Document:

Exhibit 10.4

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED.

 

Execution Version

 

 

 

 

 

 

 

EXCLUSIVE LICENSE AGREEMENT

 

between

 

ONCOLOGY VENTURE, APS

 

and

 

2-BBB MEDICINES BV

 

Dated as of March 27, 2017

 

 

 

 

 

 

 

 

 

     

     

    

 

Execution Version

 

TABLE OF CONTENTS

 

	 	Page
	 	 
	ARTICLE 1 Definitions and Rules of Construction	1
	Section
    1.1	Definitions.	1
	Section
    1.2	Terms Defined Elsewhere in this Agreement.	13
	Section
    1.3	Rules of Construction.	14
	 	 	 
	ARTICLE 2 Grant of Rights	15
	Section
    2.1	Grant of 2-BBB Intellectual Property and Retention of Rights.	15
	Section
    2.2	Sublicenses.	16
	Section
    2.3	Expanded Field	16
	Section
    2.4	Trademark(s).	16
	Section
    2.5	Rights to Improvements	17
	 	 	 
	ARTICLE 3 Product Development	17
	Section
    3.1	Governance	17
	Section
    3.2	Development	18
	Section
    3.3	Transfer	18
	Section
    3.4	Assistance	18
	Section
    3.5	Pharmacovigilance	19
	Section
    3.6	Manufacturing	20
	Section
    3.7	No Other Rights	20
	Section
    3.8	Bankruptcy	20
	Section
    3.9	No Representation	20
	 	 	 
	ARTICLE 4 Commercialization Activities	21
	Section
    4.1	Commercialization Responsibilities	21
	 	 	 
	ARTICLE 5 Non-Compete	21
	Section
    5.1	Non-Compete	21
	Section
    5.2	Change of Control Exception	21
	 	 	 
	ARTICLE 6 Product Acquisition	22
	Section
    6.1	Third Party Acquirer	22
	 	 	 
	ARTICLE 7 Payments	22
	Section
    7.1	Upfront Payment	22
	Section
    7.2	Royalties.	22
	Section
    7.3	Milestones	24
	Section
    7.4	Additional Payment Terms	26
	Section
    7.5	Currency Conversion	27
	Section
    7.6	Taxes	27
	 	 	 
	ARTICLE 8 Regulatory Matters	27
	Section
    8.1	Compliance with Laws	27
	Section
    8.2	Regulatory Approval	27

 

    -i-

     

    

 

TABLE OF CONTENTS

 

	 	 	Page
	 	 	 
	ARTICLE 9 Intellectual Property	28
	Section
    9.1	Ownership of Intellectual Property	28
	Section
    9.2	Patent Filings, Prosecution and Maintenance of 2-BBB Intellectual Property and any Joint Intellectual Property	29
	Section
    9.3	Extensions of Patent Term for Product.	30
	Section
    9.4	Enforcement of 2-BBB Intellectual Property and Joint Intellectual Property	31
	Section
    9.5	Enforcement of OV Technology	31
	Section
    9.6	Defense of Infringement Claims of 2-BBB Intellectual Property and Joint Intellectual Property	32
	Section
    9.7	Enforcement of 2-BBB Trademark(s)	32
	 	 	 
	ARTICLE 10 Indemnification	33
	Section
    10.1	Indemnification by 2-BBB.	33
	Section
    10.2	Indemnification by OV	34
	Section
    10.3	Waiver	35
	Section
    10.4	Insurance	35
	Section
    10.5	Limitation of Consequential Damages	35
	 	 	 
	ARTICLE 11 Representations and Warranties	35
	Section
    11.1	General Corporate Matters	35
	Section
    11.2	Intellectual Property Matters	36
	Section
    11.3	2-BBB Covenants.	38
	Section
    11.4	OV Covenants	38
	 	 	 
	ARTICLE 12 Confidentiality and Publicity	39
	Section
    12.1	Confidentiality	39
	Section
    12.2	Publicity	40
	 	 	 
	ARTICLE 13 Record-keeping and Audits	40
	Section
    13.1	Records Retention	40
	Section
    13.2	Audit Request.	41
	 	 	 
	ARTICLE 14 Term and Termination	42
	Section
    14.1	Term	42
	Section
    14.2	Rights of Termination.	42
	Section
    14.3	Surviving Rights and Obligations	44
	Section
    14.4	Effect of Expiration or Termination; Remaining Inventory	44
	 	 	 
	ARTICLE 15 Miscellaneous	45
	Section
    15.1	Entire Agreement; Amendments	45
	Section
    15.2	Governing Law	45
	Section
    15.3	Dispute Resolution	45
	Section
    15.4	Partial Illegality	46
	Section
    15.5	Waiver of Compliance	47
	Section
    15.6	Notices	47

 

    -ii-

     

    

 

TABLE OF CONTENTS

 

	 	 	Page
	 	 	 
	Section
    15.7	Limitation on Liability	48
	Section
    15.8	Counterparts	48
	Section
    15.9	Further Assurances	48
	Section
    15.10	Injunctive Relief	48
	Section
    15.11	Jointly Prepared	48
	Section
    15.12	Assignment	48
	Section
    15.13	Relationship of Parties	48
	Section
    15.14	Force Majeure	49
	Section
    15.15	Severability	49
	Section
    15.16	Third-Party Beneficiaries	49
	Section
    15.17	Expenses	49

 

    -iii-

     

    

 

Execution Version

 

LIST OF EXHIBITS

 

	A	Clinical Development Plan
	B	Product
	C	Press Release

 

LIST OF SCHEDULES

 

	1	Major Countries
	2	Patents
	3.6	Manufacturing
	11.2(a)	Ownership
	11.2(d)	Third Party Obligations

 

 

    -iv-

     

    

 

EXCLUSIVE LICENSE AGREEMENT

 

This Exclusive License Agreement
(this “Agreement”) is entered into as of March 27, 2017 (the “Effective Date”), between Oncology
Venture, ApS, a company organized and existing under the laws of Denmark, whose principal place of business is located at Venlighedsvej
1, DK-2970 Hoersholm, Denmark (“OV”)

 

and

 

2-BBB
Medicines BV, a company organized and existing under the laws of The Netherlands, whose principal place of business is located at J.H.
Oortweg 19, Leiden Bioscience Park, 2333 CH Leiden, The Netherlands (“2-BBB”).

 

RECITALS

 

A. 2-BBB is a clinical stage
biotechnology company focusing on enhanced drug delivery across the blood-brain barrier, which is currently developing one of its products
(i.e., 2B3-101) combining 2-BBB’s brain drug targeting platform (i.e., G-Technology®) with the existing chemotherapeutic agent
Doxorubicin to enable treatment of brain metastases and glioma.

 

B. OV and its Affiliates (defined
below) desires to obtain an exclusive license under the 2-BBB Intellectual Property (defined below) to exclusively develop 2B3-101 pursuant
to this Agreement. OV and 2-BBB have previously executed a Binding Term Sheet (dated September 22, 2016) (the “Binding Term
Sheet”) setting out the primary terms of such proposed license.

 

C. 2-BBB is willing to grant
to OV an exclusive license under the 2-BBB Intellectual Property for its product 2B3-101 subject to the conditions set forth in, and
pursuant to, this Agreement.

 

AGREEMENT

 

In consideration of the mutual
covenants set forth in this Agreement, OV and 2- BBB hereby agree as follows.

 

ARTICLE 1

Definitions and Rules of Construction

 

The definitions and rules of
constructions set forth below shall apply throughout this Agreement.

 

Section 1.1 Definitions.

 

“2-BBB Intellectual
Property” means 2-BBB Patents and 2-BBB Know-How.

 

“2-BBB Patents”
means the Product-Specific Patents and the Platform Patents.

 

    1

     

    

 

“2-BBB Know-How”
means Know-How owned or Controlled by 2-BBB or its Affiliates as of the Effective Date or during the Term of this Agreement that
is necessary or useful to Develop, Manufacture, or Commercialize the Product in the Field in the Territory.

 

“Adverse Event”
has the meaning set forth in the Applicable Law for such term (or comparable term), and will generally mean any untoward medical
occurrence in a subject in any Clinical Trial who has received a Product, medical device or placebo, and that does not necessarily have
a causal relationship with such Product, medical device or placebo, including any unfavorable and unintended sign (including an abnormal
laboratory finding), symptom or disease temporally associated with the use of the applicable Product, whether or not related to such
Product.

 

“Affiliate”
means, with respect to a Person, any Person that is controlled by, controls, or is under common control with such first Person, as
the case may be. For purposes of this definition, the term “control” means (a) direct or indirect ownership of fifty percent
(50%) or more of the voting interest in the entity in question, or fifty percent (50%) or more interest in the income of the entity in
question; provided, however, that if local Law requires a minimum percentage of local ownership of less than fifty percent
(50%), control will be established by direct or indirect beneficial ownership of one hundred percent (100%) of the maximum ownership
percentage that may, under such local Law, be owned by foreign interests, or (b) possession, directly or indirectly, of the power to
direct or cause the direction of management or policies of the entity in question (whether through ownership of securities or other ownership
interests, by contract or otherwise).

 

“Annual Net Sales”
means, on a Product-by-Product basis, total Net Sales by the Selling Parties in the Territory of such Product in a particular Calendar
Year, it being understood and agree that “Annual Net Sales” does not include any sales of diagnostic products.

 

“Applicable Laws”
means all applicable common law, statutes, ordinances, rules, regulations, guidances and orders of any Governmental Authority, including
Regulatory Laws.

 

“Binding Term Sheet”
has the meaning set forth in the recitals.

 

“Business Day”
means a day on which banking institutions in both Amsterdam, The Netherlands and Copenhagen, Denmark are open for business, excluding
any Saturday or Sunday.

 

“Calendar Quarter”
means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 or December 31, during the
Term, or the applicable part thereof during the first or last calendar quarter of the Term.

 

“Calendar Year”
means any calendar year ending on December 31, or the applicable part thereof during the first or last year of the Term.

 

“Change of Control”
means, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party which results in the stockholders
or equity holders of such Party or any Parent Corporation not owning at least fifty percent (50%) of the combined voting power of the
surviving entity immediately after such merger or consolidation, or (b) except in the case of a bona fide equity or debt financings,
whether private or public, in which a Party issues new shares of its capital stock or securities convertible into shares of such Party,
a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner of
fifty percent (50%) or more of the combined voting power of the outstanding securities of such Party or Parent Corporation or (c) the
sale or other transfer to a Third Party of all or substantially all of such Party’s business to which the subject matter of this
Agreement relates.

 

    2

     

    

 

“Clinical Development
Plan” means the development plan governing the Phase 2 Clinical Trial to be conducted by OV with respect to the Product, the
initial draft of which is attached to this Agreement as Exhibit A, as may be amended from time to time by the JDC pursuant to Section
3.1.

 

“Clinical Trials”
means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a) establish that a pharmaceutical
product is reasonably safe for continued testing; (b) investigate the safety and efficacy of the pharmaceutical product for its intended
use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range
to be prescribed; or (c) support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product.

 

“Combination Product”
means a Product that contains one or more additional active ingredients (whether co-formulated or co-packaged) that are neither 2B3-101
nor generic compositions of matter equivalents thereof.

 

“Commercialization”
means any and all activities of marketing, promoting, distributing, offering for sale or selling the Product in the Field in the
Territory, including, for example, marketing, branding, pricing, distribution, sales, obtaining health insurance reimbursement coverage,
market research, business analytics, pharmacovigilance and medical affairs activities, pre-commercial launch market development activities
conducted in anticipation of Regulatory Approval to sell or market the Product, seeking pricing and reimbursement approvals for the Product
(if applicable), preparing advertising and promotional materials, sales force training, and all interactions and correspondence with
a Regulatory Authority regarding Clinical Trials commenced following Regulatory Approval. When used as a verb, “Commercialize”
means to engage in Commercialization.

 

“Commercially Reasonable
Efforts” means with respect to the performing Party, a level of efforts and resources, not less than reasonable efforts and
resources, that is consistent with the efforts and resources that 2-BBB or OV, as applicable, typically devotes to a product or compound
owned by it or to which it has rights of the type it has hereunder, or similar market potential at a similar stage in the development
or product life thereof, taking into account scientific and commercial factors, including issues of safety and efficacy, product profile,
the pricing and launching strategy for the respective product, difficulty in developing or manufacturing the Product, competitiveness
of alternative Third Party products in the marketplace, the Patent or other proprietary position of the Product (including the ability
to obtain or enforce, or have obtained or enforced, such Patent or other proprietary positions), the regulatory requirements involved
and the potential profitability, cost, market share, price or reimbursement to the performing Party of the Product marketed or to be
marketed.

 

    3

     

    

 

“Competitive Product”
means, other than the Product, any pharmaceutical product (i) that contains a Glutathione-enhanced PEG-liposomal formulation of Doxorubicin
as an active ingredient(s) (including an active moiety) as such approved Product; (ii) is approved for use in such country pursuant to
(a) Article 10.1 of Directive 2001/83/EC of the European Parliament and Council of 6 November 2001, or any enabling legislation thereof,
or any amended or successor abbreviated route of approval, or (b) any Laws or abbreviated routes of approval in any other countries worldwide
that are comparable to those described above; and (iii) is sold in the same country as such Product by any Third Party that is not a
sublicensee of OV or its Affiliates and did not purchase such product in a chain of distribution that included any of OV or any of its
Affiliates or its sublicensees. A pharmaceutical product that is AB-rated or comparably rated in any jurisdiction outside the United
States to the applicable Product shall be a Competitive Product with respect to such Product in such country.

 

“Control”
or “Controlled” means, with respect to any intellectual property right, information, documents or materials of
a Party (or, as described below, a Future Acquirer), that such Party or its Affiliates, or a Future Acquirer, (a) owns or has a license
to such intellectual property right, information, documents or materials (other than pursuant to this Agreement); and (b) has the ability
to grant access, a license or a sublicense to such intellectual property right, information, documents or materials to the other Party
as provided in this Agreement without violating an agreement with or other rights of any Third Party, provided that any intellectual
property Controlled by a Future Acquirer of a Party shall not be treated as “Controlled” by such Party for purposes of this
Agreement, except to the extent that, and only to the extent that, such intellectual property (i) is actually used by such Party or its
Affiliates, or the Future Acquirer, to Develop, Manufacture or Commercialize the Product after the Future Acquirer qualifies as such;
or (ii) comes under the Control of such Future Acquirer due to reference or access by such Future Acquirer to, or use by such Future
Acquirer of, intellectual property of such Party. Notwithstanding the foregoing, with respect to any intellectual property acquired after
the Effective Date for which a Party will be required to make payments to any Third Party in connection with the access, licenses and
sublicenses granted to the other Party under this Agreement, such intellectual property shall not be treated as “Controlled”
by the licensing Party except to the extent that, and only to the extent that and for so long as, the other Party agrees and does promptly
pay to the licensing Party all such payments arising out of the grant of the license to the other Party (as mutually agreed between the
Parties in good faith).

 

“Cover”,
“Covering” or “Covered” means, with respect to a claim of a Patent and a Product, that the manufacture,
use, offer for sale, sale or importation of the Product would infringe a Valid Claim of such Patent in the country in which such activity
occurred, but for the licenses granted in this Agreement (or ownership thereof).

 

“Damages”
means all claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs (including reasonable legal expenses,
costs of litigation and reasonable attorney’s fees), or judgments, whether for money or equitable relief, of any kind and is not
limited to matters asserted by Third Parties against a Party, but includes claims, threatened claims, damages, losses, suits, proceedings,
liabilities, costs (including reasonable legal expenses, costs of litigation and reasonable attorney’s fees) or judgments incurred
or sustained by a Party in the absence of Third Party claims; provided that no Party shall be liable to hold harmless or indemnify the
applicable indemnified party, as applicable, for any claims, threatened claims, damages, losses, suits, proceedings, liabilities, costs
or judgments for punitive or exemplary damages, except to the extent the Party seeking indemnification is actually liable to a Third
Party for such punitive or exemplary damages in connection with a claim by such Third Party.

 

    4

     

    

 

“Data” shall
mean all data and information generated, collected or filed, in relation to research and development activities relating to the Product
in the Field in the Territory, including toxicology data, pharmacological data, non-clinical reports, clinical reports, single patient
clinical report forms, data points and the databases, and stability data, chemical data, quality control data (excluding the closed portion
of any drug master file), adverse event and pharmacovigilance data, marketing data, pharmaco-economic data, branding and naming research
reports, and all CMC data (including CMC (chemistry, manufacturing and control) development reports).

 

“Development”
means all activities related to research, preclinical testing, clinical development efforts, test method development and stability
testing, assay development, toxicology, formulation, process development, formulation development, delivery system development, quality
assurance and quality control development, statistical analysis, clinical pharmacology, clinical studies (including Clinical Trials)
and clinical study regulatory activities, seeking Regulatory Approval and otherwise handling regulatory affairs, statistical analysis
and report writing with respect to the Product. Development shall not include Manufacturing or Commercialization. When used as a verb,
“Develop” means to engage in Development.

 

“EMA”
means the European Medicines Agency, and any successor entity thereto.

 

“Expanded Field”
shall mean any and all preventative, therapeutic and/or diagnostic uses related to cancer in humans.

 

“FDA” means
the United States Food and Drug Administration (or any successor agency having the administrative authority to grant Regulatory Approval
in the United States).

 

“Field”
means, as of the Effective Date, the central nervous system (“CNS”) and/or cerebrocardiovascular drug application,
including the (preventive) treatment of peripheral effects of agents causing CNS disease or symptoms. Effective on receipt by 2-BBB or
its Affiliates to rights in the Expanded Field, references to “Field” in this Agreement shall be deemed to include rights
so received in the Expanded Field from time to time.

 

“Field Action”
means any action by a Party that meets the criteria of “recall,” “correction,” or “removal” or
similar field or customer action as defined by applicable Regulatory Law, including where any event, incident or circumstance has occurred
that may result in the need for a recall from the market, market suspension or market withdrawal of the Product by a Party in the Territory.

 

“First Commercial
Sale” means, with respect to a Product and any country in the Territory, the first sale of such Product under this Agreement
by a Selling Party for use in the Field to a Third Party in such country, after such Product has been granted Regulatory Approval for
distribution, marketing and sale (in each case to the extent required by Applicable Laws) in the Field by the competent Regulatory Authorities
in such country. For avoidance of doubt, First Commercial Sales exclude transfers or dispositions of a Product for charitable, promotional
(including samples), pre-clinical, clinical or regulatory purposes.

 

“Force Majeure”
means any war, revolution, civil commotion, act of terrorism, blockade, epidemic, embargo, labor strike or lock-out, scarcity of
raw materials, flood, fire, earthquake, tsunami, nuclear disaster, unforeseen change in Applicable Law or similar event that is beyond
the reasonable control of the Party affected.

 

    5

     

    

 

“Future Acquirer”
means the Third Party to any Change of Control transaction and any of such Third Party’s Affiliates.

 

“Good Clinical Practices”
or “GCP” means the then-current ethical and scientific quality standards for designing, conducting, recording, and
reporting trials that involve the participation of human subjects as are required by applicable Regulatory Authorities or Law in the
relevant jurisdiction. In the United States, GCP shall be based on Good Clinical Practices established through FDA guidances (including
Guideline for Good Clinical Practice – ICH Harmonized Tripartite Guideline (ICH E6)), and, outside the United States, GCP shall
be based on Guideline for Good Clinical Practice – ICH Harmonized Tripartite Guideline (ICH E6), as each may be amended and/or
updated from time to time.

 

“Good Laboratory
Practices” or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by
the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the United States,
as they may be amended and/or updated from time to time).

 

“Good Manufacturing
Practices” or “GMP” means all applicable then-current standards relating to manufacturing practices for
fine chemicals, intermediates, bulk products and/or finished pharmaceutical products, including (a) all applicable requirements detailed
in the FDA’s current Good Manufacturing Practices regulations, U.S. 21 C.F.R. Parts 210 and 211 and “The Rules Governing
Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products”, as each may be amended
and/or updated from time to time, and (b) all Applicable Laws promulgated by any Governmental Authority having jurisdiction over the
manufacture of any Product, as applicable.

 

“Governmental Authority”
means in any country the government entity having authority over the manufacturing, marketing, selling, pricing, reimbursement, testing,
investigating or regulating of the Product, and all states or other political subdivisions thereof and supranational bodies applicable
thereto, including the European Union, and all agencies, commissions, officials, courts or other instrumentalities of the foregoing.

 

“Grant Project Agreement”
means that certain agreement, by and between Stichting voor de Technische Wetenschappen, Stichting Koningin Wilhelmina Fonds voor de
Nederlandse Kankerbestrijding (KWF Kankerbestrijding), VU University Medical Center, University Medical Center Utrecht (UMC), University
of Twente and 2-BBB,signed by 2-BBB on February 5, 2017.

 

“IFRS”
means the International Financial Reporting Standards developed by the International Accounting Standards Board (IASB).

 

“IND”
means an Investigational New Drug application, Clinical Study Application, Clinical Trial Exemption, or similar application or submission
for approval to conduct Clinical Trials filed with or submitted to a Regulatory Authority in the applicable jurisdiction in conformance
with the requirements of such Regulatory Authority.

 

    6

     

    

 

“Insolvency Event”
means that the Party has (a) commenced a voluntary proceeding under any insolvency law, or (b) had an involuntary proceeding commenced
against it under any insolvency law which has continued undismissed or unstayed for 60 consecutive days, or (c) had a receiver, trustee
or similar official appointed for it or for any substantial part of its property, or (d) made a general assignment for the benefit of
creditors, or (e) had an order for relief entered with respect to it by a court of competent jurisdiction under any insolvency law. For
purposes hereof, the term “insolvency law” means any applicable bankruptcy, insolvency or other similar law now or hereafter
in effect.

 

“Inventions”
means any process, method, composition of matter, article of manufacture, discovery, improvement or finding that is discovered, generated
or invented (whether patentable or not) in the course of activities performed under this Agreement.

 

“ITRI Agreement”
means that certain Technology and Patent License Agreement, by and between to-BBB Taiwan Ltd. (an Affiliate of 2-BBB) and Industrial
Technology Research Institute (“ITRI”), dated 1 August 2008.

 

“Joint Know-How”
means any Know-How that is conceived or developed or, in the case of Patentable Know-How, including any Inventions, jointly by one
or more employees of 2-BBB or its Affiliates (or a Third Party acting on any of their behalf) and one or more employees of OV or its
Affiliates (or a Third Party acting on any of their behalf) in the course of such Person’s performance of activities in connection
with this Agreement.

 

“Joint Intellectual
Property” means the Joint Know-How and the Joint Patents, and all intellectual property rights therein.

 

“Joint Patent”
means any Patent that Covers Joint Know-How.

 

“Know-How”
means (a) any research information (including trade secrets, inventions (whether patentable or not), methods, knowledge, skill, experience,
data, results (including pharmacological, toxicological and clinical test data and results, chemical structures, sequences, processes,
formulae, techniques, research data, reports, standard operating procedures and batch records), analytical and quality control data,
analytical methods (including applicable reference standards), full batch documentation, packaging records, release, stability, storage
and shelf-life data, and manufacturing process information, results or descriptions, software and algorithm and (b) tangible manifestations
thereof. As used in this Agreement, “clinical test data” shall include all information related to clinical or non-clinical
testing, including patient report forms, investigators’ reports, biostatistical, pharmaco-economic and other related analyses,
regulatory filings and communications, and the like.

 

“Knowledge”
means knowledge after reasonable due inquiry with respect to the applicable facts and information.

 

“Major Country”
means the countries listed hereto on Schedule 1.

 

“Manufacture”
or “Manufacturing” means all operations necessary or appropriate to make, test, release, package, store, label,
supply and ship a Product, in accordance with applicable packaging, controls industry standards, GMPs, Applicable Laws, and the Product’s
specifications.

 

    7

     

    

 

“Marketing Authorization
Application” or “MAA” shall mean an application for Regulatory Approval in the European Union to market
a product in any country, whether filed with the EMA under the centralized EMA filing procedure or a Regulatory Authority in any country
in the European Union or any former country of the European Union.

 

“NDA”
means a “New Drug Application,” as defined in the United States Federal Food, Drug, and Cosmetic Act, as amended, and applicable
regulations promulgated thereunder by the FDA and all amendments and supplements thereto filed with the FDA, or the equivalent application
filed with any Regulatory Authority, including all documents, data, and other information concerning Product, which are necessary for
gaining Regulatory Approval to market and sell Product in the relevant jurisdiction.

 

“Net Sales”
means, on a country-by-country and Product-by-Product basis in the Territory, with respect to any period for each country, the gross
amounts invoiced by OV, its Affiliates or its or their sublicensees (each, a “Selling Party”), as applicable, to non-sublicensee
Third Parties for sales of a Product in the Field in such country, less the following deductions to the extent included in the gross
invoiced sales price for such Product or otherwise directly paid, incurred, allowed, accrued or specifically allocated by the Selling
Parties with respect to the sale of such Product in such country: (a) discounts, including trade, quantity or cash discounts, credits,
adjustments or allowances, including those granted on account of price adjustments, billing errors, rejected goods, or damaged goods,
which discounts are applied on a basis consistent with the selling Person’s practices with respect to the selling Person’s
other pharmaceutical products; (b) rebates and chargebacks allowed, given or accrued (including cash, governmental and managed care rebates,
hospital or other buying group chargebacks, cash and non-cash coupons, retroactive price reductions, and governmental taxes in the nature
of a rebate based on usage levels or sales of such Product); (c) sales, excise, turnover, inventory, value-added, import, export, excise
(including annual fees due under Section 9008 of the United States Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111-48)
and other comparable laws) and other taxes levied on, absorbed, determined or imposed with respect to the sale of such Product (excluding
income or net profit taxes or franchise taxes of any kind); (d) freight and insurance charges, customs charges, postage, shipping, handling,
REMS compliance costs and other transportation costs incurred in shipping such Product; (e) amounts paid or credited to customers for
inventory management services; and (f) the portion of any management fees paid during the relevant time period to group purchasing organizations,
wholesalers and managed care organizations to the extent determined by sales or utilization of such Product. Net Sales will be determined
in accordance with IFRS. Without limiting the generality of the foregoing, transfers or dispositions of a Product for charitable, promotional
(including samples), pre-clinical, clinical, or regulatory purposes will be excluded from Net Sales, as will sales or transfers of a
Product among the Selling Parties.

 

Subject to the above deductions, Net Sales shall
be deemed to occur on, and only on, the first sale by a Selling Party to a non-sublicensee Third Party. If non-monetary consideration
is received by a Selling Party for the Product in the relevant country, Net Sales will be calculated based on the average price charged
for such Product, as applicable, during the preceding period, or in the absence of such sales, the fair market value of the Product,
as applicable, as determined by the Parties in good faith.

    8

     

    

 

If a Product is sold as part of a Combination
Product, Net Sales will be the product of (i) Net Sales of the Combination Product calculated as above (i.e., calculated as for a non-Combination
Product) and (ii) the fraction (A/(A+B)), where:

 

“A” is the gross invoice price in
such country of the Product comprising 2B3-101 as the sole therapeutically active ingredient; and

 

“B” is the gross invoice price in
such country of the other therapeutically active ingredients

contained in the Combination Product.

