not (i) actively seek prospective purchasers for the Product
for use in the Licensed Territory; (ii) engage in any advertising or promotional activities relating to the Product directed primarily
to prospective purchasers for use in the Licensed Territory; or (iii) solicit orders from any prospective purchaser for sale and
use in the Licensed Territory. If Company receives any order from a prospective purchaser in the Licensed Territory, Company shall
promptly refer that order to SpePharm and shall not accept any such orders. Company shall not sell any Product to a purchaser if
Company knows that such purchaser intends to resell or otherwise distribute or provide such Product to a prospective purchaser
for use in the Licensed Territory.


 


2.8         ROFN
for Additional Products. Company hereby grants to SpePharm the first right to negotiate for the exclusive rights to market,
sell, distribute and commercialize in the Licensed Territory any imaging agent for [*] Controlled by Company or any of its Affiliates
during the Term (the “Additional Products”) (the “ROFN”) in accordance with this Section
2.8. In the event that Company or any of its Affiliates proposes to, directly or indirectly, enter into, a license or other arrangement
with a Third Party at any time during the Term pursuant to which such Third Party would receive rights to market, sell, distribute
and/or commercialize any Additional Product (an “Additional Product License”), then Company shall so notify
SpePharm in writing (the “ROFN Notice”) prior to engaging in any such activities. For clarity, Company shall
notify SpePharm upon receipt of, or prior to entering into discussions or a binding commitment with respect to, an unsolicited
offer or proposal for an Additional Product License from a Third Party. If within thirty (30) days of receiving the ROFN Notice,
SpePharm notifies Company in writing that it wishes to exercise its ROFN, the Parties shall negotiate in good faith on an exclusive
basis for a period not to exceed ninety (90) days after Company’s receipt of such written notification. If the Parties reach
agreement on the terms to include such Additional Product under this Agreement, the Parties shall amend this Agreement based upon
the agreed upon terms. If, at the end of the 90-day period, Company and SpePharm are unable to reach agreement on such terms, Company
shall be free to enter into an Additional Product License for such Additional Product and Company shall have no further obligation
to SpePharm with respect to such Additional Product. For clarity, (a) an agreement with a contractor, contract research organization,
contract manufacturer or other Third Party which agreement provides solely for the performance of contract services on behalf of
Company, shall not be subject to this Section 2.8; and (b) this Section 2.8 shall not be triggered by a Business Combination of
Company, or an assignment or transfer of this Agreement or any right or obligation hereunder to a Third Party pursuant to Section
17.8. In the event Company is acquired by a Third Party in connection with a Business Combination, the terms of this Section 2.8
will no longer apply.


 




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2.9         Additional
Indications.


 


(a)          In
the event that either Party or its Affiliates is interested in developing a Product for an indication other than the Initial Indication
(each an “Additional Indication”), it shall propose such development to the JMC for discussion by the Parties.
If the other Party indicates, within sixty (60) business days of such proposal for development by the other Party (the “AI
Notice Period”), it is interested in jointly developing the Product for the Additional Indication with the first Party,
the Parties agree to negotiate the terms of such development, including a development plan that would satisfy the requirements
of the FDA and EMA for such Additional Indication, the roles and responsibilities of the Parties in such development and the sharing
of costs and expenses that would be incurred by the Parties in developing the Product for such Additional Indication. The Parties
agree that such negotiations shall occur for at least sixty (60) days after the other Party referenced above has indicated its
interest in the Additional Indication, or for such other period of time mutually agreed by the Parties (“Negotiation Period”).
If the Parties reach mutual agreement on such terms, the Parties shall document such agreement in writing.


 


(b)          If
the Parties do not reach agreement on terms for developing the Product for the Additional Indication within the Negotiation Period,
or if a Party has indicated it is not interested in, or has failed to indicate (within the AI Notice Period) it is interested in,
jointly developing with the other Party the Product for the Additional Indication, then each Party shall have the right to independently
develop the Product for such Additional Indication for its respective Territory, provided that, notwithstanding anything to the
contrary in this Agreement (including Sections 2.1 and 11.1(f)):


 


(i)          such
right to independently develop the Product is subject to, and without limitation of, Section 4.4;


 


(ii)         any
and all Information (including raw clinical data and manufacturing information) generated by or on behalf of such Party (the “Developing
Party”) or its Affiliates or licensees or sublicensees in the conduct of the development and commercialization of the
Product in and for the Additional Indication (“Excluded Information”) shall be excluded from any and all licenses
and other rights granted to the other Party (the “Non-Developing Party”) under this Agreement, provided that
if such Excluded Information was generated in the conduct of development and/or commercialization of the Product in and for (A)
the Additional Indication and (B) either (1) the Initial Indication or (2) a different Additional Indication which the Parties
have mutually agreed to develop pursuant to Section 2.9(a) above, then the Excluded Information shall not be excluded from the
license and other rights granted to the Non-Developing Party with respect to the Initial Indication and such different Additional
Indication;


 




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(iii)        the
Non-Developing Party and its Affiliates and licensees and sublicensees shall have no right to, and shall not, refer to, rely upon
or otherwise make any use of any Excluded Information, or any Regulatory Materials for the Product for the Additional Indication
that are Controlled by the Developing Party or its Affiliates or licensees or sublicensees (“Excluded Regulatory Materials”),
other than (A) solely as necessary to comply with any safety reporting obligations of a Regulatory Authority and (B) with respect
to the Initial Indication and any different Additional Indications which the Parties have mutually agreed to develop pursuant to
Section 2.9(a) above;


 


(iv)        subject
to the RA Field Licensee’s rights in the RA Field under the RA Field License Agreement, neither Party nor any of its Affiliates
or licensees or sublicensees shall seek or obtain any Product Approval for the Product for the Additional Indication in the Developing
Party’s Territory; and


 


(v)         for
avoidance of doubt, subject to clauses (ii) and (iii) above, the Field shall continue to include the Additional Indication, including
for purposes of the licenses granted to SpePharm and its Affiliates under Section 2.1 for the Licensed Territory.


 


If a Non-Developing
Party desires to obtain access to any Excluded Information or Excluded Regulatory Materials, the Developing Party agrees to negotiate
in good faith the terms of such access, including the consideration to be paid by the Non-Developing Party for such access.


 


For purposes of this
Section 2.9(b), references to “licensees,” when referring to Company’s licensees, shall not include SpePharm
or its Affiliates.


 


2.10       RA
Field.


 


(a)          [*].


 


(b)          Notwithstanding
anything to the contrary herein:


 




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(i)          RA
Field Licensee shall not have, and Company and its Affiliates and other licensees (excluding SpePharm and its Affiliates) shall
not have in the RA Field, any license, sublicense or other rights (including any right to reference or rely upon) to or under,
directly or indirectly, any (A) Information, Confidential Information or Patent Rights Controlled (other than where Controlled
as a result of the licenses granted under Section 2.1) by SpePharm or any of its Affiliates or licensees or sublicensees (including
any General IP), (B) any Product IP, (C) any Information generated under this Agreement from clinical studies funded (in whole
or in part) by SpePharm or any of its Affiliates), (D) any Regulatory Materials owned, held or possessed by SpePharm or any of
its Affiliates or licensees or sublicensees, including any Product Approvals for any Product in the Licensed Territory, but excluding
Product Approvals, Regulatory Data and Regulatory Materials assigned or licensed by Company to SpePharm under this Agreement, ((A)
through (D) collectively, the “SpePharm Excluded Rights”); or (E) the Product Marks;


 


(ii)         neither
Company nor any of its Affiliates or any other Person acting by, for or through them, shall, directly or indirectly, (A) grant
or otherwise convey to the RA Field Licensee any license, sublicense or other rights (including any right to reference or rely
upon) to or under any SpePharm Excluded Rights or any Product Marks, or (B) disclose or otherwise make available any SpePharm Excluded
Rights to the RA Field Licensee;


 


(iii)        neither
Company nor any of its Affiliates or licensees or sublicensees (other than the RA Field Licensee pursuant to the RA Field License
Agreement) shall, directly or indirectly, sell, distribute or otherwise Commercialize the Product in or for the RA Field in the
Licensed Territory;


 


(iv)        if
the RA Field Licensee, directly or indirectly, sells, distributes or otherwise Commercializes the Product in any country of the
Initial Territory, such Product shall be deemed a Generic Product for each and every country of the Initial Territory, and Section
10.4(c) shall apply for as long as such sale, distribution or Commercialization continues;


 


(v)         if
the RA Field Licensee, directly or indirectly, sells, distributes or otherwise Commercializes the Product in any country of the
Expanded Territory, such Product shall be deemed a Generic Product for such country of the Expanded Territory, and Section 10.4(c)
shall apply for as long as such sale, distribution or Commercialization continues; and


 


(vi)        if
the RA Field Licensee, directly or indirectly, sells, distributes or otherwise Commercializes the Product in any country of the
Licensed Territory, SpePharm’s obligation to pay any milestone payments under Sections 10.2 and 10.3 that come due after
the first date of such sale, distribution or Commercialization, shall terminate.


 




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2.11       Expanded
Territory. [*] after the Effective Date, SpePharm shall provide Company with a development plan for each of [*]. Each such
plan shall include those activities designed to obtain Product Approval in a timely manner consistent with the exercise of Commercially
Reasonable Efforts and will include the initiation of material development activities, consistent with Commercially Reasonable
Efforts, not later than [*] from the date of such plan. From time to time during the Term, SpePharm shall have the right to make
Commercially Reasonable amendments to such development plans. SpePharm will provide any proposed amendments to the JMC for its
review, and will reasonably consider any comments from the JMC with respect to such amendments. SpePharm will update the JMC from
time to time on its plans to develop the Product in the Expanded Territory countries aside from [*]. The Licensed Territory shall
be redefined to exclude [*] where SpePharm does not provide a development plan for such country in accordance with this Section
2.11, and such redefinition of the Licensed Territory shall constitute Company’s sole remedy for such non-provision of such
development plan.


 


ARTICLE
III – GOVERNANCE


 


3.1         Joint
Management Committee.


 


(a)          Promptly
after the Effective Date the Parties will establish a joint management committee (“JMC”) composed of at least
three (3) representatives from each Party, that number not necessarily required to be the same for each Party. Each Party may change
its representatives on the JMC from time to time, in its sole discretion, effective upon notice to the other Party of such change.
These representatives shall have appropriate experience and knowledge. The JMC shall coordinate the activities of the Parties under
this Agreement and discuss measures facilitating the Product’s successful development and Commercialization in the Licensed
Territory. Upon written notice to the other Party, either Party may invite a reasonable number of non-member representatives (including,
without limitation, its employees or non-employee professional representatives), who have a reasonable purpose for attending such
meeting or portion of such meeting and are bound to obligations of confidentiality at least as protective as those set forth in
this Agreement.


 


(b)          Meetings.
The JMC shall meet at least on a semi-annual basis and at such other times as the Parties may agree. Meetings shall be held
at such dates and locations as are mutually agreed, and may be held in person, by teleconference or videoconference. The Parties
agree that the costs incurred by each Party in connection with its participation at any meetings under this Section 3.1 shall be
borne solely by such Party.


 


(c)          Role
of the JMC. Subject to the foregoing, the JMC shall be responsible for:


 




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(i)          reviewing
and discussing the strategy for obtaining Product Approval and for reviewing strategic Regulatory Materials, as needed, including
Product Approval filings, for the Product in the Licensed Territory;


 


(ii)         reviewing
and discussing the development, manufacturing, marketing, distribution and Commercialization of the Product in the Licensed Territory,
including (A) any Chemistry, Manufacturing and Controls (“CMC”) work which may be required or necessary for
the approval of [*] by the EMA and (B) the Commercialization Plan;


 


(iii)        reviewing
and discussing progress of the clinical trials required to fulfill Paediatric Investigation Plans agreed with the FDA and EMA;


 


(iv)        reviewing
and discussing clinical trials involving the Product (including market access trials) conducted in the Licensed Territory;


 


(v)         reviewing
and discussing the Company Development Plan and SpePharm Development Plan;


 


(vi)        establishing
such joint subcommittees or committees as the Parties may agree in writing as necessary to achieve the objectives and intent of
this Agreement; and


 


(vii)       performing
such other functions as agreed by the Parties in writing.


 


Notwithstanding any
other provision of this Section 3.1, the JMC shall have only the powers assigned expressly to it in this Section 3.1 and elsewhere
in this Agreement.


 


(d)          Quorum
and Decision-Making. The quorum for meetings of the JMC shall be two (2) representatives from each Party. At any meeting, the
JMC members from each respective Party shall have one (1) aggregate vote, irrespective of the number of representatives from each
Party actually in attendance of the meeting. No decision of the JMC shall be made unless both Parties have voted in favor thereof.


 


(e)          Chair.
Unless otherwise mutually agreed between the Parties, the chair of the JMC shall alternate between representatives of each of the
Parties at each meeting of the JMC. The first chair of the JMC shall be a representative of SpePharm.


 


(f)          Decision-Making.
If the JMC cannot unanimously resolve a disagreement within thirty (30) days after first addressing such a matter, either Party
may, by written notice to the other Party, have such dispute referred to the Chief Operating Officer or closest equivalent (“Relevant
Executive Member”) of each Party or their designees for attempted resolution by good faith negotiations within thirty
(30) days after such notice is received. If the Relevant Executive Members are unable to agree on any matter or resolve any issue
referred to it within fifteen (15) days after such matter was referred to them, or in such longer period as the Parties may agree,
such dispute shall be referred to the Chief Executive Officer of each Party or their designees for attempted resolution by good
faith negotiations within fifteen (15) days after such notice is received; provided, however, that each of the Parties
shall have the final decision-making authority and discretion with respect to the following matters, as and to the extent set forth
in this Agreement:


 




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(i)          SpePharm’s
Decision. SpePharm shall have the authority and discretion to decide any matter (A) related to (i) except as provided
in Section 3.1(f)(ii)(B), development of the Product in the Licensed Territory, and Regulatory Materials, Product Approvals and
regulatory matters concerning the Product in the Licensed Territory, (ii) conduct of any clinical trials involving the Product
to be conducted in the Licensed Territory (including any clinical trials which may be done for market access and pricing and reimbursement
purposes for the Products in the Licensed Territory); and (iii) the Commercialization of the Product within the Licensed Territory,
including the Commercialization Plan (but excluding the training to be provided pursuant to Section 9.2(a), which shall require
mutual agreement of the Parties); (B) related to CMC work which may be required or necessary for Product Approval of the Product
in the Licensed Territory after the first Product Approval of [*] in the Licensed Territory by the EMA; and (C) related to seeking
Product Approval for [*] in the Expanded Territory and maintaining Product Approvals for the Product, in the Licensed Territory;
and (D) related to activities in the Licensed Territory that could reasonably be deemed to have a material adverse effect on the
Commercialization of the Product in the Field, in the Licensed Territory.


 


(ii)         Company’s
Decision. Company shall have the authority and discretion to decide (A) any matter relating to the development, manufacture
or commercialization of the Product in the Company Territory; and/or (B) the conduct of CMC work which may be required or necessary
for the first Product Approval of [*] in the Licensed Territory by the EMA.


 


Notwithstanding the
foregoing, the Party having final decision-making authority under this Section 3.1(f) shall not have the right to exercise its
final decision-making authority to unilaterally: (1) determine that it has fulfilled any obligations under this Agreement or that
the other Party has breached any obligation under this Agreement, (2) determine that a milestone event required for the payment
of a milestone payment has or has not occurred, (3) make a decision that is expressly stated to require the mutual agreement of
the Parties (which, for clarity, does not encompass matters to be approved by the JMC), (4) otherwise expand its rights or reduce
its obligations under this Agreement, (5) determine any issue in a manner that would conflict with the terms and conditions of
this Agreement, or (6) require Company to make any expenditures or conduct any activities not otherwise specified in the Company
Development Plan or require SpePharm to make any expenditures or conduct any activities not otherwise specified in the SpePharm
Development Plan.


 




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ARTICLE
IV – PRODUCT DEVELOPMENT


 


4.1         Product
Development. Subject to the terms of this Agreement, SpePharm will be responsible for the development of the Product in the
Licensed Territory except as expressly assigned to Company.


 


4.2         Development
Responsibilities of Company. Company shall be responsible, at its sole cost and expense (except as provided in Section 4.2(b)),
for the following activities for the Product for the Licensed Territory:


 


(a)          designing
and conducting, in accordance with Applicable Laws and protocols mutually agreed by the Parties, any non-clinical and clinical
trials which may be required for Product Approval (excluding pricing and reimbursement approval) of the Products in the Initial
Territory by any Regulatory Authorities;


 


(b)          designing
and conducting, in accordance with Applicable Laws and protocols mutually agreed by the Parties, any clinical trials which may
be required to fulfill Paediatric Investigation Plans agreed with the EMA (“PIP Trials”); provided that Company
and SpePharm will share equally in the out-of-pocket costs and expenses of any such PIP Trials, as will be mutually agreed by the
Parties in writing prior to the commencement of such PIP Trials, with SpePharm’s share not to exceed [*]; and


 


(c)          conducting
any CMC work which may be required or necessary for the first Product Approval of [*] by the EMA in the Licensed Territory and
as may be required or necessary in connection with the supply of Product to SpePharm under the Supply Agreement;


 


in each case
subject to review by and discussion at the JMC.


 


The development plan
detailing the foregoing development activities is attached hereto as Exhibit G (the “Company Development Plan”).
From time to time during the Term, Company shall have the right to amend the then-current Company Development Plan. Company will
provide any proposed amendments to the JMC for its review, and will reasonably consider any comments from the JMC with respect
to such amendments. Company shall use Commercially Reasonable Efforts to conduct the development activities set forth in the Company
Development Plan.


 




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4.3         Development
Responsibilities of SpePharm. SpePharm shall be responsible, at its sole cost and expense, for:


 


(a)          designing
and conducting any clinical trials required or necessary for market access and pricing and reimbursement purposes for the Products
in the Licensed Territory;


 


(b)          providing
reasonable requested advice and expertise to Company with respect to CMC work conducted by Company which may be required or necessary
for the first Product Approval of [*] by the EMA in the Licensed Territory;


 


(c)          conducting
any CMC work which may be required or necessary for Product Approvals after the first Product Approval of [*] by the EMA in the
Licensed Territory, except as provided in Section 4.2(c); and


 


(d)          using
Commercially Reasonable Efforts to conduct other Commercially Reasonable development activities (other than those that are Company’s
responsibility pursuant to Section 4.2) that may be required or necessary to obtain Product Approvals for [*] in the Licensed Territory.


 


[*], SpePharm shall
prepare a plan setting forth the development activities (including any market access or other studies) that will be conducted by
SpePharm for the Initial Territory pursuant to this Section 4.3 (the “SpePharm Development Plan”). From time
to time during the Term, SpePharm shall have the right to amend the then-current SpePharm Development Plan. SpePharm will provide
any proposed amendments to the JMC for its review, and will reasonably consider any comments from the JMC with respect to such
amendments. SpePharm shall use Commercially Reasonable Efforts to conduct the development activities set forth in the SpePharm
Development Plan. Without limiting the generality of the foregoing, the Parties shall review and discuss, through the JMC, a schedule
for filing of regulatory applications for such Product Approvals in such countries.


 


In the event that SpePharm
determines that it is not Commercially Reasonable to file a regulatory application for Product Approval for the Product or Commercialize
the Product, in any particular country in the Licensed Territory, then SpePharm shall promptly discuss such matter with the JMC.


 




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4.4         Clinical
Trials. 


 


(a)          The
Parties shall discuss, at the JMC, the conduct by SpePharm of market access studies for use in generating pricing and reimbursement
data for the Product in the Licensed Territory.


 


(b)          If
SpePharm intends to initiate and conduct any investigator led trials or clinical trials necessary or desirable to seek and maintain
Product Approvals for the Product in the Licensed Territory, SpePharm shall discuss such trials with Company reasonably in advance
of their initiation and shall in good faith consider Company’s reasonable comments and suggestions in respect thereof.


 


(c)          Except
for any clinical trials required to be conducted by Company pursuant to Section 4.2, neither Company nor its Affiliates or licensees
may sponsor or conduct any investigator led trials or clinical trials involving the Product in the Licensed Territory without SpePharm’s
prior written approval (such approval not to be unreasonably withheld, delayed or conditioned).


 


(d)          If
Company or its Affiliates or licensees sponsor or conduct any investigator led trials or clinical trials involving the Product
in the Company Territory, Company agrees to discuss and review such trials at the JMC (provided that neither SpePharm nor the JMC
shall have any approval rights, and all decisions regarding such trials shall be in Company’s sole discretion).


 


4.5         Product
Development Activities. Each Party agrees that it shall consult with and keep the other Party reasonably apprised of the developing
Party’s conduct, directly or indirectly, of any clinical development activity using the Product in its respective Territory,
including the evaluation of the Product for use in additional fields or applications.


 


4.6         Records;
Information Sharing; Right of Reference. 


 


(a)          Records,
Data and Information. Each Party shall maintain complete, current and accurate records of all work conducted by it under this
Agreement and all data and other Information resulting from the performance of such activities in sufficient detail and in a good
scientific manner appropriate for patent and regulatory purposes.


 




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(b)          Data
Generated by SpePharm. Subject to Sections 2.9 and 2.10, SpePharm shall promptly provide Company with copies of final reports
and of all Information (including raw clinical data) generated by or on behalf of SpePharm or its Affiliates or Sublicensees in
conducting any activities under this Agreement that are Controlled by SpePharm and are necessary or useful for the development,
manufacture or Commercialization of the Product. SpePharm shall provide such Information to Company as soon as reasonably practical
and through information sharing procedures to be established by mutual agreement of the Parties. Notwithstanding any other provision
of this Agreement to the contrary, SpePharm acknowledges and agrees that, subject to Sections 2.9 and 2.10, Company may disclose
any and all such Information to Company’s Affiliates and licensees and that Company and such Affiliates and licensees may
use, free of charge, any such Information solely for (i) the research, development, manufacture and commercialization of the Product
in the Company Territory, and (ii) the research, development, manufacture and commercialization of any product controlled by Company
(other than the Product in the Licensed Territory) as of the Effective Date or during the Term.


 


(c)          Data
Generated by Company. Subject to Section 2.9, Company shall promptly provide SpePharm with copies of final reports and of all
Information (including raw clinical data and manufacturing information) generated by or on behalf of Company or its Affiliates
or licensees prior to the Effective Date as well as during the Term in the conduct of the development and commercialization of
the Product that are necessary or useful for the development, Product Approval or Commercialization of the Product in the Field
by SpePharm for the Licensed Territory. Company shall provide such Information to SpePharm as soon as reasonably practical and
through information sharing procedures to be established by mutual agreement of the Parties. Notwithstanding any other provision
of this Agreement to the contrary, Company acknowledges and agrees that, subject to Section 2.9, SpePharm may disclose any and
all such Information with SpePharm’s Affiliates and Sublicensees and that SpePharm and such Affiliates and Sublicensees may
use, free of charge, any such Information solely for the research, development, manufacture and commercialization of the Product
in the Licensed Territory.


 


(d)          Right
of Reference. Subject to Section 2.9, Company hereby grants to SpePharm, its Affiliates and Sublicensees a Right of Reference
to all Regulatory Data and all Regulatory Materials Controlled by Company or its Affiliates relating to the Product solely to the
extent necessary or useful to develop, manufacture, market, promote, use, sell, distribute and Commercialize the Product in the
Field in or for the Licensed Territory, consistent with the terms of this Agreement. Subject to Sections 2.9 and 2.10, SpePharm
hereby grants to Company, its Affiliates and licensees a Right of Reference to all Regulatory Data and Regulatory Materials Controlled
by SpePharm or its Affiliates relating to the Product solely to the extent necessary or useful to develop, manufacture, market,
promote, use, sell, distribute and Commercialize the Product in or for the Company Territory. Each Party shall provide a signed
statement regarding the foregoing, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous
Applicable Laws recognized outside of the United States).


 




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ARTICLE
V – REGULATORY MATTERS; PHARMACOVIGILANCE


 


5.1         Transfer
of Existing Product Approvals. The Parties shall take, and shall cause their Affiliates to take, such actions as are reasonably
necessary to transfer Product Approvals for Product 1 [*] to SpePharm or an Affiliate designated by SpePharm within three (3) months
after the receipt of Product Approval for [*] in the Initial Territory, including Company providing all Regulatory Data to SpePharm
that is required to be submitted to Regulatory Authorities in connection with SpePharm’s or its designated Affiliate’s
application to assume such Product Approvals. Each Party shall be responsible for its own costs and expenses incurred in connection
with such transfer, provided that SpePharm shall be responsible for any fees payable to Regulatory Authorities in connection with
such transfer. Until transfer of the Product Approvals for Product 1 to SpePharm, or in the event of failure to transfer such Product
Approvals to SpePharm or its designated Affiliate, Company hereby consents and grants to SpePharm and its Affiliates the right
to access and reference (without any further action required on the part of Company, whose authorization to file this consent with
any Regulatory Authority is hereby granted) any such Product Approval.


 


5.2         Preparation
and Filing of Product Approvals for [*].


 


(a)          Product
Approval for Product 1 has been obtained as of the Effective Date in the Initial Territory. Subject to SpePharm’s input and
final approval (not to be unreasonably withheld), Company shall, at its expense, prepare submission-ready Regulatory Materials
to obtain Product Approvals for the Initial Indication for [*] in the Initial Territory and file all such Regulatory Materials
to obtain such Product Approvals in the Initial Territory. SpePharm shall provide Company with such advice and reasonable consultation
and assistance as may be requested by Company in connection with the foregoing activities.


 


(b)          SpePharm,
at its expense, shall be responsible for preparing and filing all Regulatory Approvals to obtain Product Approvals for the Initial
Indication for [*] in the Expanded Territory. Company shall provide SpePharm with such advice and reasonable consultation and assistance
as may be requested by SpePharm in connection with the foregoing activities, including supplying to SpePharm copies of all Regulatory
Data and Regulatory Materials possessed by Company and its Affiliates and licensees.


 


(c)          SpePharm
shall, at its expense, use Commercially Reasonable Efforts to obtain, in consultation with Company through the JMC, Product Approvals
for the Initial Indication for [*] in the Expanded Territory in those countries of the Expanded Territory where it is Commercially
Reasonable to do so (subject to Section 2.11).


 




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5.3         Maintenance
of Product Approvals.


 


(a)          After
transfer of each Product Approval in the Licensed Territory to SpePharm or its designated Affiliate, or obtaining of each Product
Approval in the Licensed Territory by SpePharm or its designated Affiliate, SpePharm or such designated Affiliate shall use Commercially
Reasonable Efforts to maintain, in consultation with Company through the JMC, such Product Approvals. SpePharm shall be responsible
for all costs and expenses incurred in maintaining such Product Approvals, including amounts required to be paid to Regulatory
Authorities, but excluding any costs and expenses incurred by Company or its Affiliates.


 


(b)          As
between the Parties, all Product Approvals for the Product in the Licensed Territory shall be in the name of SpePharm or its designated
Affiliate, and shall indicate SpePharm or such designated Affiliate is the holder of such Product Approvals. SpePharm shall be
responsible for obtaining and maintaining any other approvals, permits or licenses necessary for its distribution, promotion, and
sale of the Product in the Licensed Territory.


 


5.4         Review
of Regulatory Materials; Communications with Regulatory Authorities.


 


(a)          Company
shall provide to SpePharm for its review and comment any proposed material Regulatory Materials to be submitted (other than routine
correspondence) to a Regulatory Authority in the Licensed Territory relating to the Product at least ten (10) business days in
advance of submission, and Company shall reasonably consider and incorporate such comments. From and after such time that Product
Approvals for Product 1 [*] are held in the name of SpePharm, Company shall not submit any Regulatory Materials to a Regulatory
Authority in the Licensed Territory relating to the Product. SpePharm shall furnish to Company copies of material Regulatory Materials
(other than routine correspondence) in advance of submission where practical that SpePharm submits to or receives from any Regulatory
Authority in the Licensed Territory relating to the Product (and consider Company’s comments in good faith), as well as contact
reports concerning substantive conversations or substantive meetings with any such Regulatory Authority, in each case relating
to any such material Regulatory Materials.


 


(b)          Each
Party shall provide the other Party with prior written notice, to the extent the Party has advance knowledge, of any meeting, conference,
or discussion (including any advisory committee meeting) with a Regulatory Authority in the Licensed Territory relating to the
Product, within two (2) business days after the Party or its Affiliate, licensee or Sublicensee first receives notice of the scheduling
of such meeting, conference, or discussion (or within such shorter period as may be necessary in order to give the other Party
a reasonable opportunity to attend such meeting, conference, or discussion). To the extent permitted by the Regulatory Authority,
the other Party shall have the right to attend as an observer (but not participate in unless otherwise agreed in advance) all such
meetings, conferences, and discussions.


 




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5.5         Pharmacovigilance.
The responsibilities of each Party in regards to pharmacovigilance activities, including the exchange of safety information,
adverse event reporting, governmental reporting and related follow-up, to the extent they relate to the Product, shall be set forth
in a separate Pharmacovigilance Agreement (“PV Agreement”) between the Parties (or, as the case may be, Affiliates
or experienced Third Parties acting on their behalf) for such Product, which shall be entered into within ninety (90) days after
the Effective Date and attached hereto as Exhibit D. Company shall maintain and will be the recognized holder of a global
safety database for adverse event reports related to the Product received by either Party or their Affiliates, licensees and Sublicensees,
and SpePharm shall have access thereto, as shall be further specified in the PV Agreement.


 


5.6         Product
Recalls. 


 


(a)          SpePharm
has the sole discretion to make a decision for recalling, or issuing an advisory letter or other safety-related communication with
respect to, Product in the Licensed Territory and handling such recalls. SpePharm shall bear all costs associated with such recalls,
except to the extent that any recall is attributable to a breach of this Agreement by, or the gross negligence or willful misconduct
of, Company or its Affiliates or to the manufacture of the Product by or on behalf of Company. SpePharm shall notify Company in
a timely manner in connection with any such action. Each Party agrees to provide reasonable assistance to the other Party in the
event of any recall or issuance of any advisory letter. In the event that Company has determined to initiate a recall of the Product
outside the Licensed Territory, it shall so notify SpePharm and the Parties shall immediately discuss the cause of such action
and whether to initiate a recall or take other action in the Licensed Territory.


 


(b)          If
and when SpePharm becomes aware of any information that reasonably suggests that a Product sold in the Licensed Territory may have
caused or contributed to a death or serious injury or has malfunctioned and that the Product would be likely to cause or contribute
to a death or serious injury if the malfunction were to recur, SpePharm agrees to furnish such information to Company within the
time periods specified in the PV Agreement.


 


(c)          If
and when Company becomes aware of any information that reasonably suggests that a Product sold in the Company Territory may have
caused or contributed to a death or serious injury or has malfunctioned and that the Product would be likely to cause or contribute
to a death or serious injury if the malfunction were to recur, Company agrees to furnish such information to SpePharm within the
time periods specified in the PV Agreement.


 




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5.7         No
Harmful Actions. If either Party reasonably believes that the other Party is taking or intends to take any action with respect
to the Product that could reasonably be expected to have a material adverse impact upon the regulatory status of the Product in
the Licensed Territory (in the case of SpePharm) or the Company Territory (in the case of Company), such Party shall have the right
to bring the matter to the attention of such other Party and the Parties shall meet and discuss the impact of such action.


 


ARTICLE
VI – PRODUCT MANUFACTURING AND SUPPLY 


 


6.1         Product
Manufacturing and Supply. The Parties shall negotiate in good faith and enter into a definitive supply agreement governing
the clinical and commercial supply of Product by Company to SpePharm and SpePharm’s purchase of Product from Company, consistent
with the terms and conditions of the term sheet attached hereto as Exhibit F, within ninety (90) days of the Effective Date.


 


ARTICLE
VII – COMMERCIALIZATION


 


7.1         Product
Commercialization. Subject to the terms and conditions of this Article 7, SpePharm shall be the responsible Party for the Commercialization
of the Product in the Field in the Licensed Territory. Without limiting the foregoing, SpePharm shall be responsible for: (a) developing
and using its Commercially Reasonable Efforts in executing a commercial launch and pre-launch plan, (b) negotiating with applicable
Regulatory Authorities regarding price and reimbursement, (c) using its Commercially Reasonable Efforts in marketing and promotion
of the Product in the Licensed Territory, and (d) except where Company has such responsibility under the Supply Agreement, manufacture,
storage, shipment, transportation, distribution and invoicing in the Licensed Territory.