 

If “A” or “B” cannot
be determined by reference to non-Combination Product sales as described above, then Net Sales will be calculated as above, but the gross
invoice price in the above equation shall be determined by mutual agreement reached in good faith by the Parties prior to the end of
the accounting period in question based on an equitable method of determining the same that takes into account, in the applicable country,
variation in dosage units and the relative fair market value of each therapeutically active ingredient in the Combination Product.

 

“Order” means
any award, injunction, judgment, decree, order, ruling, verdict or other decision issued, promulgated or entered by or with any Governmental
Authority of competent jurisdiction.

 

“Out-of-Pocket Costs”
means, with respect to certain activities hereunder, direct expenses paid or payable by either Party or its Affiliates to Third Parties
(other than employees of such Party or its Affiliates) that are specifically identifiable and incurred to conduct such activities for
the Product hereunder and have been recorded in accordance with either U.S. generally accepted accounting principles or International
Financial Reporting Standards, as designated and used by the applicable Party in preparing its financial statements from time to time.

 

“OV Platform Technology”
means all Patents and Know-How Controlled by OV and/or its Affiliates (a) as of the Effective Date, and (b) during the Term that do not
Cover Inventions and are not Know-How arising in the course of the conduct of Development activities under this Agreement. The Parties
understand and agree that any Patents, Know-How and/or Inventions related to OV’s proprietary biomarker generation platform Drug
Response Predictor (DRPTM) (including without limitation OV’s DRPTM biomarker for Doxorubicin/Epirubicin), and any new
DRPTM biomarker created for Product, shall always be considered “OV Platform Technology” hereunder (unless, but
only if, OV has specifically requested the research assistance of 2-BBB and such research assistance results in Joint Intellectual Property
under a Clinical Development Plan).

 

“Parent Corporation”
means any Person which owns, directly or indirectly, at least fifty percent (50%) of the outstanding voting securities of any Party.

 

“Party”
means 2-BBB and/or OV, as the context requires.

 

“Patent” means
any and all (a) patent applications filed under Applicable Laws in any jurisdiction, including all provisional applications, substitutions,
continuations, continuations-in- part, divisions, renewals, and all patents granted thereon; (b) all patents, reissues, reexaminations
and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates
or the equivalent thereof; and (c) any other form of government-issued right substantially similar to any of the foregoing.

 

    9

     

    

 

“Person” means
any individual or entity (including partnerships, corporations, limited liability companies, trusts and Governmental Authorities).

 

“Phase 1 Clinical
Trial” means (a) both a Phase 1a Clinical Trial and a Phase 1b Clinical Trial, or (b) a single trial that may contain elements
of both a Phase 1a Clinical Trial and a Phase 1b Clinical Trial.

 

“Phase 1a Clinical
Trial” means a human clinical trial of a compound, the principal purpose of which is a preliminary determination of safety,
pharmacokinetics, and pharmacodynamic parameters in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar
clinical study prescribed by the Regulatory Authorities in a foreign country.

 

“Phase 1b Clinical
Trial” means a human clinical trial of a compound, the principal purpose of which is a further determination of safety and
pharmacokinetics (including exploration of trends of a biomarker-based or clinical endpoint-based efficacy relationship to dose which
are not designed to be statistically significant) of the compound whether or not in combination with concomitant treatment after an initial
Phase 1a Clinical Trial, prior to commencement of Phase 2 Clinical Trials or Phase 3 Clinical Trials, and which provides (itself or together
with other available data) sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Phase 3 Clinical
Trial with Regulatory Authorities, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

 

“Phase 2 Clinical
Trial” means a human clinical trial of a product in any country that would satisfy the requirements of U.S. 21 C.F.R. Part
312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical
safety and effectiveness for a particular indication or indications in a target patient population, or a similar clinical study prescribed
by the relevant Regulatory Authorities in a country other than the United States.

 

“Phase 3 Clinical
Trial” means a human clinical trial of a product in any country that would satisfy the requirements of U.S. 21 C.F.R. Part
312.21(c) and is intended to (a) establish that the product is safe and efficacious for its intended use, (b) define contraindications,
warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support
Regulatory Approval for such product, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other
than the United States.

 

“Pivotal
Clinical Trial” means a human clinical trial of a product on a sufficient number of subjects that, prior to commencement
of the trial, satisfies both of the following ((a) and (b)):

 

(a) such trial is designed
to establish that such product has an acceptable safety and efficacy profile for its intended use, and to determine warnings, precautions,
and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support
Regulatory Approval of such product, or a similar clinical study prescribed by the U.S. or EMA; and

 

    10

     

    

 

(b) such trial is a registration
trial sufficient for filing an application for a Regulatory Approval for such product in the U.S. or the EMA, as evidenced by (i) an
agreement with or statement from the FDA or the EMA on a Special Protocol Assessment or equivalent, or (ii) other guidance or minutes
issued by the FDA or EMA, for such registration trial.

 

“Platform Patents”
means those Patents listed on Schedule 2 attached hereto under the heading “Platform Patents” as well as any Patent,
other than the Product-Specific Patents, owned or Controlled by 2-BBB or its Affiliates as of the Effective Date and during the Term
that: (a)(i) claims or Covers any 2-BBB Know-How and/or the Product, and (ii) is necessary or useful to Develop, Manufacture or Commercialize
the Product in the Field in the Territory, and (b) does not specifically describe or reference a Product or exploitation of a Product
in the Field. For clarity, a Patent owned or Controlled by 2-BBB or its Affiliates that arises after the Effective Date cannot be both
a Platform Patent and a Product-Specific Patent.

 

“Product-Specific
Patents” means those Patents listed on Schedule 2 attached hereto under the heading “Product-Specific Patents”
as well as any Patent, other than the Platform Patents, owned or Controlled by 2-BBB or its Affiliates as of the Effective Date and during
the Term that: (a)(i) claims or Covers any 2-BBB Know-How and/or the Product, and (ii) is necessary or useful to Develop, Manufacture
or Commercialize the Product in the Field in the Territory, and (b) specifically describes or references a Product or exploitation of
a Product in the Field. For clarity, a Patent owned or Controlled by 2-BBB or its Affiliates that arises after the Effective Date cannot
be both a Platform Patent and a Product-Specific Patent.

 

“Product”
means all preparations, compositions and formulations of 2-BBB’s pharmaceutical drug known as 2B3-101 (as more specifically
described on Exhibit B), a cancer drug that is a Glutathione-enhanced PEG-liposomal formulation of the chemotherapeutic Doxorubicin,
together with all current and future formulations, versions, compositions and presentations of product, together with any improvements
or modifications, that use 2B3-101 as its active pharmaceutical ingredient alone or in combination with other therapeutically or prophylactically
active pharmaceutical ingredients as part of a Combination Product.

 

“Product Complaint”
means any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability,
safety, delivery, effectiveness or performance of the Product after it is released by OV for distribution.

 

“Proprietary Information”
means a Party’s trade secrets, know-how, business plans, manufacturing processes, clinical strategies, product specifications,
scientific data, market analyses, formulae, designs, training manuals and other non-public information (whether business, financial,
commercial, scientific, clinical, regulatory or otherwise) that the Party treats as proprietary and uses Commercially Reasonable Efforts
to protect.

 

“Prosecute”
or “Prosecution” means, with respect to Patents, the preparation of, filing for, prosecuting, responding to oppositions,
nullity actions, re-examinations, revocation actions and similar proceedings (including conducting or participating in interference,
oppositions, reissue proceedings, reexaminations, post-grant proceedings and any other similar proceeding relating thereto) filed by
Third Parties against, and maintaining, Patents.

 

    11

     

    

 

“Regulatory Approval”
means the approval and authorization of a Regulatory Authority in a country or regulatory jurisdiction necessary to develop, manufacture,
distribute, sell or market a pharmaceutical product in that country or regulatory jurisdiction (including without limitation all applicable
pricing and reimbursement approvals in any country or regulatory jurisdiction in the Territory, other than the United States, whether
or not required under Applicable Laws (all such applicable pricing and reimbursement approvals, “Pricing and Reimbursement Approval”));
it being understood and agreed that, if OV enters into a Program Acquirer Agreement with a Program Acquirer for Development of the Product
that does not require Pricing and Reimbursement Approval for purposes of satisfying milestone payment obligations owed to OV in connection
with Regulatory Approval of the Product in the Territory under the Program Acquirer Agreement, Pricing and Reimbursement Approval shall
not be required for purposes of achieving the Development Milestone Events hereunder.

 

“Regulatory Authority”
means, with respect to any country or jurisdiction, any Governmental Authority involved in granting Regulatory Approval or in administering
Regulatory Laws in that country or jurisdiction.

 

“Regulatory Documentation”
shall mean all applications, registrations, licenses, authorizations, approvals (including all Regulatory Approvals), and correspondence
(registration and licenses, pricing and reimbursement correspondence, regulatory drug lists, advertising and promotion documents) submitted
to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory
Authority) and all supporting documents in connection therewith, and all non-clinical, preclinical trials and Clinical Trials, tests
and biostudies, relating to the use of the Product in the Field, or as required for regulatory purposes (including all Regulatory Approvals)
and all Data contained in any of the foregoing, including all INDs, NDAs and Regulatory Approvals, regulatory drug lists, advertising
and promotion documents, manufacturing data and records, drug master files, inspection reports, Data from Clinical Trials, the SMS Oncology
Report, adverse event files and complaint files, in each case related to the Product in the Field, or as required for regulatory purposes.

 

“Regulatory Laws”
means all Applicable Laws governing the import, export, testing, investigation, manufacture, marketing or sale of a product, or establishing
recordkeeping or reporting obligations for Product Complaints or Adverse Events, or relating to Field Actions or similar regulatory matters.

 

“Right
of Reference or Use” means a “Right of Reference or Use” as that term is defined in 21 C.F.R. §314.3(b),
and any non-United States equivalents.

 

“Royalty Term”
means, on a Product-by-Product and country-by-country basis, the period of time commencing on the First Commercial Sale of any Product
in such country and expiring upon the latest of (a) the expiration of the last Valid Claim of a Patent within (i) the 2-BBB Intellectual
Property and/or (ii) the Joint Intellectual Property in such country (if, but only if, such Joint Intellectual Property arose from activities
under the Clinical Development Plan) , or (b) the tenth (10th) anniversary of the date of First Commercial Sale of such Product
in such country.

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“Sale Agreement”
means that certain sales agreement between 2-BBB and the receiver (Mr. Udink) dated 24 March 2015 (including an addendum to this sales
agreement dated 7 September 2015).

 

“SMS Oncology Report”
means the clinical trial study report for prior clinical trials of 2B3-101 (Study No. SMS-0357/2B3-101-CR-001) being prepared, as of
the Effective Date, by SMS Oncology BV, a clinical research organization having offices at Science Park 408, 1098 XH Amsterdam, The Netherlands,
which Report was ordered by 2-BBB for the benefit of OV and paid for by OV and shall be owned by 2-BBB; it being understood and agreed
that 2-BBB’s interest in the “SMS Oncology Report” shall be deemed included in the Data transferred to OV hereunder.

 

“Successful Completion”
means that the Phase 2 Clinical Trial to be conducted by OV and/or its Affiliates or sublicensees hereunder results in at least a fifty
percent (50%) increase of response rate or progression free survival in treated patients as compared to a patient population in which
DRPTM biomarker was not used to select patients (as defined in the SMS Oncology Report).

 

“Territory”
means worldwide.

 

“Third Party”
means any Person other than the Parties and their Affiliates.

 

“US” or
“United States” means the United States of America.

 

“Valid Claim”
means, with respect to a particular country, (a) a claim of a pending Patent claiming priority from any Patent that has been pending
for no more than five (5) years following the earliest priority filing date for such Patent and that has not been abandoned, finally
rejected or expired without the possibility of appeal or refiling or (b) a claim of an issued and unexpired Patent and that has not been
held permanently revoked, held unenforceable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction,
which decision is unappealed or unappealable within the time allowed for appeal and has not been cancelled, withdrawn, abandoned, disclaimed
or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; it being understood and agreed that “Valid
Claims” shall only apply to claims for the composition of matter or method of use of a Product in the Field. For clarity, a claim
of a patent that ceased to be a Valid Claim before it issued because it had been pending too long, but subsequently issued and is otherwise
described by clause (a) of the foregoing sentence shall again be considered to be a Valid Claim once it issues. A Product is “Covered”
by a Valid Claim if its registration, manufacture, use, sale, offer for sale, marketing, Commercialization, distribution, importation
or exportation by OV in a given country in the Territory would, but for the rights granted by 2-BBB to OV under this Agreement, infringe
such Valid Claim.

 

Section 1.2 Terms Defined
Elsewhere in this Agreement.

 

Capitalized terms defined
in other provisions of this Agreement shall have the meanings specified therein. Those terms include the following:

 

	Term	 	Section
	 	 	 
	2-BBB	 	Preamble

 

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	Term	 	Section
	 	 	 
	2-BBB Indemnified Parties	 	Section 10.2(a)
	2-BBB Trademarks	 	Section 2.4(a)
	Additional Third Party License	 	Section 7.2(e)
	Agreement	 	Preamble
	Auditee	 	Section 13.2(e)
	Audit Rights Holder	 	Section 13.2(e)
	 Audit Team	 	Section 13.2(a)
	Business Program	 	Section 5.2
	Challenge	 	Section 14.2(e)
	Claim	 	Section 10.1
	Confidential Information	 	Section 12.1(a)
	Development Milestone Events	 	0
	Dispute	 	Section 15.3
	Effective Date	 	Preamble
	ICC	 	Section 15.3
	Infringement Claim	 	Section 9.6
	JDC	 	Section 3.1(a)
	OV	 	Preamble
	OV Indemnified Parties	 	Section 10.1
	OV Know-How	 	Section 9.1(b)
	OV Patents	 	Section 9.1(b)
	OV Technology	 	Section 9.1(b)
	Program Acquirer	 	Section 6.1
	Program Acquirer Agreement	 	Section 6.1
	Recovery	 	Section 9.4(a)
	Rules	 	Section 15.3
	Sales Milestone Events	 	0
	Term	 	Section 14.1
	Trademark Recovery	 	Section 9.7

 

Section 1.3 Rules of
Construction.

 

(a) Elements of this Agreement.
When a reference is made in this Agreement to a Recital, an Article, a Section, a Schedule, an Attachment or an Exhibit, such reference
is to a Recital, Article or Section of, or a Schedule, Attachment or Exhibit to, this Agreement, unless otherwise indicated.

 

(b) Meaning of “Include”
and Variations Thereof. Whenever the words “include,” “includes” or “including” are used in this
Agreement, they shall be understood to be followed by the words “without limitation.”

 

(c) Use of Pronouns.
Pronouns, including “he,” “she” and “it,” when used in reference to any person, shall be deemed applicable
to entities or individuals, male or female, as appropriate in any given case.

 

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(d) Headings. Article,
Section and other headings contained in this Agreement are for reference purposes only and are not intended to describe, interpret, define
or limit the scope, extent or intent of any provision of this Agreement.

 

(e) Variations on Terms.
Standard variations on defined terms (such as the plural form of a term defined in the singular form, and the past tense of a term
defined in the present tense) shall be deemed to have meanings that correlate to the meanings of the defined terms.

 

(f)
Currency References. All references to “dollars” or “$” shall be deemed to be references to the
lawful currency of the United States.

 

ARTICLE 2

Grant of Rights

 

Section 2.1 Grant of
2-BBB Intellectual Property and Retention of Rights.

 

(a) During the Term, subject
to the terms and conditions of this Agreement, 2-BBB, on behalf of itself and its Affiliates, hereby grants to OV and OV’s Affiliates
an exclusive (even as to 2-BBB), royalty-bearing right and license under the 2-BBB Intellectual Property to develop, make, have made,
store, use, sell, have sold, import, export and otherwise Commercialize Product in the Field in the Territory. For clarity, in the foregoing
sentence, “exclusive” means that neither 2- BBB nor its Affiliates shall, for its or their own account, and shall not grant
to any Third Party the right and license under the 2-BBB Intellectual Property to, develop, make, have made, store, use, sell, have sold,
import, export and otherwise commercialize Product in the Field in the Territory.

 

(b) 2-BBB, on behalf of itself
and its Affiliates, hereby grants OV and OV’s Affiliates a Right of Reference or Use to all Data and Regulatory Documentation (including
all Regulatory Approvals) related to the Product owned or Controlled by 2-BBB or its Affiliates as of the Effective Date and during the
Term for all uses in connection with the Product for Development, Manufacturing and Commercialization in the Field in the Territory.

 

(c) OV hereby grants to 2-BBB
a non-exclusive license, with the right to sublicense to use the 2-BBB Intellectual Property for the specific research purpose as further
described in the Grant Project Agreement solely for pre-clinical research in pediatric cancers in combination therapy with other pharmaceutical
products (and in no case involving Development involving Clinical Trials or Commercialization of the Product). Any Patents or Know-How
resulting from use of such non-exclusive license by 2-BBB and its Affiliates and permitted sublicensees, which shall be owned by 2-BBB
or its Affiliates, shall be deemed included in the 2-BBB Intellectual Property. Any Patents or Know-How resulting from use of such non-exclusive
license by 2-BBB and its Affiliates and permitted sublicensees, which shall not be owned by 2-BBB or its Affiliates, shall not be deemed
included in the 2-BBB Intellectual Property. In the latter case, 2-BBB shall assist OV and use its Commercial Reasonable Efforts to obtain
a license to these Patents or Know- How on fair market conditions.

 

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Section 2.2 Sublicenses.

 

(a)
OV shall have the right to grant sublicenses with respect to OV’s rights and obligations under this Agreement to (i) any
Affiliates of OV and (ii) Third Parties; provided that, with respect to sublicenses granted to Third Parties, subject to Section
6.1, (x) OV provides 2-BBB with written notice of such sublicense promptly after the grant of such sublicense, which notice shall not
be required for rights granted to distributors, wholesalers or marketing agents, (y) such sublicense shall be in writing and shall be
consistent with the applicable terms and conditions of this Agreement, and (z) OV shall remain responsible for performance of this Agreement.

 

(b) Should this Agreement
terminate for any reason, 2-BBB shall have the right but not the obligation to grant such sublicensee a direct license to the 2-BBB Intellectual
Property in the Territory and the Field.

 

Section 2.3 Expanded Field.
2-BBB shall use its Commercially Reasonable Efforts to obtain the Expanded Field from ITRI and its Affiliates within twelve (12) months
following the Effective Date; provided, that in the event 2-BBB and/or its Affiliates are unable to obtain such rights within twelve
(12) months following the Effective Date, the rest of the terms and conditions of this Agreement with respect to obtaining rights to
the Expanded Field shall remain in effect (subject to Section 7.2(a)). The Parties understand and agree that, effective on 2-BBB’s
or its Affiliates’ receipt of the Expanded Field (whether or not prior to twelve (12) months following the Effective Date), the
rights and licenses granted to OV hereunder shall automatically be deemed to include the Expanded Field. If 2-BBB has not been able to
obtain rights to the Expanded Field within twelve (12) months of the Effective Date, the Parties understand and agree that OV shall be
entitled to directly negotiate with ITRI, its Affiliates or any other Third Party for the Expanded Field. For the avoidance of doubt,
during the first twelve (12) months of this Agreement, OV shall not be entitled to directly negotiate with and/or contact ITRI, its Affiliates
or any other Third Party for the Expanded Field without the prior written approval of 2-BBB.

 

Section 2.4 Trademark(s).

 

(a) Subject to the terms
and conditions of this Agreement, 2-BBB hereby grants to OV and its Affiliates an exclusive, sublicensable, right to use the trademark(s)
associated with the Product for use in the Field in the Territory (the “2-BBB Trademarks”); provided, however, that
OV shall not be obliged to use such trademark(s). 2-BBB shall be the sole and exclusive owner of the 2-BBB Trademark(s). OV acknowledges
the rights of 2-BBB in and to the 2-BBB Trademark(s) and agrees that: (i) OV has not acquired, and OV will not represent in any manner
that OV has acquired, any ownership rights in the 2-BBB Trademark(s); (ii) the restrictions and limitations with respect to OV’s
use of the 2-BBB Trademark(s) under this Agreement apply to all forms and formats used in commerce; and (iii) all goodwill associated
with the 2-BBB Trademark(s) is the property of 2-BBB and shall inure directly and exclusively to the benefit of 2- BBB.

 

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(b)
To the extent OV or its Affiliates uses any 2-BBB Trademark(s), OV shall, and shall cause its Affiliates, to use such trademark(s) in
accordance with, and subject to, the terms of this Agreement and any other non-monetary conditions or other requirements that are reasonably
necessary to maintain quality control, as imposed by 2-BBB in writing from time to time. It is understood that OV shall not acquire and
shall not claim any title to such 2-BBB Trademark(s) adverse to 2-BBB by virtue of the license granted herein. In order to preserve the
inherent value of the 2-BBB Trademark(s), OV shall use reasonable efforts to ensure that its or its Affiliates use, if any, of the 2-BBB
Trademark(s) conforms to reasonable industry standards for quality and otherwise complies with all Applicable Laws. OV shall use
reasonable efforts to ensure that it or its Affiliates include all markings and legends in connection with its/their use of the 2-BBB
Trademark(s) as required by Applicable Laws or reasonably appropriate in order to give appropriate notice of trademark rights. At 2-BBB’s
written request, OV agrees to assist 2-BBB to the extent reasonably necessary to verify OV’s compliance with the foregoing quality
control and markings provisions. 2-BBB retains any and all rights under the 2-BBB Trademark(s) relating to the Product that are registered
by 2-BBB necessary for 2-BBB to perform its obligations under this Agreement. 2-BBB shall retain any and all exclusive rights to the
2-BBB Trademark(s) relating to the Product. 2-BBB shall be solely responsible for maintaining and renewing, enforcing and defending,
the 2-BBB Trademarks and shall solely bear the costs associated therewith.

 

(c) Subject to the terms
and conditions of this Agreement, OV and/or its designee shall have the right, but not the obligation, to register its own trademark(s)
relating to the use of the Product in the Field in the Territory. Neither 2-BBB nor any of its Affiliates will challenge any such trademark
applications that OV or its designee files.

 

Section 2.5 Rights to Improvements. OV,
its Affiliates and permitted sublicensees shall have the right to make improvements to the 2-BBB Intellectual Property, and to utilize
such improvements to develop, make, have made, store, use, sell, have sold, import, export and otherwise commercialize Product in the
Field in the Territory.

 

ARTICLE 3

Product Development

 

Section 3.1 Governance.

 

(a) Within thirty (30) days
after the Effective Date, 2-BBB and OV will establish a joint development committee (the “JDC”) to implement and oversee
Development activities in the Field in the Territory pursuant to the Clinical Development Plan, and will serve as a forum for exchanging
data, information and Development strategy regarding the Product. The JDC will consist of five (5) voting representatives, which initial
representatives shall be as follows: (i) for OV, Peter Buhl-Jensen (who shall serve as Chairman), Steen Knudsen and Mogens Winkel Madsen;
(ii) for 2-BBB, Pieter Gaillard; and (iii) one (1) additional member as the Parties shall mutually agree from time to time. OV shall
additionally have the right to appoint a non-voting member to sit on the JDC, which initial non-voting member shall be Bruce Pratt. Each
Party will designate a JDC member who will be the primary contact on the JDC for that Party. Each Party may send a delegate to a meeting
of the JDC or replace any or all of its representatives on the JDC at any time upon written notice to the other in accordance with Section
15.6 of this Agreement. Notwithstanding anything to the contrary contained herein, the Parties understand and agree that the JDC shall
be disbanded upon the earlier to occur of (x) Regulatory Approval of the Product by (1) the FDA, (2) the European Medicines Agency or
(3) any Regulatory Authority in the United Kingdom, Germany or France and (y) the execution of the Program Acquirer Agreement; it being
understood that, for clarity, all further Development activities shall either be, subject to ARTICLE 6, conducted by OV or the Program
Acquirer and/or their Affiliates or sublicensees (provided that the Parties may agree to certain joint development activities of Product
under this Agreement pursuant to the Clinical Development Plan). On a semi-annual basis during the Term after upon disbandment of the
JDC, OV shall deliver to 2-BBB a detailed written report summarizing the Development and Commercialization activities conducted by or
on behalf of OV with respect to the Product hereunder.

 

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(b) The JDC shall meet at
least once per Calendar Quarter (or more frequently as the Parties deem necessary) in person or by video or telephone conference. Meetings
of the JDC that are held in person shall be held at the offices of OV, or at such other place as the Parties may agree. Each Party will
bear its own costs for travel, accommodation and the like in relation to attending such meetings. The specific timing and location of
the JDC meetings will be determined by the Chairman (provided, that such meetings shall only be held on dates as such Parties mutually
agree). An agenda shall be agreed upon by the JDC members and be distributed to the Parties by OV no less than ten (10) Business Days
before any meeting. OV shall be responsible for creating the meeting minutes. OV will bear the aforementioned costs of the additional
member and the non- voting member of the JDC in relation to attending the meetings of the JDC. Each Party shall use reasonable efforts
to cause its representatives to attend the meetings of the JDC, provided that at least one (1) of OV’s representatives and the
2-BBB representative must be present at each meeting. Each JDC representative shall have one (1) vote on the JDC.

 

(c) The JDC will be responsible
for (i) implementing and overseeing the Clinical Development Plan and regulatory strategy for the Product in the Field in the Territory,
(ii) attempting to resolve disputes arising under this Agreement with respect to Development activities and (iii) performing such other
Development functions set forth in this Agreement.

 

(d) Except as otherwise set
forth in this Agreement, all decisions of the JDC shall be made by a simple majority vote (consisting of more than fifty percent (50%)
of the votes cast), with each representative having one (1) vote. If the JDC cannot agree on a matter for which the JDC has decision-making
authority within fifteen (15) Business Days after it has met and attempted to reach such decision, then the Chairman shall have the controlling
vote and decision.

 

Section 3.2 Development.
Subject to Article 6, OV (directly or through one or more Affiliates and/or sublicensees) shall either (a) be solely responsible for,
and use Commercially Reasonable Efforts to, obtain Regulatory Approval for the Product in the Field in the Major Countries, whether or
not pursuant to the Clinical Development Plan, or (b) enter into an agreement with a Program Acquirer pursuant to Section 6.1 for the
further Development of Product. Subject to the terms and conditions of this Agreement, OV shall bear one hundred percent (100%) of all
costs and expenses associated with the Development of Product.

 

Section 3.3 Transfer.
Within sixty (60) days after the Effective Date, 2-BBB shall disclose and provide to OV, at 2-BBB’s cost, all tangible embodiments
of data and information concerning the 2-BBB Intellectual Property, Regulatory Documentation and Data (including as applicable (a) all
safety data for the Product and (b) by providing reasonable assistance with respect to the transfer of ownership, control and sponsorship,
as applicable, of any INDs relating to the Product, as well as preclinical and clinical data, manufacturing and CMC data, in its Control
as of the Effective Date critical to, necessary or useful for developing, making, using or selling Products in the Territory).