 


7.2         Commercialization
Plans. [*] prior to the anticipated commercial launch by SpePharm or its Affiliates or Sublicensees of the Product in the Licensed
Territory, SpePharm shall provide to Company for review and comment, a commercialization plan outlining SpePharm’s good faith
plan for the Commercialization of Product in the Licensed Territory (the “Commercialization Plan”). The Commercialization
Plan will, in reasonable detail, include information, sales forecasts and timelines regarding SpePharm’s Commercialization
activities.


 


7.3         Commercialization
Diligence.


 


(a)          General.
SpePharm shall use Commercially Reasonable Efforts to Commercialize [*] in the Initial Territory in those countries in which
it receives Product Approval and in which it is Commercially Reasonable to Commercialize the Product. Without limiting any of the
foregoing, SpePharm shall use its Commercially Reasonable Efforts to: (i) develop marketing and market access dossiers (including
pricing and reimbursement where applicable) as may be required in SpePharm’s sole determination; (ii) diligently promote
the sale of [*] in the countries of the Licensed Territory in which it receives Product Approvals in accordance with Applicable
Laws; and (iii) be responsible for all medical education programs with professional clinical liaisons within the Licensed Territory.



 




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(b)          Major
EU Market Countries. [*]:


 


(i)          if,
during such ninety (90) day period, SpePharm (or its Affiliates or Sublicensees) has commercially launched [*] in [*] of the Major
EU Market Countries, such termination shall be deemed withdrawn and of no further force or effect; or


 


(ii)         to
the extent that SpePharm (or its Affiliates or Sublicensees) has not commercially launched [*] in at least [*] of the Major EU
Market Countries in accordance with the terms of this Section 7.3(b) above due to (A) the occurrence of adverse events that raise
serious safety issues with respect to the Product; (B) any regulatory hold, constraint or material restriction imposed or raised
by a Regulatory Authority with respect to the Product; (C) manufacture or supply delays or failures with respect to the Product;
(D) any Force Majeure Event; or (E) a Third Party alleges in writing that the manufacture, use or sale of the Product infringes
its intellectual property or there is a pending infringement action, or decision of a court or a settlement relating to an infringement
action that prevents SpePharm from commercially launching the Product, then in each of (A) through (E) to the extent that (1) such
event occurs within the applicable Major EU Market Country, (2) such event would have a materially, adverse impact on a Commercially
Reasonable launch of such Product therein, and (3) SpePharm is using Commercially Reasonable Efforts to remove the existence of
such event, then the foregoing termination right shall be tolled during the pendency of such event and the material adverse impact
thereof.


 


The foregoing termination
right shall cease to apply after [*] has been commercially launched in [*] of the Major EU Market Countries. After [*] has been
commercially launched in a Major EU Market Country, SpePharm shall use Commercially Reasonable Efforts to Commercialize [*] in
each such Major EU Market Country.


 


(c)          Expanded
Territory. SpePharm shall use Commercially Reasonable Efforts to Commercialize [*] in those countries of the Expanded Territory
in which it receives Product Approval and in which it is Commercially Reasonable to Commercialize the Product.


 


(d)          JMC
Review. At Company’s request, SpePharm shall discuss at the JMC meeting following such request the basis on which
SpePharm has determined it is not Commercially Reasonable to Commercialize the Product in a country in which it has received Product
Approval.


 




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7.4         Price.
SpePharm may sell the Product in the Licensed Territory at prices determined by it in its sole discretion.


 


7.5         Company
Support. Upon SpePharm’s request, Company will use Commercially Reasonable Efforts to support SpePharm in its pre-launch
and launch activities, as set forth in the Commercialization Plan, and at SpePharm’s cost and expense, to the extent provided
in the Commercialization Plan. Upon SpePharm’s request and at SpePharm’s cost and expense, Company may provide direct
support to SpePharm’s customers and in such case SpePharm shall provide Company with SpePharm’s customers’ names
and information that Company may reasonably request in order for Company to provide such support to such customers.


 


7.6         Commercialization
Reports. SpePharm shall update the JMC periodically at each regularly scheduled JMC meeting regarding SpePharm’s Commercialization
activities with respect to the Product in the Licensed Territory, which update shall summarize SpePharm’s significant Commercialization
activities with respect to each Product on a country-by-country basis in the Licensed Territory pursuant to this Agreement, covering
subject matter at a level of detail sufficient to enable Company to determine SpePharm’s compliance with its diligence obligations
pursuant to Section 7.3 above.


 


ARTICLE
VIII – CERTAIN OBLIGATIONS OF THE PARTIES


 


8.1         Compliance
with Laws. Each Party will perform or cause to be performed any and all of its obligations or the exercise of any and all of
its rights hereunder in compliance in all material respects with all Applicable Laws.


 


8.2         Insurance.



 


(a)          Each
Party will maintain at its sole cost and expense, an adequate liability insurance or self-insurance program (including product
liability insurance) to protect against potential liabilities and risk arising out of activities to be performed under this Agreement
(including coverages, deductible limits and self-insured retentions) as are customary in the pharmaceutical industry for the activities
to be conducted by such Party under this Agreement.


 


(b)          The
insurance required herein shall be maintained during the term of this Agreement and, if on a “claims made” basis, for
a period of at least five (5) years thereafter. Each Party shall be solely responsible for the payment of any deductible under
any such policies maintained by it.


 




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ARTICLE
IX – PROMOTIONAL MATERIALS; TRAINING


 


9.1         Promotional
Materials. During the Term, SpePharm shall at its expense be responsible for the creation of all marketing and technical information
concerning the Product in the Licensed Territory that are necessary or helpful for the promotion of Product in the Licensed Territory,
including but not limited to brochures, instructional material, advertising literature and other Product data (the “Marketing
Materials”). All Marketing Materials created by SpePharm shall remain the property of SpePharm. Any liability or consumer
claim arising from any inaccurate Marketing Materials or translation provided by SpePharm or the creation of such Marketing Materials
shall be the sole responsibility of SpePharm, except that Company shall be solely responsible for any such liability or consumer
claim to the extent attributable to any Information (including Regulatory Data) or Regulatory Materials licensed or otherwise provided
by Company to SpePharm for use in Marketing Materials. To assist SpePharm with the creation of Marketing Materials, Company shall
provide SpePharm with sample branding and marketing information and/or brochures (in English) utilized by Company in the Company
Territory. All such information and materials provided by Company shall remain the property of Company, and SpePharm shall return
the same to Company upon termination of this Agreement, to the extent they are then in SpePharm’s possession or control.


 


9.2         Training.


 


(a)          Company
shall provide to SpePharm a reasonable level of Product-specific training on a planned and periodic basis for SpePharm personnel
(e.g., sales force, medical liaisons or marketing personnel) at a mutually agreed upon facility, as mutually agreed by the
Parties at the JMC.


 


(b)          Subject
to Company providing training pursuant to Section 9.2(a), SpePharm shall ensure that all of its employees and agents who are engaged
in the promotion and sales of the Product under this Agreement are adequately trained with respect to the Product.


 


ARTICLE
X – FINANCIAL PROVISIONS


 


10.1       Upfront
License Payment. In partial consideration of the licenses and rights granted to SpePharm hereunder, SpePharm shall pay
to Company a non-refundable, non-creditable payment of two million U.S. dollars (U.S. $2,000,000) within ten (10) days after the
Effective Date.


 


10.2       [*]
Milestone Payments. SpePharm shall pay to Company the following non-refundable, non-creditable (except as set forth
in Section 10.9), one-time milestone payments upon first achievement of such milestone for [*]:


 




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	Milestone	Milestone Payment
	[*]	[*]
	[*]	[*]
	[*]	[*]
	[*]	[*]
	[*]	[*]


 


SpePharm shall notify
Company in writing within thirty (30) days following the achievement of each milestone event above, and shall make the applicable
milestone payment within forty-five (45) days after the achievement of such milestone event.


 


10.3       Sales
Milestone Payments. SpePharm shall pay to Company the following non-refundable, non-creditable (except as set forth
in Section 10.9), one-time milestone payments upon first achievement of such milestone for [*]:


  


	Milestone	Milestone Payment
	[*]	[*]
	[*]	[*]


 


10.4       Royalties.


 


(a)          SpePharm
shall pay to Company royalties on aggregate Net Sales of the Product in the Licensed Territory for each Calendar Year as set forth
below:


 




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	Calendar Year Net Sales in the

Licensed Territory	Royalty Rate
	 	 
	Portion of aggregate Net Sales in the Licensed Territory less than or equal [*] in any Calendar Year	[*]
	 	 
	Portion of aggregate Net Sales in the Licensed Territory greater [*] in any Calendar Year	[*]


 


(b)          The
royalties payable under Section 10.4 shall apply, on a country-by-country basis, on Net Sales of the Product in each country in
the Licensed Territory commencing on the date of the First Commercial Sale of the Product in such country and continuing until
the later of [*] (such period, the “Royalty Term”).  


 


(c)          If,
on a country-by-country and calendar quarter-by-calendar quarter basis, a Generic Product is sold in such country during such calendar
quarter, then following the date of first commercial launch of such Generic Product in such country, the royalties payable with
respect to Net Sales of the Product pursuant to Section 8.4(a) in such country thereafter shall be reduced by [*] of the royalties
otherwise payable pursuant to Section 8.4(a).


 


(d)          If
SpePharm or any of its Affiliates or Sublicensees enters into an agreement with a Third Party to obtain a license under a patent
right or other right that is deemed by its counsel to be necessary to use, sell or otherwise Commercialize the Product in the Licensed
Territory or otherwise to practice the rights under the Company Patents or Company Know-How granted to SpePharm in Section 2.1,
or if SpePharm or any of its Affiliates or Sublicensees shall be subject to a final court or other binding order or ruling or settlement
agreement requiring any payments in respect of the use, sale or other Commercialization of any Product in a country in the Licensed
Territory, SpePharm may deduct from royalties due to Company [*] of any payments actually paid to such Third Party for such license,
or pursuant to such final court or other binding order or ruling or settlement agreement, with respect to such Product in such
country; provided that the royalties payable to Company for any particular calendar quarter for such Product in such country shall
not be reduced by more than [*] by reason of this Section 10.4(d), provided further that any such payments to Third Parties not
applied to reduce royalties as a result of the forgoing proviso may be carried over to subsequent calendar quarters and applied
to reduce royalties (subject to the aforementioned [*] limitation) in such subsequent calendar quarters.


 


(e)          Within
forty-five (45) days after the end of each calendar quarter, SpePharm shall provide a royalty report showing, on a country-by-country
basis:


 




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(i)          the
number of units of the Product sold by SpePharm and its Affiliates and Sublicensees during such calendar quarter reporting period;


 


(ii)         The
gross sales associated with each Product sold by SpePharm and its Affiliates and Sublicensees during such calendar quarter;


 


(iii)        the
Net Sales of the Product sold by SpePharm and its Affiliates and Sublicensees during such calendar quarter reporting period (together
with reasonable supporting information underlying the calculation of Net Sales in such period);


 


(iv)        the
royalties payable in Euros which shall have accrued hereunder with respect to such Net Sales; and


 


(v)         details
of any corrections or true-ups from previously reported Net Sales amounts;


 


(vi)        withholding
taxes, if any, required by Applicable Laws to be deducted with respect to such royalties; and


 


(vii)       the
rate of exchange used by SpePharm under Section 10.5.


 


Concurrent with these reports, SpePharm
shall remit to Company all payment due for the applicable calendar quarter. If no royalty or payment is due for any royalty period
hereunder, SpePharm shall so report.


 


10.5       Manner
of Payment and Exchange Rate. All milestone payments to be made by SpePharm to Company under this Agreement shall be made in
United States Dollars, and all royalty payments to be made by SpePharm to Company under this Agreement shall be made in Euros,
and shall be paid by electronic transfer in immediately available funds to a bank account in the United States designated in writing
by Company. If any Net Sales are made in a currency other than Euros and currency conversion is required, the rate of exchange
shall be calculated using the arithmetic daily average of the relevant published currency exchange rate from the European Central
Bank from the source http://fxtop.com, across the calendar quarter for which the relevant royalty payment is due pursuant to Section
10.4.


 


10.6       Late
Payments. Any amount due not received by the due date may, at the billing Party’s sole discretion, be subject to a charge
equal to the lesser of (i) an annual rate of [*] above EURIBOR (one month) per annum, and (ii) the maximum rate permitted by Applicable
Law governing this Agreement. Interest shall be calculated daily on the basis of a year of 365 days and the actual number of days
for which interest is due.


 




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10.7       Records
and Audits. SpePharm shall maintain complete and accurate books and records with respect to the sale and distribution of the
Product in accordance with Accounting Standards. Company shall have the right, during reasonable business hours and with reasonable
prior notice, but not more than once per calendar year, to inspect such books and records for purposes of verifying SpePharm’s
payments under this Agreement. SpePharm shall maintain all records and reports required under this Agreement relating to the Product
for a period of five (5) years or longer as required by Applicable Law. Company shall make inspections permitted hereunder at its
sole cost and expense; provided, however, that in the event such audit reveals an underpayment of the annual royalties
by more than [*] SpePharm shall bear the reasonable out-of-pocket costs and expenses of the audit. If, as a result of any audit
performed pursuant to this Section 10.7, it is determined that SpePharm under-reported any information necessary to calculate royalties
for Product, and as a result Company received less than it should have under this Agreement, SpePharm shall, no later than thirty
(30) days after receiving notice of such underpayment, remit to Company the amount of the underpayment. If as a result of the audit
performed pursuant to this Section 10.7, it is determined that SpePharm over-reported any information used to calculate the royalties
for the Product and as a result Company has received more than it should have under this Agreement, SpePharm shall be entitled
to a credit against the royalties due to Company in the next applicable period in the amount of such excess.


 


10.8       Taxes.


 


(a)          Taxes
on Income. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly
or indirectly from the collaborative efforts of the Parties under this Agreement.


 


(b)          Tax
Cooperation. To the extent SpePharm is required to deduct and withhold taxes on any payment to Company, SpePharm shall pay
the amounts of such taxes to the proper governmental authority in a timely manner and promptly transmit to Company an official
tax certificate or other evidence of such withholding sufficient to enable Company to claim such payment of taxes. Company shall
provide SpePharm any tax forms that may be reasonably necessary in order for SpePharm to not withhold tax or to withhold tax at
a reduced rate under an applicable bilateral income tax treaty. Company shall use reasonable efforts to provide any such tax forms
to SpePharm at least thirty (30) days prior to the due date for any payment for which Company desires that SpePharm apply a reduced
withholding rate. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by Applicable
Law, of withholding taxes, value added taxes, or similar obligations resulting from payments made under this Agreement, such recovery
to be for the benefit of the Party bearing such withholding tax or value added tax.


 




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(c)          Taxes
Resulting From SpePharm Action. If SpePharm is required by any taxing authority outside of the United States to make a payment
to Company subject to a deduction of tax or withholding tax, then (i) if such withholding or deduction obligation arises as a result
of any action by SpePharm, including any assignment or sublicense, or any failure on the part of SpePharm to comply with applicable
laws or filing or record retention requirements, that has the effect of modifying the tax treatment of the Parties hereto (an “SpePharm
Withholding Tax Action”), then the sum payable by SpePharm (in respect of which such deduction or withholding is required
to be made) shall be increased to the extent necessary to ensure that Company receives a sum equal to the sum which it would have
received had no such SpePharm Withholding Tax Action occurred, and (ii) otherwise, the sum payable by SpePharm (in respect of which
such deduction or withholding is required to be made) shall be made to Company after deduction of the amount required to be so
deducted or withheld, which deducted or withheld amount shall be remitted in accordance with applicable law; provided, however,
that SpePharm shall have no obligation to pay any additional amount to the extent that the deduction of tax or withholding tax
would not have been imposed but for (A) the failure by Company to qualify for an exemption from or reduction in the rate of withholding
tax under any applicable income tax convention between the United States and Switzerland, (B) the assignment by Company of its
rights under this Agreement or any redomiciliation of Company outside of the United States, or (C) the assertion by a taxing authority
in a jurisdiction other than the United States or Switzerland that a payment by SpePharm to Company hereunder is derived from sources
within such other jurisdiction and therefore is subject to withholding tax in such other jurisdiction.


 


10.9       Right
to Set-off. SpePharm shall have the right at all times to retain and set-off against all amounts due and owing to Company any
damages recovered by SpePharm for any Losses incurred by SpePharm as determined in a final judgment.