 

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Section 3.4 Assistance.
During the Term, 2-BBB will cooperate with OV to provide reasonable assistance requested by OV to facilitate the transfer of (a) ownership,
control and sponsorship, as applicable, of any INDs relating to the Product, (b) Development, Manufacture and Commercialization responsibilities
to OV as required under this Agreement, including providing reasonable assistance with respect to regulatory and Manufacturing transition
matters related to Product, and (c) the Know-How licensed to OV under Section 2.1, including without limitation preclinical and clinical
data, manufacturing and CMC data, in its Control as of the Effective Date critical to, necessary or useful for developing, making, using
or selling Product in the Territory. Such cooperation will include providing OV with reasonable access by teleconference or in-person
to 2-BBB personnel involved in the research, Development and Manufacture of Product. Only if and to the extent requested by OV, 2-BBB
shall provide OV with a reasonable level of assistance and consultation in connection with the assistance described in this Section 3.4.
OV shall pay a fair compensation for 2-BBB’s assistance and consulting activities which have been mutually pre-agreed by the Parties
(including Out-of-Pocket Costs).

 

Section 3.5 Pharmacovigilance.
OV will deploy and administer any safety monitoring activity implemented for the Product in the Territory, and be responsible for all
pharmacovigilance activities for the Product in the Territory. In addition:

 

(a) 2-BBB shall cooperate
with OV and share information concerning the pharmaceutical safety of Product, including any Product complaints, adverse event information
and safety data from clinical studies that shall become in its possession and control during the Term. 2-BBB shall promptly advise OV
of any information that comes to its knowledge that may affect the safety, effectiveness or labelling of such Product and any actions
taken in response to such information, as such actions may be required for 2-BBB’s and OV’s compliance with pharmacovigilance
requirements towards Third Parties.

 

(b) Subject to any obligations
owed by OV to Third Parties, OV shall cooperate with 2-BBB and share information concerning the pharmaceutical safety of Product, at
2-BBB’s expense, including any Product complaints, adverse event information and safety data from clinical studies that shall become
in its possession and control during the Term. OV shall promptly advise 2-BBB of any information that comes to its knowledge that may
affect the safety, effectiveness or labelling of such Product and any actions taken in response to such information, as such actions
may be required for OV’s and 2-BBB’s compliance with pharmacovigilance requirements towards Third Parties.

 

(c) OV shall be solely responsible
for reporting all adverse drug experiences associated with the Product in the Territory, and for establishing, holding and maintaining
the global safety database for Product. 2-BBB shall provide OV with all Product complaints, adverse event information and safety data
from clinical studies that are in its possession and control and that are necessary or desirable for OV to comply with all Applicable
Laws with respect to Product, as such actions may be required for 2-BBB’s and OV’s compliance with pharmacovigilance requirements
towards Third Parties.

 

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Section 3.6 Manufacturing.
OV shall be solely responsible for Manufacturing and supplying Product in the Territory and shall be entitled to identify and manage
Third Party contract manufacturers, as well as lead all supply chain management and quality control activities. 2-BBB hereby agrees to
transfer to OV all of the inventory of drug substance for Product hereunder held by 2-BBB on the Effective Date (including raw materials,
intermediates, and finished, unfinished, or partially finished goods) in the Territory. 2-BBB agrees to and shall use reasonable efforts
to assist OV with (i) the establishment of a manufacturing agreement for Product with TTY BioPharm (the existing manufacturer in Taiwan),
(ii) the manufacturing and release, by TTY BioPharm, of at least 2 GMP batches of Product, (iii) the establishment of an agreement with
NOF Corporation (the existing manufacturer in Japan) for supplying the critical excipient DSPE- PEG2000-mal (= N-[N’-(3’-Maleimido-1’-oxopropyl)aminopropyloxyethylene
oxycarbonyl]- 1,2-distearoyl-sn-glycero-3-phosphoethanolamine) necessary to formulate Product, and (iv) the establishment of an agreement
with Almac Clinical Services (the existing importer in the United Kingdom) for import of Product into the EU, labeling, secondary packing,
final QP release and world-wide distribution of Product to investigational/clinical trial sites. Pursuant to Section 8.2 of the ITRI
Agreement, certain Product (as defined in the ITRI Agreement) may not be commercially manufactured outside the Republic of China without
the approval of the Ministry of Economic Affairs of the Republic of China, as and to the extent set forth on Schedule 3.6. 2-BBB shall
use its Commercially Reasonable Efforts to work with ITRI to obtain such approval.

 

Section 3.7 No Other Rights.
2-BBB and OV each acknowledges and agrees that, except as expressly granted under this Agreement, no right, title, or interest of any
nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by either Party to the other Party. All rights
with respect to technology, Patents or other Intellectual Property Rights that are not specifically granted herein are reserved.

 

Section 3.8 Bankruptcy.
Subject to Applicable Law (including Dutch bankruptcy law), as and to the extent applicable (taking into account principles of comity),
all rights and licenses granted under or pursuant to this Agreement, including amendments hereto, are, for all purposes of 11 U.S.C.
§ 365(n), licenses of rights to intellectual property as defined in the United States Bankruptcy Code, and any comparable Law of
a relevant jurisdiction. Each Party may elect to retain and may fully exercise all of its rights and elections under 11 U.S.C. §
365(n). The Parties further agree that, in the event of the commencement a bankruptcy proceeding by or against 2- BBB under the United
States Bankruptcy Code (taking into account principles of comity), OV shall be entitled to a complete duplicate of (or complete access
to, as appropriate) any intellectual property licensed to OV and all embodiments of such intellectual property, which, if not already
in OV’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon OV’s
written request therefor, unless 2-BBB elects to continue to perform all of its obligations under this Agreement or (b) if not delivered
under clause (a), following the rejection of this Agreement by 2-BBB upon written request therefor by OV.

 

Section 3.9 No Representation.
Subject to the foregoing obligation to use Commercially Reasonable Efforts, neither Party makes any representation, warranty or guarantee
that the Product will be successful, or that any other particular results will be achieved with respect to the Product hereunder.

 

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ARTICLE 4

Commercialization Activities.

 

Section 4.1 Commercialization
Responsibilities. Subject to the terms and conditions of this Agreement, OV will be responsible, at its own cost, for all Commercialization
activities for the Product in the Field in the Territory where Regulatory Approval is expected to be or has been obtained, including
all costs and expenses relating thereto. Within forty-five (45) days after the end of each Calendar Quarter beginning with the Calendar
Year in which the First Commercial Sale is made in a country following receipt of Regulatory Approval in such country, OV shall deliver
to 2-BBB a report setting forth for the previous Calendar Quarter the Selling Parties’ gross sales and Net Sales in the Territory
on a country-by-country basis, and inventory levels. OV shall have sole discretion to establish the pricing and other terms and conditions
of sale of the Product to its customers.

 

ARTICLE 5

Non-Compete.

 

Section 5.1 Non-Compete.
Except as contemplated under this Agreement with respect to the Product, neither Party nor its Affiliates shall, at any time during the
Term, either on its own behalf or through any Affiliate or Third Party, directly or indirectly make, market, promote, sell, offer for
sale, import, export or otherwise Commercialize (a) a Competitive Product, or (b) any anthracycline combined with 2-BBB’s Glutathione-enhanced
PEG-liposomal delivery system (an “Enhanced Anthracycline”) or (c) any other liposomal formulations of anthracyclines,
in the case of (a) – (c), in the Field in the Territory.

 

Section 5.2 Change of
Control Exception. Notwithstanding Section 5.1, if a Change of Control occurs with respect to a Party and, in each case, the Third
Party (or any of such Third Party’s then-existing Affiliates) already has, or the acquired assets contain, as applicable, a program
that existed prior to the Change of Control that would otherwise violate Section 5.1 at the time of such Change of Control (a “Business
Program”), then such Third Party (or such Third Party’s Affiliate) or such Party, as applicable, shall be permitted to
continue such Business Program after the closing of such Change of Control and such continuation shall not constitute a violation of
Section 5.1 provided that (i) neither the 2-BBB Intellectual Property nor the Joint Intellectual Property shall be used in the Business
Program, and (ii) the research or development activities required under this Agreement shall be segregated from any research or development
activities directed to such Business Program, including the maintenance of separate lab notebooks and records (password-protected to
the extent kept on a computer network) and the use of separate personnel to perform the activities under this Agreement and the activities
covered under such Business Program. The Party undergoing the Change of Control shall adopt reasonable procedures to limit the dissemination
of the other Party’s Confidential Information to only those personnel having a need to know such Confidential Information in order
for such Party or the Third Party, as applicable, to perform its obligations or to exercise its rights under this Agreement, including
adopting reasonable procedures and policies that prohibit and limit the use and disclosure of such Confidential Information in a competitive
manner against the other Party and its Affiliates, and adopting reasonable procedures and policies that prohibit or limit such Confidential
Information from being disclosed to or used by any Person who is also working on or making scientific, intellectual property or commercial
decisions regarding the Product at the time of receipt or use of any such Confidential Information, or within three (3) years following
receipt or use of any such Confidential Information.

 

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ARTICLE 6

Product Acquisition

 

Section 6.1 Third Party
Acquirer. Following completion of a Phase 2 Clinical Trial for the Product pursuant to the Clinical Development Plan, OV and 2-BBB
shall cooperate to identify one or more potential Third Party (a “Program Acquirer”) to acquire (whether through sale,
license, merger or otherwise) and assume the rights to Develop, Manufacture and Commercialize the Product in the Field in the Territory.
The Parties understand and agree that entry into any such agreement with a Program Acquirer (the “Program Acquirer Agreement”)
shall be at the sole discretion of OV with the consent of 2-BBB, not to be unreasonably withheld or delayed; provided that 2-BBB shall
be deemed to consent to such transaction where the Program Acquirer, together with its Affiliates, had at least Fifty Million US Dollars
($50,000,000.00) of sales in the immediately preceding Calendar Year derived from sales of pharmaceutical products. If a suitable Third
Party Acquirer is not secured within twelve (12) months following the completion of a Phase 2 Clinical Trial OV shall continue to use
Commercially Reasonable efforts, either itself or through its Affiliates, to advance the Product through Phase 3 Clinical Trials and
Commercialize the Product.

 

ARTICLE 7

Payments

 

Section 7.1 Upfront Payment.
In consideration of the rights granted to OV under this Agreement, OV shall pay to 2-BBB a one-time, non-refundable and non-creditable
payment of [***] payable as follows: [***] no later than ten (10) Business Days after the Effective Date; and [***] having already been
paid, prior to the Effective Date, pursuant to the Binding Term Sheet – of which [***] was for the SMS Oncology Report.

 

Section 7.2 Royalties.

 

(a) Product Royalties.
OV shall pay 2-BBB royalties on Annual Net Sales equal to the following portions of Annual Net Sales multiplied by the applicable royalty
rate for such portion during the applicable Royalty Term for each such Product in accordance with Section 7.2(g(g):

 

	Annual
    Net Sales	Royalty
    Rate
	Annual
    Net Sales above $0, up to and including One Hundred Million U.S. Dollars ($100,000,000.00)	[***]
	Annual
    Net Sales above One Hundred Million U.S. Dollars ($100,000,000.00), up to and including Two Hundred Fifty Million U.S. Dollars ($250,000,000.00)	[***]
	Annual
    Net Sales above Two Hundred Fifty Million U.S. Dollars ($250,000,000.00)	[***]

 

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Each Royalty Rate set forth in the table above
will apply only to that portion of the Annual Net Sales of Product in the Territory during a given Calendar Year that falls within the
indicated range.

 

For example, if Annual Net Sales of Product in
the Territory by OV, its Affiliates and sublicensees was Three Hundred and Fifty Million U.S. Dollars ($350,000,000), then the royalties
payable with respect to such Annual Net Sales, subject to adjustment as set forth in this Section 7.2, would be:

 

[***]

 

Notwithstanding anything to the contrary contained
herein, the Parties understand and agree that if 2-BBB is unable to expand the Field to include the entire Expanded Field within twelve
(12) months of the Effective Date, the Royalty Rates set forth in the table above shall be irrevocably reduced by [***] and, for clarity,
such reduced Royalty Rate shall be subject to the rest of the provisions of this Section 7.2.

 

(b) Fully Paid-Up, Royalty
Free License. Following expiration of the Royalty Term for the Product in a given country, no further royalties will be payable in
respect of sales of Product in such country and, thereafter the license granted to OV hereunder with respect to Product in such country
will automatically become fully paid-up, perpetual, irrevocable and royalty-free.

 

(c)
Royalty Term; Reduction. OV’s royalty obligations to 2-BBB under Section 7.2 shall be on a country-by-country basis for
the applicable Royalty Term in such country; provided that the royalty amounts payable with respect to Annual Net Sales shall be reduced
on a country-by-country basis, to [***] of the amounts otherwise payable pursuant to Section 7.2(a),
during any portion of the Royalty Term in which there is not at least one (1) Valid Claim of a Patent within the 2-BBB Intellectual Property
that Covers such Product in such country. Only one royalty shall be payable by OV to 2-BBB for each sale of a Product. For avoidance
of doubt, for countries in which there shall be at least one (1) Valid Claim of a Patent within the 2- BBB Intellectual Property that
Covers such Product, the aforementioned reduction shall not be applicable.

 

(d) Royalty Reduction for
Competitive Product Competition. If, on a Product- by-Product, country-by-country and Calendar Quarter-by-Calendar Quarter basis,

 

A Competitive Product(s)
has a market share of greater than twenty-five percent (25%) but less than or equal to fifty percent (50%); or

 

A Competitive Product(s)
has a market share of more than fifty percent (50%);

 

then the royalties payable with respect to Annual
Net Sales pursuant to Section 7.2(a) in such country during such Calendar Quarter shall be reduced by [***] if subsection

(a) applies, and [***] if subsection (b) applies,
respectively, of the royalties otherwise payable pursuant to Section 7.2(a). Market share shall be based on the aggregate market in such
country of such Product and the Competitive Product(s) (based on sales of units of such Product and such Competitive Product(s) in the
aggregate, as reported by IMS International, or if such data are not available, such other reliable data source as reasonably agreed
by the Parties).

 

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(e)
Royalty Reduction for Third Party Payments. If OV or its Affiliates or sublicensees can show by competent proof to 2-BBB that
a license to Third Party intellectual property rights for the Development, Manufacture, or Commercialization of Product is reasonably
necessary to the Commercialization of the Product, then OV or its Affiliates or sublicensees shall negotiate and obtain a license under,
or otherwise pay amounts with respect to any litigation regarding, such Third Party’s intellectual property rights (each such Third
Party license or payment referred to herein as an “Additional Third Party License”). Any royalty otherwise payable
to 2-BBB under this Agreement with respect to Annual Net Sales of any Product by OV, its Affiliates or sublicensees in such country will
be reduced by [***] of the amounts payable to Third Parties pursuant to any Additional Third Party
Licenses, such reduction to continue (and be carried forward for use) until all such amounts have been expended. Solely where the use
of any OV Platform Technology infringes any Third Party intellectual property rights with respect to the Development, Manufacture, or
Commercialization of the Product, OV or its Affiliates or sublicensees shall be responsible for negotiating and obtaining an Additional
Third Party License for purposes of infringement, at its own cost, and such Additional Third Party License shall not reduce OV’s
royalty obligations to 2-BBB under this Agreement.

 

(f)
Cumulative Effect of Royalty Reductions. In no event shall the royalty reductions described in Sections 7.2 (a), (c), (d) and
(e), alone or together, reduce the royalties payable by OV for a given Calendar Quarter pursuant to Section 7.2(a) to less than [***]
of the amounts payable by OV for a given Calendar Quarter pursuant to Section 7.2(a). OV may carry over
and apply any such royalty reductions which are incurred or accrued in a Calendar Quarter and are not deducted in such Calendar Quarter,
to any subsequent Calendar Quarter(s), and shall begin applying such reduction to such royalties as soon as practicable and continue
applying such reduction on a Calendar Quarterly basis thereafter.

 

(g) Payment of Royalties.
OV shall: (a) within forty-five (45) days following the end of each Calendar Quarter in which a royalty payment accrues, provide to 2-BBB
a report for each country in the Territory in which sales of Product occurred in the Calendar Quarter covered by such statement, specifying
for such Calendar Quarter: the number of Product sold; the gross sales and Annual Net Sales in each country’s currency; the applicable
royalty rate under this Agreement; the royalties payable in each country’s currency, including an accounting of deductions taken
in the calculation of Annual Net Sales in accordance with OV’s normal practices used to prepare its audited financial statements
for internal and external reporting purposes; the applicable exchange rate to convert from each country’s currency to U.S. Dollars
under Section 7.5; and the royalty calculation and royalties payable in U.S. Dollars, and (b) make the royalty payments owed to 2-BBB
hereunder in accordance with such royalty report in arrears, within sixty (60) days from the end of each Calendar Quarter in which such
payment accrues.

 

Section 7.3 Milestones.
OV shall pay 2-BBB the applicable milestones set forth in this Section 7.2(g). For each of Sections 7.3(a) and (b) of this Agreement,
the Parties understand and agree that in no event will more than one (1) milestone payment be paid with respect to any specific event
triggering a payment under this Agreement. From and after the date of any notice of termination is received by a Party, no milestones
with respect to the Product shall be payable by OV to 2-BBB, except to the extent any amounts are due but unpaid.

 

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(a) Sales Milestones.
OV shall make the following sales milestone payments to 2-BBB that are set forth below upon the first achievement by or on behalf of
OV, its Affiliates or sublicensees of the sales milestone events (“Sales Milestone Events”) set forth below with respect
to aggregate Annual Net Sales of Product in a given Calendar Year in the Territory. For clarity, each milestone set forth below shall
be due and payable one time only.

 

	Sales
    Milestone Event	Milestone
    Payments 

    (in $ millions)
	First
    time aggregate Annual Net Sales of Product in a given Calendar Year in the Territory achieve Five Hundred Million U.S. Dollars ($500,000,000.00).	[***]
	First
    time aggregate Annual Net Sales of Product in a given Calendar Year in the Territory achieve One Billion U.S. Dollars ($1,000,000,000.00).	[***]
	Second
    time aggregate Annual Net Sales of Product in a given Calendar Year in the Territory achieve One Billion U.S. Dollars ($1,000,000,000.00).	[***]

 

(b) Development Milestones. OV shall make
the following approval milestone payments to 2-BBB that are set forth below upon the first achievement by or on behalf of OV, its Affiliates
or sublicensees of the Development milestone events (“Development Milestone Events”) set forth below with respect
to the first Product that achieves such event. For clarity, each milestone set forth below shall be due and payable one time only (regardless
of the number of Product or indications to achieve any such Development Milestone Event).

 

	Milestone
    Number	Development
    Milestone Event

    (For the first Product that achieves such event)	Milestone
    Payments

    (in $ millions)
	1	Enrollment
    of the first 10 patients in a Phase 2 Clinical Trial for the Product	[***]
	2	Successful
    Completion of a Phase 2 Clinical Trial for the Product	[***]
	3	Dosing
    of the first patient in a Phase 3 Clinical Trial for the Product	[***]
	4	Submission
    of an NDA to the FDA for the Product in the United States	[***]

 

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	5	Submission
    of an MAA to the EMA for the Product in the European Union	[***]
	6	Submission
    of an NDA to the applicable Regulatory Authorities for the Product in the first of either China or India	[***]
	7	Receipt
    of Regulatory Approval of the Product in the United States	[***]
	8	Receipt
    of Regulatory Approval of the Product in the European Union	[***]
	9	Receipt
    of Regulatory Approval of the Product in the first of either China or India	[***]

 

The Parties understand and
agree that upon achievement of Milestone Number 2, Milestone Number 1 shall become automatically payable as well, if Milestone Number
1 has not been achieved yet. Upon achievement of Development Milestone Number 3, Development Milestone Number 2 shall become automatically
payable as well, if Development Milestone Number 2 has not yet been achieved. Upon achievement of Milestone Number 4, 5 or 6, Milestone
Number 3 shall become automatically payable as well if Milestone Number 3 has not been achieved yet. The Parties agree that the first
Clinical Trial to be conducted under the Clinical Development Plan is to be considered a Phase 2 Clinical Trial.

 

(c)
Payment of Milestones. The sales milestones under Section 7.3(a) and the development milestones under Section 7.3(b) shall be
paid to 2-BBB no later than ten (10) Business Days after the respective Sales Milestone Event or Development Milestone Event has been
achieved by or on behalf of OV, its Affiliates or sublicensees. Notwithstanding any anything to the contrary contained herein, the Parties
understand and agree that, prior to 2-BBB’s expansion of the Field to include the entire Expanded Field, with respect to any Development
Milestone Event or Sales Milestone Event, as applicable, which occurs prior to expansion of the Field to include the entire Expanded
Field, the corresponding Milestone Payment shall be irrevocably reduced by [***]).

 

Section 7.4 Additional
Payment Terms.

 

(a)
Accounting. All payments hereunder shall be made in the United States in U.S. Dollars by wire transfer to a bank in the
Netherlands designated in writing by 2-BBB. Conversion of sales recorded in local currencies to Dollars shall be performed in a manner
consistent with OV’s normal practices used to prepare its audited financial statements for internal and external reporting purposes.

 

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(b)
Late Payments. Any payments or portions thereof due hereunder that are not paid on the date such payments are due under this Agreement
shall bear interest at an annual rate equal to the lesser of: (a) one and one half percentage points (1.5%) above the prime rate as
published by Citibank, N.A., New York, New York, or any successor thereto, at 12:01 a.m. on the first day of each Calendar Quarter in
which such payments are overdue or (b) the maximum rate permitted by Applicable Law; in each case calculated on the number of days such
payment is delinquent, compounded monthly.

 

Section 7.5 Currency Conversion.
All amounts payable and calculations under this Agreement will be in U.S. Dollars. As applicable, Net Sales and any Milestone Payments
will be translated into U.S. Dollars using OV’s then-current standard exchange rate methodology for the translation of foreign
currency sales into U.S. Dollars (in accordance with IFRS). If, due to restrictions or prohibitions imposed by national or international
authority, a given payment cannot be made as provided in this Section 7.5, the Parties will consult with a view to finding a prompt and
acceptable solution. If the Parties are unable to identify a mutually acceptable solution regarding such payment, then OV may elect,
in its sole discretion, to deliver such payment in the relevant jurisdiction and in the local currency of the relevant jurisdiction.

 

Section 7.6 Taxes.
OV may withhold from payment made to 2-BBB under this Agreement any income tax required to be withheld by OV under the laws of the country
or jurisdiction where OV has commercially sold Product. If any tax is withheld by OV, OV shall provide 2-BBB receipts or other evidence
of such withholding and payment to the appropriate tax authorities on a timely basis following that tax payment. Each Party agrees to
cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or
treaty which is in effect. The Parties shall discuss applicable mechanisms for minimizing such taxes to the extent possible in compliance
with Applicable Law. In addition, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value
added tax, sales tax, consumption tax and other similar taxes) in connection with this Agreement.

 

ARTICLE 8

Regulatory Matters

 

Section 8.1 Compliance
with Laws. Each Party shall comply in all material respects with all Applicable Laws, including all Regulatory Laws, that pertain
to its activities under this Agreement and, except as otherwise provided herein, each Party shall bear its own cost and expense of such
compliance.

 

Section 8.2 Regulatory
Approval. In seeking any Regulatory Approval in the Territory, OV shall have primary responsibility for all communications, submissions
and interactions with Regulatory Authorities, including serving as sponsor of any required investigational new drug or device applications
or exemptions and preparing and submitting the application for Regulatory Approval. 2-BBB shall fully cooperate with OV, provide consulting
advice on regulatory strategies, communications and submissions, and provide any additional regulatory documentation and data reasonably
requested by OV in connection with seeking Regulatory Approval in the Territory. OV shall bear all costs and expenses of obtaining such
Regulatory Approval, including a fair compensation for 2-BBB’s consulting activities which have been mutually pre-agreed by the
Parties (including Out-of-Pocket Costs). OV shall maintain such approval throughout the Term (and bear all associated costs and expenses).
OV shall own all and be responsible for preparing, filing and maintaining all regulatory filings and Regulatory Approval that are required
for the Development, Manufacture, use, or Commercialization of the Product in the Field in the Territory, provided that: (i) OV shall
provide 2-BBB with copies of material regulatory submissions to, and material communications with, any Governmental Authority in the
Territory and 2-BBB shall have the right to review and comment on such submissions and communications, and (ii) OV shall take such actions
and otherwise cooperate with 2-BBB as may be reasonably requested by 2-BBB to enable 2-BBB to perform activities assigned to 2-BBB under
this Agreement.

 

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ARTICLE 9

Intellectual Property

 

Section 9.1 Ownership
of Intellectual Property.

 

(a) Inventorship.
Inventorship of Inventions shall be determined by application of U.S. patent law pertaining to inventorship.

 

(b) OV. As between
the Parties, OV will be the sole owner of any Inventions and intellectual property rights therein that are discovered, developed, invented
or created solely by OV, its Affiliates or Third Parties acting on its or its Affiliates’ behalf while conducting activities under
this Agreement (such Inventions and intellectual property rights, “OV Know-How”) and any Patents that claim such OV
Know-How (“OV Patents” and, together with the OV Know- How, the “OV Technology”), and will retain
all of its rights, title and interest thereto.

 

(c) Joint Intellectual
Property. Any Joint Intellectual Property will be owned jointly by OV and 2-BBB on an equal and undivided basis, including all rights,
title and interest thereto, subject to any assignment, rights or licenses expressly granted by one Party to the other Party under this
Agreement. Except as expressly provided in this Agreement, neither Party will have any obligation to account to the other for profits
with respect to, or to obtain any consent of the other Party to license or exploit, Joint Intellectual Property by reason of joint ownership
thereof, and each Party hereby waives any right it may have under the laws of any jurisdiction to require any such consent or accounting.
At the reasonable written request of a Party, the other Party will in writing confirm that no such accounting is required to effect the
foregoing regarding Joint Intellectual Property. To the extent necessary in any jurisdiction to effect the foregoing, each Party hereby
grants to the other Party a non-exclusive, royalty-free, fully-paid, worldwide license, with the right to grant sublicenses, to practice
such Joint Intellectual Property for any and all purposes, subject to any licenses granted by one Party to the other under this Agreement.

 

(d) OV Platform Technology.
As between the Parties, OV will own and retain all of its rights, title and interest in and to the OV Platform Technology.

 

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(e)
Cooperation. The determination of whether Know-How and inventions claimed in Patents that are conceived, discovered, developed
or otherwise made or reduced to practice by a Party for the purpose of allocating proprietary rights (including Patent, copyright or
other intellectual property rights) therein, will, for purposes of this Agreement, be made in accordance with Applicable Law in the United
States. In the event that United States law does not apply to the conception, discovery, development, making or reduction to practice
of any Know-How or Patents hereunder, each Party will, and does hereby, assign, and will cause its Affiliates to so assign, to the other
Party, without additional compensation, such right, title and interest in and to any Know-How and Patents as well as any intellectual
property rights with respect thereto, as is necessary to fully effect ownership as would have been determined under U.S. law unless otherwise
provided in this Article 9.

 

Section 9.2 Patent Filings,
Prosecution and Maintenance of 2-BBB Intellectual Property and any Joint Intellectual Property.

 

(a) The Parties agree to
cooperate in the Prosecution of all Patents and Patent applications under this Section 9.2, including obtaining and executing necessary
powers of attorney and assignments by the named inventors, providing relevant technical reports to the filing Party concerning the invention
disclosed in such Patents and Patent applications, obtaining execution of such other documents which are needed in the Prosecution of
such Patents and Patent applications, and shall cooperate with the other Party so far as reasonably necessary with respect to furnishing
all information and data in its possession reasonably necessary to obtain or maintain such Patents and Patent applications.

 

(b) 2-BBB shall be obliged
to Prosecute any Platform Patents and Platform Patent applications on a country by country basis, in 2-BBB’s name and at 2-BBB’s
expense, and to control any interferences, oppositions, reissue proceedings, reexaminations, post-grant proceedings and any other similar
proceeding relating thereto, in each such country in the Territory. 2-BBB shall inform and consult with OV regarding the Prosecution
of all such Platform Patents and Platform Patent applications sufficiently in advance of any deadline for taking any substantive action
in connection therewith to permit meaningful consultation, and shall give due consideration to any of OV’s suggestions or recommendations.
Each Party shall pay for its own costs with respect to this consultation.

 

(c) OV shall have the first
right (but not the obligation) to Prosecute any Product- Specific Patents and Product-Specific Patent applications, in OV’s name
and at OV’s expense, and to control any interferences, oppositions, reissue proceedings, reexaminations, post-grant proceedings
and any other similar proceeding relating thereto, in such country in the Territory. OV shall inform and consult with 2-BBB regarding
the Prosecution of all such Product-Specific Patents and Product-Specific Patents applications sufficiently in advance of any deadline
for taking any substantive action in connection therewith to permit meaningful consultation, and shall give due consideration to any
of 2-BBB’s suggestions or recommendations. Each Party shall pay for its own costs with respect to this consultation.

 

(d)
OV shall have the first right (but not the obligation) to Prosecute any Patents and Patent applications for any Joint Intellectual Property,
in OV’s name, and to control any interferences, oppositions, reissue proceedings, reexaminations, post-grant proceedings and any
other similar proceeding relating thereto, in the Territory; provided that the costs of such Prosecution shall be borne equally by the
Parties. OV shall inform and consult with 2-BBB regarding the Prosecution of all such Joint Intellectual Property sufficiently in advance
of any deadline for taking any substantive action in connection therewith to permit meaningful consultation, and shall give due
consideration to any of 2-BBB’s suggestions or recommendations. Each Party shall pay for its own costs with respect to this consultation.

 

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(e) If OV elects in any country
not to Prosecute, or elects to abandon any Product- Specific Patents or Joint Intellectual Property, or declines to control any related
interference, opposition, reissue proceeding, reexamination, post-grant proceeding and similar proceeding, OV shall give 2-BBB reasonable
written notice to this effect sufficiently in advance (but in any event no later than at least sixty (60) days prior to the date upon
which the subject matter of such Patent shall become unpatentable or such Patent shall lapse or become abandoned) to permit 2-BBB, in
its sole discretion and expense, to undertake such Prosecution, or to control such interferences, oppositions, reissue proceedings, reexaminations,
post-grant proceedings and similar proceeding, without a loss of rights. If 2-BBB does so elect, then OV shall provide such cooperation
to 2- BBB, including the execution and filing of appropriate instruments, as may reasonably be requested to facilitate the transition
of such Patent activities, and shall assign all of its right, title and interest to such Patents, other than its rights thereto provided
by this Agreement, to 2-BBB electing to pursue such Patent activities. For clarity, 2-BBB shall have the right, in its sole discretion,
to abandon such Patent at any time after it takes control pursuant to this Section 9.2(e).

 

(f) Each Party agrees to
cooperate with the other with respect to the Prosecution of 2- BBB Intellectual Property and Joint Intellectual Property and related
interferences, oppositions, reissue proceedings, reexaminations, post-grant proceedings and similar proceeding thereof. If required under
Applicable Law in order for the prosecuting Party to control such interferences, oppositions, reissue proceedings, reexaminations, post-grant
proceedings and similar proceeding relating to the 2-BBB Intellectual Property or Joint Intellectual Property, the other Party shall
join as a party to such interferences, oppositions, reissue proceedings, reexaminations, post-grant proceedings and similar proceeding.

 

Section 9.3 Extensions
of Patent Term for Product.

 

(a) 2-BBB shall be obliged,
to seek, in 2-BBB’s name if so required, patent term extensions, adjustments, restorations, or supplementary protection certificates
under Applicable Law with respect to any Platform Patent in the Territory; it being understood and agreed that, if 2- BBB seeks a patent
term extension, then OV agrees to cooperate with respect to any measures required by Applicable Law for 2-BBB to obtain such extension.
2-BBB, its agents and attorneys will give due consideration to all suggestions and comments of OV regarding any such activities, including
the choice of which Patent to apply term extensions to, but in the event or a disagreement between the Parties, 2-BBB shall have the
final decision making authority. For clarity, any such extended Patent will remain included in the definition of Valid Claim for purposes
of extending the Term.

 

(b)
OV shall have the first right, but not the obligation, to seek, in OV’s name if so required, patent term extensions, adjustments,
restorations, or supplementary protection certificates under Applicable Law with respect to any Product-Specific Patent in the Territory;
it being understood and agreed that, if OV seeks a patent term extension, then 2-BBB agrees to cooperate with respect to any measures
required by Applicable Law for OV to obtain such extension. OV, its agents and attorneys will give due consideration to all suggestions
and comments of 2-BBB regarding any such activities, including the choice of which Patent to apply term extensions to, but in
the event of a disagreement between the Parties, OV shall have the final decision making authority. For clarity, any such extended Patent
will remain included in the definition of Valid Claim for purposes of extending the Term.

 

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Section 9.4 Enforcement
of 2-BBB Intellectual Property and Joint Intellectual Property.

 

(a) If either Party learns
of any infringement or violation by a Third Party of any 2- BBB Intellectual Property or Joint Intellectual Property in the Territory,
whether or not within the Field, it shall notify the other Party as soon as practicable. Thereafter, (a) OV shall have the sole right
(but not the obligation) at its own cost to take the appropriate steps to enforce or defend any Product-Specific Patents in the Field
and/or Joint Intellectual Property, as applicable, against Third Parties and (b) 2-BBB shall be obliged at its own cost to take the appropriate
steps to enforce or defend any Platform Patents in the Field against Third Parties. Any settlements, damages or other monetary awards
relating to such infringement or violation by a Third Party of any Product- Specific Patent and/or Joint Intellectual Property (a “Recovery”)
recovered by either Party will be forwarded to OV (if not then previously paid to OV) and any such Recovery pursuant to a suit, action
or proceeding brought pursuant to this Section 9.4(a) will be allocated first to the costs and expenses of the enforcing or defending
Party, and second, all remaining Recoveries shall be deemed to be Net Sales.

 

(b) If OV brings any suit,
action or proceeding under this Section 9.4, 2-BBB agrees to be joined as party plaintiff if necessary to prosecute the suit, action
or proceeding and to give OV reasonable authority to file and prosecute the suit, action or proceeding; provided, however, that OV will
not be required to transfer any right, title or interest in or to any property to 2-BBB to confer standing on 2-BBB hereunder. 2-BBB
will provide reasonable assistance to OV, including by providing access to relevant documents and other evidence and making its employees
available, subject to OV’s reimbursement of any reasonable Out-of-Pocket Costs incurred by 2-BBB in providing such assistance.

 

Section 9.5 Enforcement
of OV Technology. If either Party learns of any infringement or violation by a Third Party of any OV Technology in the Territory,
it shall notify the other Party as soon as practicable. Thereafter, OV shall have the sole right to (a) enforce all OV Technology against
Third Parties and (b) any settlements, damages or other monetary awards recovered pursuant to a suit, action or proceeding brought pursuant
to this Section 9.5.

 

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Section 9.6 Defense of
Infringement Claims of 2-BBB Intellectual Property and Joint Intellectual Property. If any Third Party asserts a claim, demand, action,
suit or proceeding against a Party (or any of its Affiliates), alleging that any Product, the use or practice of the 2-BBB Intellectual
Property or the Joint Intellectual Property infringes, misappropriates or violates the intellectual property rights of any Person (any
such claim, demand, action, suit or proceeding being referred to as an “Infringement Claim”), the Party first having notice
of the Infringement Claim shall promptly notify the other Party thereof in writing specifying the facts, to the extent known, in reasonable
detail. With respect to any Infringement Claim in the Field in the Territory, the Parties shall negotiate in good faith a resolution
with respect thereto. If the Parties cannot settle such Infringement Claim with the Third Party within thirty (30) days after receipt
of the notice pursuant to the notice pursuant to this Section 9.6, then subject to indemnification requirements of ARTICLE 10, the following
shall apply:

 

(a) In the case of any such
Infringement Claim against either Party individually or against both OV and 2-BBB, in each case, with respect to the Product in the Field
in the Territory, then OV shall assume control of the defense of such Infringement Claim, at its own expense. 2- BBB, upon request of
OV and if required by Applicable Law, agrees to join in any such litigation at OV’s expense, and in any event to reasonably cooperate
with OV at OV’s expense. 2-BBB will have the right to consult with OV concerning such Infringement Claim and to participate in
and be represented by independent counsel in any litigation in which 2-BBB is a party, at its own expense. OV shall have the exclusive
right to settle any Infringement Claim against OV alone or both Parties without the consent of 2-BBB at OV’s sole expense, unless
such settlement shall have a material adverse impact on 2-BBB (in which case the consent of 2-BBB shall be required). If OV fails to
assume control of the defense of such Infringement Claim, 2-BBB shall have the right (but not the obligation) to control the defense
of such Infringement Claim, and OV upon request of 2-BBB and if required by Applicable Law, agrees to join in any such litigation at
2-BBB’s expense.

 

(b) If either Party individually
shall control of the defense of any such Infringement Claim described in this Section 9.6, the other Party shall cooperate, and shall
cause its and its Affiliates’ employees to cooperate, with the controlling Party in all reasonable respects in connection therewith,
including giving testimony and producing documents lawfully requested, and using its reasonable efforts to make available to the controlling
Party, at the controlling Party’s cost, such employees who may be helpful with respect to such suit, investigation, claim or other
proceeding.

 

(c) Neither Party, nor its
Affiliates, nor its or their employees, agents or independent contractors, shall be liable to the other Party or any of its Affiliates
in respect of any good faith act, omission, default, or neglect of such Party, any of its Affiliates, or its or their employees, agents
or independent contractors in connection with the Prosecution of 2-BBB Intellectual Property, OV Technology or Joint Intellectual Property,
except in case of willful breach.

 

Section 9.7 Enforcement
of 2-BBB Trademark(s). If OV elects to use a 2-BBB Trademark to Commercialize the Product then OV shall not, and shall ensure its
Affiliates shall not, directly or indirectly: (a) apply for any rights or interests in any 2-BBB Trademark(s) relating to the Product
that are registered by 2-BBB in the Territory; (b) contest or aid others in contesting the validity, or ownership by 2-BBB, of the 2-BBB
Trademark(s) relating to the Product; or (c) take any other action in derogation of any 2-BBB Trademark(s) relating to the Product in
the Territory. Each Party promptly after acquiring knowledge thereof shall notify the other Party of any unauthorized attempt to use
any of the 2-BBB Trademark(s) used by OV (if any), including any infringement or any trademark which is substantially identical with
or deceptively similar to any of such 2-BBB Trademark(s), or any legal action instituted against OV with respect to OV’s use of
any such 2-BBB Trademark. Thereafter, 2-BBB shall have the right (but not the obligation) to take the appropriate steps to enforce such
2-BBB Trademark(s) against Third Parties. If 2-BBB fails to enforce such 2-BBB Trademark(s) in the Territory within ninety (90) days
(or such shorter period of time as necessary to avoid any Party losing meaningful rights under Applicable Law) of the date one Party
has provided notice to the other Party pursuant herein of such unauthorized attempt to use any of the 2-BBB Trademark(s) or any legal
action instituted against OV with respect to OV’s use of any such 2-BBB Trademark, then OV shall have the right (but not the obligation),
at its own expense, to enforce such 2-BBB Trademark(s) by counsel of its own choice and 2-BBB will have the right, at its own expense,
to be represented in any such action by counsel of its own choice. OV shall not, without the prior written consent of 2-BBB (in its sole
discretion), enter into any compromise or settlement relating to any enforcement action that OV may bring under this Section 9.7 involving
the 2-BBB Trademark(s) that requires 2-BBB to pay any sum of money, or otherwise adversely affects the rights of 2-BBB with respect to
such 2-BBB Trademark(s) (including the rights to receive payments). Any settlements, damages or other monetary awards relating to such
enforcement of any 2-BBB Trademark(s) in the Territory (a “Trademark Recovery”) recovered by either Party will be forwarded
to OV (if not then previously paid to OV) and any such Trademark Recovery pursuant to a suit, action or proceeding brought pursuant to
this Section 9.7 will be allocated first to the costs and expenses of the Party bringing such enforcement action, and second, all remaining
Recoveries shall be deemed to be Net Sales.

 

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OV shall (at 2-BBB’s
sole expense) execute any and all documents and take or not take such other actions as may, in the opinion of 2-BBB’s legal counsel,
be reasonably necessary to carry out the enforcement and defense of the 2-BBB Trademark(s) or otherwise assist 2-BBB in taking such action
as 2-BBB may reasonably request to stop such activities. OV shall take no action nor incur any expenses on 2-BBB’s behalf without
2-BBB’s prior written approval. 2-BBB shall also have the right to select legal counsel and control all matters with respect to
any legal action brought against OV or its Affiliates, by a Third Party with respect to any use of any 2-BBB Trademark(s). OV shall be
entitled to undertake the defense or prosecution of any legal action relating to trademarks owned or otherwise Controlled by OV and/or
its Affiliates, in its sole discretion.

 

ARTICLE 10

Indemnification

 

Section 10.1 Indemnification
by 2-BBB.

 

(a) Scope. 2-BBB shall
indemnify and hold harmless OV and its Affiliates and their respective, directors, officers, employees and agents (collectively, the
“OV Indemnified Parties”) from and against any and all Damages, arising out of or resulting from any claim, demand,
action, suit or proceeding (collectively, a “Claim”) based upon or arising from: (i) any breach by 2-BBB of any of
its representations, warranties or obligations under this Agreement; (ii) any actual violation by 2-BBB of Applicable Laws or any Development
of the Product on or prior to the Effective Date; or (iii) any willful act or omission of 2-BBB or its Affiliates or subcontractors or
any of their respective employees or agents relating to the activities in connection with this Agreement; provided however that, such
indemnity shall not apply to the extent OV has an indemnification obligation pursuant to Section 10.2 for such damages or claims.

 

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(b)
Defense. OV shall give 2-BBB prompt written notice of any Claim with respect to which 2-BBB’s indemnification obligations
apply, but any delay or failure of such notice shall not excuse 2-BBB’s indemnification obligations except to the extent that 2-BBB’s
legal position is actually and materially prejudiced thereby. 2-BBB shall have the right to assume and control the defense and settlement
of any Third Party Claim; provided, however, that following conditions must be satisfied: (i) 2-BBB must provide to OV written
acknowledgement to OV of 2-BBB’s obligation to indemnify OV hereunder against Damages that may result from the Third Party Claim,
and (ii) OV shall not have given 2-BBB written notice that it has determined, in the exercise of its reasonable discretion based on the
advice of counsel, that a conflict of interest makes separate representation by OV’s own counsel advisable, (iii) the Third Party
Claim does not include damages other than monetary damages for which indemnity hereunder is available, (iv) the Third Party Claim does
not relate to or arise in connection with any criminal proceeding, action, indictment, criminal allegation or investigation, and (v)
if requested by OV, 2-BBB has reasonably demonstrated 2-BBB’s financial ability to pay for the defense of such Third Party Claim
and to satisfy the full amount of any Damages that may result from such Third Party Claim. OV shall have the right to participate in
the defense of the Claim at its own expense, but in any event shall cooperate with 2-BBB in the investigation and defense of the Claim.

 

(c) Settlement. If
2-BBB is entitled to, and does, assume and control the defense and settlement of any Claim with respect to which its indemnification
obligations apply, then 2-BBB shall not settle such Claim without OV’s prior written consent (which consent shall not be unreasonably
withheld, conditioned or delayed), unless (i) the sole relief provided in such settlement is monetary in nature and shall be paid in
full by 2-BBB and (ii) such settlement does not include any finding or admission of a violation by OV, its Affiliates or sublicensees
of any Applicable Laws or Third Party’s rights.

 

Section 10.2 Indemnification
by OV.

 

(a) Scope. OV shall
indemnify and hold harmless 2-BBB and its Affiliates and their respective directors, officers, employees and agents (collectively, the
“2-BBB Indemnified Parties”) from and against any and all Damages in connection with any Claim based upon or arising
from: (i) any breach by OV or any of its Affiliates of any of OV’s representations, warranties or obligations under this Agreement;
(ii) any actual violation by OV, any of its Affiliates, or sublicensees of Applicable Laws; (iii) any willful act or omission of OV,
its Affiliates, or sublicensees or any of their respective employees, consultants, subcontractors or agents relating to the activities
in connection with this Agreement; or (iv) Commercialization by OV, its Affiliates, or sublicensees of the Product; provided however
that, such indemnity shall not apply to the extent 2-BBB has an indemnification obligation pursuant to Section 10.1 for such damages
or claims.

 

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(b)
Defense. 2-BBB shall give OV prompt written notice of any Claim with respect to which OV’s indemnification obligations apply,
but any delay or failure of such notice shall not excuse OV’s indemnification obligations except to the extent that OV’s
legal position is actually and materially prejudiced thereby. OV shall have the right to assume and control the defense and settlement
of any such Claim; provided, however, that following conditions must be satisfied: (i) OV must provide to 2-BBB written acknowledgement
to 2-BBB of OV’s obligation to indemnify 2-BBB hereunder against Damages that may result from the Third Party Claim, and (ii) 2-BBB
shall not have given OV written notice that it has determined, in the exercise of its reasonable discretion based on the advice of counsel,
that a conflict of interest makes separate representation by 2-BBB’s own counsel advisable, (iii) the Third Party Claim does not
include damages other than monetary damages for which indemnity hereunder is available, (iv) the Third Party Claim does not relate to
or arise in connection with any criminal proceeding, action, indictment, criminal allegation or investigation, and (v) if requested
by 2-BBB, OV has reasonably demonstrated OV’s financial ability to pay for the defense of such Third Party Claim and to satisfy
the full amount of any Damages that may result from such Third Party Claim. 2-BBB shall have the right to participate in the defense
of the Claim at its own expense, but in any event shall cooperate with OV in the investigation and defense of the Claim.

 

(c) Settlement. If
OV is entitled to, and does, assume and control the defense and settlement of any Claim with respect to which its indemnification obligations
apply, then OV shall not settle such Claim without 2-BBB’s prior written consent (which consent shall not be unreasonably withheld,
conditioned or delayed), unless (i) the sole relief provided in such settlement is monetary in nature and shall be paid in full by OV
and (ii) such settlement does not include any finding or admission of a violation by 2-BBB, its Affiliates or sublicensees of any Applicable
Laws or Third Party’s rights.

 

Section 10.3 Waiver.
Any waiver by an indemnified Party of its rights under this ARTICLE 10 must be set forth expressly and in writing in order to be effective.

 

Section 10.4 Insurance.
Each Party shall maintain insurance with creditworthy insurance companies or self insure in accordance with Applicable Laws against such
risks and in such amounts as are usually maintained or insured against by such Party.

 

Section 10.5 Limitation
of Consequential Damages. Except for (a) Third Party Claims that are subject to indemnification under this ARTICLE 10, (b) claims
arising out of a Party’s willful misconduct or (c) a Party’s breach of ARTICLE 5 or ARTICLE 12 or any other confidentiality
obligations under this Agreement, neither Party nor any of its Affiliates will be liable to the other Party or its Affiliates in connection
with this Agreement for any incidental, consequential, special, punitive or other indirect damages or lost or imputed profits or royalties,
lost data or cost of procurement of substitute goods or services, whether liability is asserted in contract, tort (including negligence
and strict product liability), indemnity or contribution, and irrespective of whether that Party or any representative of that Party
has been advised of, or otherwise might have anticipated the possibility of, any such loss or damage.

 

ARTICLE 11

Representations and Warranties

 

Section 11.1 General Corporate
Matters. Each Party hereby represents and warrants to the other Party that:

 

(a) Organization and Power.
It is a corporation or limited liability company duly organized, validly existing and in good standing under the laws of its jurisdiction
of incorporation or organization. It has all requisite power and authority to conduct its business and engage in the transactions provided
for in this Agreement.

 

(b)
Authorization and Validity of Agreements. The execution, delivery and performance by it of this Agreement, and the consummation
by it of the transactions contemplated hereby, have been duly authorized and approved by all necessary corporate or equivalent action
on its part. This Agreement has been duly executed and delivered by it and constitutes its legal, valid and binding obligation, enforceable
against it in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency or other
laws relating to or affecting creditors’ rights generally and by general equity principles.

 

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(c) Absence of Conflicts.
The execution, delivery and performance by it of this Agreement, and the consummation by it of the transactions contemplated hereby,
do not and will not: (i) violate any Applicable Laws; (ii) conflict with, or result in the breach of any provision of, its certificate
or articles of incorporation, bylaws or equivalent organizational documents; (iii) result in the creation of any lien or encumbrance
of any nature upon any property being transferred or licensed by it pursuant to this Agreement; or (iv) violate, conflict with, result
in the breach or termination of, or constitute a default under (or event which, with notice, lapse of time or both, would constitute
a default under), any permit, contract or agreement to which it is a party or by which any of its properties or businesses are bound.

 

(d) Consents. No authorization,
consent or approval of, or notice to or filing with, any Governmental Authority is required for the execution, delivery and performance
by it of this Agreement (excluding approvals of Regulatory Authorities as contemplated herein).

 

(e) Affiliates. Where
this Agreement refers to an action or obligation to be undertaken by a Party’s Affiliates, such Party will cause such Affiliates
to undertake such obligations or other actions, and such Party will be responsible and liable for any acts or omissions by its Affiliates.

 

Section 11.2 Intellectual
Property Matters. 2-BBB hereby represents and warrants to OV that, as of the Effective Date:

 

(a) Ownership. Except
as set forth in Schedule 11.2(a), 2-BBB has sole and exclusive ownership of the 2-BBB Intellectual Property. 2-BBB has
not granted to any Person other than OV a license, covenant not to sue or similar right with respect to any component of the 2-BBB Intellectual
Property in the Field (including the Expanded Field) in the Territory. The 2-BBB Intellectual Property in the Field in the Territory
are free of any lien, covenant, easement, lien, lease, sublease, option, encumbrance, security interest, mortgage, pledge or claim of
any nature, including limitations on transfer or any subordination arrangement in favor of a Third Party. Schedule 11.2(a)
sets forth a complete and accurate list of all agreements under which 2-BBB or any of its Affiliates has obtained a license or sublicense
rights, covenant not to sue or similar right with respect to any component of the 2-BBB Intellectual Property to which 2-BBB or any of
its Affiliates is a party as of the Effective Date, as further specified in such Schedule (including any sublicense or other arrangement
between 2-BBB and any Affiliate, the “2-BBB In-Licenses”). 2- BBB and its Affiliates are not in breach (and as a result
of the delivery and execution of this Agreement will not be in breach) of any 2-BBB In-Licenses pursuant to which 2-BBB and/or its Affiliates
receive a license, sublicense, covenant not to sue or similar right with respect to any 2- BBB Intellectual Property. The Parties acknowledge
that as of the Effective Date “Field” means CNS and/or cerebrocardiovascular drug application, including the (preventive)
treatment of peripheral effects of agents causing CNS disease or symptoms.

 

(b)
Patents. Schedule 2 sets forth a complete and correct list of all 2-BBB Patents owned or otherwise Controlled by 2-BBB
and its Affiliates, and, except as set forth on Schedule 2, 2-BBB, together with its Affiliates, is the sole and exclusive
owner of, and has the sole right, title and interest in and to, the 2-BBB Patents listed on Schedule 2 (as updated from
time to time) and the related Know-How. To its Knowledge, the 2-BBB Patents are valid and enforceable and none of the 2-BBB Patents
are currently involved in any court, administrative, interference, reissue, re-examination, cancellation or opposition proceedings, and
neither 2-BBB nor any of its Affiliates has received any written notice from any Third Party of such actual or threatened proceedings
or challenge.

 

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(c) No Additional IP.
To 2-BBB’s Knowledge, there is no intellectual property right, in particular no 2-BBB Patents, owned by or licensed to 2-BBB
or its Affiliates other than the 2- BBB Intellectual Property, that are necessary for OV or its Affiliates and sublicensees to Develop
and Commercialize the Product as set forth herein.

 

(d) Third Party Obligations.
Other than as set forth on Schedule 11.2(d), 2-BBB and its Affiliates are not subject to any milestone, royalty or
other payment obligations to Third Parties as a result of the execution or performance of this Agreement. The Parties understand and
agree that 2-BBB and/or its Affiliates shall remain solely responsible for any milestone, royalty or other payment obligations disclosed
on Schedule 11.2(d) or payable as a result of execution or performance of this Agreement (whether or not such obligations
are included on Schedule 11.2(d).

 

(e) Data and Information.
2-BBB has furnished or made available to OV all material information that is in 2-BBB’s or its Affiliates’ possession
concerning the 2-BBB Intellectual Property and Product relevant to the safety, efficacy, or CMC data thereof, and all Regulatory Documentation,
Data and other correspondence with Regulatory Authorities relating to the Product, and to 2-BBB’s Knowledge, such information is
accurate, complete and true in all material respects.

 

(f) Non-Infringement.
As of the Effective Date and to 2-BBB’s Knowledge, the use, manufacture, marketing, sale, promotion, importation, distribution
and commercialization of the Product in the Field in the Territory does not infringe, violate or misappropriate the intellectual property
rights of any Person.

 

(g) IP Claims. As
of the Effective Date, no Person has made, nor has 2-BBB received, nor to the Knowledge of 2-BBB has any Person threatened, any written
or oral, claim of ownership, inventorship or Patent 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 2-BBB or any predecessor)
with respect to the 2-BBB Intellectual Property, or initiated a lawsuit against 2-BBB, in any case (i) challenging the ownership, validity
or enforceability of any of the 2-BBB Intellectual Property in the Field in the Territory, (ii) alleging that the license, use or practice
of them infringes, violates or misappropriates: (A) the intellectual property rights of any Person; or (B) the rights of any Third Party,
or (iii) seeking to enjoin or restrain such use or practice. 2-BBB has no knowledge that any Person intends to assert such a claim or
initiate such a lawsuit, or that any Person has a valid basis to do so.