 


ARTICLE
XI – INTELLECTUAL PROPERTY


 


11.1       Intellectual
Property Ownership.


 


(a)          The
Parties acknowledge and agree that, as between the Parties, except for the licenses and rights granted to SpePharm hereunder, all
right, title and interest in and to the Company Patents and Company Know-How shall reside solely in Company. Subject to Sections
11.1(c) and 11.1(e), any inventions made, developed, conceived, or reduced to practice by or on behalf of SpePharm or its Affiliates,
solely or jointly, in the performance of this Agreement (collectively “Inventions”), to the extent solely related
to the composition of matter, use, manufacture or development of the Product, and any data and other Information generated by or
on behalf of SpePharm or its Affiliates, solely or jointly, in the performance of this Agreement that solely relate to the Product,
and any intellectual property rights in any of the foregoing (including Information and Patent Rights), shall be owned by Company
(collectively, “Product IP”). SpePharm hereby assigns and transfers to Company all right, title and interest
it may have in and to such Product IP and agrees to take all further acts reasonably required to evidence such assignment and transfer
to Company, at Company’s cost and expense.


 




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(b)          Subject
to Sections 11.1(c) and 11.1(e), any Inventions that are not Product IP, and any data and other Information generated by or on
behalf of SpePharm or its Affiliates, solely or jointly, in the performance of this Agreement that do not solely relate to the
Product, and any intellectual property rights in any of the foregoing (including Information and Patent Rights) shall be owned
by SpePharm (collectively “General IP”). Company hereby assigns and transfers to SpePharm all right, title and
interest it may have in and to such General IP and agrees to take all further acts reasonably required to evidence such assignment
and transfer to SpePharm, at SpePharm’s cost and expense.


 


(c)          Notwithstanding
Sections 11.1(a) and (b), but subject to Section 11.1(e), any inventions made, developed, conceived, or reduced to practice jointly
by SpePharm (including its Affiliates) and Company (including its Affiliates) in the performance of this Agreement, and any data
and other Information jointly generated by SpePharm (including its Affiliates) and Company (including its Affiliates) in the performance
of this Agreement, and any intellectual property rights in any of the foregoing (including Information and Patent Rights), shall
be owned jointly by SpePharm and the Company (collectively, “Joint IP”). Each Party will have an undivided one-half
interest in and to such Joint IP. Each Party will exercise its ownership rights in and to such Joint IP, including the right to
license and sublicense or otherwise to exploit, transfer or encumber its ownership interest, without an accounting or obligation
to, or consent required from, the other Party, but subject to the licenses hereunder and the other terms and conditions of this
Agreement. Each Party hereby assigns to the other Party a joint and undivided interest in and to all Joint IP.


 


(d)          
Each Party shall promptly disclose to the other Party any invention disclosures, or other similar documents, submitted to it by
its employees, agents or independent contractors describing Inventions and all Information relating to such Inventions to the extent
necessary for the preparation, filing and maintenance of any Patent with respect to such invention.


 


(e)          Notwithstanding
Sections 11.1(a), 11.1(b) and 11.1(c), and subject to Sections 2.9 and 2.10, (i) each Party will solely own all data generated
from clinical studies conducted pursuant to this Agreement that are funded solely by such Party or its Affiliates, and (ii) Company
will solely own all data generated from clinical studies conducted pursuant to this Agreement that are funded jointly by the Parties
or their respective Affiliates (“Jointly Funded Data”). SpePharm hereby assigns and transfers to Company all
right, title and interest it may have in and to such Jointly Funded Data and agrees to take all further acts reasonably required
to evidence such assignment and transfer to Company, at Company’s cost and expense.


 




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(f)          Subject
to the terms and conditions of this Agreement (including Sections 2.9 and 2.10), SpePharm hereby grants to Company an exclusive
(even as to SpePharm and its Affiliates) right and license, with the right to grant sublicenses in accordance with Section 2.2
(mutatis mutandis), under the General IP and Joint IP to the extent necessary or useful to develop, market, promote, import,
use, sell, offer for sale, distribute, manufacture, have manufactured and otherwise commercialize the Product in the Field in the
Company Territory. Notwithstanding the foregoing, SpePharm retains all rights and interests in and to the General IP and joint
ownership rights in the Joint IP other than expressly granted under this Section 11.1(f), including the right to use and practice
the General IP and Joint IP in connection with the exercise of the rights granted to it under Section 2.1.


 


11.2       Patent
Prosecution and Maintenance.


 


(a)          Company
shall have the first right, but not the obligation, to be responsible for the preparation, filing, prosecution, maintenance and
extension of the Company Patents and the Patent Rights within the Product IP in the Licensed Territory, at its expense. Company
shall keep SpePharm advised on the status of preparation, filing and prosecution of all patent applications included within the
Company Patents in the Licensed Territory and the maintenance and extension of any issued patents within the Company Patents in
the Licensed Territory, and shall allow SpePharm a reasonable opportunity and reasonable time to review and comment regarding relevant
material communications and drafts of any material responses or proposed filings by Company before any applicable filings are submitted
to any relevant patent office or government authority, and incorporate any reasonable comments offered by SpePharm in any final
filings submitted by Company to any relevant patent office or government authority in the Licensed Territory.


 


(b)          If
Company decides not to file, prosecute, maintain or extend a Company Patent or Patent Rights within the Product IP, in each case,
in the Licensed Territory, it shall give SpePharm reasonable notice to that effect sufficiently in advance of any deadline for
any filing with respect to such Patent Right to permit SpePharm to carry out such activity. After such notice, SpePharm may file,
prosecute, maintain and extend such Patent Right, and perform such acts as may be reasonably necessary for it to file, prosecute,
maintain or extend such Patent Right, at its sole cost and expense, provided that SpePharm may deduct one hundred percent (100%)
of its costs and expenses incurred in such filing, prosecution, maintenance and extension of such Patent Rights from the royalties
or any other amounts payable by SpePharm to Company under this Agreement, provided that the royalties payable to Company shall
not be reduced by more than fifty percent (50%) by reason of this Section 11.2(b), and any such payments to Third Parties not applied
to reduce royalties as a result of the forgoing proviso may be carried over to subsequent calendar quarters and applied to reduce
royalties (subject to the aforementioned fifty percent (50%) limitation) in such subsequent calendar quarters. If SpePharm does
so elect, then Company shall provide such cooperation to the SpePharm, including the execution and filing of appropriate instruments,
as may reasonably be requested to facilitate the transition of such patent activities.


 




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(c)          The
filing, prosecution, maintenance and extension of any Patent Rights within Joint IP will be jointly managed by the Parties on mutually
agreeable terms (including as to costs and expenses) to be entered into by the Parties at the time any such Patent Rights are first
filed. The filing, prosecution, maintenance and extension of any Patent Rights within General IP will be managed by SpePharm, at
its cost and expense.


 


(d)          The
Parties shall cooperate, if necessary and appropriate, with each other in gaining patent term extensions, including supplementary
protection certificates and any other extensions that are now or become available in the future wherever applicable to Patent Rights
that are applicable to the Product in the Licensed Territory. The Parties shall, if necessary and appropriate, use reasonable efforts
to agree upon a joint strategy relating to patent term extensions, but, in the absence of mutual agreement with respect to any
extension issue, a Patent Right shall be extended in the Licensed Territory only as and if SpePharm elects in writing to extend
such Patent Right.


 


11.3       Trademark
License; Trademark Prosecution, Maintenance and Enforcement.


 


(a)          Product
Marks. Subject to Applicable Law and the requirements of applicable Regulatory Authorities, the Product shall be marketed and
sold in the Licensed Territory using the Company Marks, Product Marks and other trade dress and logos as mutually agreed by the
Parties (in accordance with Section 11.3). In the event that SpePharm provides Company with written notice indicating good commercial
reason for the removal of a Company Mark or Product Mark from the Product, or association therewith, the Parties shall discuss
in good faith such removal, and mutually agree upon an alternative mark as set forth in Section 11.3(c). Such use shall be conducted
in accordance with the license rights granted hereunder and Company’s trademark usage policies provided from time to time
in writing to SpePharm as available, provided that SpePharm shall not be required to implement any changes arising from modified
trademark usage policies provided by Company if SpePharm would incur any additional costs as a result thereof without SpePharm’s
consent (not to be unreasonably withheld), other than such changes required by a Regulatory Authority in the Licensed Territory,
or with respect to any written Third Party claim that a Company Mark and/or Product Mark infringes the intellectual property rights
of such Third Party in the Licensed Territory. SpePharm is not authorized to use the Company Marks in any manner except as expressly
authorized herein. SpePharm shall acquire no right (except as expressly set forth below), title, or interest in or to the Company
Marks or Product Marks, or any other trademarks, trade names, or service mark owned by Company. SpePharm understands and agrees
that it is not authorized to use the name “Navidea” in connection with its general business or to imply to Third Parties
that its relationship with Company is other than a licensee under this Agreement.


 




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(b)          License
and Usage. Subject to the terms and conditions of this Agreement, Company hereby grants to SpePharm and its Affiliates (i)
the limited, non-exclusive, royalty-free (except as provided in Section 15.1) right and license to use Company’s trademarks,
trade names and logos that are listed in Part I of Exhibit C (including any replacements or successors thereof, the “Company
Marks”), and (ii) the limited, exclusive, royalty-free (except as provided in Section 15.1) right and license, to use
any of the Product Marks that are listed in Part II of Exhibit C, including additional trademark applications and registrations
for any of the Product Marks, anywhere in the Licensed Territory, in each case solely in connection with its manufacture, use,
sale, offer for sale, keeping (whether for sale or otherwise), importation and Commercialization of the Product hereunder, including
in each case with respect to the Company Marks, to indicate that it is a licensee of Company for the Product in the Licensed Territory,
and only during the Term of this Agreement and only in the Licensed Territory. The foregoing license shall be sublicensable by
SpePharm to its Affiliates and Sublicensees pursuant to, and in accordance with, Section 2.2, solely in accordance with the Products,
provided that the rights granted to SpePharm pursuant to Section 11.3(c) shall not apply to Sublicensees. SpePharm recognizes Company’s
exclusive ownership or control of the Company Marks and Product Marks and agrees to comply with any reasonable usage requirements
and/or quality control guidelines with respect to the Company Marks and Product Marks as Company may reasonably prescribe in writing
from time to time. All goodwill resulting from the use of the Company Marks and Product Marks by SpePharm shall belong to and inure
solely to the benefit of Company. SpePharm shall not knowingly undertake any act that would impair the Company Marks or Product
Marks or the goodwill associated therewith. SpePharm shall promptly notify Company in writing of any actual or suspected infringement
of the Company Marks or Product Marks by a Third Party of which SpePharm becomes aware. SpePharm shall not make or permit
alteration or removal of any tags, labels, or other identifying marks placed, in accordance with Applicable Law, by Company on
the Product.


 


(c)          SpePharm
House Marks; Alternative Product Marks. At SpePharm’s option, the Product packaging, Marketing Materials and Product
labeling for use in the Licensed Territory may, in addition to the Company Marks and Product Marks, carry house marks of SpePharm
or its Affiliates as may be chosen by SpePharm in its sole discretion. In the event that the Product Marks are not available or
suitable (due to, for example, translation or other reasons) for registration in any particular jurisdiction within the Licensed
Territory, SpePharm shall have the right, in consultation with and subject to Company’s written approval (not to be unreasonably
withheld), to select an alternative trademark for use with the Product in such jurisdiction in addition to the Company Marks. Such
alternative trademark shall be deemed a Product Mark and subject to the terms of this Section 11.3.


 




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(d)           Prosecution
and Maintenance.


 


(i)          Company
shall have the first right, but not the obligation, to be responsible for the clearance, preparation, filing, prosecution and maintenance
of the Product Marks in the Licensed Territory, at its expense. Company shall keep SpePharm advised on the status of preparation,
filing and prosecution of all applications for Product Marks in the Licensed Territory and the maintenance of any registered Product
Marks in the Licensed Territory, and shall allow SpePharm a reasonable opportunity and reasonable time to review and comment regarding
relevant material communications and drafts of any material responses or proposed filings by Company before any applicable filings
are submitted to any relevant trademark office or government authority, and incorporate any reasonable comments offered by SpePharm
in any final filings submitted by Company to any relevant trademark office or government authority in the Licensed Territory.


 


(ii)         If
Company decides not to clear, prepare, file, prosecute or maintain a Product Mark in the Licensed Territory, it shall give SpePharm
reasonable notice to that effect sufficiently in advance of any deadline for any filing with respect to such Product Mark to permit
SpePharm to carry out such activity. After such notice, SpePharm may clear, prepare, file, prosecute and maintain such Product
Mark, and perform such acts as may be reasonably necessary for it to clear, prepare, file, prosecute and maintain such Product
Mark, at its sole cost and expense, provided that SpePharm may deduct one hundred percent (100%) of its costs and expenses incurred
in such filing, prosecution and maintenance of such Product Mark from the royalties or any other amounts payable by SpePharm to
Company under this Agreement, provided that the royalties payable to Company shall not be reduced by more than fifty percent (50%)
by reason of this Section 11.3(c), and any such payments to Third Parties not applied to reduce royalties as a result of the forgoing
proviso may be carried over to subsequent calendar quarters and applied to reduce royalties (subject to the aforementioned fifty
percent (50%) limitation) in such subsequent calendar quarters. If SpePharm does so elect, then Company shall provide such cooperation
to SpePharm, including the execution and filing of appropriate instruments, as may reasonably be requested to facilitate the transition
of such trademark activities.


 


(e)           Enforcement.


 


(i)          Each
Party will promptly notify, in writing, the other Party upon learning of any actual or suspected infringement of the Product Marks
by a Third Party, or of any claim of invalidity, unenforceability, or non-infringement of the Product Marks, and will, along with
such notice, supply the other Party with any evidence in its possession pertaining thereto.


 




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(ii)          As
between the Parties, SpePharm will have the first right, but not the obligation, to seek to abate any infringement of the Product
Marks in the Licensed Territory, including to file suit against any such Third Party for such infringement. If SpePharm does not
take steps to abate such infringement, or file suit to enforce the Product Marks against such Third Party, within ninety (90) days
after the first notice under Section 11.3(d)(i), Company will have the right (but not the obligation) to take action to enforce
the Product Marks against such Third Party for such infringement. The controlling Party will pay all its costs and expenses incurred
for such enforcement.


 


(iii)         With
respect to any infringement or defensive action identified above in this Section 11.3(d):


 


(A)         If
a controlling Party ceases to pursue or withdraws from such action, it will promptly notify the other Party (in good time to enable
the other Party to meet any deadlines by which any action must be taken to preserve any rights in such infringement or defensive
action) and such other Party may continue or may substitute itself for the withdrawing Party and proceed under the terms and conditions
of this Section 11.3(d).


 


(B)         The
Parties will reasonably cooperate with each other, whether or not controlling any such action, including (1) providing access to
relevant documents and other evidence, (2) making its and its Affiliates and licensees and Sublicensees and all of their respective
employees, subcontractors, consultants and agents available at reasonable business hours and for reasonable periods of time, but
only to the extent relevant to such action, and (3) if necessary, by being joined as a party, subject for this clause (3) if and
when the joined Party is not controlling such action, the controlling Party agreeing to indemnify such non-controlling Party for
its involvement as a named party in such action and paying those reasonable costs and expenses incurred by such Party in connection
with such joinder. If only one Party is controlling any such action, the Party controlling any such action will keep the non-controlling
Party updated with respect to any such action, including providing copies of all documents received or filed in connection with
any such action.


 


(C)         If
only one Party is controlling any such action, the non-controlling Party will have the right to participate or otherwise be involved
in any such action, in each case at the participating Party’s sole cost and expense. If a Party elects to so participate
or be involved, the controlling Party will provide the participating Party and its counsel with an opportunity to consult with
the controlling Party and its counsel regarding the prosecution of such action (including reviewing the contents of any correspondence,
legal papers or other documents related thereto), and the controlling Party will take into account reasonable requests of the participating
Party regarding such enforcement or defense.


 


(iv)        Neither
Party will settle or consent to an adverse judgment in any action described in this Section 11.3(d), including any judgment which
affects the scope, validity or enforcement of any Product Marks involved therewith, without the prior written consent of the other
Party (such consent not to be unreasonably withheld or delayed).


 




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(v)         Unless
otherwise agreed by the Parties, all monies recovered upon the final judgment or settlement of any action described in this Section
11.3(d) will be used first to reimburse each of the Parties, on a pro rata basis for each of their reasonable out-of-pocket
costs and expenses relating to the action, with the balance of any such recovery being considered Net Sales.