 

(h)
Claims. There are no claims, litigations, suits, actions, disputes, arbitrations, or legal, administrative or other proceedings
or governmental investigations pending or, to 2-BBB’s Knowledge, threatened against 2-BBB, nor is 2-BBB a party to any judgment
or settlement, which would be reasonably expected to adversely affect or restrict the ability of 2-BBB to consummate the transactions
contemplated under this Agreement and to perform its obligations under this Agreement, or which would affect the 2-BBB Intellectual
Property, or 2-BBB’s Control thereof, or the Product.

 

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(i) Infringement by Others.
As of the Effective Date and to the knowledge of 2- BBB, 2-BBB has no reason to believe that any Person has infringed, violated or misappropriated
any of the 2-BBB Intellectual Property in the Field in the Territory.

 

Section 11.3 2-BBB Covenants.

 

(a) 2-BBB will not, and will
cause its Affiliates not to (i) license, sell, assign or otherwise transfer to any Person any 2-BBB Intellectual Property (or agree to
do any of the foregoing) or (ii) incur or permit to exist, with respect to any 2-BBB Intellectual Property, any lien, encumbrance, charge,
security interest, mortgage, liability, grant of license to Third Parties or other restriction (including in connection with any indebtedness).
For the avoidance of doubt, this Section 11.3(a) covers 2-BBB Intellectual Property to the extent it is necessary or useful to Develop,
Manufacture, or Commercialize the Product in the Field in the Territory.

 

(b) Neither 2-BBB nor any
of its Affiliates will effect any corporate restructuring or enter into any new agreement, transfer ownership of the 2-BBB Intellectual
Property, or 2-BBB’s interest in the Joint Intellectual Property, or obligate itself to any Third Party, or amend an existing agreement
with a Third Party, in each case, in a manner that restricts, limits, or encumbers the rights granted to OV under this Agreement.

 

(c) 2-BBB will not transfer
any 2-BBB Intellectual Property to any entity other than a wholly-owned subsidiary, and 2-BBB shall either (i) cause any such subsidiary
to remain a wholly- owned subsidiary or (ii) prior to the date any such subsidiary is no longer wholly-owned by 2- BBB, cause any such
subsidiary to transfer back all rights with respect to any 2-BBB Intellectual Property that such entity owns or otherwise Controls.

 

(d) 2-BBB will update Schedule
2 from time to time to include any Patents that are necessary or useful to Develop, Manufacture or Commercialize the Product
in the Field in the Territory (including, for the avoidance of doubt, any Patents Covering 2-BBB’s interest in any Joint Intellectual
Property); provided that, regardless of 2-BBB’s failure to update such Schedule 2, such Patents shall be deemed to
be included in the definition of 2-BBB Patents. 2-BBB will use reasonable efforts to assist OV in reviving the abandoned U.S. Patent
application published as US2014227185 and shall pay the United States Patent and Trademark Office’s fees with respect to such revival.

 

(e) During the Term, with
respect to the 2-BBB Intellectual Property, in no event shall 2-BBB or its Affiliates enable or assist any Third Party in obtaining a
right or license in the Expanded Field, or otherwise grant a right of use, license, option, acquisition or other rights to a Third Party
in the Expanded Field.

 

Section 11.4 OV Covenants.
OV shall, and shall cause its Affiliates and sublicensees to, perform all of its obligations under this Agreement, and shall comply in
all material respects with all Applicable Laws in the marketing, distribution and sale of the Product and shall cause its Affiliates
and sublicensees to perform and comply as well. OV’s specifications for the text (including any trademarks, logos or other graphics)
for all marketing material used in connection with Product, and any such marketing material for the Product provided by OV or its designee,
shall be true and accurate in all respects, comply in all material respects with all Applicable Laws and not infringe or otherwise violate
the intellectual property of any person.

 

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ARTICLE 12

Confidentiality and Publicity

 

Section 12.1 Confidentiality.
In the course of their activities pursuant to this Agreement, the Parties anticipate that they may disclose Confidential Information
to one another and that either Party may, from time to time, be a disclosing Party or a recipient of Confidential Information. The Parties
wish to protect such Confidential Information in accordance with this Section 12.1. The provisions of this Section 12.1 shall apply to
disclosures furnished to or received by a Party and its agents and representatives (which may include agents and representatives of its
Affiliates). Each Party shall advise its agents and representatives of the requirements of this Section 12.1 and shall be responsible
to ensure their compliance with such provisions.

 

(a) Definition of Confidential
Information. For purposes hereof, “Confidential Information” with respect to a disclosing Party means all Proprietary
Information, in any form or media, concerning the disclosing Party or its Affiliates that the disclosing Party or its Affiliates furnish
to the recipient, whether furnished before or after the date hereof, and all notes, analyses, compilations, studies and other materials,
whether prepared by the recipient or others, that contain or reflect such Proprietary Information; provided, however, that Confidential
Information does not include information that (i) is or hereafter becomes generally available to the public other than as a result of
a disclosure by the recipient, (ii) was already known to the recipient prior to receipt from the disclosing Party as evidenced by prior
written documents in its possession not subject to an existing confidentiality obligation to the disclosing Party, (iii) is disclosed
to the recipient on a non-confidential basis by a person who is not in default of any confidentiality obligation to the disclosing Party,
(iv) is independently developed by or on behalf of the recipient without reliance on the Confidential Information received hereunder,
or (v) is required to be submitted to a governmental agency for the purpose of obtaining product approval, provided that the recipient
will make a good faith attempt to obtain confidential treatment of the information by such agency. The contents of this Agreement shall
be deemed to be Confidential Information of each Party. For clarity, Confidential Information shall not include clinical data contained
in clinical reports that are not permitted under Applicable Laws to be redacted.

 

(b)
Treatment of Confidential Information. The recipient of Confidential Information shall (i) use such Confidential Information solely
and exclusively in connection with the discharge of its obligations under this Agreement and (ii) not disclose such Confidential Information
without the prior written consent of the disclosing Party to any Person other than those of its and/or its Affiliates’ agents and
representatives who need to know such Confidential Information in order to accomplish the objectives for which it was disclosed. Notwithstanding
the foregoing, if the recipient of Confidential Information becomes legally compelled to disclose any Confidential Information in order
to comply with Applicable Laws or with an order issued by a court or regulatory body with competent jurisdiction, the recipient shall
(x) provide prompt written notice to the disclosing Party so that the disclosing Party may seek a protective order or other appropriate
remedy or waive its rights under this Section 12.1; and (y) disclose only the portion of Confidential Information that is legally required
to furnish; provided that, in connection with such disclosure, the recipient shall use Commercially Reasonable Efforts to obtain
assurance that confidential treatment will be given with respect to such Confidential Information. If any Party is required to file this
Agreement with any Governmental Authority, such Party shall redact the terms of this Agreement to the extent possible in order to keep
particularly sensitive provisions confidential.

 

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(c) Return and Destruction.
Upon the termination or expiration of this Agreement, upon the request of the disclosing Party, the recipient of Confidential Information
shall promptly redeliver to the disclosing Party all Confidential Information provided to the recipient in tangible form or destroy the
same and certify in writing that such destruction has occurred; provided, however, that nothing in this Agreement shall require the alteration,
modification, deletion or destruction of computer backup tapes made in the ordinary course of business. All notes or other work product
prepared by the recipient based upon or incorporating Confidential Information of the disclosing Party shall be destroyed, and such destruction
shall be certified in writing to the disclosing Party by OV. Notwithstanding the foregoing, legal counsel to the recipient shall be permitted
to retain in its files one copy of all Confidential Information to evidence the scope of and to enforce the Party’s obligation
of confidentiality under this Section 12.1.

 

(d) Term of Obligation.
The obligations under this Section 12.1 shall remain in effect from the date hereof through the seventh (7th) anniversary
of the expiration or termination of this Agreement.

 

(e) Prior Agreements.
The provisions of this Section 12.1 shall supersede and replace any prior agreements between the Parties relating to Confidential Information
covered hereby, including, for the avoidance of doubt, that certain Confidentiality Agreement dated November 25, 2015 by and between
2-BBB and OV.

 

Section 12.2 Publicity.
Upon or following the Effective Date, the Parties shall issue the press release attached hereto as Exhibit C. Neither Party shall issue
any other press release or otherwise publicize this Agreement without the prior written consent of the other Party, which consent shall
not be unreasonably withheld, conditioned or delayed; provided, however, that consent shall not be required in connection with disclosures
(a) required by Applicable Law, (b) relating to previously disclosed information, and (c) expressly authorized by Section 12.1. In the
event of a required press release or other public announcement, the Party making such announcement shall provide the other Party with
a copy of the proposed text prior to such announcement.

 

ARTICLE 13

Record-keeping and Audits

 

Section 13.1 Records Retention.
OV and its Affiliates shall maintain reasonably detailed records of Net Sales, and any other information reasonably necessary for the
calculation of payments to be made to 2-BBB pursuant to this Agreement. OV shall be fully responsible for its Affiliates retention obligations
herein. Each Party shall maintain reasonably detailed records of any information necessary to comply with Applicable Laws or this Agreement.
OV and its Affiliates shall maintain its sales records for at least three (3) years following the date of sale.

 

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Section 13.2 Audit Request.

 

(a) Audit Team. Each
Party may, upon request and at its expense (except as provided for herein), cause an internationally recognized independent accounting
firm selected by it (except one to whom the Auditee has a reasonable objection) (the “Audit Team”) to audit during
ordinary business hours the books and records of the other Party and the correctness of any payment made or required to be made to or
by such Party, and any report underlying such payment (or lack thereof), pursuant to the terms of this Agreement. Prior to commencing
its work pursuant to this Agreement, the Audit Team shall enter into an appropriate confidentiality agreement with the Auditee obligating
the Audit Team to be bound by obligations of confidentiality and restrictions on use of such Confidential Information that are no less
restrictive than the obligations set forth in Article 13.

 

(b) Limitations. In
respect of each audit of the Auditee’s books and records: (i) the Auditee may be audited only once per year, (ii) no records for
any given year for an Auditee may be audited more than once; provided that the Auditee’s records shall still be made available
if such records impact another financial year which is being audited, and (iii) the Audit Rights Holder shall only be entitled to audit
books and records of an Auditee from the three (3) calendar years prior to the Calendar Year in which the audit request is made.

 

(c) Audit Notice.
In order to initiate an audit for a particular Calendar Year, the Audit Rights Holder must provide written notice to the Auditee. The
Audit Rights Holder exercising its audit rights shall provide the Auditee with notice of one or more proposed dates of the audit not
less than sixty (60) days prior to the first proposed date. The Auditee will reasonably accommodate the scheduling of such audit. The
Auditee shall provide such Audit Team(s) with full and complete access to the applicable books and records and otherwise reasonably cooperate
with such audit.

 

(d) Payments. If the
audit shows any under-reporting or underpayment, or overcharging by any Party, that under-reporting, underpayment or overcharging shall
be reported to the Audit Rights Holder and the underpaying or overcharging Party shall remit such underpayment or reimburse such overcompensation
(together with interest at a rate per annum equal to the lesser of the three (3) month LIBOR (but no less than zero percent (0%)) plus
five percent (5%), as reported by The Wall Street Journal) to the underpaid or overcharged Party within forty-five (45) days after receiving
the audit report. Further, if the audit for an annual period shows an under-reporting or underpayment or an overcharge by any Party for
that period in excess of five percent (5%) of the amounts properly determined, the underpaying or overcharging Party, as the case may
be, shall reimburse the applicable underpaid or overcharged Audit Rights Holder conducting the audit, for its respective audit fees and
reasonable Out-of-Pocket Costs in connection with said audit, which reimbursement shall be made within forty-five (45) days after receiving
appropriate invoices and other support for such audit-related costs.

 

(e)
Definitions. For the purposes of the audit rights described herein, an individual Party subject to an audit in any given
year will be referred to as the “Auditee” and the other Party who has certain and respective rights to audit the books
and records of the Auditee will be referred to as the “Audit Rights Holder.”

 

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(f) Any information received
by a Party pursuant to this Section 13.2 shall be deemed to be Confidential Information for purposes of Section 12.1. Such information
shall be used solely for the purpose for which the audit was conducted.

 

ARTICLE 14

Term and Termination

 

Section 14.1 Term. This
Agreement shall become effective as of the Effective Date and shall continue in full force and effect on a Product-by-Product and country-by-country
basis until expiration of the applicable Royalty Term (the “Term”). This Agreement may be terminated before expiration
of the Term only by mutual agreement of the Parties in writing or in accordance with Section 14.2.

 

Section 14.2 Rights
of Termination.

 

(a) Termination for Material
Breach. In the event that a Party commits a material breach of its overall obligations under this Agreement in a manner that fundamentally
frustrates the purpose of this Agreement (other than payment obligations), taken as a whole, and such material breach of its overall
obligations is not cured within ninety (90) days (or such other time period as mutually agreed by the Parties), or a material breach
of its payment obligations under this Agreement that is not cured within thirty (30) days, after such Party receives written notice from
the non-breaching Party, which notice shall specify the nature of the breach and demand its cure, the non-breaching Party may terminate
this Agreement in its entirety upon written notice to the breaching Party.

 

(i) Notwithstanding
the foregoing, if a material breach is not susceptible to cure within the cure period specified in Section 14.2(a), the non-breaching
Party’s right of termination shall be suspended only if, and for so long as, (i) the breaching Party has provided to the non-breaching
Party a written plan that is reasonably calculated to effect a cure, (ii) such plan is reasonably acceptable to the non-breaching Party
and (iii) the breaching Party commits to and does carry out such plan; provided, however, that, unless otherwise mutually agreed by the
Parties in such plan, in no event shall such suspension of the non-breaching Party’s right to terminate extend beyond (30) days
after the original cure period.

 

(ii) Notwithstanding
the foregoing, if either Party is alleged to be in material breach and disputes such 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 are being pursued by the allegedly breaching Party in good faith 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 this Section 14.2(a).

 

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(b)
Termination for Convenience. Prior to its expiration, OV may terminate this Agreement in its entirety, in its sole discretion,
at any time upon at least one hundred and twenty (120) days prior written notice to 2-BBB for any reason.

 

(c) OV Right of Termination
for Safety Reasons. Notwithstanding anything to the contrary in this Agreement, OV shall have the right to terminate this Agreement
upon thirty (30) days written notice in the event that:

 

(i) a competent
Regulatory Authority in a Major Country prohibits the further clinical use of the Product in the applicable country or regulatory jurisdiction
within the Territory under 21 C.F.R. § 312.44 on grounds of safety (or equivalent grounds with respect to any country or regulatory
jurisdiction in the Territory outside of the United States); or

 

(ii) a clinical
hold imposed by a competent Regulatory Authority in a Major Country relating to the Product is definitively converted to “inactive
status” by such Regulatory Authority under 21 C.F.R. § 312.45 on grounds of safety (or equivalent grounds with respect to
any country or regulatory jurisdiction in the Territory outside of the United States), despite OV’s use of Commercially Reasonable
Efforts to eliminate such clinical hold.

 

(d) Bankruptcy. This
Agreement may be terminated by written notice by a Party at any time during the Term if the other Party shall file in any court or agency,
pursuant to any statute or regulation of any state or country, a petition in bankruptcy or other Insolvency Event 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.

 

(e)
Termination for Patent Challenge. 2-BBB shall have the right to terminate this Agreement upon written notice to OV effective upon
receipt, if OV or any of its wholly-owned Affiliates formally challenges the validity of any Patents that are licensed to OV under this
Agreement (subject to the exceptions described in this Section 14.2(e), a “Challenge”) (other than as may be necessary
or reasonably required to assert a defense, cross-claim or a counter-claim in an action or proceeding asserted by OV or any of its wholly-owned
Affiliates under this Agreement against 2-BBB or any of its Affiliates or to respond to a court request or order or administrative law,
request or order); it being understood and agreed that 2-BBB’s right to terminate this Agreement under this Section 14.2(e) shall
not apply to any actions undertaken by an Affiliate of OV that first becomes such an Affiliate as a result of a Change of Control involving
OV, where such new Affiliate was undertaking any of the activities described in the foregoing clause prior to such Change of Control;
provided that 2-BBB’s right to terminate this Agreement under this Section 14.2(e) shall apply to actions undertaken by such new
Affiliate if OV is the acquirer in such Change of Control and such new Affiliate does not terminate or otherwise cease participating
in such action, proceeding, challenge or opposition within thirty (30) days after the effective date of such Change of Control. If a
sublicensee of OV initiates a Challenge of the intellectual property described in this Section 14.2(e), then OV shall, upon written notice
from 2-BBB, terminate such sublicense. Neither Party shall, and each Party shall ensure that its Affiliates and sublicensees do
not, use or disclose any Confidential Information of the other Party or any nonpublic information regarding the Prosecution or enforcement
of any Patents to which a Party or any of its Affiliates or sublicensees are or become privy as a consequence of the rights granted to
such Party pursuant to this Agreement, in initiating, requesting, making, filing or maintaining, or in funding or otherwise assisting
any other Person with respect to, any Challenge.

 

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Section 14.3 Surviving
Rights and Obligations. Any provisions required for the interpretation or enforcement of this Agreement shall survive the expiration
or termination of this Agreement. Expiration or termination of this Agreement shall not relieve any Party of any obligations that are
expressly indicated to survive expiration or termination. Except as otherwise expressly provided, expiration or termination 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 expiration
or termination. If a license to intellectual property rights survives expiration or termination, the licensor Party promptly shall provide
to the licensee Party (to the extent it has not previously done so) all proprietary information reasonably useful or necessary for the
licensee Party to exploit such license, including reasonable technical assistance; provided that such proprietary information shall remain
subject to Section 12.1 so long as it is possessed by other Party. The termination of this Agreement shall not relieve the Parties of
any obligation accruing prior to such expiration or termination. Without limiting the forgoing, the provisions of Articles 1, 7, 10,
12, 13, and 14, and Sections 15.2, 15.3, 15.6, and 15.7 shall survive the termination of this Agreement.

 

Section 14.4 Effect
of Expiration or Termination; Remaining Inventory.

 

(a) Upon expiration or termination
of this Agreement, neither Party shall have any further rights or obligations hereunder in the Territory except pursuant to provisions
that expressly survive such expiration or termination (including, for the avoidance of doubt, this Section 14.4).

 

(b) After expiration (but
not after early termination) of this Agreement pursuant to Section 14.1, the rights and licenses granted by 2-BBB to OV under this Agreement
to Develop, Manufacture and Commercialize the Product in the Field throughout the Territory shall convert to irrevocable, exclusive,
royalty-free, fully paid-up, non-terminable rights and licenses, with the right to grant sublicenses (through multiple tiers).

 

(c) Upon early termination
of this Agreement, subject to Section 14.3 and this Section 14.4, OV shall immediately discontinue and cease all use of any trademark(s)
registered by 2-BBB in the Territory. Following any such termination of this Agreement, subject to Section 14.3 and this Section 14.4,
2-BBB shall have the right and option to purchase any trademark(s) registered by OV or its Affiliates for the Product on a country-by-country
basis. The purchase price shall be negotiated by the Parties on a country-by-country basis in good faith on the basis of a third party
willing and able to purchase such trademark(s). If the Parties are unable to come to an agreement on the purchase price within thirty
(30) days (or such other days as mutually agreed upon by the Parties) of 2-BBB exercising the right and option to purchase, the Parties
will appoint an independent third party valuator to conduct a valuation of such trademark(s) on the basis of how much a willing and able
third party will pay for such trademark(s), and the Parties shall share the costs of such third party valuation. The valuation of the
third party will be the purchase price to be paid by 2-BBB to OV.

 

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(d)
Upon termination of this Agreement in its entirety any and all rights of OV under Article 2 shall cease to exist. OV shall transfer,
or cause the transfer by an Affiliate, after the full completion or early termination of the (ongoing) Clinical Trials being conducted
by OV (subject to this Section 14.4(d)): (i) with respect to any Data and Regulatory Documentation for the Product resulting from any
Phase 1 Clinical Trial or Phase 2 Clinical Trial (other than any randomized Phase 2 Clinical Trial) conducted by OV, OV shall provide
2-BBB with all such Data and Regulatory Documentation (subject to 2-BBB’s prior reimbursement of OV’s costs incurred in connection
with shipping or otherwise providing such Data and Regulatory Documentation), and (ii) with respect to any Data and Regulatory
Documentation for the Product resulting from a randomized Phase 2 Clinical Trial, Phase 3 Clinical Trial, Pivotal Clinical Trial or post-Regulatory
Approval Clinical Trial (“Later Stage Data”) conducted by OV, 2-BBB and OV shall seek to negotiate in good faith a
price at which 2-BBB shall obtain such Later Stage Data. However, to the extent such a transfer is not permitted under Applicable Laws
for Data for which 2-BBB has elected to reimburse OV pursuant to this Section 14.4(d), OV and its Affiliates will provide 2- BBB an automatic
Right of Reference or Use to such Regulatory Documentation for the Product. For clarity, in the event that 2-BBB does not elect to reimburse
OV for the aforementioned shipping costs or to pay for Later Stage Data, then 2-BBB shall not be entitled to the transfer of any efficacy
or other data (other than safety data) generated by such Clinical Trials.

 

(e) In the event of any (A)
termination by 2-BBB pursuant to Section 14.2(a), (d) or (e) or (B) termination by OV pursuant to Section 14.2(b), 2-BBB shall be entitled
to conclude direct license agreements with OV’s sublicensees with respect to the Product.

 

ARTICLE 15

Miscellaneous

 

Section 15.1 Entire Agreement;
Amendments. This Agreement, including the Exhibits hereto, constitutes the entire agreement between the Parties concerning its subject
matter and supersedes all previous negotiations, agreements and commitments with respect thereto, as of the Effective Date. This Agreement
shall not be released, discharged, amended or modified in any manner except by a written instrument signed by duly authorized officers
or representatives of each of the Parties. There are no covenants, promises, agreements, warranties, representations, conditions or understandings,
either oral or written, between the Parties other than as are set forth herein and therein.

 

Section 15.2 Governing
Law. Any claim or controversy relating in any way to this Agreement shall be governed by and interpreted exclusively in accordance
with the laws of the State of New York, without regard to the conflicts of law principles thereof. This Agreement shall not be governed
by the United Nations Convention on Contracts for the International Sale of Goods of April 11, 1980.

 

Section 15.3 Dispute Resolution.
The Parties shall attempt in good faith to resolve any dispute or claim between them arising out of or relating to this Agreement (“Dispute”)
promptly by negotiations between executives or other representatives of the Parties with authority to resolve the Dispute. If a Dispute
should arise, such representatives shall confer in person or by telephone at least once and attempt to resolve the matter. Such conference
shall take place within ten (10) days of a written request therefor at a mutually agreed time and location (if the conference shall be
in person).

 

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If the Dispute is not settled
within thirty (30) days of the conference or time to confer described above, either Party may submit the Dispute for arbitration. The
Dispute shall be finally settled under the Rules of Arbitration (the “Rules”) of the International Chamber of Commerce
(the “ICC”). The place of the arbitration shall be New York. The language of the arbitration shall be English. There
shall be three (3) arbitrators, one of whom shall be appointed by each of the Parties in accordance with the Rules, and the third of
whom shall be appointed by the ICC. The arbitrator appointed by the ICC shall act as the chairperson of the arbitrating body. The arbitrators
shall decide the matters in the Dispute in accordance with the laws of the State of New York, without reference to the conflict of laws
rules thereof or the United Nations Convention on Contracts for the International Sale of Goods.

 

The arbitration shall be
commenced and shall proceed according to the Rules, except as otherwise provided herein. Any Confidential Information disclosed in the
arbitration shall be subject to the confidentiality provisions of this Agreement. Any time period specified in the Rules shall be extended
or accelerated upon the Parties’ written agreement. At the request of either Party, all time periods specified in the Rules may,
at the discretion of the arbitrators, be accelerated or extended to the extent necessary to comply with the timetables specified in the
Rules or for the reasonable management of the arbitration.

 

The procedures specified
in this Section 15.3 shall be the sole and exclusive procedures for the resolution of Disputes; provided, however, that a Party may,
in addition or as an alternative to seeking interim relief from the ICC, seek injunctive or other provisional judicial relief in any
court of competent jurisdiction if in its reasonable judgment such action is necessary to avoid irreparable harm or to preserve the status
quo.

 

The decision of the arbitrators
shall be final and binding on all Parties to the arbitration. Judgment upon any award rendered by the arbitrators may be entered by any
court having jurisdiction over the Party against whom enforcement is sought. Each of the Parties hereby consents, for the benefit of
the other Party, to the service of process by certified or registered mail or by an express delivery service providing a return receipt
at its address set forth for notices herein.

 

While the procedures set
forth above are being followed, the Parties shall continue to perform their respective obligations under this Agreement. Each Party shall
bear its own costs and fees, including attorneys’ fees and expenses, in connection with the arbitration, except that the arbitrators
shall be empowered to assess costs and fees against any Party who the arbitrators find to have acted in bad faith or to have maintained
a frivolous position in the arbitration.

 

Section 15.4 Partial Illegality.
If any provision of this Agreement or the application thereof to any Party or circumstances shall be declared void, illegal or unenforceable,
the remainder of this Agreement shall be valid and enforceable to the extent permitted by Applicable Laws. In such event, the Parties
shall use their best efforts to replace the invalid or unenforceable provision by a provision that, to the extent permitted by the Applicable
Laws, achieves the purposes intended under the invalid or unenforceable provision. Any deviation by any Party from the terms and provisions
of this Agreement in order to comply with Applicable Laws shall not be considered a breach of this Agreement.

 

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Section 15.5 Waiver of
Compliance. No provision of this Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees,
except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party, which
waiver shall be effective only with respect to the specific obligation and instance described therein.

 

Section 15.6 Notices.
All notices and other communications in connection with this Agreement shall be in writing and shall be sent to the respective Parties
at the following addresses, or to such other addresses as may be designated by the Parties in writing from time to time in accordance
with this Section 15.6, by registered or certified mail, postage prepaid, or by express courier service, service fee prepaid, or with
a hard copy to follow via mail or express courier service, or by email upon confirmed delivery sent by the recipient in return in accordance
with this Section 15.6.

 

	To 2-BBB:	2-BBB Medicines BV
	 	J.H. Oortweg 19
	 	Leiden Bioscience Park
	 	2333 CH Leiden, The Netherlands
	 	Attention: Pieter J. Gaillard
	 	Email: PieterGaillard@2-BBB.com

 

	To OV:	Oncology Venture, ApS
	 	Venlighedsvej 1
	 	DK-2970 Hoersholm, Denmark
	 	Attention: Dr. Peter Buhl Jensen, M.D.
	 	Email: pbj@oncologyventure.com

 

	 	With a copy to:
	 	 
	 	Dechert LLP
	 	1900 K Street, NW
	 	Washington D.C. 20006
	 	Tel number: (202) 261-3440
	 	Attention: David E. Schulman
	 	Email: david.schulman@dechert.com

 

All notices shall be deemed given and received
(a) if delivered by hand, immediately, (b) if sent by mail, ten (10) Business Days after posting, (c) if delivered by express courier
service, three (3) Business Days in the jurisdiction of the recipient, or (d) if sent by email, the date indicated as being sent in the
recipient’s email browser.

 

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Section
15.7 Limitation on Liability. NOTWITHSTANDING THE FOREGOING, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL,
INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES UNDER THIS AGREEMENT, EXCEPT TO THE EXTENT THE DAMAGES RESULT FROM A PARTY’S
WILLFUL MISCONDUCT, GROSS NEGLIGENCE OR ARE PAYABLE IN CONNECTION WITH A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 10 FOR
LIABILITY OWED TO THIRD PARTIES.

 

Section 15.8 Counterparts.
This Agreement may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed
to be one and the same instrument.

 

Section 15.9 Further Assurances.
From time to time, as and when requested by any Party, the other Party shall execute and deliver, or cause to be executed and delivered,
all such documents and instruments and shall take, or cause to be taken, all such further actions as such other Party may reasonably
deem necessary or desirable to carry out the intentions of the Parties embodied in this Agreement.

 

Section 15.10 Injunctive
Relief. The Parties acknowledge and agree that, in addition to any other remedies available in law or equity, either Party shall
be entitled to temporary and permanent injunctive relief in the event of a breach under this Agreement.

 

Section 15.11 Jointly
Prepared. This Agreement has been prepared jointly and shall not be strictly construed against either Party. Ambiguities, if any,
in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous
provision.

 

Section 15.12 Assignment.
A Party shall not have the right to assign, by operation of law or otherwise, any of its rights or obligations under this Agreement without
the prior written consent of the other Party, which shall not be unreasonably withheld, except that OV shall be permitted, without any
need for 2-BBB’s consent, to assign any of its rights and/or obligations hereunder in whole or in part to its Affiliates, provided
that OV remains liable for the performance of its obligations hereunder. Any assignment not in accordance with this Section 15.12 shall
be void. Notwithstanding the foregoing, the Parties understand and agree that OV shall be entitled, upon completion of the first Phase
2 Clinical Trial for use of the Product in the Field, to assign this Agreement in its entirety to an Affiliate or a successor to all
or substantially all of its business or assets to which this Agreement relates, in accordance with Section 6.1. Notwithstanding the foregoing,
the Parties understand and agree that 2-BBB shall be entitled to assign this Agreement in its entirety to its successor in connection
with the merger, consolidation, or sale of all or substantially all of its assets (provided that all of the 2-BBB Intellectual Property
is included in such merger, consolidation, or sale) or that portion of its business pertaining to the subject matter of this Agreement,
without any need for OV’s consent.

 

Section 15.13 Relationship
of Parties. Each Party to this Agreement is an independent contractor, and nothing in this Agreement shall be construed to give either
Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the
relationship of partners, principal and agent, or joint-venture partners between the Parties. Employees and agents of one Party are not
employees or agents of the other Party, shall not hold themselves out as such, and shall not have any authority or power to bind the
other Party to any contract or other obligation.

 

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Section 15.14 Force Majeure.
If the performance of any obligation under this Agreement is prevented, restricted or interfered with by reason of any Force Majeure
event, then the Party so affected shall be excused, upon giving prior written notice to the other Party, from such performance to the
extent of such prevention, restriction or interference, provided that the Party so affected shall use Commercially Reasonable Efforts
to avoid or remove such causes of nonperformance and shall continue performance to the extent reasonably possible and, in any event,
at such time as the Force Majeure conditions come to an end. If the Force Majeure conditions prevent performance completely and such
prevention continues for more than one hundred and eighty days (180) days, then the Parties shall attempt to negotiate a mutually acceptable
compromise within the spirit and intent of this Agreement. If they are unable to reach a mutually acceptable compromise within ninety
(90) days and if performance is still completely prevented at the end of that time, then the Party who is not affected by the Force Majeure
conditions shall have the option, by delivery of written notice of termination to the affected Party, to terminate this Agreement with
immediate effect.

 

Section 15.15 Severability.
If any one or more of the terms or provisions of this Agreement is held by a court of competent jurisdiction or arbitrator to be void,
invalid or unenforceable in any situation in any jurisdiction, such holding shall not affect the validity or enforceability of the remaining
terms and provisions hereof or the validity or enforceability of the invalid, void or unenforceable term or provision in any other situation
or in any other jurisdiction and the term or provision shall be considered severed from this Agreement, unless the invalid or unenforceable
term or provision is of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have
entered into this Agreement without the invalid or unenforceable term or provision. If the final judgment of such court or arbitrator
declares that any term or provision hereof is invalid, void or unenforceable, the Parties agree to (a) reduce the scope, duration, area
or applicability of the term or provision or to delete specific words or phrases to the minimum extent necessary to cause such term or
provision as so reduced or amended to be enforceable, and (b) make a good faith effort to replace any invalid or unenforceable term or
provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

 

Section 15.16 Third-Party
Beneficiaries. Nothing in this Agreement, whether express or implied, is intended to confer any rights or remedies under or by reason
of this Agreement on any Persons other than the Parties hereto and their respective successors, assigns, and Affiliates.

 

Section 15.17 Expenses.
Except as expressly provided herein (including with respect to the allocation of Out-of-Pocket Costs), each of OV and 2-BBB agrees to
pay, without right of reimbursement from the other, all costs and expenses incurred by it and its Affiliates incident to the preparation,
execution and delivery by it of this Agreement and the performance of its obligations hereunder, including the fees and disbursements
of counsel, accountants, financial advisors, experts, consultants and employees employed by such party in connection with the preparation,
execution and delivery by it of this Agreement and with the performance of its obligations contemplated hereby.

 

[REMAINDER OF PAGE INTENTIONALLY
BLANK; 

SIGNATURE PAGE FOLLOWS]

 

    49

     

    

 

Execution Version

 

The Parties have executed this Agreement as of
the Effective Date to evidence their agreement to the terms and provisions set forth herein.

 

	 	Oncology Venture, ApS
	 	 
	 	By:	 
	 	 
	 	 
	 	2-BBB Medicines BV
	 	 
	 	By:	         

 

 

 

(Signature Page to Exclusive License Agreement]

 

     

     

    

 

Execution Version

 

EXHIBIT A

 

Clinical Development Plan

 

[***]

 

     

     

    

 

EXHIBIT B

 

Product

 

2.1.P Drug Product 2B3-101

 

2.1.P.1 Description and Composition of
2B3-101

 

2B3-101 is a sterile brown-reddish solution containing
2 mg/mL of glutathione-PEGylated liposomal Doxorubicin hydrochloride.

 

The drug product is supplied in 10 mL Type I
clear glass vials with siliconised bromobutyl stopper and flip-off aluminium seal with blue cap. To remove the exactly labelled 10 mL
volume from the vial, an overfill of 0.7 mL is applied. The qualitative composition of 2B3- 101 is listed in Table 20.

 

Table 20: Qualitative composition of 2B3-101

 

	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]
	[***]	[***]	[***]

 

     

     

    

 

EXHIBIT C

 

Press Release

 

[See following page]

 

     

     

    

 

 

Press release issued by Oncology Venture Sweden
AB

Hoersholm, Denmark, March 2Xth 2017

Press release

 

 

 

Oncology Venture
in-licenses 2BBB’s Phase 2 lead product ‘2B3-101’ for 2X Oncology’s pipeline

 

Hoersholm, Denmark; Leiden, the Netherlands,
March XX 2017 – Oncology Venture Sweden AB (OV:ST) and 2-BBB Medicines BV announce today to have entered into an exclusive global
license agreement on 2-BBB’s Phase 2 lead product 2B3-101 – now called 2X-111. The drug is a liposomal formulation of doxorubicin

utilizing
the so-called G-Technology, which enables the drug to pass the Blood Brain Barrier to enhance treatment of brain metastases and primary
brain tumors. 2X-111 has demonstrated clinical activity in a phase 2 study in metastatic Breast Cancer patients and in patients with
Glioblastoma (primary brain cancer) both hard to treat cancers with a huge unmet medical need. 2X-111 will be combined with its Drug
Response Predictor (DRPTM) as a companion diagnostic in DRPTM focused Phase 2 trials for selected, high-likelihood responder patients.
The drug will be developed as a 2X Oncology Inc. pipeline drug. 2X Oncology Inc. is a

spinout of Oncology Venture developing Precision
medicine for Women’s cancers.

 

The active anticancer drug in 2X-111, doxorubicin,
is an almost identical molecule to epirubicin, for which it was recently announced that the DRPTM biomarker can, with certainty,
identify those patients who benefit from treatment with the drug. A retrospective-prospective validation (i.e. the highest validation
level) has been achieved for the epirubicin DRPTM, and 2X-111 therefore has a similar risk reduced profile (as is also the case
with LiPlaCis in the Oncology Venture pipeline).

 

Under
the terms of the agreement, Oncology Venture will be responsible for the development and commercialization of 2X-111 in oncology. Further
terms of the agreement were not disclosed. Oncology Venture will, through 2X Oncology, fund and execute the mutually agreed upon clinical
development plan, which includes an initial phase 2 clinical study in metastatic Breast Cancer through screening of approximately 250
patients in Denmark and potentially other countries with its DRPTM biomarker as a predictive/companion diagnostic.

 

“I’m excited for the opportunity
to in-license the liposomal doxorubicin compound from 2-BBB. I believe that the cutting-edge science and compelling clinical data behind
the drug (now called 2X-111) in combination with our unique Drug Response Predictor (DRPTM) biomarker technology gives an exceptional
risk reduced opportunity to develop effective treatments for hard to treat cancers,” says Adjunct Professor Peter Buhl Jensen,
M.D., CEO of Oncology Venture. 

 

“2X-111 will be developed in two focused
Phase 2 trials in metastatic Breast Cancer and in Glioblastoma in 2X Oncology Inc. a precision medicines company for Women’s Cancers
– a spinout from Oncology Venture,” Peter Buhl Jensen further commented.

 

Sijme Zeilemaker, Head of Business at 2-BBB
and CEO Pieter Gaillard adds: “We are proud to see 2B3-101 move into the next phase of clinical development for such devastating
diseases. Oncology Ventures spinout 2X Oncology Inc. is the right partner for the product, highly knowledgeable in difficult-to-treat
cancer types, and able to enhance the efficacy by screening patients who are likely to respond using their DRPTM biomarker. The
license deal further validates 2-BBB’s technology and development strategy through crucially improving medicines for patients in
need.”

 

 

     

     

    

 

About 2X-111 (previously 2B3-101)

2-BBB has applied its proprietary G-Technology
to its lead product 2B3-101 now 2X-111 to enhance the delivery of doxorubicin to the brain and enable better treatment of metastatic
cancer types and primary brain tumors. In preclinical studies, 2-BBB has shown that conjugation of glutathione to the tips of PEGylated
liposomes can provide a five-fold increased delivery of doxorubicin to the brain compared to untargeted liposomes. 2B3-101 has been studied
in a phase 1/2a clinical trial in 10 clinical sites in the Netherlands, Belgium, France and the United States, confirming its tolerable
safety profile in 85 patients and showing encouraging signs of anti-tumor activity in amongst others metastatic Breast Cancer and Glioblastoma
(primary brain tumor).

 

About
the Drug Response Predictor (DRPTM) biomarker technology

Oncology Venture (OV) and 2X Oncology Inc. use
the multi gene DRPTM from MPI (Medical Prognosis Institute A/S; MPI.ST) to select those patients that by the genetic signature in
their cancer is found to have a high likelihood of response to a given drug. The goal is to develop the drug for the right patients and
by screening patients with a drug-specific DRPTM biomarker before treatment the response rate can be significantly increased. This
DRPTM method builds on the comparison of sensitive vs. resistant human cancer cell lines including genomic information from cell
lines combined with clinical tumor biology and clinical correlates in a systems biology network. The DRPTM is based on messenger
RNA from the patients’ biopsies. The DRPTM platform, i.e. the DRPTM and the PRPTM tools, can be used in all cancer
types, and is patented for more than 70 anti-cancer drugs in the US. The PRPTM is used by MPI for Personalized Medicine. The DRPTM
is used in Oncology Venture and 2X Oncology Inc., a spinout of OV for drug development.

 

About 2-BBB Medicines BV

2-BBB is created to develop medicines for the
treatment of devastating brain diseases. We believe that we can transform the lives of those affected faster and more successful by combining
known disease targets and compounds with established drug delivery systems united with safe targeting technology. This has led to two
programs in clinical development: 2B3-101 for brain cancer and 2B3-201 for neuro- inflammatory diseases. 2-BBB is based in the Netherlands
on the Leiden Bio Science Park, and its subsidiary to-BBB Taiwan Ltd. is based in Taipei, Taiwan.

 

About Oncology Venture Sweden AB

Oncology Venture Sweden AB is engaged in the
research and development of anti-cancer drugs via its wholly owned Danish subsidiary Oncology Venture ApS. Oncology Venture has an exclusive
license to use the Drug Response Predictor (DRPTM) platform in order to significantly increase the probability of success in clinical
trials. DRPTM has proven its ability to provide a statistically significant prediction of clinical outcomes from drug treatment
in cancer patients in 29 of the 37 clinical studies that were examined. The Company uses a model that alters the odds in comparison with
traditional pharmaceutical development. Instead of treating all patients with a particular type of cancer, patients’ tumors genes
are screened first and only those who are most likely to respond to the treatment will be treated. Via a more well-defined patient group,
the risk and costs are reduced while the development process becomes more efficient. The current product portfolio: LiPlaCis for Breast
Cancer in collaboration with Cadila Pharmaceuticals, Irofulven developed from a fungus for prostate cancer and APO010 – an immuno-oncology
product for Multiple Myeloma.

 

     

     

    

 

Oncology Venture has spun out two companies in
Special Purpose Vehicles: 2X Oncology Inc. a US based company focusing on Precision medicine for women’s cancers with a pipeline
of three promising phase 2 product candidates (OV currently owns 92% of the shares in 2X Oncology) and Danish OV-SPV 2 will test and
potentially develop an oral phase 2 Tyrosine Kinase inhibitor.

 

For further information, please contact

 

	Oncology Venture	Or	Oncology Venture
	Ulla Hald Buhl, COO and	 	Peter Buhl Jensen, CEO
	Chief IR & Communications	 	Mobile: +45 21 60 89 22
	Mobile: +45 2170 1049	 	E-mail: pbj@oncologyventure.com
	uhb@oncologyventure.com	 	 

 

	2-BBB	2-BBB
	Sijme Zeilemaker	Pieter Gaillard
	Head of Business	CEO
	Phone: +31 6 30 415 770	Phone: +31 6 21 525 000
	E-mail: SijmeZeilemaker@2-
    BBB.com	E-mail: PieterGaillard@2-BBB.com

 

This information is information that Oncology
Venture Sweden AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication,
through the agency of the contact person set out above, on March XXth 2017. 

 

     

     

    

 

Execution Version

 

Schedule 1

 

Major Countries

 

United States, Canada, Germany, France, the United
Kingdom, Spain, Italy, China, Japan, Russia, Brazil, and Australia.

 

     

     

    

 

Execution Version

 

Schedule 2

 

2-BBB Patents

 

		2	Platform Patents and applications

		a.	ITRI license _ Glutathione-based delivery system (19-12-2005)

		1.	TW94147661A / TWI365754B

		2.	CN1985804A / CN1985804B

		3.	CN101385859A / CN101385859B

		4.	JP2010150264A / JP5394944B2

		5.	JP2007169252A / JP4773200B2

		6.	EP1891962A1 / EP1891962B1

		7.	EP2837384A1

		8.	US20070141133A1 / US7446096B2

		9.	US20080095836A1 / US7704956B2

		10.	US20090060991A1 / US7700564B2

		11.	US20090123531A1 / US8067380B2

		12.	US20100166849A1 / US8569239B2

		13.	US2012046445A1 / US8673863B2

 

		b.	2-BBB owned _ Targeted intracellular delivery of antiviral agents /
                                            Conjugates for targeted drug delivery across the blood-brain barrier (21-03-2008)

		1.	US2015290234A1

		2.	EP2308514A2 / EP2308514B1

		3.	TW201417832A / TWI537005B

 

		2	Product-Specific Patents and applications

		a.	2-BBB owned _ Glutathione-based drug delivery system (20-02-2010)

		1.	NZ594310B

		2.	AU2010216512B2

		3.	JP5564517B2

		4.	CN102316902B

		5.	CA2752373B

		6.	EP2398500A2

		7.	US2014227185*

 

		*	Abandoned Patent which the Parties shall
                                            seek to revive pursuant to the terms of the Agreement.

 

     

     

    

 

Execution Version

 

Schedule 3.6

 

Manufacturing

 

[***]

 

     

     

    

 

Execution Version

 

Schedule 11.2(a)

 

[***]

 

     

     

    

 

Execution Version

 

Schedule 11.2(d)

 

Third Party Obligations

 

[***]Exhibit 10.5

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED
BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

EXECUTION VERSION

 

 

 

ONCOLOGY VENTURE ApS

 

 

 

and

 

 

 

R-PHARM US OPERATING, LLC

 

 

 

 

 

 

DEVELOPMENT, OPTION AND LICENSE
AGREEMENT

 

 

 

 

 

 

     

     

    

 

THIS DEVELOPMENT, OPTION AND LICENSE AGREEMENT
(this “Agreement”) is made and entered into effective as of the 1st day of March, 2019 (the “Effective
Date”)

 

BY AND BETWEEN:

 

		(1)	Oncology Venture ApS, a company organized and existing under the laws of
Denmark, whose principal place of business is located at Venlighedsvej 1, 2970 H0rsholm, Denmark (“OV”); and

 

		(2)	R-PHARM US Operating, LLC, a limited liability corporation organized and
existing under the laws of Delaware, with offices at 3120 Princeton Pike, Suite 201, Lawrence, N.J. 08648 U.S.A. (“R-Pharm”).
OV and R-Pharm are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS,
R-Pharm owns or controls certain intellectual property and other rights with respect to the Compound (as defined below) and markets and
sells the Product (as defined below) in certain countries, including the United States;

 

WHEREAS,
R-Pharm does not currently develop and/or commercialize, by itself or through its Affiliates (as defined below) and/or Third Parties (as
defined below), the Product in the Field (as defined below) in the Territory (as defined below);

 

WHEREAS,
the Compound has previously been tested in phase II and III clinical trials in the Territory for treatment of metastatic breast cancer,
but has not received Regulatory Approval (as defined below) from the European Medicines Agency (EMA) in the Territory;

 

WHEREAS,
OV has previously developed and validated the DRP Biomarker (as defined below) specific for the Compound, which is useful for selecting
highly likely responder patients for the Compound;

 

WHEREAS,
OV desires to conduct a clinical trial using the Product and the DRP Biomarker for the treatment of patients with metastatic breast cancer,
as more particularly described in the Clinical Development Plan (as defined below);

 

WHEREAS, R-Pharm
and OV desire to collaborate with respect to the conduct of such clinical trial as set forth herein; and

 

WHEREAS,
OV wishes to obtain, and R-Pharm wishes to grant to OV, a license to develop the Product in new clinical trials in the Territory and an
Exclusive Option (as defined below) to an exclusive license with respect to the Product under R-Pharm’s intellectual property and other
rights therein for the purposes of exploiting the Product and the DRP Biomarker as a companion diagnostic in the Field in the Territory
in accordance with the terms and conditions set forth below, as more particularly described herein.

 

NOW, THEREFORE,
in consideration of the mutual covenants and agreements herein contained, and other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows:

 

		1.	DEFINITIONS

 

The capitalized terms used in this Agreement shall have
the meanings as defined below:

 

    	2

     

    

 

 1.1 “Adverse Ruling” has the meaning set forth in Section 11.4.

 

 1.2 “Affiliate” means, with respect to a Party, any Person that directly or indirectly controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” shall mean: (a) direct or indirect, ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation; (b) fifty percent (50%) or more of the equity interest in the case of any other type of legal entity or status as a general partner in any partnership; (c) any other arrangement whereby the entity or Person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity; (d) if a Party is exposed, or has rights, to variable returns from its involvement with an entity or Person and has the ability to affect its returns through its power over such entity or Person; or (e) the ability to cause the direction of the management or policies of a corporation or other entity. In the case of entities organized under the Applicable Laws of certain countries, the maximum percentage ownership permitted by Applicable Law for a foreign investor may be less than fifty percent (50%), and in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity. The Parties understand and agree that, with respect to OV, “Affiliates” expressly includes Medical Prognosis Institute, ApS (“MPI”) and 2X Oncology, Inc. (“2X”).

 

 1.3 “Agreement” has the meaning set forth in the preamble hereto.

 

 1.4 “Agreement IP” means all Know-How, Patents and other intellectual property under the Control of a Party that was conceived, discovered, developed or otherwise made by or on behalf of a Party under or in connection with this Agreement, or by use of or reference to the other Party’s Background IP.

 

 1.5 “Amount” has the meaning set forth in Section 7.8.

 

 1.6 “Applicable Law” means all applicable federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, regulatory guidelines, or other requirements of the Regulatory Authorities, that may be in effect from time to time during the Term and applicable to a particular activity or country or other jurisdiction hereunder, including all data protection requirements such as those specified in the EU Data Protection Directive and the regulations issued under the United States Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

 

 1.7 “Background IP” means Know-How, Patents and other intellectual property under the Control of a Party that was conceived, discovered, developed or otherwise made or acquired (other than from the other Party) by the Party prior to the Effective Date or independently and outside the activities contemplated by this Agreement without reference to or use of the other Party’s Confidential Information or Background IP. Background IP ofOV expressly includes DRP Biomarker.

 

 1.8 “Breaching Party” has the meaning set forth in Section 11.4.

 

 1.9 “Business Day” means a day (other than a Saturday, Sunday or a public holiday) on which the banks are open for business in Princeton, New Jersey, or Basel, Switzerland or Copenhagen, Denmark.

 

 1.10 “Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.

 

    	3

     

    

 

 1.11 “Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.

 

 1.12 “cGCP” means the current Good Clinical Practices as such term is defined from time to time by the EMA or FDA pursuant to its regulations, guidelines or otherwise, as well as, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), that may be in effect from time to time and are applicable to the conduct of the mBC Clinical Trial hereunder.

 

 1.13 “cGMP” means the current Good Manufacturing Practices officially published and interpreted by EMA, FDA, or other applicable Regulatory Authorities that may be in effect from time to time and are applicable to the manufacture of the Product or DRP Biomarker.

 

 1.14 “Change of Control” means, with respect to a Party, that: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such Third Party in the voting securities of such Party is increased through stock redemption, cancellation, or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty percent (50%) of the total voting power of all of the then outstanding voting securities of such Party; (b) a merger, consolidation, recapitalization or reorganization of such Party is consummated, other than any such transaction, which would result in shareholders or equity holders of such Party immediately prior to such transaction, owning at least fifty percent (50%) of the outstanding voting securities of the surviving entity (or its parent entity) immediately following such transaction; or (c) the sale or transfer to a Third Party of all or substantially all of such Party’s consolidated assets taken as a whole. The announced and imminent merger between OV and its Affilate MPI shall not be deemed a Change of Control event hereunder.

 

 1.15 “Clinical Development Plan” means OV’s plan for the Development of Product in the Field in the Territory, including the conduct of the mBC Clinical Trial, using the DRP Biomarker to select and enroll highly likely responder patients, as may be amended from time to time at the discretion of the Joint Development Committee. The initial Clinical Development Plan will be agreed to by the Parties and attached hereto as Exhibit A within ninety (90) days after the Effective Date.

 

 1.16 “Commercialization Data” has the meaning set forth in Section 5.7.

 

 1.17 “Commercialization Plan” has the meaning set forth in Section 5.3a).

 

 1.18 “Commercialize” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of the Product, including activities related to marketing, promoting, distributing, importing and exporting such Product, and interacting with Regulatory Authorities regarding any of the foregoing. “Commercializing” and “Commercialization” shall have correlative meanings.

 

 1.19 “Commercially Reasonable Efforts” means those diligent efforts and resources consistent with customary practices of comparable companies in the specialty pharmaceutical industry that such a company typically devotes to a product or compound owned by it or to which it has rights of the type it has hereunder, or similar market potential at a similar stage in the development or product life thereof, in light of the intellectual property and competitive landscape relevant to such product, the safety and efficacy profile of a product, pricing and launching strategy for the respective product, the development and regulatory approval (including any reimbursement approval) risks associated with such product, the Patent or other proprietary position of the Product (including the ability to obtain or enforce, or have obtained or enforced, such Patent or other proprietary positions), the regulatory requirements involved and the potential profitability, cost, market share, price or reimbursement to the performing Party of the Product marketed or to be marketed.

 

    	4

     

    

 

1.20 “Competing
Product” means any product containing Ixabepilone, an epothiline or epothilone derivative, other than the Product.

 

1.21 “Compound”
means the compound Ixabepilone (Ixempra®) (CAS No. 219989-84-1) as further described in Exhibit B.

 

 1.22 “Compound Agreement IP” has the meaning set forth in Section 8.lb)(i).

 

1.23 “Confidential
Information” means any and all proprietary Know-How, information and data, including scientific, pre-clinical, clinical, regulatory,
manufacturing, marketing, financial and commercial information or data, whether communicated in writing or orally or by any other method,
which is provided by or on behalf of one Party or its Affiliate to the other Party or its Affiliate in connection with this Agreement.
All information disclosed under that certain Mutual Non-Disclosure and Confidentiality Agreement by and betweenR-Pharm US LLC and OV dated
October 11, 2017 shall be deemed Confidential Information under this Agreement.

 

1.24 “Control” or “Controlled” means
with respect to any item of Know-How, Patent or other proprietary right, the possession of the right, whether directly or indirectly
(other than through the rights granted under this Agreement), to grant a license, sublicense or other right to any such Know-How, Patent
or other proprietary right without violating the terms of any agreement or other arrangement with any Third Party. Notwithstanding the
foregoing, for the purpose of defining whether intellectual property, Patents, Know-How, Confidential Information or other proprietary
right is Controlled by a Party, if such intellectual property, Patents, Know-How, Confidential Information or other proprietary right
is first acquired, licensed or otherwise made available to such Party after the Effective Date and if the use, practice or exploitation
thereof by or on behalf of the other Party, its Affiliates or sublicensees would require the first Party to pay any additional amounts
to the Third Party from which the first Party acquired, licensed or otherwise obtained such intellectual property, Patents, Know-How,
Confidential Information or other proprietary right (“Additional Amounts”), following the Effective Date, such intellectual
property, Patents, Know-How, Confidential Information or other proprietary right shall be deemed to be Controlled by the first Party only
if the other Party agrees to pay (if necessary) and does in fact pay all Additional Amounts with respect to such other Party’s use of
or license to such intellectual property, Patents, Know-How, Confidential Information or other proprietary right to the extent specified
in this Agreement.

 

1.25 “Cover,”
“Covering” or “Covered” means that, with respect to a product or technology and a Patent, but for ownership of
or a license under such Patent, the Development, Commercialization or other use of such product or practice of such technology by a Person
would infringe a claim of such Patent or, with respect to a claim included in any patent application, would infringe such claim if such
patent application were to issue as a patent.