 


11.4       Patent
Enforcement and Defense.


 


(a)          Each
Party will promptly notify, in writing, the other Party upon learning of any actual or suspected Competitive Infringement (defined
below) of any Patent Right within the Company Patents, Product IP, General IP or Joint IP by a Third Party, or of any claim of
invalidity, unenforceability, or non-infringement of any Patent Rights within the Company Patents, Product IP, General IP or Joint
IP, and will, along with such notice, supply the other Party with any evidence in its possession pertaining thereto. For purposes
of this Agreement, “Competitive Infringement” means any allegedly infringing activity in the Field in the Licensed
Territory with respect to a Patent Right within the Company IP, Product IP, General IP or Joint IP.


 


(b)          As
between the Parties, SpePharm will have the first right, but not the obligation, to seek to abate any Competitive Infringement
of any Patent Rights within the Company Patents, Product IP, General IP or Joint IP in the Licensed Territory, or to file suit
against any such Third Party for such Competitive Infringement. If SpePharm does not take steps to abate such Competitive Infringement,
or file suit to enforce such Patent Rights against such Third Party with respect to such Competitive Infringement, within ninety
(90) days after the first notice under Section 11.4(a), Company will have the right (but not the obligation) to take action to
enforce such Patent Rights against such Third Party for such Competitive Infringement. The controlling Party will pay all its costs
and expenses incurred for such enforcement.


 


(c)          As
between the Parties, Company will have the first right, but not the obligation, to defend against a declaratory judgment action
or other action challenging any Patent Rights within the Company Patents and Product IP and any Patent Rights within the Joint
IP in the Company Territory, and SpePharm will have the first right, but not the obligation, to defend against a declaratory judgment
action or other action challenging any Patent Rights within the General IP and any Patent Rights within the Joint IP in the Licensed
Territory, other than with respect to any action by a Third Party in response to an enforcement action brought pursuant to Section
11.4(b), which defense will be controlled by the Party or Parties controlling such enforcement action. If such Party does not take
steps to defend within a commercially reasonably time, or elects not to continue any such defense (in which case it will promptly
provide notice thereof to the other Party), then the other Party will have the right (but not the obligation) to defend any such
Patent Right.


 




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(d)          With
respect to any infringement or defensive action identified above in this Section 11.4:


 


(i)          If
a controlling Party ceases to pursue or withdraws from such action, it will promptly notify the other Party (in good time to enable
the other Party to meet any deadlines by which any action must be taken to preserve any rights in such infringement or defensive
action) and such other Party may continue or may substitute itself for the withdrawing Party and proceed under the terms and conditions
of this Section 11.4.


 


(ii)         The
Parties will reasonably cooperate with each other, whether or not controlling any such action, including (1) providing access to
relevant documents and other evidence, (2) making its and its Affiliates and licensees and Sublicensees and all of their respective
employees, subcontractors, consultants and agents available at reasonable business hours and for reasonable periods of time, but
only to the extent relevant to such action, and (3) if necessary, by being joined as a party, subject for this clause (3) if and
when the joined Party is not controlling such action, the controlling Party agreeing to indemnify such non-controlling Party for
its involvement as a named party in such action and paying those costs and expenses incurred by such Party in connection with such
joinder. If only one Party is controlling any such action, the Party controlling any such action will keep the non-controlling
Party updated with respect to any such action, including providing copies of all documents received or filed in connection with
any such action.


 


(iii)        If
only one Party is controlling any such action, the non-controlling Party will have the right to participate or otherwise be involved
in any such action, in each case at the participating Party’s sole cost and expense. If a Party elects to so participate
or be involved, the controlling Party will provide the participating Party and its counsel with an opportunity to consult with
the controlling Party and its counsel regarding the prosecution of such action (including reviewing the contents of any correspondence,
legal papers or other documents related thereto), and the controlling Party will take into account reasonable requests of the participating
Party regarding such enforcement or defense.


 


(e)          Neither
Party will settle or consent to an adverse judgment in any action described in this Section 11.4 without the prior written consent
of the other Party (such consent not to be unreasonably withheld or delayed), provided that with respect to any settlement that
limits the scope, validity or enforcement of any Company Patents, Product IP or Joint IP involved therewith, Company’s consent
may be given or withheld in its sole discretion, and with respect to any settlement that limits the scope, validity or enforcement
of any General IP or Joint IP involved therewith, SpePharm’s consent may be given or withheld in its sole discretion.


 




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(f)          Unless
otherwise agreed by the Parties, all monies recovered upon the final judgment or settlement of any action described in this Section
11.4 will be used first to reimburse each of the Parties, on a pro rata basis for each of their reasonable out-of-pocket
costs and expenses relating to the action, with the balance of any such recovery being considered Net Sales.


 


11.5       Third
Party Licenses. Company shall have the right to obtain, subject to SpePharm’s prior written approval (such approval not
to be unreasonably withheld or delayed) rights or licenses to any Third Party intellectual property to the extent Company determines
that it is Commercially Reasonable and necessary to enable the sale of the Product in the Field in the Licensed Territory. In the
event of such approval, Company and SpePharm shall share all costs payable to such Third Party with respect to such license on
a 50/50 basis. In the event SpePharm does approve such Third Party license, then Company shall be free to obtain such license in
its sole discretion and such intellectual property rights shall not be deemed “Controlled” within the definition of
the Company Know-How and Company Patents.


 


ARTICLE
XII – REPRESENTATIONS AND WARRANTIES 


 


12.1       Representations
and Warranties of Each Party. Each Party hereby represents and warrants to the other Party as of the Effective Date that:


 


(a)          such
Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has
full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;


 


(b)          such
Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance
of its obligations hereunder;


 


(c)          this
Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable
against it in accordance with the terms hereof; and


 


(d)          the
execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof,
or any instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation
of any court, governmental body or administrative or other agency having jurisdiction over such Party.


 


12.2       Additional
Company Representations and Warranties. Company hereby represents and warrants to SpePharm as of the Effective Date that:


 




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(a)          A
true and complete copy of each of the Upstream Agreements, as each exists as of the Effective Date (including any amendments),
has been provided to SpePharm prior to the Effective Date, and there are no oral or side agreements with respect thereto. Each
of the Upstream Agreements is in full force and effect, all payments to date required to be made thereunder by Company have been
made, and Company is in compliance in all material respects with its material obligations thereunder. Company has not received
or provided any notice of termination of either of the Upstream Agreements, or any notices of material breach of either of the
Upstream Agreements. Company has the right to sublicense its rights under the Upstream Agreements to SpePharm within the scope
of the license granted in Section 2.1, and Company is not aware of any provision under either of the Upstream Agreement which is
or could reasonably be expected to be inconsistent with the provisions of this Agreement in any material respect.


 


(b)          The
execution, delivery and performance of this Agreement by Company does not conflict with the RA Field License Agreement, the [*],
any other agreement between Company or its Affiliates, R-NAV and/or TcRA, or any provision thereof. The RA Field License Agreement
is the only agreement pursuant to which Company or any of its Affiliates has granted to the RA Field Licensee or any other Person
any rights with respect to the RA Field. [*].


 


(c)          Exhibit
A sets forth a complete and correct list of all Company Patents owned by or licensed to Company and its Affiliates, and Company,
together with its Affiliates, is the sole and exclusive owner or licensee of, and has the sole right, title and interest in and
to, the Company Patents listed on Exhibit A as owned by the Company, and the Company Know-How, in each case free and clear
of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien, lease, sublease, option, or charge of
any kind, limitations on transfer or any subordination arrangement in favor of a Third Party that would preclude the grant of the
licenses and rights hereunder.


 


(d)          All
of the Company Patents listed on Exhibit A, and the Product Marks in the Initial Territory, are in force or pending and
have not been abandoned as of the Effective Date, and to Company’s knowledge, all such Company Patents and Product Marks
have been duly applied for and registered in accordance with Applicable Laws. Company is not aware of any facts or circumstances
that could reasonably be expected to impair the validity or enforceability of any of the Company Patents or the Product Marks.


 


(e)          Neither
Company nor any of its Affiliates has granted any license, option or other rights of any kind to or in favor of a Third Party under
the Company Patents or Company Know-How or Product Marks in the Licensed Territory that are inconsistent with this Agreement.


 




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(f)          Except
for the Upstream Agreement, neither Company nor any of its Affiliates is party to any agreement pursuant to which Company or any
of its Affiliates has been licensed or granted any rights in or to any Company Patents or Company Know-How or Product Marks for
the Field and Licensed Territory.


 


(g)          There
is no intellectual property right, in particular no Patent Rights, owned by or licensed to Company or its Affiliates other than
the Company Patents and Company Know-How, that are necessary for SpePharm or its Affiliates to develop and commercialize the Products
as set forth herein.


 


(h)          Company
and its Affiliates have not received any written or oral claim, and to Company’s knowledge no licensor of any Company Patents
or Company Know-How has received any written or oral claim, of ownership, inventorship or patent infringement or trademark infringement,
or any other claim of intellectual property misappropriation or violation, from any Third Party (including by current or former
officers, directors, employees, consultants, or personnel of Company or any predecessor) with respect to the Company Patents or
Company Know-How or Product Marks or the Product, and Company is not aware of any reasonable basis for any such claim.


 


(i)          Neither
Company nor any of its Affiliates is a party to or otherwise bound by any oral or written contract or agreement that shall result
in any person or entity obtaining any interest in, or that would give to any entity or person any right to assert any claim in
or with respect to, any of SpePharm’s rights granted under this Agreement.


 


(j)          There
are no claims, judgments or settlements pending against Company or its Affiliates, or to the knowledge of Company against any licensor
of any Company Patents or Company Know-How, with respect to any Company Patents or Company Know-How or Product Marks or Product,
and Company has not received notice that any such claims, judgments or settlements are threatened.


 


(k)          Except
as set forth on Schedule 12.2, no Company Patents are subject to, or were developed pursuant to any funding agreement with any
government authority.


 


(l)          To
its knowledge, the research, development, manufacture, use, sale, offer for sale and import of the Products (in the form such Products
exist as of the Effective Date) in the Field in the Licensed Territory does not infringe, misappropriate or violate any intellectual
property rights of a Third Party, and Company and its Affiliates have not received any written or oral claim alleging such infringement,
misappropriation or violation.


 




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(m)         To
its knowledge, no Patent Rights or other intellectual property rights owned by a Third Party exist that are reasonably expected
to serve as a basis for interferences, oppositions, invalidations or similar proceedings with respect to the Company Patents.


 


(n)          Company
has furnished or made available to SpePharm all material information that is in Company’s possession and of which it is aware
concerning the Products and relevant to the safety or efficacy of the Products, and all Regulatory Materials and other correspondence
with Regulatory Authorities relating to the Products, and such information is accurate, complete and true in all material respects
and has been prepared and filed in accordance with all Applicable Laws.


 


12.3       Warranty
Disclaimer. THE FOREGOING WARRANTIES OF EACH PARTY ARE IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTIES OF NONINFRINGEMENT, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR
PURPOSE ALL OF WHICH ARE HEREBY SPECIFICALLY EXCLUDED AND DISCLAIMED. EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY
THAT THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF THE PRODUCTS UNDER THIS AGREEMENT WILL BE SUCCESSFUL.


 


ARTICLE
XIII – INDEMNIFICATION 


 


13.1       Indemnification
by SpePharm. SpePharm shall indemnify Company, its Affiliates, and their respective officers, directors, and employees and
agents (the “Company Indemnitees”), for any reasonable out-of-pocket costs and expenses (including court and
arbitration costs and reasonable attorneys’ fees), non-appealed or non-appealable judicial or arbitration damage awards,
and settlement payments (collectively, “Losses”) payable or owed by such parties in connection with any demands,
investigations, lawsuits and other legal actions of Third Parties (“Third Party Claims”) to the extent arising
from: (a) the development of the Product undertaken by SpePharm pursuant to the SpePharm Development Plan and those development
plans for the Extended Territory contemplated by Section 2.11; (b) the Commercialization of the Product in the Licensed Territory,
including, to the extent caused by SpePharm’s or its Affiliates’ or Sublicensees’ off-label promotion of the
Product or storage, handling or transportation of Product in a manner that is not compliant with applicable specifications therefrom,
Third Party Claims based upon product liability; (c) any breach of any of SpePharm’s obligations under this Agreement, including
any representation, warranty, covenant or agreement on the part of SpePharm under this Agreement; or (d) the negligence or intentional
misconduct of SpePharm, its Affiliates, or the officers, directors, employees, or agents of SpePharm or its Affiliates; except
in each case, to the extent caused by the gross negligence or willful misconduct of Company or any of its Affiliates, or their
respective officers, directors, and employees, or by breach of this Agreement by Company. The foregoing indemnity obligation shall
not apply to the extent that any Third Party Claim arises from, is based on, or results from any activity set forth in Section
13.2 for which Company is obligated to indemnify the SpePharm Indemnitees.


 




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13.2       Indemnification
by Company. Company shall indemnify SpePharm and its Affiliates, and their respective officers, directors, and employees and
agents (the “SpePharm Indemnitees”), for any Losses payable or owed by such parties in connection with any Third
Party Claim to the extent arising from: (a) any breach of any of Company’s obligations under this Agreement, including any
representation, warranty, covenant or agreement on the part of Company under this Agreement; (b) the development of the Product
undertaken by Company pursuant to the Company Development Plan; (c) subject to Section 13.3, a claim that the use, sale, offer
for sale, or import of the Product (excluding any modifications to the Product made by SpePharm to the Product after the Effective
Date to the extent such modifications are the basis for such Third Party Claim) in the Licensed Territory infringes, misappropriates
or violates the intellectual property rights of a Third Party; (d) the Commercialization of the Product in the Company Territory,
including Third Party Claims based upon product liability; or (e) the negligence or intentional misconduct of Company, its Affiliates,
or the officers, directors, employees or agents of Company or its Affiliates; except in each case, to the extent caused by the
gross negligence or willful misconduct of SpePharm or any of its Affiliates, or their respective officers, directors, and employees,
or by breach of this Agreement by SpePharm. The foregoing indemnity obligation shall not apply to the extent that any Third Party
Claim arises from, is based on, or results from any activity set forth in Section 13.1 for which SpePharm is obligated to indemnify
the Company Indemnitees.


 




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13.3       IP
Infringement. If any Third Party Claim for which indemnity is or may be sought by SpePharm Indemnitees pursuant to Section
13.2(c), is made or appears reasonably possible, SpePharm agrees (i) promptly to notify Company in writing; (ii) to cooperate with
Company, and to allow Company sole authority to control the defense and settlement of such Third Party Claim at Company’s
cost and expense (subject to Section 11.5); and (iii) to permit Company to take such actions necessary, as the Party’s reasonably
agree and in good faith and at the Party’s equally shared cost and expense, to enable SpePharm to continue to use the allegedly
infringing aspect of the Product or to obtain licenses (subject to Section 11.5) for, modify or replace any such infringing material
to make it non-infringing (provided that such modifications or replacements do not require SpePharm to obtain approval from a Regulatory
Authority in order to manufacture, sell or Commercialize the Product containing such modifications or replacements). In the event
the Company desires to obtain any license for any Third Party intellectual property right for the Product in the Field and Territory,
it shall first offer SpePharm the right to obtain such license (in which case the terms of Section 10.4(d) shall apply) or Company
may take such license with prior notice to SpePharm (in which the terms of Section 11.5 shall apply). In no event shall Company
be obligated to indemnify SpePharm for Third Party Claims for which indemnity is or may be sought by SpePharm Indemnitees pursuant
to Section 13.2(c) in amounts in excess of fifty percent (50%) all amounts paid by SpePharm to Company hereunder as of the date
of such Third Party Claim. If Company ceases to indemnify the SpePharm Indemnitees for such Third Party Claim, then SpePharm shall
have the right, upon written notice to Company, to assume sole authority to control the defense and settlement of such Third Party
Claim. Notwithstanding, if a Third Party Claim has been filed against a SpePharm Indemnitee in a court of competent jurisdiction
for which indemnity is or may be sought by such SpePharm Indemnitee pursuant to Section 13.2(c), and Company determines that none
of the foregoing alternatives is reasonably available and provides written notice of the same to SpePharm, SpePharm, its Affiliates
and Sublicensees will have the option to, in SpePharm’s sole discretion, either (a) cease sale, distribution and use of,
and, if applicable, return, such materials as are the subject of the relevant infringement claim, or (b) continue the sale, distribution
and use of such materials, in which case Company’s obligation to indemnify the SpePharm Indemnitees pursuant to Section 13.2(c)
in respect of such infringement claim shall be limited solely to liability resulting from sales, distributions and uses of such
materials occurring prior to receipt of such notice from Company.


 




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13.4       Conditions
and Limitations of Indemnification Obligation. Each Party shall notify the other in the event it becomes aware of a claim for
which indemnification may be sought hereunder pursuant to this Section 13. In case any proceeding (including any governmental investigation)
shall be instituted involving any Party in respect of which indemnity may be sought pursuant to this Section 13, such Party (the
“Indemnified Party”) shall provide the other Party (the “Indemnifying Party”) with prompt
written notice of such proceeding (the “Indemnification Claim Notice”). Promptly after the Indemnifying Party
receives the Indemnification Claim Notice, the Indemnifying Party and Indemnified Party shall meet to discuss how to respond to
any claims that are the subject matter of such proceeding. At its option, the Indemnifying Party may assume the defense of any
Third Party claim subject to indemnification as provided for in this Section 13 by giving written notice to the Indemnified Party
within thirty (30) days (or within such time provided in any applicable extension to appropriately answer any complaint, if any,
but no longer than seventy (70) days, provided that the Indemnified Party makes all reasonable efforts to obtain any such extension)
after the Indemnifying Party’s receipt of an Indemnification Claim Notice, provided that (a) the claim solely seeks monetary
damages and (b) the Indemnifying Party expressly agrees in writing that, as between the Indemnifying Party and the Indemnified
Party, the Indemnifying Party shall be solely obligated to satisfy and discharge the claim in full (the matters described in (a)
and (b), the “Litigation Conditions”). The Indemnified Party may, at any time, assume all such defense if the
Litigation Conditions are not satisfied. Upon assuming the defense of a Third Party claim in accordance with this Section 13, the
Indemnifying Party shall be entitled to appoint lead counsel in the defense of the Third Party claim. Should the Indemnifying Party
assume and continue the defense of a Third Party Claim, except as otherwise set forth in this Section 13, the Indemnifying Party
shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection
with the analysis, defense or settlement of the Third Party claim. Without limiting this Section 13, any Indemnified Party shall
be entitled to participate in, but not control, the defense of a Third Party Claim for which it has sought indemnification hereunder
and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at the Indemnified Party’s
own expense unless (i) the employment thereof has been specifically authorized by the Indemnifying Party in writing; (ii) the Indemnifying
Party has failed to assume and actively further the defense and employ counsel in accordance with this Section 13.4 (in which case
the Indemnified Party shall control the defense); or (iii) the Indemnifying Party no longer satisfies the Litigation Conditions.
With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim that shall not
result in the Indemnified Party’s becoming subject to injunctive or other relief or otherwise adversely affect the business
of the Indemnified Party in any manner, and as to which the Indemnifying Party shall have acknowledged in writing the obligation
to indemnify the Indemnified Party hereunder, and subject to the Litigation Conditions being satisfied, the Indemnifying Party
shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Losses,
on such terms as the Indemnifying Party, in its reasonable discretion, shall deem appropriate (provided that such terms shall include
a complete and unconditional release of the Indemnified Party from all liability with respect thereto), and shall transfer to the
Indemnified Party all amounts which said Indemnified Party shall be liable to pay prior to the time of the entry of judgment. With
respect to all other Losses in connection with Third Party Claims, where the Indemnifying Party has assumed the defense of the
Third Party claim in accordance with this Article 13, the Indemnifying Party shall have authority to consent to the entry of any
judgment, enter into any settlement or otherwise dispose of such Liability, provided that it obtains the prior written consent
of the Indemnified Party (which consent shall be at the Indemnified Party’s reasonable discretion). The Indemnifying Party
that has assumed the defense of the Third Party Claim in accordance with this Article 13 shall not be liable for any settlement
or other disposition of a Loss by an Indemnified Party (but in no event to include any court judgment or judicial or administrative
order or disposition) that is reached without the written consent of such Indemnifying Party. No Indemnified Party shall admit
any liability with respect to, or settle, compromise or discharge, any Third Party Claim without first offering to the Indemnifying
Party the opportunity to assume the defense of the Third Party Claim in accordance with this Article 13. If the Indemnifying Party
chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall cooperate in the defense or prosecution thereof
and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings,
hearings, trials and appeals as may be reasonably requested in connection with such Third Party Claim. Such cooperation shall include
access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of,
records and information that are reasonably relevant to such Third Party Claim, and making employees and agents available on a
mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying
Party shall reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation.


 




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13.5       Limitation
of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR LOSS
OF PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 13.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS
OR OBLIGATIONS OF ANY PARTY UNDER SECTION 13.1 OR 13.2, OR DAMAGES AVAILABLE FOR A PARTY’S INFRINGEMENT OR MISAPPROPRIATION
OF A PARTY’S INTELLECTUAL PROPERTY RIGHTS, OR BREACH OF (A) CONFIDENTIALITY OBLIGATIONS IN ARTICLE 14, OR (B) SECTIONS 2.6,
2.7 OR 2.8.


 


ARTICLE
XIV – CONFIDENTIALITY


 


14.1       Confidentiality;
Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing, the Parties agree that
the receiving Party (the “Receiving Party”) shall keep confidential and shall not publish or otherwise disclose
or use for any purpose other than as provided for in this Agreement any information or other confidential and proprietary information
and materials, patentable or otherwise, in any form (written, oral, photographic, electronic, magnetic, or otherwise) which is
disclosed to it by the other Party (the “Disclosing Party”) or otherwise received or accessed by a Receiving
Party in the course of performing its obligations or exercising its rights under this Agreement, including but not limited to trade
secrets, know-how, inventions or discoveries, proprietary information, formulae, processes, techniques and information relating
to a Party’s past, present and future marketing, financial, and research and development activities of any product or potential
product or useful technology of the Disclosing Party and the pricing thereof (collectively, “Confidential Information”),
except to the extent that it can be established by the Receiving Party that such Confidential Information: (a) was in the lawful
knowledge and possession of the Receiving Party prior to the time it was disclosed to, or learned by, the Receiving Party, or was
otherwise developed independently by the Receiving Party, as evidenced by contemporaneous written records kept in the ordinary
course of business, or other documentary proof of actual use by the Receiving Party; (b) was generally available to the public
or otherwise part of the public domain at the time of its disclosure to the Receiving Party hereunder; (c) became generally available
to the public or otherwise part of the public domain after its disclosure hereunder and other than through any act or omission
of the Receiving Party in breach of this Agreement; or (d) was disclosed to the Receiving Party, other than under an obligation
of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others.
All information disclosed under that certain Mutual Confidentiality/Non-Disclosure Agreement between the Parties dated as of May
24, 2013, as amended December 11, 2014, shall be deemed to be Confidential Information hereunder and such agreement shall be superseded
by the terms hereof and terminated effective as of the Effective Date.


 




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14.2       Authorized
Disclosure. Except as expressly provided otherwise in this Agreement, a Receiving Party may use and disclose Confidential Information
of the Disclosing Party as follows: (a) to the Receiving Party’s Affiliates, potential and actual sublicensees or subdistributors,
employees, officers, directors, agents, consultants, and/or other Third Parties under appropriate confidentiality provisions no
less stringent than those in this Agreement, in connection with the performance of its obligations or exercise of its rights under
this Agreement; or (b) to the extent such disclosure is reasonably necessary in defending litigation, complying with applicable
governmental regulations or otherwise required by Applicable Law (including as required to seek, obtain and maintain Product Approvals);
provided, however, that if a Receiving Party is required by Applicable Law to make any such disclosure of a Disclosing Party’s
Confidential Information it will, except where impracticable for necessary disclosures, for example in the event of medical emergency,
give reasonable advance notice to the Disclosing Party of such disclosure requirement and, except to the extent inappropriate in
the case of patents, will use its reasonable efforts to secure confidential treatment of such Confidential Information required
to be disclosed; or (c) to potential or actual acquirers, merger candidates or investors or venture capital firms, investment bankers
or other financial institutions or investors, provided that in connection with such disclosure, such Receiving Party shall inform
each disclosee of the confidential nature of such Confidential Information and cause each disclosee to treat such Confidential
Information as confidential; or (d) to the extent mutually agreed to in writing by the Parties; provided, however,
that, in each of the above situations, the Receiving Party shall remain responsible for any failure by any Person who receives
the Confidential Information pursuant to this Section 14.2 to treat such Confidential Information as required under this Article
14.


 


14.3       Disclosure
of Agreement. The Parties have agreed to jointly issue a public announcement of the execution of this Agreement, on or promptly
after the Effective Date, and a draft of which is attached hereto as Exhibit B. Neither Party shall be free to issue any
press release or other public disclosure regarding the Agreement or the other Parties’ activities hereunder, except (a) with
the other Party’s prior written consent, or (b) for any disclosure that is reasonably necessary to comply with applicable
national securities exchange listing requirements or Applicable Laws. The Parties agree to consult with each other reasonably and
in good faith with respect to the text and timing of any such press releases prior to the issuance thereof, and a Party may not
unreasonably withhold, delay or condition consent to such releases. Except to the extent required by Applicable Law or as otherwise
permitted in accordance with this Section 14.3, neither Party shall make any public announcements concerning this Agreement or
the subject matter hereof without the prior written consent of the other, which shall not be unreasonably withheld, delayed or
conditioned. Notwithstanding the foregoing, to the extent information regarding this Agreement has already been publicly disclosed
in the same context, either Party may subsequently disclose the same information to the public without the consent of the other
Party. Each Party shall be permitted to disclose the terms of this Agreement, in each case under appropriate confidentiality provisions
substantially equivalent to those of this Agreement, to any actual or potential investors, acquirers, merger partners, licensees
or sublicensees, or purchasers of assets of such Party and to the professional advisors thereof. Each Party shall give the other
Party a reasonable opportunity where practical to review all filings with the United States Securities and Exchange Commission
describing the terms of this Agreement prior to submission of such filings, and shall give due consideration to any reasonable
comments by the non-filing Party relating to such filing, including without limitation the provisions of this Agreement for which
confidential treatment should be sought; provided that no further review shall be provided for disclosures for which consent has
been obtained. Notwithstanding, with respect to the filing of this Agreement by Company with the United States Securities and Exchange
Commission, Company shall provide SpePharm with at least five (5) business days to review and comment on such proposed filing.


 




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14.4       Publication.
SpePharm recognizes that Company may wish to publish, report or present scientific information relating to the Product. All publications,
reports and presentations involving the Product will first be submitted by Company to SpePharm. SpePharm will have fifteen (15)
days to review the publication, report and/or presentation for potential patent right or other intellectual property rights protection.
If SpePharm identifies subject matter in such publication, report and/or presentation which, if published would adversely affect
either Party’s patent rights, then upon SpePharm’s written request, Company will delay submission of its publication,
report and/or presentation for an additional period, not to exceed ninety (90) days, in order to allow for the filing of a patent
application or other appropriate intellectual property protection.


 


ARTICLE
XV – TERM AND TERMINATION


 


15.1       Term.
This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 15, shall remain
in effect on a Product-by-Product and country-by-country basis, until expiration of the Royalty Term in such Country (the “Term”).
Upon expiration of this Agreement pursuant to this Section 15.1 with respect to a particular Product in a particular country, (a)
the licenses granted to SpePharm pursuant to Section 2.1 with respect to such Product in such country shall become fully paid-up
and non-terminable, and (b) if, with respect to a particular Product in a particular country, SpePharm or its Affiliates or Sublicensees
elect to continue use of the Product Marks pursuant to Section 11.3(a) with respect to such Product in such country, SpePharm shall
pay to Company a royalty equal to [*] of Net Sales of such Product in such country.


 




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15.2       Termination
by Company.


 


(a)          For
Breach. Company shall have the right to terminate this Agreement upon thirty (30) days’ prior written notice if SpePharm
materially breaches this Agreement and does not cure such breach within ninety (90) days (or thirty (30) days for non-payment)
(except as otherwise provided in this Agreement) following written notice by Company, which notice shall specify the nature of
the breach and demand its cure; provided, however, that a breach by SpePharm that relates to SpePharm’s obligations
under this Agreement with respect to one or more specific Product and/or one or more specific countries, where such breach does
not materially adversely impact the performance by SpePharm of its obligations under this Agreement with respect to other Product
and/or other countries, shall give Company a termination right only as to such affected Product(s) and/or countries. 


 


(b)          For
Failure to Launch. Company shall have the right to terminate this Agreement pursuant to Section 7.3(b).


 


15.3       Termination
by SpePharm for Breach. SpePharm shall have the right to terminate this Agreement as a whole upon thirty (30) days’ prior
written notice if Company materially breaches this Agreement and does not cure such breach within ninety (90) days following written
notice by SpePharm, which notice shall specify the nature of the breach and demand its cure. Upon a final determination of Company’s
material breach under this Agreement, and exhaustion of Company’s cure period, in lieu of termination, but not in lieu of
any damages or other remedies arising from such breach, SpePharm shall have the right to continue with the Agreement in effect
(including all payment obligations) and to assume those activities for which Company was determined to be in material breach and
any activities necessary or reasonably required to perform such breached activities. Company and its Affiliates shall reasonably
cooperate with SpePharm and its designees to facilitate a smooth, orderly and prompt transition to SpePharm or its designees of
such activities.


 


15.4       Tolling.
Notwithstanding Sections 15.2 and 15.3, if either Party is alleged to be in material breach and disputes in good faith such breach
and/or termination through the dispute resolution procedures set forth in this Agreement, then the other Party’s right to
terminate this Agreement shall be tolled for so long as such dispute resolution procedures set forth in Article XVI are being pursued
by the allegedly breaching Party in good faith and the Party is complying with its obligations under this Agreement, including
payment, and if it is finally and conclusively determined that the allegedly breaching Party is in material breach, then the breaching
Party shall have the right to cure such material breach after such determination within the cure period provided above in Section
15.2 or 15.3, as applicable.


 




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15.5       Insolvency
Event. Either Company or SpePharm may terminate this Agreement if the other Party, during the Term, shall file in any court
or agency, pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization
or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets, or if the other Party shall
be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed
within sixty (60) days after the filing thereof, or if the other Party shall propose or be a Party to any dissolution or liquidation,
or if the other Party shall make a general assignment for the benefit of its creditors. Termination under this Section 15.5 shall
be effective upon twenty (20) days’ prior written notice.


 


15.6       Termination
by SpePharm for Convenience. Prior to its expiration, this Agreement may be terminated in its entirety or on a Product-by-Product
and/or country-by-country basis, in its sole discretion, at any time by SpePharm effective upon at least one hundred and eighty
(180) days’ prior written notice to Company for any reason; provided however, if SpePharm terminates this Agreement, whether
in whole or in part, in any of the Major EU Market Countries, such termination shall be deemed a termination of this Agreement
in its entirety.


 


15.7       Termination
for Patent Challenge. Company may terminate this Agreement in its entirety immediately upon written notice to SpePharm if SpePharm
or its Affiliates or Sublicensees (directly or indirectly, individually or in association with any other person or entity) challenges
in a legal or administrative proceeding the validity, enforceability or scope of any Company Patents anywhere in the world (except
as a defense against a claim, action or proceeding asserted by Company or its Affiliates or licensees against SpePharm or its Affiliates
or Sublicensees) (a “Patent Challenge”); provided that with respect to any such Patent Challenge by any Sublicensee
of SpePharm, Company will not have the right to terminate this Agreement under this Section 15.7 if SpePharm (A) causes such Patent
Challenge to be terminated or dismissed or (B) terminates such Sublicensee’s sublicense to the Company Patents being challenged
by the Sublicensee, in each case ((A) and (B)) within thirty (30) days of Company’s notice to SpePharm under this Section
15.7. Notwithstanding the foregoing, Company’s termination right under this Section 15.7 shall not apply to any Affiliate
of SpePharm that first becomes an Affiliate of SpePharm after the Effective Date of this Agreement in connection with a Business
Combination, where such Affiliate of SpePharm was undertaking activities in connection with a Patent Challenge prior to such Business
Combination; provided however that SpePharm causes such Patent Challenge to terminate within forty-five (45) days
after such Business Combination. For the avoidance of doubt, an action by SpePharm in accordance with Section 11.2 to amend claims
within a pending patent application of the Company Patents during the course of SpePharm’s prosecution and maintenance of
such pending patent application or in defense of a Third Party proceeding, or to make a negative determination of patentability
of claims of a patent application in the Company Patents or to abandon a patent application in the Company Patents during the course
of SpePharm’s prosecution and maintenance of such pending patent application, shall not constitute a Patent Challenge.