 

 1.26 “Default Notice” has the meaning set forth in Section 11.4.

 

 1.27 “Delivery” has the meaning set forth in Section 6.2a).

 

1.28
“Develop” means all activities related to research, pre-clinical and other non-clinical testing, test method
development and stability testing, toxicology, formulation, process development, clinical trials, statistical analysis and report
writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all
other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in
support of obtaining or maintaining a Regulatory Approval. “Developing” and “Development” shall have
correlative meanings.

 

    	5

     

    

 

 1.29 “Disclosing Party” has the meaning set forth in Section 10.1.

 

 1.30 “Dollars” or”$” means United States Dollars.

 

1.31 “DRP
Biomarker” means the proprietary, gene-expression-based, predictive biomarker for the Product, developed and validated by OV
at any time, which DRP Biomarker is useful for selecting patients likely to respond to the Product.

 

 1.32 “DRP Biomarker Agreement IP” has the meaning set forth in Section 8.lb)(ii).

 

1.33 “Drug
Approval Application” means an application for Regulatory Approval to market and sell the Product in a country or region, including
a Marketing Authorization Application (a “MAA”) filed with the EMA or with the applicable Regulatory Authority of a country
in the European Union with respect to the mutual recognition or any other national approval procedure, and all supplements, amendments,
variations, extensions and renewals thereof that may be filed with respect to the foregoing.

 

 1.34 “Effective Date” has the meaning set forth in the preamble hereto.

 

1.35 “EMA”
means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function.

 

1.36 “EU
Data Protection Directive” means Directive 95/46/EC of the European Union and any successor law, including the General Data Protection
Regulation (GDPR) (Regulation (EU) 2016/679).

 

 1.37 “Exclusions List” has the meaning set forth in the definition of Violation.

 

 1.38 “Exclusive Option” has the meaning set forth in Section 2.1.

 

 1.39 “Exclusive Option Exercise Payment” has the meaning set forth in Section 7.2.

 

1.40 “Existing
Regulatory Documentation” means, to the extent in R-Pharm’s possession or available to R-Pharm, all data, documentation, and
clinical materials (including any and all CTA (Clinical Trial Authorization) and IMPD (Investigational Medical Product Dossier) and related
EMA regulatory submissions and correspondence) and IND (Investigational New Drug) applications and related FDA regulatory submissions
and correspondence, including such Existing Regulatory Documentation from R-Pharm’s licensee in Switzerland and from prior Compound owner,
Bristol Myers Squibb Inc., solely relating to the Compound and reasonably necessary for the conduct of the Compound development program
in the Territory.

 

1.41 “FDA”
means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function.

 

1.42 “Field”
means, (i) during the Option Period, any and all therapeutic and/or diagnostic uses related to mBC, or (ii) following the Option Exercise
Date, any and all therapeutic and/or diagnostic uses in humans.

 

1.43
“First Commercial Sale” means, with respect to the Product in a given country in the Territory, the first commercial
sale of Product by OV, its Affiliate, or permitted sublicensee to a non- sublicensee Third Party on arm’s length terms for end use
or consumption of Product in the Field in such country following Regulatory Approval of Product in such country or, ifno such
Regulatory Approval (or similar approval) is required to market Product in such country, the date on which Product is first
commercially launched in the Field in such country by OV, its Affiliate or permitted sublicensee. For clarity, First Commercial Sale
shall be determined on a Product-by-Product and country-by-country basis.

 

    	6

     

    

 

 1.44 “Force Majeure” has the meaning set forth in Section 14.21.

 

1.45 “Generic
Product” means, with respect to a Product in a country, any product that (i) is sold in such country by a Third Party that is
not a permitted sublicensee of OV and did not purchase such product in a chain of distribution that included any of OV or its Affiliates
or permitted sublicensees under a Regulatory Approval granted by a Regulatory Authority to a Third Party; (ii) contains the Compound as
the sole active ingredient; and (iii) is approved for sale by the applicable Regulatory Authority in such country in the Field for the
same Indication.

 

1.46 “Governmental
Authority” means any court, agency, department, authority or other instrumentality of any national, supra-national, state, county,
city or other political subdivision.

 

 1.47 “HIPAA” has the meaning set forth in the definition of Applicable Law.

 

 1.48 “Indemnification Claim Notice” has the meaning set forth in Section 13.3b).

 

 1.49 “Indemnified Party” has the meaning set forth in Section 13.3b).

 

 1.50 “Indemnifying Party” has the meaning set forth in Section 13.3b).

 

1.51 “Indication” means a separate and distinct
disease or medical condition in humans for which the Product has received Regulatory Approval with an approved label claim to treat such
disease or condition, as applicable; it being understood that references to Indications with regard to the Product shall be based upon
entirely different diseases or condition (including but not limited to cancers arising from different tissues) in particular target patient
populations (and, for the avoidance of doubt, different line therapies for the same disease or condition, such as (for example) first
line treatment for a disease or condition as compared to second line treatment for such same disease or condition, shall not be deemed
to be a different Indication).

 

 1.52 “Indirect Taxes” has the meaning set forth in Section 7.9.

 

 1.53 “Insolvency Event” has the meaning set forth in Section 11.5.

 

 1.54 “Joint Agreement IP” has the meaning set forth in Section 8.lb)(iv).

 

 1.55 “Joint Development Committee” or “JDC” has the meaning set forth in Section 3.1a).

 

1.56
“Know-How” means any and all technical, scientific and other know-how and information (whether patentable or not),
including (a) ideas, discoveries, inventions, improvements, technology or trade secrets, (b) pharmaceutical, chemical and biological
materials, products, components or compositions, (c) methods, procedures, formulas, processes, tests, assays, techniques, regulatory
requirements and strategies, (d) biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical,
clinical, safety, manufacturing and quality control data and information related thereto, (e) technical and non-technical data and
other information related to the foregoing, (f) drawings, plans, designs, diagrams, sketches, specifications or other documents
containing or relating to such information or materials and (g) all applications, registrations, licenses, authorizations, approvals
and correspondence submitted to Regulatory Authorities.

 

    	7

     

    

 

1.57 “Litigation
Conditions” means, with respect to a Third Party Claim, (a) such Third Party Claim does not seek injunctive relief or non-monetary
damages from the Indemnified Party and (b) the Indemnifying Party expressly agrees in writing that as between the Indemnifying Party and
Indemnified Party, the Indemnifying Party shall be solely obligated to satisfy and discharge such Third Party Claim in full and is able
to reasonably demonstrate that it has sufficient financial resources to meet such indemnification obligations.

 

 1.58 “Losses” has the meaning set forth in Section 13.1.

 

 1.59 “MAA” has the meaning set forth in the definition of Drug Approval Application.

 

 1.60 “mBC” means metastatic breast cancer.

 

 1.61 “mBC Clinical Trial” has the meaning set forth in Section 4.1.

 

 1.62 “mBC Clinical Trial Completion” has the meaning set forth in Section 4.4d).

 

1.63 “mBC
Clinical Trial Data” means all data (including raw data) and results generated by or on behalf of a Party in the performance
of the mBC Clinical Trial.

 

 1.64 “mBC Clinical Trial Report” has the meaning set forth in Section 4.4d).

 

 1.65 “Milestone Events” has the meaning set forth in Section 7.3.

 

 1.66 “Milestone Payments” has the meaning set forth in Section 7.3.

 

1.67 “Net
Sales” means, with respect to a given period, the gross amount billed or invoiced for sale of Product (or if not billed or invoiced,
the amount received) during such period by OV, its Affiliates, or permitted sublicensees (each, a “Selling Party”)to
Third Parties less the following deductions :

 

		a)	discounts (including trade, quantity and cash discounts),
cash and non-cash coupons, retroactive price reductions, and charge-back payments and rebates granted to any Third Party (including to
Governmental Authorities, purchasers, reimbursers, customers, distributors, wholesalers, and group purchasing and managed care organizations
or entities (and other similar entities and institutions));

 

		b)	credits or allowances, if any, on account of price adjustments,
recalls, claims, damaged goods, rejections or returns of items previously sold (including Products returned in connection with recalls
or withdrawals);

 

		c)	rebates (or their equivalent), administrative fees, chargebacks
and retroactive price adjustments and any other similar allowances granted by a Selling Party (including to Governmental Authorities,
purchasers, reimbursers, customers, distributors, wholesalers, and group purchasing and managed care organizations and entities (and
other equivalent entities and institutions)) which effectively reduce the selling price or gross sales of the Product, normal and customary
inventory management fees and other bona fide service fees paid to distributors and wholesalers;

 

    	8

     

    

 

		d)	insurance, customs charges,
freight, postage, shipping, handling, and other transportation costs to the extent added to the sale price and set forth separately as
such in the total amount invoiced; and

 

		e)	import taxes, export taxes, excise taxes, sales tax, value-added
taxes, consumption taxes, duties or other taxes levied on, absorbed, determined or imposed with respect to such sales (excluding income
or net profit taxes or franchise taxes of any kind).

 

There should be no double counting
in determining the foregoing deductions from gross amounts invoiced to calculate “Net Sales” hereunder.

 

 1.68 “Non-Breaching Party” has the meaning set forth in Section 11.4.

 

 1.69 “Option Exercise Date” has the meaning set forth in Section 2.2.

 

 1.70 “Option Request Notice” has the meaning set forth in Section 2.2.

 

 1.71 “Option Fee” has the meaning set forth in Section 7.1.

 

 1.72 “Option Period” shall have the meaning set forth in Section 2.la).

 

 1.73 “OV” has the meaning set forth in the preamble hereto.

 

 1.74 “OV Confidential Information” has the meaning set forth in Section 10.1.

 

 1.75 “OV Indemnitees” has the meaning set forth in Section 13.1.

 

 1.76 “Party” and “Parties” have the meaning set forth in the preamble hereto.

 

1.77 “Patents”
means all national, regional and international patents and patent applications, including any continuations, continuations-in-part,
divisionals, provisionals, or any substitute applications, any patent issued with respect to any such patent applications, any reissue,
reexamination, renewal, or extension (including any supplemental protection certificate) of any such patent, and any confirmation patent
or registration patent or patent of addition based on any such patent.

 

 1.78 “Payment” has the meaning set forth in Section 9.3.

 

1.79 “Person”
means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or
other entity.

 

1.80 “Product”
means any pharmaceutical product containing the Compound, in all forms, presentations, formulations, methods of administration, and
dosage forms.

 

 1.81 “Receiving Party” has the meaning set forth in Section 10.1.

 

1.82 “Regulatory
Approval” means, with respect to a country or other jurisdiction in the Territory, any and all approvals (including Drug Approval
Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize the Product in such country
or other jurisdiction.

 

1.83 “Regulatory
Authority” means any applicable Government Authority involved in granting approvals for the manufacturing, marketing, reimbursement
or pricing of a Product in the Territory.

 

    	9

     

    

 

1.84
“Regulatory Documentation” means all (a) applications (including all Drug Approval Applications), registrations,
licenses, authorizations, and approvals (including Regulatory Approvals), and (b) correspondence and reports submitted to or
received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any
Regulatory Authority), in each case ((a) and (b)) relating to the Product.

 

1.85 “Regulatory
Exclusivity” means, with respect to any country in the Territory, an additional market protection, other than Patent protection,
granted by a Regulatory Authority in such country which confers an exclusive Commercialization period during which OV or its Affiliates
or permitted sublicensees have the exclusive right to market and sell the Product in such country through a regulatory exclusivity right
(e.g., new chemical entity exclusivity, orphan drug exclusivity or pediatric exclusivity).

 

 1.86 “Regulatory Submissions” has the meaning set forth in Section 4.6b).

 

1.87 “Royalty
Term” means, with respect to the Product and a given country of sale in the Territory, the period beginning on the date of the
First Commercial Sale of such Product in such country of sale, and ending on the latest to occur of(a) the first date on which there is
no Valid Claim that Covers such Product or such Product in combination with the DRP Biomarker in such country of sale, and (b) the seventh
(7th) anniversary of the First Commercial Sale of such Product in such country of sale.

 

 1.88 “R-Pharm” has the meaning set forth in the preamble hereto.

 

 1.89 “R-Pharm Confidential Information” has the meaning set forth in Section 10.1.

 

 1.90 “R-Pharm Indemnitees” has the meaning set forth in Section 13.2.

 

1.91
“R-Pharm Know-How” means all Know-How that is (a) Controlled by R-Pharm or any of its Affiliates as of the Effective
Date or at any time during the Term and (b) necessary or reasonably useful for the Development or Commercialization of the Product.
The use of “Affiliate” in this definition shall exclude any Third Party that becomes an Affiliate due to such Third
Party’s or such Third Party’s Affiliate’s acquisition of R-Pharm as a result of a Change of Control.

 

1.92 “R-Pharm
Patents” means the Patents that are (a) Controlled by R-Pharm or any of its Affiliates as of the Effective Date or at any time
during the Term and (b) claim or cover (i) the Product, or the Development or Commercialization thereof, or (ii) any R-Pharm Know-How,
in each case, that are necessary or reasonably useful for the Development or Commercialization of the Product. The use of “Affiliate”
in this definition shall exclude any Third Party that becomes an Affiliate due to such Third Party’s or such Third Party’s Affiliate’s
acquisition of R-Pharm as a result of a Change of Control.

 

1.93 “Sublicense
Income” means all consideration, including, upfront payments, license fees, and milestone payments, actually received by OV or
its Affiliates for the grant by OV or its Affiliates of a sublicense or grant of rights with respect to a Product or the R-Pharm Know-How
or R-Pharm Patents to a Third Party; provided, however, that Sublicense Income shall not include (1) royalties on Net Sales for which
R-Pharm will receive a royalty payment pursuant to Section 7.4, (2) any proceeds from the sale of securities payments made at fair market
value in arms length transactions, or (3) any proceeds involving funding or reimbursement of Development costs, at fair market value in
arms length transactions, for the performance of development activities only to the extent that such payments are specifically allocated
to develop Product at rates standard and customary in the industry.

 

 1.94 “Term” has the meaning set forth in Section 11.1.

 

    	10

     

    

 

1.95
“Terminated Product Technology” has the meaning set forth in Section 11.6c)1.1.1(a)(ii).

 

1.96 “Territory”
means all current and future countries of the European Union (EU), including Great Britain but excluding Switzerland and Lichtenstein.

 

 1.97 “Third Party” shall mean any Person other than a Party or an Affiliate of a Party.

 

 1.98 “Third Party Claims” has the meaning set forth in Section 13.1.

 

1.99 “Valid
Claim” means a claim of: (a) an issued and unexpired patent, which claim has not lapsed or been dedicated to the public, withdrawn,
cancelled, abandoned, disclaimed, revoked or held unpatentable, unenforceable or invalid by an unappealable decision of a court or other
governmental agency of competent jurisdiction, or has not been appealed within the time allowed for appeal, and which claim has not been
abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re- examination or disclaimer or otherwise, or
(b) a patent application that has been pending less than six (6) years from the date of filing of the earliest patent application from
which such patent application claims priority, which claim has not been cancelled, withdrawn or abandoned or finally rejected by an administrative
agency action from which no appeal can be taken.

 

1.100 “Violation” means that a Party or any of
its officers or directors or any other personnel (or other permitted agents of a Party performing activities hereunder) has been: (1)
convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services,
Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (http://oig.hhs.gov/exclusions/authorities.asp); (2) identified
in the OIG List of Excluded Individuals/Entities (LEIB) database (http://exclusions.oig.hhs.gov/) or listed as having an active exclusion
in the System for Award Management (http://www.sam.gov); or (3) listed by any US Federal agency as being suspended, debarred, excluded
or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a (http://www.fda.gov/ora/compliance_ref/debar/)
(each of (1), (2) and (3) collectively the “Exclusions Lists”).

 

 1.101 “Withholding Party” has the meaning set forth in Section 7.8.

 

		2.	GRANT OF RIGHTS; OVERVIEW

 

2.1 Grant
of Exclusive Option & Rights to OV. Subject to OV’s compliance with its payment obligations of the Option Fee according to Section
7.1, R-Pharm hereby grants OV:

 

		a)	an exclusive option, exercisable by OV any time on or prior
to November 15, 2020 (the “Option Period”), to obtain the licenses set forth in Section 2.3 (the “Exclusive
Option”).

 

		b)	a non-sublicenseable, non-transferrable exclusive, royalty-free
license during the Option Period under the R-Pharm Patents and the R-Pharm Know-How to Develop the Product in the Field in the Territory
solely for the purposes of performing its obligations as set forth in, and subject to, the Clinical Development Plan, including for the
purposes of conducting the mBC Clinical Trial.

 

    	11

     

    

 

2.2
Exercise of the Exclusive Option. OV may exercise the Exclusive Option by providing written notice to R-Pharm on any Business
Day during the Option Period, but no later than thirty (30) days in advance of the end of the Option Period (the “Option
Request Notice”); provided, however, that OV shall not be deemed to have entered into the licenses set forth in Section
2.3 unless OV first offers in writing to R-Pharm the right to enter into an agreement pursuant to which OV would grant to R-Pharm an
exclusive license to Develop and otherwise exploit the Product together with the DRP Biomarker as a companion diagnostic in
the Territory (a “Re-Acquisition Agreement”). Within three (3) months following R-Pharm’s receipt of the
Option Request Notice (the “R-Pharm Option Term”), if R-Pharm desires to enter into a Re-Acquisition Agreement,
R-Pharm shall send a written reply to such effect (the “Re-Acquisition Reply”). Upon OV’s receipt of the
Re-Acquisition Reply, R-Pharm and OV shall negotiate the terms of a Re-Acquisition Agreement in good faith for a period not to
exceed the R-Pharm Option Term, which period may be mutually extended in writing by the Parties. The terms of any Re-Acquisition
Agreement shall include fair market value terms and conditions that are customary in agreements of a nature similar to the
Re-Acquisition Agreement. If R-Pharm fails to send a Re-Acquisition
Reply or, after providing a Re-Acquisition Reply, the Parties fail, despite good faith negotiations, to execute a Re-Acquisition
Agreement, then OV shall be deemed to have entered into the licenses set forth in Section 2.3 as of the expiration of the R-Pharm
Option Term (the “Option Exercise Date”). If OV
fails to provide the Option Request Notice before the expiration of the Option Period, then the Exclusive Option shall expire and
this Agreement will terminate pursuant to Section 11.3.

 

2.3 Grant
of Exclusive License. Upon the Option Exercise Date and subject to OV’s compliance with its payment obligations according to Section
7.l(b) and Section 7.2, R-Pharm hereby grants to OV:

 

 a) an exclusive (including with regard to R-Pharm and its Affiliates) license, with the right to grant sublicenses solely in accordance with Section 2.4, under the R-Pharm Patents, the R-Pharm Know-How, R-Pharm’s interests in the Joint Agreement IP and R-Pharm’s rights in the mBC Clinical Trial Data, to Develop and Commercialize the Product in the Field in the Territory.

 

 b) an exclusive (including with regard to R-Pharm and its Affiliates) license and right of reference, with the right to grant sublicenses and further rights of reference solely in accordance with Section 2.5, under the Regulatory Approvals and any other Regulatory Documentation that R-Pharm or its Affiliates may Control with respect to the Product as necessary for purposes of Developing and Commercializing the Product in the Field in the Territory.

 

 c) The grants set forth in this Section 2.3 will automatically come into full force and effect on the Option Exercise Date without any further action required by either Party under this Agreement.

 

2.4 License
Grants to R-Pharm. Upon the Effective Date, OV grants to R-Pharm a non- exclusive, royalty-free license, without the right to grant
sublicenses, under the DRP Biomarker Agreement IP, and OV’s interests in the Joint Agreement IP and any other Agreement IP, to Develop
and manufacture the Product solely for purposes of performing its obligations as set forth in the Clinical Development Plan and solely
as necessary for such purposes.

 

2.5 Sublicenses.
OV shall have the right to sublicense any or all of the rights granted to OV pursuant to Section 2.3 to its Affiliates or to Third Parties
without the consent of R-Pharm. OV shall ensure that each of its Third Party sublicensees is bound by a written agreement that is consistent
with, and subject to the applicable terms and conditions of, this Agreement. In addition, OV shall be responsible for the performance
of any of its sublicensees that are exercising rights under a sublicense of the rights granted by R-Pharm to OV under this Agreement and
the grant of any such sublicense shall not relieve OV of its obligations under this Agreement. Promptly following the execution of each
Third Party sublicense agreement, OV shall provide R-Pharm with a copy of each such sublicense agreement, which copy may be redacted to
remove provisions that are not necessary to monitor compliance with this Section 2.5. To the extent, OV sublicenses its rights to commercialize
Product, any such sublicensee will be required to purchase the Product from R-Pharm, according to the terms and conditions herein.

 

    	12

     

    

 

2.6
Subcontracting. OV may not engage a Third Party subcontractor to perform its activities hereunder, including the mBC Clinical Trial
(or any portion thereof), unless approved by R-Pharm in writing, such approval not to be unreasonably withheld, conditioned or delayed.
OV shall remain solely and fully liable for the performance of its activities by such subcontractors, and shall ensure that each of its
subcontractors performs its obligations in accordance with the terms of this Agreement. In all cases, any such subcontracting shall be
consistent with the applicable terms and conditions of this Agreement, including confidentiality provisions no less stringent than those
contained in this Agreement and intellectual property provisions that assign to OV the rights in all Inventions as set forth herein.

 

2.7 Retention
of Rights. All rights and licenses not expressly granted to OV pursuant to this Agreement are reserved by R-Pharm.

 

2.8 Exclusivity.
During the Term, OV shall not, and shall cause its Affiliates not to, (i) directly or indirectly, research, develop, commercialize or
manufacture any Competing Product, or (ii) license, authorize, appoint, or otherwise enable any Third Party to research, develop, commercialize,
or manufacture any Competing Product.

 

2.9 Obligations
of OV. Following the Effective Date and as more fully set forth in Article 4, OV will, either itself or through its Affiliates, use
Commercially Reasonable Efforts to:

 

 a) supply and utilize the DRP Biomarker for the Product during the Option Term;

 

b) establish the Clinical Development Plan, which shall include a detailed development plan
of the Product in combination with the DRP Biomarker as a companion diagnostic to select patients. The Clinical Development Plan shall
include a design and implementation plan for at least one targeted-enrollment Phase 2 trial of Product in metastatic breast cancer, utilizing
the DRP Biomarker to select high likely responder patients. The Clinical Development Plan is expected to include the screening of approximately
250 patients to then enroll (on a rolling basis) pre-selected patients identified as high likely responders to Product. OV will continue
the screening and selection process to identify and enroll fifteen (15) patients (the “15 Required Patients”). OV may, in its
sole discretion, decide to continue to identify and enroll additional patients beyond the 15 Required Patients including patients for
randomized trial(s). OV will utilize its existing breast cancer patient screen in Denmark to facilitate the project. OV anticipates that
such trial will be completed within twelve (12) to eighteen (18) months of the Effective Date.

 

c) fund
and conduct all DRP Biomarker screening to identify likely responder patients for the mBC Clinical Trial.

 

d)
fund and conduct the mBC Clinical Trial as outlined in the Clinical Development Plan.

 

e) if
OV has exercised its Exclusive Option and the Parties have not executed a Re- Acquisition Agreement, Develop and Commercialize Product
in the Field in the Territory.

 

2.10 Obligations of R-Pharm. Following the Effective Date
and as more fully set forth herein, R-Pharm will, either itself or through its Affiliates, use Commercially Reasonable Efforts to:

 

a) provide OV with copies of any Existing Regulatory
Documentation within thirty (30) days following the Effective Date.

 

b)
provide OV with existing, unexpired, clinical grade stock of Product sufficient for the 15 Required Patients but no more than 20
patients to enable OV’s conduct of the mBC Clinical Trial. Such Product shall be provided to OV at no cost. Additional Product will
be provided at an additional cost in accordance with Section 2.lO(c)

 

    	13

     

    

 

c) provide
OV with additional clinical grade stock of Product sufficient for any subsequently approved (by R-Pharm) Phase 2/3 pivotal trial conducted
by OV, which supply shall be provided to OV at a cost of twenty percent (20%) above R-Pharm’s documented manufacturing cost.

 

d) cooperate
and reasonably assist OV, as may be requested by OV, in the conduct of the mBC Clinical Trial and OV’s activities set forth herein, as
well as any regulatory filings and regulatory meetings pertaining to the conduct of the mBC Clinical Trial. OV shall solely bear the costs
of conducting any targeted-enrollment trial(s), including the mBC Clinical Trial, and shall pay to R-Pharm an agreed-upon, fair compensation
for provided cooperation and assistance.

 

2.11 Future
Product Supply & Manufacturing. As more fully set forth in Section 6.lb), if OV has exercised its Exclusive Option and the Parties
have not executed a Re-Acquisition Agreement, then one year prior to the anticipated receipt of Regulatory Approval for the Product the
Parties shall negotiate a separate supply agreement for the manufacturing and supply of Product for the post-approval marketing and commercial
sale in Territory in the Field. Such post-approval supply shall be provided to OV at a cost of thirty percent (30%) above R-Pharm’s documented
manufacturing cost.

 

2.12 New
Regulatory Filings & Approvals. As more fully set forth in Article 4, OV shall seek Regulatory Exclusivity of the Product in the
Territory, whereby OV will seek additional market protection from the relevant Regulatory Authority which confers an exclusive commercialization
period in the applicable country through a regulatory exclusivity right, such as data protection, data exclusivity, market exclusivity,
new chemical entity exclusivity, new use or Indication exclusivity, new formulation exclusivity, or orphan drug exclusivity. OV shall
obtain all approvals of the Product (including Regulatory Exclusivities) in the name of R-Pharm; provided that to the extent applicable
law in a country in the Territory requires any such approval to be held in the name of OV, OV shall hold such approval on behalf of and
for the benefit of R-Pharm. To the extent in OV’s name, upon termination or expiration of this Agreement, OV will transfer and assign
all approvals for the Product (and all data and documentation included in, referenced in, or filed therein support thereof) to R-Pharm
or its designee. In the event that OV elects to exercise its Exclusive Option and the Parties do not execute a Re-Acquisition Agreement,
R-Pharm shall transfer and assign all approvals and regulatory filings for the Product in Territory to OV, in the name ofOV.

 

2.13 Third
Party Acquirer. OV shall have the right to identify and secure a Third Party to acquire (via sale, license, merger or otherwise) and
assume the rights to the DRP Biomarker. Any agreement with such a Third Party to the DRP Biomarker shall be at the sole discretion ofOV,
with advance written notice to R-Pharm.

 

		3.	GOVERNANCE

 

 3.1 Joint Development Committee.

 

a) Formation. Within
60 days of the Effective Date, the Parties shall establish a joint development committee (the “Joint Development
Committee” or “JDC”). The JDC shall consist of four (4) representatives, with two (2) representatives from each
of the Parties, as follows:

 

		●	Peter Buhl-Jensen, M.D., CEO of OV, as Chairman of the JDC.