 




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15.8       Termination
for Pricing and Reimbursement Matters. SpePharm may terminate this Agreement on thirty (30) days’ prior written notice
if (a) the market access studies contemplated under Section 4.3(a) do not generate data adequate, in SpePharm’s reasonable
judgment, to support a level of pricing and reimbursement approvals in the Initial Territory that would make it Commercially Reasonable
to Commercialize the Product in the Licensed Territory, or (b) achievement of pricing and reimbursement approval in the Major EU
Market Countries is not feasible within the customary reimbursement timeframes in such countries, as reasonably determined by SpePharm.


 


15.9       Effect
of Termination.


 


(a)          Upon
termination of this Agreement in its entirety, or with respect to a particular Product or a particular country in the Licensed
Territory, then the following consequences shall apply:


 


(i)          Each
Party shall return to the other Party all Confidential Information of the other Party (except that each Party shall be permitted
to retain, through its legal counsel, one (1) copy of the other Party’s Confidential Information to the extent required under
any Applicable Laws or to the extent necessary to exercise any rights surviving termination of this Agreement);


 


(ii)         SpePharm’s
rights and each of SpePharm and Company’s obligations under this Agreement with respect to the Licensed Territory, or such
Product or country, as applicable, shall automatically terminate;


 


(iii)        The
JMC and all other committees shall be abolished and thereafter Company shall have the right to make the decisions and take the
actions previously reserved to the JMC and such other committees;


 


(iv)        All
trademarks, marks, trade names, patents, copyrights, designs, drawings, formulas or other data, photographs, samples, literature,
and sales and promotional aids of every kind (including Company Marks) of Company shall remain the sole and exclusive property
of Company with respect to the particular Product, as applicable. Within thirty (30) days after the effective date of termination
of this Agreement, but only if this Agreement is terminated in its entirety, SpePharm shall destroy all tangible items bearing,
containing, or contained in, any of the foregoing, in its possession or control and provide written certification of such destruction,
or prepare such tangible items for shipment to Company, as Company may direct, at Company’s expense. SpePharm shall not make
or retain any copies of any confidential or proprietary items or information, which may have been entrusted to it (except that
SpePharm shall be permitted to retain, through its legal counsel, one (1) copy of such confidential or proprietary items or information
to the extent required under any Applicable Laws or to the extent necessary to exercise any rights surviving termination of this
Agreement). Effective upon the termination of this Agreement, SpePharm shall cease to use all Company Marks with respect to the
particular Product and countries, as applicable. SpePharm shall transfer and assign to Company to the extent not already owned
by Company, all right, title and interest in and to any trademarks, trade dress, and logos developed by SpePharm under this Agreement
after the Effective Date solely for use in connection with Commercializing the Product in the Licensed Territory and all intellectual
property rights in and to the Marketing Materials;


 




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(v)         SpePharm
hereby grants to Company a worldwide, fully-paid, royalty-free, right and license, with the right to grant sublicenses (through
multiple tiers) subject to subsection (xiii) below, under the General IP that, prior to termination, had been developed by Company
and assigned to SpePharm and which is necessary or reasonably useful, to develop, market, promote, import, use, sell, offer for
sale, distribute, manufacture, have manufactured and otherwise commercialize the Product, solely to develop, market, promote, import,
use, sell, offer for sale, distribute, manufacture, have manufactured and otherwise commercialize the Products and other products.
The foregoing license shall be exclusive with respect to Products, and non-exclusive with respect to other products.


 


(vi)        If
requested by Company, SpePharm shall grant to Company an exclusive (even as to SpePharm and its Affiliates), worldwide, royalty-bearing
right and license, with the right to grant sublicenses (through multiple tiers) subject to subsection (xiii) below, under the General
IP (to the extent not licensed under Section 15.9(a)(v) above), Joint IP and SpePharm IP which is necessary or reasonably useful,
to develop, market, promote, import, use, sell, offer for sale, distribute, manufacture, have manufactured and otherwise commercialize
the Product, solely to develop, market, promote, import, use, sell, offer for sale, distribute, manufacture, have manufactured
and otherwise commercialize the Product. The Parties shall establish a commercially reasonable royalty rate and terms for such
license prior to effective date of termination and in the event the Parties are unable to so agree, then the matter shall be decided
by an independent industry expert selected by Company and reasonably acceptable to SpePharm. Until such matter is finally resolved,
SpePharm will grant the license on a royalty-free basis with the finally determined royalty applying on a retroactive basis to
the date of first sale of the Product by Company under the license granted hereunder. In addition, Company would to be responsible
for its pro-rata share of costs and expenses owed by SpePharm to a third party pursuant to a license under which SpePharm has procured
third party technology constituting SpePharm IP hereunder;


 


(vii)       Neither
Party shall be released from paying any amount which accrued prior to the effective date of such termination;


 




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(viii)      Company
may, in its reasonable discretion in accordance with Applicable Laws, appoint itself as successor to SpePharm or appoint a Third
Party that is located in the Licensed Territory, organized under the laws of the Licensed Territory and legally competent to hold
and maintain the Product Approvals (with respect to the particular Product, as applicable) under the laws of the Licensed Territory,
as successor to SpePharm solely for those Products and countries that have been terminated (the “Successor Entity”).
SpePharm shall transfer and assign to Company or the Successor Entity, as applicable, all permits, filings and authorizations and
Product Approvals (including reimbursement authorizations), if any, obtained, maintained or renewed that are under SpePharm’s
name that are held by SpePharm solely for the purpose of marketing, distributing and selling the terminated Products in the terminated
countries of the Licensed Territory, as soon as practicable after this Agreement is terminated and at Company’s expense.
SpePharm shall reasonably cooperate, at Company’s request and expense, in making any filings, executing any instruments,
or taking other actions reasonably necessary to make such transfer of any Product Approvals (including pricing approvals) effective.
In addition, SpePharm shall transfer and assign to Company all Regulatory Materials in the Licensed Territory that are Controlled
by SpePharm;


 


(ix)         SpePharm
shall, at Company’s request and expense, promptly assign to Company or the Successor Entity, as applicable, all of SpePharm’s
rights and obligations under all contracts, to the extent assignable, for such terminated Products in the terminated countries
of the Territory with any Third Parties to the extent solely related to the development or Commercialization of the Product in
the Licensed Territory.


 


(x)          SpePharm
shall provide Company with a complete inventory of Products in SpePharm’s possession or in transit to SpePharm from Company
or otherwise in SpePharm’s control, within ten (10) days after the effective date of the termination. Company may inspect
SpePharm’s Product inventory and audit SpePharm’s records in the manner provided hereinabove. Acceptance of any Product
Order from, or sale or license of, any Product to SpePharm after the effective date of termination of this Agreement shall not
be construed as a renewal or extension hereof, or as a waiver of termination of this Agreement.


 


(xi)         Company
shall, at its option, have the right to repurchase from SpePharm, and SpePharm shall sell to Company, all of the Products for the
countries for which this Agreement has terminated, as applicable, and in SpePharm’s stock at the applicable Repurchase Price
actually paid by SpePharm for such Product(s). Any such repurchase shall be made within sixty (60) days after the effective date
of termination, and SpePharm shall promptly ship such Products to a destination specified by Company in accordance with shipping
instructions used by Company to SpePharm. Such Products and parts so delivered shall be subject to inspection by Company to be
completed no later than ten (10) business days after receipt, and payment therefore shall be made within forty-five (45) days of
final acceptance by Company of such Products so inspected. Company shall purchase from SpePharm, and SpePharm agrees to sell to
Company, all of SpePharm’s inventory of the terminated Products, as applicable, that are not obsolete, damaged or expired
on the effective date of such termination. The price of such inventory shall be SpePharm’s fully burdened cost of goods (the
“Repurchase Price”). Products repurchased from SpePharm by Company pursuant to this Section 15.9(a)(x) shall
be shipped promptly by SpePharm to a location specified by Company and Company shall reimburse SpePharm for all pre-approved reasonable
out-of-pocket costs of shipment.


 




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(xii)        For
a period not to exceed [*] following the effective date of termination of this Agreement, SpePharm and its Affiliates shall reasonably
cooperate with Company and its designees to facilitate a smooth, orderly and prompt transition to Company or its designees of its
activities with respect to Products, including any ongoing development, manufacturing and Commercialization of Products, and including
any agreements related to the Product which SpePharm is unable to assign to Company or elects not to assign to Company due to such
agreements not being solely related to the Product. During the pendency of any transition, SpePharm will not take any action that
would reasonably be expected to have a material adverse effect on the Product. In connection with the transfer of activities under
this Section 15.9(a)(xii), the Parties will develop and agree upon a written plan to effect such transition, and Company shall
reimburse SpePharm for its reasonable costs and expenses incurred with such transfer.


 


(xiii)       With
respect to each sublicense granted by Company pursuant to subsections (v) or (vi) above, Company shall remain primarily responsible
for all of its Affiliates’ and sublicensees’ activities and any and all failures by its Affiliates and sublicensees
to comply with the applicable terms of this Agreement. The Parties agree that agreements with Third Parties acting only as distributors
or wholesalers of Company or its Affiliates or providing products or services to Company or its Affiliates and which are not otherwise
granted any sublicense of SpePharm’s rights under this Agreement, shall not be deemed a sublicense. Within fifteen (15) days
after entering into the sublicense agreement for the General IP or SpePharm Product IP with a non-Affiliated sublicensee, Company
shall provide to SpePharm a copy of the executed sublicense agreement, which may be redacted as necessary to protect commercially
sensitive information.


 


15.10    Survival.
Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued
to the benefit of any Party prior to such termination, relinquishment or expiration including the payment obligations hereunder
and any and all damages or remedies arising from any breach hereunder. Such termination, relinquishment or expiration shall not
relieve any Party from obligations which are expressly indicated to survive termination of this Agreement. The provisions of Articles
I, XIII, XIV, XV, XVI and XVII, and Sections 8.2, 10.1-10.5 (as to any amounts accrued prior to the effective date of termination)
10.6, 10.7, 10.8, 11.1, 11.3 (for so long as Norgine elects its license under Section 15.1) and 12.3 shall survive the expiration
or termination of this Agreement for any reason. All other rights and obligations of the Parties shall cease upon termination of
this Agreement.


 




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ARTICLE XVI –
DISPUTES


 


16.1       Disputes.
The Parties shall attempt to resolve all disputes between the Parties arising out of or relating to this Agreement and all related
agreements, collectively or separately, amicably through good faith discussions upon the written request of any Party. In the event
of a dispute arising out of or relating to this Agreement either Party shall provide written notice of the dispute to the other,
in which event the dispute shall be referred to the executive officers designated below or their successors, for attempted resolution
by good faith negotiations within thirty (30) days after such notice is received. Said designated officers are initially as follows:


 


	For Company:	 its President 
	 	 
	For SpePharm: 	its  Managing Director


 


In the event the designated
executive officers do not resolve such dispute within the allotted sixty (60) days, such dispute may be resolved by litigation
pursuant to Section 16.2.


 


16.2       Venue;
Jurisdiction. Each Party hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the federal
courts located in the Southern District of New York, for any actions, suits or proceedings arising out of or relating to this Agreement
and the transactions contemplated hereby. Each Party hereby irrevocably and unconditionally waives any objection to the laying
of venue of any action, suit or proceeding arising out of or relating to this Agreement and the transactions contemplated hereby
in the federal courts located in the Southern District of New York, and waives and agrees not to plead or claim in any such court
that any such action, suit or proceeding brought in such court has been brought in an inconvenient forum. Notwithstanding the foregoing,
a Party shall be entitled to seek enforcement of a judgment entered pursuant to this Section in any court having competent jurisdiction
thereof where enforcement is deemed necessary.


 


16.3       Exclusions.
Nothing in this Article 16 shall preclude a Party from seeking and obtaining in a court of competent jurisdiction injunctive or
equitable relief to preserve the status quo or prevent immediate harm to the Party. The terms of this Article 16 shall not apply
to any disputes relating to a material breach of Article 14 (Confidentiality) or any claim relating to the intellectual property
rights of a Party, each of which may be brought in a court of competent jurisdiction.


 




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ARTICLE
XVII – MISCELLANEOUS


 


17.1       Force
Majeure. Nonperformance by either Party shall be excused to the extent that performance is rendered beyond such Party’s
reasonable control by industrial conflicts, mobilization, requisition, embargo, currency restriction, insurrection, general shortage
of transport, material or power supply, fire, flood, earthquake, explosion, stroke of lightning, other force majeure and similar
casualties or other events beyond either Party’s reasonable control (“Force Majeure Events”), as well
as default in deliveries from subcontractors due to such circumstances as defined in this Section 17.1. If a Force Majeure Event
exists for more than one hundred and eighty (180) days, then the affected Party shall have the right to terminate this Agreement
upon written notice to the other Party and the terms of Section 15.9 shall apply. If either Party is affected by a Force Majeure
Event, it shall promptly as soon as it is known that such circumstances are likely to have a detrimental impact on the performance
of its obligations under the terms of this Agreement, immediately verbally notify the other Party and follow up in writing describing
the nature and extent of the circumstances, the likely and potential duration and the foreseeable impact on its ability to perform
any of its obligations under this Agreement. During the continuance of any Force Majeure Event, the affected Party shall use all
reasonable efforts to overcome, remove or minimize the effects of such Force Majeure Event and to perform its obligations under
this Agreement as soon as reasonably possible.


 


17.2       Performance
by Affiliates. Each Party agrees to cause its Affiliates to comply with the provisions of this Agreement as applicable to such
Affiliate and to guarantee the payment and performance thereof. Any breach by a Party’s Affiliate of any of such Party’s
obligations under this Agreement will be deemed a breach by such Party, and the other Party may proceed directly against such Party
without any obligation to first proceed against such Party’s Affiliate.


 


17.3       Independent
Contractors. It is understood that both Parties are independent contractors and are engaged in the operation of their own respective
businesses. Neither Party is the agent of the other for any purpose whatsoever, and neither Party has any authority, express or
implied, to enter into any contracts or assume any obligations for the other, to pledge the credit of the other or make any warranties
or representations on behalf of the other, except where expressly authorized in writing to do so. Nothing in this Agreement or
in the activities of either Party shall be deemed to create an agency, partnership or joint venture relationship.


 


17.4       No
Partnership. The Parties agree and acknowledge that this Agreement is not intended to create, or be deemed to be or otherwise
treated as, a partnership for United States federal, state or local income tax purposes or for purposes of the laws of any state
of the United States or the District of Columbia. No Party shall file or cause to be filed any Internal Revenue Service Form 1065
(U.S. Return of Partnership Income), or any equivalent form for state or local tax purposes, with respect to the arrangements contemplated
by this Agreement, and each Party agrees that any and all United States federal, state and local income tax returns it files will
be consistent with the provisions of this Section 17.4. The transactions contemplated by this Agreement shall not be conducted
under a joint or combined business name and no Party shall hold itself out to any person as being in a partnership, joint venture,
or combined business with the other Party. The Parties shall not open any joint bank accounts or otherwise commingle their respective
funds.


 




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17.5         Notices.
All notices, requests, claims, demands and other communications hereunder shall be in writing and shall be given (and shall be
deemed to have been duly given upon receipt) by delivery in person or via internationally recognized overnight delivery, or by
registered or certified mail (postage prepaid, return receipt requested), or by facsimile or email with confirming letter sent
by mail as provided above, to the following address (or at such other address for which such Party gives notice hereunder):


 


	If to SpePharm:	SpePharm AG
	 	Kapellplatz 1
	 	6004  
	 	Luzern, Switzerland
	 	Attention:  Dr. Adrian von Segesser
	 	Fax:  [*]
	 	 
	with a copy to Norgine.	 
	 	 
	If to Norgine:	Norgine BV
	 	Hogehilweg 7
	 	1101 CA Amsterdam Zuid-Oost
	 	The Netherlands
	 	Attention: Managing Director
	 	Fax: [*] 
	 	 
	If to Company:	Navidea Biopharmaceuticals, Inc.
	 	5600 Blazer Parkway, Suite 200
	 	Dublin, OH 43017 U.S.A.
	 	Attention: President
	 	Fax:  [*]


 




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	with a copy to (which shall not constitute notice):
	 	 
	 	Cooley LLP
	 	One Freedom Square
	 	Reston Town Center
	 	11951 Freedom Drive
	 	Reston, VA  20190-5656
	 	United States of America
	 	Attention:  Ken Krisko


 


Notices shall be considered delivered when
mailed or sent by confirmed email or facsimile in accordance with the provisions of this Section 17.5, subject to proof of receipt
or facsimile confirmation or by mail receipt.


 


17.6       Governing
Law. This Agreement, and the rights and obligations of the Parties hereunder, shall be governed, construed and interpreted
in accordance with the laws of the State of New York, U.S.A., without reference to conflict of laws and choice of law principles
and excluding the United Nations Convention on Contracts for the International Sale of Good.


 


17.7       Entire
Agreement. This Agreement, including the Exhibits, sets forth the entire agreement and understanding of the Parties relating
to the subject matter hereof, and supersedes all prior oral and written, and all contemporaneous oral, agreements, understandings
and arrangements. No modification of or amendment to this Agreement shall be effective unless signed by the Parties.


 


17.8       Assignment.
This Agreement may not be assigned by either Party, nor may either Party delegate its obligations or otherwise transfer licenses
or other rights created by this Agreement, except as expressly permitted hereunder or otherwise without the prior written consent
of the other Party, which consent will not be unreasonably withheld, delayed or conditioned; provided that without consent (i)
SpePharm may assign this Agreement to (x) an Affiliate, (y) Norgine (for so long as Norgine is an Affiliate of SpePharm) or (z)
its successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of
its business pertaining to the subject matter of this Agreement, and (ii) Company may assign this Agreement to (x) an Affiliate
or (y) its successor in connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion
of its business pertaining to the subject matter of this Agreement; provided however that, except in the case where a Party is
involved in a merger or consolidation where it is the surviving entity and no assets of such Party have been transferred as a result
of such merger or consolidation, that (A) such assigning Party provides the other Party to this Agreement with at least thirty
(30) days advance written notice of such assignment(s), subject to any confidentiality obligations, and the assigning Party agrees
in a written agreement delivered prior to such assignment(s) to the non-assigning Party (and upon which such non-assigning Party
may rely) to remain fully liable for the performance of its obligations under this Agreement by its assignee(s), (B) the assignee(s)
agree in a written agreement delivered prior to such assignment(s) to the non-assigning Party (and upon which such non-assigning
Party may rely) to assume performance of all such assigned obligations, (C) in the case of any assignment(s) by Company, rights
to all Company Patents and Company Know-How licensed to SpePharm for the Licensed Territory will be transferred to such assignee(s)
effective as of such assignment(s), and (D) all of the matters referred to in clauses (A), (B) and (C), as applicable, will be
set forth in documentation reasonably acceptable to the non-assigning Party prior to any such assignment(s) (and with such reasonable
acceptance not to be unreasonably withheld, conditioned or delayed) and in all cases will provide the non-assigning Party with
the full benefits of its rights under this Agreement (after taking into account all risks involving applicable counter-party performance
and bankruptcy and insolvency risks, including those involving contractual rejection under 11 USC §365) as if no such assignment(s)
had occurred. The terms of this Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators
and permitted assigns of the Parties. Any purported assignment in violation of this Section 17.8 will be null and void ab initio.


 




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17.9       Guaranty.
In consideration of the rights granted hereunder, Norgine hereby guarantees in favor of Company the full payment and performance
by SpePharm of all obligations of SpePharm under this Agreement, in accordance with the terms and conditions of this Agreement,
including any applicable notice or cure periods. This guaranty shall be enforceable upon the failure by SpePharm to perform any
obligation it may have under this Agreement in accordance with its terms, and shall be effective regardless of the solvency or
insolvency of SpePharm at any time, the extension or modification of the obligations of this Agreement by operation of law, or
the subsequent reorganization, merger, consolidation or other restructuring of SpePharm. Norgine hereby expressly waives any requirement
that Company exhaust any right, power or remedy under this Agreement, or proceed against any other SpePharm entity under this Agreement,
for any obligation or performance hereunder prior to proceeding directly against Norgine under this Section 17.9. In the event
that this Agreement is transferred or assigned by SpePharm to a Third Party which is not an Affiliate of Norgine, or if a Business
Combination occurs with respect to SpePharm and a Third Party which is not an Affiliate of Norgine, then Norgine’s obligations
under this Section 17.9 shall terminate, and the successor to SpePharm’s rights in this Agreement or the successor to SpePharm,
as the case maybe, shall assume such obligations under this Section 17.9.


 


17.10     Severability.
If any provision of this Agreement is held to be invalid by a court of competent jurisdiction, then the remaining provisions shall
remain, nevertheless, in full force and effect. The Parties agree to renegotiate in good faith any term held invalid and to be
bound by the agreed substitute provision in order to give the most approximate effect intended by the Parties.


 




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17.11     Headings.
The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation
of this Agreement. Any article, section, recital, exhibit, schedule or party references are to this Agreement unless otherwise
stated. No Party or its counsel shall be deemed to be the drafter of this Agreement for purposes of construing the provisions hereof,
and all provisions of this Agreement shall be construed in accordance with their fair meaning, and not strictly for or against
any Party.


 


17.12     Export
Control. SpePharm understands and acknowledges that Company is subject to regulation by agencies of the U.S. Government, including
but not limited to, the FDA and the U.S. Department of Commerce, which prohibit and/or regulate export or diversion of certain
products and technology to certain countries. Any and all obligations of Company to provide the Product as well as any other technical
information and assistance shall be subject in all respects to such United States laws and regulations as shall from time to time
govern the license and delivery of technology and products abroad by persons subject to the jurisdiction of the United States,
including without limitation the Administration Act of 1979, as amended, any successor legislation, and the Export Administration
Regulations issued by the Department of Commerce, Bureau of Import Administration. SpePharm agrees to cooperate with Company, including,
without limitation, providing required documentation, in order to obtain export licenses or exemptions there from. Company warrants
that it shall comply with the Export Administration Regulations and other United States laws and regulations governing exports
in effect from time to time. Company further warrants that, as of the Effective Date, nothing in the Export Administration Regulations
or other United States laws and regulations governing exports in any way restrict Company from providing the Product or any technical
information or assistance relating thereto to SpePharm as required by this Agreement or from performing any of Company’s
obligations under this Agreement.


 


17.13     Waiver.
No waiver of any term or condition of this Agreement shall be valid or binding on either Party unless agreed in writing by the
Party to be charged. The failure of either Party to enforce at any time any of the provisions of the Agreement, or the failure
to require at any time performance by the other Party of any of the provisions of this Agreement, shall in no way be construed
to be a present or future waiver of such provisions, nor in any way affect the validity of either Party to enforce each and every
such provision thereafter.


 


17.14     Counterparts.
This Agreement may be executed in counterparts, each of which shall be deemed an original, but both of which together shall constitute
one and the same instrument. Each Party may execute this Agreement by facsimile transmission or in AdobeTM Portable Document
Format (“PDF”) sent by electronic mail. In addition, facsimile or PDF signatures of authorized signatories of
any Party will be deemed to be original signatures and will be valid and binding, and delivery of a facsimile or PDF signature
by any Party will constitute due execution and delivery of this Agreement.


 




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IN WITNESS WHEREOF,
and intending to be legally bound hereby, the Parties have caused this Agreement to be executed by their duly authorized representatives
as of the Effective Date.


 


Navidea Biopharmaceuticals, Inc.


 


	By:	 
	 	 
	Name:
	 
	Title:


 


SpePharm AG


 


	By:	 
	 	 
	Name:
	 
	Title:


 


Norgine BV (Solely for the purposes
of Section 2.6 and Articles 14, 16 and 17)


 


	By:	 
	 	 
	Name:
	 
	Title:


 




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EXHIBIT A


 


Company Patents


 


Patents


 


	
         

        “Compositions for radiolabeling DTPA dextran”

        (Lymphoseek - Formulation)

        US 8,545,808

        [*]
	Assigned to Navidea	Issued – U.S. (2029)
	
         

        “Macromolecular Carrier for Drug and Diagnostic Agent
        Delivery”

        (Lymphoseek - Composition)

        US 6,409,990

        [*]

         
	Licensed from UCSD	Expiration 12 May 2020


 




    	Exhibits - i



    	 



    

  


EXHIBIT B


 


Press Release


 


Navidea
and Norgine Enter European Commercial Partnership for Lymphoseek®; Navidea to Receive $2 Million Upfront Payment


 


- Strategic partnership provides market
development, sales and marketing infrastructure for Lymphoseek expansion into European marketplace –


 


DUBLIN OHIO March XX, 2015 —
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) and SpePharma AG (an affiliate of Norgine BV), a European specialist pharmaceutical
company with an extensive pan-European presence, today entered into an exclusive sublicense agreement for the commercialization
and distribution of Lymphoseek® 250 microgram kit for radiopharmaceutical preparation (tilmanocept) in the European
Union. Under the terms of the agreement, Navidea will receive an upfront payment of $2 million and is eligible to receive additional
milestone payments up to $5 million, as well as royalties on European net sales.


 


Lymphoseek is
a receptor-targeted, radiopharmaceutical imaging agent approved by the U.S. Food and Drug Administration in 2013 and by the EU
in November 2014. Lymphoseek is approved in Europe for imaging and intraoperative detection of sentinel lymph nodes in patients
with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. In these procedures,
key lymph nodes adjacent to a primary tumor, that may contain tumor metastases, are identified and biopsied to determine if cancer
has spread to these lymph nodes.


 


“Launching Lymphoseek
in to new global markets is integral to Navidea’s corporate growth strategy. We believe that Norgine’s commercial,
medical and development expertise, combined with its well-established infrastructure and strong presence in the European marketplace,
make it an ideal commercialization partner to gain country-by-country reimbursement and drive Lymphoseek adoption,” said
Rick Gonzalez, President and Chief Executive Officer of Navidea. “We anticipate a successful and mutually-beneficial partnership
with Norgine based on synergistic core competencies, our shared vision for value creation and our strong commitment to providing
highly-differentiated products that improve the diagnosis and treatment of disease for patients with unmet medical needs.”


 


“This agreement with Navidea
underscores Norgine’s vision to be the partner of choice and facilitates the growth and expansion of our specialist product
portfolio to help improve the treatment of patients throughout Europe,” said Peter Stein, Chief Executive Officer of Norgine.
“We look forward to fully engaging our sales force to support commercial launch activities in a marketplace requiring a new
alternative.”


 


“Securing a partner with the commitment
to market access development was especially important to us since, unlike the United States where institutions typically rely on
unit dose distribution of radiopharmaceutical products by specialized radio-pharmacy distributors, institutions in Europe purchase
non-radiolabeled material and compound the finished product on-site,” added Mr. Gonzalez “As a specialist pharmaceutical
company, Norgine is optimally positioned to interface directly with a targeted surgical oncologist customer base with a dedicated
sales force. We expect Norgine to begin market access work immediately in the major markets in Europe with the goal of supporting
commercial launch sometime in early 2016.”


 




    	Exhibits - ii



    	 



    

  


Under terms of the exclusive license agreement,
Navidea will supply packaged Lymphoseek product to Norgine; however, Navidea will transfer responsibility for regulatory maintenance
of the Lymphoseek Marketing Authorization to Norgine. Norgine will also be responsible for pricing, reimbursement, sales, marketing,
medical affairs, and regulatory. In connection with entering into the agreement, Navidea will be entitled to an upfront payment
of $2 million, milestones totaling up to an additional $5 million, as well as royalties on European net sales. The initial territory
covered by the agreement includes all 28 member states of the European Economic Community with the option to expand into additional
geographical areas. Additional terms of the agreement were not disclosed.


 


About Lymphoseek


Lymphoseek®
(technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a
novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement
in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the
highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid
tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients
with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received
European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized
squamous cell carcinoma of the oral cavity.


 


Accurate diagnostic
evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall
in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe
may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral
cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of
head and neck/oral cancer diagnosed in Europe annually.


 


EU Lymphoseek® 250 micrograms kit for radiopharmaceutical
preparation (tilmanocept)


Indication
and Important Safety Information


Radiolabelled
Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients
with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.


 


External imaging
and intraoperative evaluation may be performed using a gamma detection device.


 


Important Safety
Information about Lymphoseek for EU & U.S. patients


In clinical trials
with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due
to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms
of dextran (such as iron dextran drugs).


 


Prior to the administration
of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified
forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and
patients observed for signs or symptoms of hypersensitivity following injection.


 




    	Exhibits - iii



    	 



    




 


Any radiation-emitting
product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive
radiation exposure to patients or health care workers.


In clinical trials,
no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain
(<1%).


 


Prescribing information
and more information about Lymphoseek for EU patients will be available at: http://ec.europa.eu/health/documents/community-register/html/h955.htm


 


For full prescribing
information and more information about Lymphoseek for U.S. patients, please visit: www.lymphoseek.com.


 


About Norgine 


Norgine is a European specialist pharmaceutical
company that has been established for over 100 years. Norgine provides expertise and ‘know how’ in Europe to develop,
manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine’s approach
and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth. Norgine is
headquartered in the Netherlands and its global operations are based in Amsterdam and in Harefield, UK. Norgine owns an R&D
site in Hengoed, Wales and two manufacturing sites, one in Hengoed, Wales and one in Dreux, France. For more information, please
visit www.norgine.com. In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative
healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.


 


About Navidea Biopharmaceuticals Inc.


Navidea
Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a commercial stage precision medicine company focused on the development and commercialization
of precision diagnostics, therapeutics and radiopharmaceutical agents. Navidea is developing multiple precision-targeted products
and platforms including ManoceptTM, NAV4694, and NAV5001, to help identify the sites and pathways of undetected disease and
enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek®(technetium
Tc 99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in
March 2013 and by the EMA in November 2014. Navidea’s strategy is to deliver superior growth and shareholder return by bringing
to market novel radiopharmaceutical agents and therapeutics, and advancing the Company’s pipeline through global partnering
and commercialization efforts. For more information, please visit www.navidea.com.


 


The Private Securities Litigation Reform
Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in
this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and
strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and
regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act.
The words “believe,” “expect,” “anticipate,” “estimate,” “project,”
and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that
such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated
results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market
acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital
funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience,
risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report
on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise
any forward-looking statements.


 




    	Exhibits - iv



    	 



    

 





Contact:


 


Source: Navidea Biopharmaceuticals, Inc.


Navidea Biopharmaceuticals


 


Brent Larson, 614-822-2330


Executive VP & CFO


Or


Sharon Correia, 978-655-2686


Associate Director, Corporate Communications


- ### -


 




    	Exhibits - v



    	 



    

 


EXHIBIT C


 


Company Marks; Product Marks


 


PART I – COMPANY MARKS


 


Navidea


 





 


	
        “Navidea”

        US Trademark Reg. No. 4,514,173

        CTM Trademark Reg. No.: 012204178

        Canada Application No. 1647179

        Japan Application Ser. No.: 2013-79448

        China Application No. (tbd)

         
	
         

        US Renewal-04/15/2024

         

        CTM Renewal-10/31/2024

	
        “Navidea Biopharmaceuticals”

        Design + Words

        Trademark Reg. No. 4,207,633

         
	Renewal-09/11/2022


 


PART II – PRODUCT MARKS


 


Lymphoseek


 





 


	
        “Lymphoseek”

        US Trademark Reg. No. 3,163,525

        CTM Trademark Reg. No.: 012204202

        Canada. Application No. 1647184

        Japan Application Ser. No.: 2013-79449

        China Application No. (tbd)

         
	
         

        US Renewal-10/24/2016

         

        CTM Renewal-10/31/2023

	
        “Lymphoseek (technetium Tc 99m tilmanocept) injection”

        Design + Words

        Trademark Application Ser. No.: 86/055,675

         
	Pending


 




    	Exhibits - vi



    	 



    

  


EXHIBIT D


 


Pharmacovigilance Agreement


 


[To be attached within 90 days]


 




    	Exhibits - vii



    	 



    




 


EXHIBIT E


 


Expanded Territory


 


[*]


 




    	Exhibits - viii



    	 



    

  


EXHIBIT F


 


Summary of Supply Agreement Terms


 


[*]


 




    	Exhibits - ix



    	 



    

 


EXHIBIT G


 


Company Development Plan


 


[to be supplied]


 




    	Exhibits - x