 

		●	Steen Knudsen, Ph.D., CSO and Founder of Medical Prognosis
Institute, ApS.

 

		●	Bheshad Sheldon, CMO of R-Pharm.

 

		●	Jignesh
Shah, COO of R-Pharm.

 

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From time
to time, each Party may substitute one (1) or more of its representatives to the JDC on written notice
to the other Party. In the event that OV grants a sublicenses in accordance with Section 2.5, OV shall substitute one (I)
of its representatives to the JDC with a representative of such sublicensee. Each Party shall have the right to designate one (1) additional
member, who may attend as anon-voting observer. The JDC will implement and oversee the Clinical Development Plan for the Product in combination
with DRP Biomarker in the Territory. In addition, in the event that OV has exercised its Exclusive Option and the Parties have not executed
a Re-Acquisition Agreement, the JDC will implement and oversee the Commercialization Plan for the Product in the Field in the Territory.

 

b) Meetings
and Minutes. The JDC shall meet (by video-conference, conference call or otherwise in person as determined by the JDC members) on
at least a quarterly basis to discuss the progress under the Clinical Development Plan. Either Party may call JDC meetings on no less
than fifteen(15) Business Days’ notice (but no more often than once per quarter, unless agreed to by the Parties); provided, that under
exigent circumstances requiring input by the JDC, either Party may call a meeting on shorter notice. The chairperson shall provide the
agenda for each meeting (provided that the chairperson shall reasonably consider inclusion of any item on the agenda proposed by a member
of the JDC). The chairperson of the JDC shall prepare and circulate for review and approval of the minutes of each meeting within thirty
(30) days after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the conclusion
of the next meeting of the JDC. Such minutes shall be deemed approved unless one or more JDC representatives object to the accuracy of
such minutes prior to the conclusion of the next meeting of the JDC. Reasonably in advance of each regularly scheduled meeting of the
JDC, OV shall provide an update in writing to R-Pharm with respect to the mBC Clinical Trial, which update shall contain information
about overall mBC Clinical Trial progress, recruitment status, interim analysis (if results available) and final analysis of the mBC
Clinical Trial.

 

c) Procedural Rules. All decisions on the JDC
will be taken by unanimous consent with each Party having a single vote. Except where any decision is granted to one Party herein, in
the event that the JDC does not reach a unanimous consent on an issue within thirty (30) days after the issue is first presented to the
JDC, then (A) OV shall have the final decision-making authority with respect to matters involving the DRP Biomarker, patient selection
in the mBC Clinical Trial and the Commercialization Plan, and (B) R-Pharm shall have the final decision making authority with respect
to all matters involving the Compound or Product and not described in clause (A). Any decision to amend the Clinical Development Plan
shall require the unanimous consent of the JDC.

 

d) Limitations
on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers,
or discretion shall be delegated to or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this
Agreement or the Parties expressly so agree in writing. The JDC shall not have the power to amend, modify, or waive compliance with this
Agreement, which may only be amended or modified as provided in Section 14.4 or compliance with which may only be waived as provided in
Section 14.10.

 

e) Expenses.
Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings
of, and otherwise participate on, the JDC.

 

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		4.	DEVELOPMENT AND REGULATORY

 

4.1 mBC
Clinical Trial. The Parties shall’ collaborate with regard to a clinical trial to be conducted by OV using the Product and the DRP
Biomarker for the treatment of patients with mBC, as more particularly described in the Clinical Development Plan (the “mBC Clinical
Trial”).

 

4.2 Amendments
to the Clinical Development Plan. Either Party, directly or through its representatives on the JDC, may propose amendments to the
then-current Clinical Development Plan from time to time as appropriate, including to add additional clinical studies to the Clinical
Development Plan (as more fully set forth in Section 4.10) or in light of changed circumstances. If approved by the JDC, the amended Clinical
Development Plan shall become effective for the applicable period on the date approved by the JDC (or such other date as the JDC shall
specify). Any JDC-approved amended Clinical Development Plan shall supersede the previous Clinical Development Plan for the applicable
period. Notwithstanding the foregoing, in the event that the JDC does not approve a given amendment to the Clinical Development Plan,
then the then-current Clinical Development Plan shall continue in effect without modification (i.e., no changes shall be made to
the Clinical Development Plan unless and until agreed to by the JDC) such that only the activities set forth in the then-current Clinical
Development Plan shall continue.

 

4.3 Development
Costs. OV shall be solely responsible for one hundred percent (100%) of all costs of the mBC Clinical Trial and for all costs incurred
by it and its Affiliates in connection with its Development of Product hereunder (and other activities related thereto as set forth in
the Clinical Development Plan, including regulatory activities); provided that, to the extent required to be supplied in accordance with
the Clinical Development Plan, R-Pharm shall supply, in accordance with this Agreement, the Product for the conduct of the mBC Clinical
Trial at its cost. OV shall supply, in accordance with this Agreement, the DRP Biomarker for use in the mBC Clinical Trial at its own
cost. In addition, R-Pharm may assist and cooperate with OV as OV may reasonably request from time to time in connection with the conduct
of the mBC Clinical Trial (including in connection with any regulatory activities), and OV shall reimburse R-Pharm for its direct costs
and for all its reasonable out-of-pocket expenses in connection therewith.

 

 4.4 Conduct of the mBC Clinical Trial and the Clinical Development Plan.

 

a) Conduct.
Subject to the terms and conditions of this Agreement and Clinical Development Plan, OV shall be responsible for operational execution
and management of the mBC Clinical Trial. OV shall conduct the mBC Clinical Trial in accordance with this Agreement and the Clinical Development
Plan.

 

b) Sponsor.
OV shall act as the sponsor of the mBC Clinical Trial. OV shall be responsible for obtaining all necessary approvals and clearances, including
IRB approvals and other Regulatory Approvals and customs clearances necessary for the conduct of the mBC Clinical Trial, and OV shall
ensure that all such approvals and clearances are obtained prior to initiating performance of the mBC Clinical Trial. OV shall ensure
that (i) the mBC Clinical Trial is performed in accordance with this Agreement, the Clinical Development Plan, and all Applicable Laws,
including cGCP, (ii) Product administered under the mBC Clinical Trial is done so in accordance with the Clinical Development Plan, and
(iii) all directions from any Regulatory Authority or ethics committee
with jurisdiction over the mBC Clinical Trial are followed.

 

c) Consent
Forms. OV shall prepare the patient informed consent form for the mBC Clinical Trial in consultation with R-Pharm. Any changes
to such model form that relate to the Product shall be subject to R-Pharm’s written consent, not to be unreasonably withheld,
conditioned, or delayed. R-Pharm will provide such consent, or a written explanation for why such consent is being withheld, within
fifteen (15) Business Days after receiving OV’s request therefor. OV shall obtain all patient authorizations and consents for the
mBC Clinical Trial, and OV shall ensure that all patient authorizations and consents in connection with the mBC Clinical Trial
permit, in accordance with HIPAA, the EU Data Protection Directive or any other similar Applicable Law, sharing of mBC Clinical
Trial Data with R-Pharm in accordance with this Agreement.

 

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d) Report.
OV shall provide R-Pharm with (a) an electronic draft of the final clinical study report and the tables and listings (“mBC
Clinical Trial Report”) for R-Pharm to provide comments to OV (which comments shall be provided within forty-five (45) days of
receipt of the draft of the mBC Clinical Trial Report) and (b) a final version of the mBC Clinical Trial Report, in each case as soon
as reasonably practicable following mBC Clinical Trial Completion. OV shall consider in good faith any comments provided by R-Pharm on
the mBC Clinical Trial Report and shall not include any statements relating to the Product which have not been approved by R-Pharm. For
purposes of the mBC Clinical Trial, “mBC Clinical Trial Completion” shall occur upon database lock of the mBC Clinical
Trial.

 

e) Suspension.
OV shall not suspend or cease the conduct of the mBC Clinical Trial (or any arm thereof) without the consent of the JDC.

 

f) Reports
and Information. OV shall maintain reports and all related documentation in good scientific manner and in compliance with Applicable
Law in connection with the mBC Clinical Trial. OV shall provide to R-Pharm all mBC Clinical Trial information and documentation reasonably
requested by R-Pharm to (i) enable R-Pharm to comply with any of its legal or regulatory obligations, or any request by any Regulatory
Authority, related to the Product, and (ii) determine whether the mBC Clinical Trial has been performed in accordance with this Agreement.

 

 4.5 mBC Clinical Trial Data.

 

a) Ownership.
mBC Clinical Trial Data will be owned by R-Pharm. In the event that OV exercises the Exclusive Option and the Parties have not executed
a Re-Acquisition Agreement, all of R-Pharm’s right, title and interest in and to such mBC Clinical Trial Data shall be included in the
exclusive license to OV. OV (on behalf of itself and its Affiliates) shall assign, and hereby assigns, to R-Pharm, its interest in and
to such mBC Clinical Trial Data. At the request of R-Pharm, OV will execute such documents (including any necessary assignments) to effect
such ownership of such mBC Clinical Trial Data.

 

b) Copies.
OV shall provide to R-Pharm copies of all mBC Clinical Trial Data generated by or on behalf of OV in the conduct of the mBC Clinical Trial,
in electronic form or other mutually agreeable alternate form on mutually agreeable timelines; provided, however, that a complete copy
of the mBC Clinical Trial Data shall be provided to R-Pharm no later than forty-five (45) days following the completion of the mBC Clinical
Trial. Such complete copy may be provided via providing access to the R-Pharm to its electronic database holding all such mBC Clinical
Trial Data.

 

c) Restrictions
on Use. OV shall not, without the prior written consent of R-Pharm, use the mBC Clinical Trial Data for any purpose other than: (i)
to perform its obligations under this Agreement; (ii) to file and prosecute patent applications for DRP Biomarker Agreement IP, and enforce
and defend any resulting patents in accordance with Article 8; (iii) as required by a Regulatory Authority or as may otherwise by required
by Applicable Law; (iv) as may be necessary to comply with such Party’s internal policies and procedures with respect to pharmacovigilance
and adverse event reporting; and (v) such other uses as consented by R-Pharm in writing.

 

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 4.6 Regulatory Responsibility with respect to the mBC Clinical Trial.

 

a) Interactions.
OV shall be responsible for taking the lead with all interactions with Regulatory Authorities (meetings, telephone, etc.) in a given country
in the Territory and for other regulatory matters related to the mBC Clinical Trial in such country in the Territory as permitted by Applicable
Law. R-Pharm shall be entitled to have reasonable representation (but no more than two people unless otherwise mutually agreed) present
at all meetings or other substantive interactions with Regulatory Authorities (and OV shall provide notice to R-Pharm sufficiently in
advance of any such meeting or interaction unless such advance notice is not possible due to the urgency of the situation, in which case
OV shall inform R-Pharm of the content of such a meeting as soon as reasonably possible after the meeting has taken place).

 

b) Regulatory
Submissions. OV shall be responsible for preparing all submissions, documents or other correspondence submitted to applicable Regulatory
Authorities for the mBC Clinical Trial (collectively, the “Regulatory Submissions”). R-Pharm shall have the right to
review, comment upon and approve (such approval not to be unreasonably withheld, conditioned, or delayed) all substantive Regulatory Submissions,
which Regulatory Submissions shall be provided by OV to R-Pharm reasonably prior to submission thereof. OV shall consider R-Pharm’s comments
to such Regulatory Submissions in good faith. OV shall obtain and maintain (including all routine maintenance) all investigational study
applications for the mBC Clinical Trial, and all such applications, shall be in the name of R-Pharm (or its Affiliate).

 

c) mBC
Clinical Trial Correspondence. With respect to the mBC Clinical Trial, OV shall (i) promptly provide to R-Pharm a copy of all substantive
correspondence from any Regulatory Authority with respect to the mBC Clinical Trial related to the Product and (ii) promptly provide to
R-Pharm a copy of final Regulatory Submissions related to the Product after submission thereof. In addition, OV shall keep R-Pharm informed
regarding all regulatory matters related to the Product with respect to the mBC Clinical Trial.

 

d) Adverse
Event Reporting. OV will be solely responsible for compliance with all Applicable Laws pertaining to safety reporting for the mBC
Clinical Trial, and for holding and maintaining the safety database with respect to information on adverse events concerning the Product
in the EU. As soon as reasonably practical after the Effective Date (but in all cases prior to the first dosing of the first patient in
the mBC Clinical Trial) the Parties will enter into a Pharmacovigilance Agreement (in substantially the form attached hereto as Exhibit
C}. to ensure the exchange of relevant safety data within appropriate timeframes and in appropriate format to enable the Parties to
fulfill local and international regulatory reporting obligations. The Pharmacovigilance Agreement will include safety data exchange procedures
governing the coordination of collection, reporting, and exchange of information concerning any adverse experiences, pregnancy reports,
and any other safety information arising from or related to the use of the Product and the DRP Biomarker in the mBC Clinical Trial, consistent
with Applicable Law. Such guidelines and procedures shall be in accordance with, and enable the Parties and their Affiliates to fulfill
local and international regulatory reporting obligations to Governmental Authorities.

 

4.7 Regulatory
Documentation. All Regulatory Documentation (including all Regulatory Approvals) relating to the Product shall be owned by, and
shall be the sole property and held in the name of, R-Pharm or its Affiliate or other designee. In furtherance of the foregoing, OV shall obtain all Regulatory Approvals of the Product
(including Regulatory Exclusivities) in the name of R-Pharm; provided that to the extent Applicable Law in a country in the
Territory requires any such Regulatory Approval to be held in the name of OV, OV shall hold such Regulatory Approval on behalf of
and for the benefit of R-Pharm. To the extent in OV’s name, upon termination or expiration of this Agreement, OV will transfer and
assign all Regulatory Documentation for the Product (and all data and documentation included in, referenced in, or filed therein
support thereof) to R-Pharm or its designee.

 

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4.8 Exchange
of Information following Exercise of the Exclusive Option. If OV has exercised its Exclusive Option and the Parties have not executed
a Re-Acquisition Agreement, the terms and conditions of this Section 4.8 shall apply as of the Option Exercise Date:

 

a) Transfer.
As soon as reasonably practicable following the Option Exercise Date and payment of the Option Exercise Payment, R-Pharm shall disclose
and provide to OV all Regulatory Documentation in the Control of R-Pharm that solely relates to the Product reasonably necessary for the
Development or Commercialization thereof and that R-Pharm has not previously provided to OV pursuant to this Agreement. For the avoidance
of doubt, all such Regulatory Documentation shall remain the sole and exclusive property of R-Pharm.

 

b) Assistance.
At the request of OV, R-Pharm shall provide OV (and its designees) with assistance as reasonably requested by OV to effectuate the transfer
to, and implementation and use by, OV of the information, documentation and materials set forth in Section 4.8a), in each case in a timely
manner. OV shall reimburse R-Pharm for its direct costs and for all its reasonable out-of-pocket expenses in connection with such assistance.

 

4.9 Regulatory
Matters following Exercise of the Exclusive Option. If OV has exercised its Exclusive Option and the Parties have not executed a Re-Acquisition
Agreement, the terms and conditions of this Section 4.9 shall apply as of the Option Exercise Date:

 

a) Regulatory Activities. As between the Parties,
OV shall have the primary responsibility to (i) prepare, obtain, and maintain Drug Approval Applications, Regulatory Approvals and other
regulatory submissions and applications for the Product in the Field in the Territory, and (ii) conduct communications with Regulatory
Authorities for the Product in the Field in the Territory. OV shall promptly notify R-Pharm of any material filings made regarding Regulatory
Approval of the Product in the Territory and of receipt of Regulatory Approval of Product in any country in the Territory. OV shall provide
R-Pharm final drafts of any such material filings for R-Pharm’s review and comment, and OV shall consider in good faith any such comments
of R-Pharm. All Regulatory Documentation (including all Regulatory Approvals) relating to Product in the Field in the Territory shall
be owned by, and shall be the sole property and held in the name of, OV or its Affiliate.

 

b) Interactions
with Regulatory Authorities. As between the Parties, OV shall have the primary responsibility to communicate and otherwise interact
with Regulatory Authorities with respect to the Product in the Field in the Territory, including with respect to any Drug Approval Applications
and other Regulatory Approvals in connection therewith. OV shall provide R-Pharm with (a) access to or copies of all material written
or electronic correspondence relating to the Development or Commercialization of the Product received by OV from the Regulatory Authorities,
and (b) copies of all meeting minutes and summaries of all meetings, conferences, and discussions held by OV with the Regulatory Authorities,
in each case ((a) and (b)) within fifteen (I 5) Business Days of its receipt or production of the foregoing, as applicable. If such written
or electronic correspondence received from any such Regulatory Authority relates to the withdrawal, suspension, or revocation of a Regulatory
Approval for the Product in the Territory, or the initiation of any investigation, review, or inquiry by such Regulatory Authority concerning
the safety of the Product, then OV shall notify R-Pharm and provide R-Pharm with copies of such written or electronic correspondence as
soon as practicable, but not later than two (2) Business Days after receipt of such correspondence.

 

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4.10 Additional Clinical
Trials. Subject to the terms of this Section 4.10, during the Option Period, OV will have the right to propose amendments to the
Clinical Development Plan to include additional clinical trials using the Product and the DRP Biomarker for the treatment of patients
with mBC. If OV desires to conduct any such additional clinical trial, it will notify the JDC in writing, and discuss such additional
clinical trial with R-Pharm at the JDC and provide the JDC any information reasonably requested by the JDC related to such additional
clinical trial. The JDC will consider in good faith any such proposal for an additional clinical trial, and if, and only if, the JDC
approves to amend the Clinical Development Plan to include such additional clinical trial, OV may thereafter conduct such additional
clinical trial (but subject to the terms and conditions imposed by the JDC as part of the JDC’s approval of the additional clinical trial).
In all cases, OV shall keep the JDC updated with respect to all such additional clinical trials (including the results generated therefrom)
at each meeting of the JDC, and shall provide to R-Pharm such other information with respect to any such additional clinical trial as
reasonably requested by R-Pharm.

 

4.11 Global
Safety Database. R-Pharm shall hold and maintain the global safety database for the Product with respect to information on adverse
events concerning the Product, as and to the extent required by Applicable Law.

 

		5.	COMMERCIALIZATION

 

5.1 General.
In the event that OV has exercised its Exclusive Option and the Parties have not executed a Re-Acquisition Agreement, OV (and its Affiliates),
either itself or with or through Third Party(ies), shall be solely responsible for Commercializing the Product in each country in the
Territory in accordance with the Commercialization Plan and this Agreement.

 

5.2 Diligence.
In the event that OV has exercised its Exclusive Option and the Parties have not executed a Re-Acquisition Agreement, and following
receipt of all applicable Regulatory Approvals, OV (itself or with or through its Affiliates) shall use Commercially Reasonable Efforts
to Commercialize the Product in the Field in the Territory.

 

 5.3 Commercialization Plan and Information.

 

a) Commercialization
Plan. No later than thirty (30) days following the initiation of pivotal clinical trial designed to generate data sufficient to file
a Drug Approval Application for the Product in the Field in the Territory, and on an annual basis thereafter, OV shall develop and submit
to the JDC for its review, comment and approval a reasonable written plan that summarizes the material Commercialization activities to
be undertaken with respect to the Product in the Field in the Territory for the following Calendar Year (each, a “Commercialization
Plan”). Each Commercialization Plan shall contain a three (3)-year rolling annual plan for the Commercialization of the Product.

 

b) Specific
Commercialization Obligations. In connection with the Commercialization of the Product in the Territory, OV shall use Commercially
Reasonable Efforts to launch the Product in each country (or other regulatory jurisdiction) after all applicable Regulatory Approvals
for the Product in such country (or other regulatory jurisdiction) have been obtained.

 

5.4 Reports.
OV shall provide R-Pharm with a summary of any material Commercialization matters resulting from OV’s Commercialization of the Product
(including, subject to confidentiality obligations to a Third Party, a summary of material Commercialization matters in connection with
the Commercialization of the Product) under this Agreement.

 

5.5 Compliance.
OV shall, in Commercializing the Product, comply with all Applicable Laws as well as all applicable Regulatory Approvals for the Product.

 

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5.6
Pricing. OV shall have the right, in consultation with R-Pharm through the JDC, to establish and modify the terms and conditions
with respect to the sale of the Product in the Territory, including any terms and conditions relating to the price (including discounts
and rebates) at which the Product will be sold in any country in the Territory.

 

5.7 Commercialization
Data. OV shall own all marketing and sales data and information resulting from the Commercialization of the Product in the Field in
the Territory (the “Commercialization Data”). Upon request from R-Pharm, OV shall provide to R-Pharm a copy of such Commercialization
Data. R-Pharm shall have the irrevocable right and license to use all Commercialization Data (and the right to grant its Affiliates and
Third Parties the right to use such Commercialization Data) in connection with the exercise of its rights and performance of its obligations
with respect to the Product under this Agreement.

 

5.8 Commercialization
Progress Updates. OV shall provide R-Pharm with a summary of any material Commercialization matters resulting from OV’s Commercialization
of the Product (including, subject to confidentiality obligations to a Third Party, a summary of material Commercialization matters in
connection with the Commercialization of the Product) under this Agreement.

 

		6.	SUPPLY

 

 6.1 Supply of Product for the mBC Clinical Trial.

 

a) Supply.
R-Pharm will, either itself or through its Affiliates, use Commercially Reasonable Efforts to provide OV such quantities of existing,
unexpired, clinical grade stock of Product sufficient to enable OV’s conduct of the mBC Clinical Trial in accordance with the Clinical
Development Plan.

 

b) Cost. The supply of Product by R-Pharm
for the mBC Clinical Trial shall be at no cost to OV.

 

c) Additional
Supply of Product. To the extent OV requires from R-Pharm any stock of Product for any additional clinical trials for the treatment
of patients with mBC, and if the JDC approves to amend the Clinical Development Plan to include such additional clinical trials, R-Pharm
will, either itself or through its Affiliates, use Commercially Reasonable Efforts to provide OV, at a cost of twenty percent (20%) above
manufacturing cost (to the extent a Third Party manufactures Product for R-Pharm, the manufacturing cost shall be the acquisition cost
(including compliance and freight cost required to release and deliver Product)), as adjusted for foreign currency exchange, such quantities
of existing, unexpired, clinical grade stock of Product sufficient to enable OV’s conduct of such additional clinical trials. If OV elects
to exercise its Exclusive Option and the Parties have not executed a Re-Acquisition Agreement, following receipt of Regulatory Approval
in the Territory, to the extent OV requires from R-Pharm any stock of Product for post-approval marketing and commercial sale in the Field
in the Territory, the Parties would need to negotiate a separate supply agreement pursuant to which R-Pharm would sell, at a cost of thirty
percent (30%) above manufacturing cost (to the extent a Third Party manufactures Product for R-Pharm, the manufacturing cost shall be
the acquisition cost (including compliance and freight cost required to release and deliver Product)), as adjusted for foreign currency
exchange, and OV would purchase, such Product for post-approval marketing and commercial sale in the Field in the Territory.

 

 6.2 Provision of Product.

 

a) Delivery;
Storage. R-Pharm will deliver the Product to OV EXW (INCOTERMS 2010) at R-Pharm’s manufacturing facility as specified by OV in
writing (“Delivery”). Risk of loss for the Product shall transfer from R-Pharm to OV at Delivery. All costs
associated with the subsequent transportation, warehousing and distribution of Product shall be borne by OV. OV will: (i) take
delivery of the Product supplied hereunder; (ii) warehouse and promptly ship the supplied Product to the Clinical Trial sites, in
compliance with cGMP, cGCP and other Applicable Law ; and (iii) provide, from time to time at the reasonable request of R-Pharm, the
following information to R-Pharm: any applicable chain of custody forms, in transport temperature recorder(s), records and receipt
verification documentation, such other transport or storage documentation as may be reasonably requested by R-Pharm, and usage and
inventory reconciliation documentation related to such Product.

 

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b) DRP
Biomarker. OV shall be solely responsible, at its own cost, for manufacturing and supplying (including acceptance and release testing)
the DRP Biomarker for the mBC Clinical Trial in accordance with the Clinical Development Plan, and the subsequent handling, storage, transportation,
warehousing and distribution of such DRP Biomarker. OV shall ensure that all such activities are conducted in compliance with cGMP, cGCP
and other Applicable Law.

 

6.3 Use,
Handling and Storage. OV shall (i) use the Product supplied hereunder solely for purposes of performing the mBC Clinical Trial; (ii)
not use the Product supplied hereunder in any manner inconsistent with this Agreement; and (iii) use, store, transport, handle and dispose
of all Product supplied hereunder in compliance with Applicable Law and all reasonable instructions of R-Pharm consistently applied.

 

6.4 Records
for the Product. OV will keep complete and accurate records pertaining to its use and disposition of the Product (including its storage,
shipping (cold chain) and chain of custody activities) and, upon request of R-Pharm, will make such records reasonably available for review
by R-Pharm for the purpose of conducting investigations for the determination of Product safety or efficacy and such OV’s compliance with
this Agreement with respect such Product.

 

		7.	PAYMENTS

 

 7.1 Initial Payments.

 

a) Upfront
Payment. In consideration of the Exclusive Option granted to OV and the rights granted hereunder and the transfer of inventory of
Product by R-Pharm to OV pursuant to Section 6.la), OV shall pay R-Pharm a non-refundable, non-creditable option fee equal to [***] (the
“Option Fee”), which shall be due on or before December 1, 2018.

 

b) Anniversary
Payment. OV shall pay R-Pharm a non-refundable, non-creditable fee equal to [***], which shall be paid by OV to R-Pharm on or before
March 1, 2020.

 

7.2 Option
Exercise Payment. In partial consideration of the rights granted under this Agreement, upon the terms and conditions contained here,
in the event OV elects to exercise the Exclusive Option following the expiration of the R-Pharm Option Term (where R-Pharm has not entered
into a Reacquistion Agreement) in accordance with Section 2.2, OV shall pay R-Pharm a non-refundable, non-creditable payment of [***],
which shall be paid by OV to R-Pharm within thirty (30) days of the Option Exercise Date.

 

7.3
Milestones Payments. As additional consideration for the grant of rights under this Agreement, and on the terms and subject to
the conditions set forth herein, in the event that the following milestone events (each a “Milestone Event” and
collectively, the “Milestone Events”) are achieved by OV, its Affiliates, or permitted sublicensees following the
expiration of the R-Pharm Option Term (where R-Pharm has not entered into a Reacquistion Agreement), then OV shall notify R-Pharm
thereof in writing within five (5) Business Days (and R-Pharm shall promptly issue an invoice for the applicable Milestone Payment),
and OV shall pay to R-Pharm the corresponding milestone payment associated with the applicable Milestone Event as set forth below
(each a “Milestone Payment” and collectively the “Milestone Payments”) within thirty (30) days of
receipt of an invoice issued by R-Pharm in respect of such Milestone Payment.

 

a) Upon
receipt of Regulatory Approval for the Product for the treatment of the first Indication in the first country in the Territory, [***];
and

 

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b) Upon
receipt of Regulatory Approval for the Product for the treatment of each additional Indication in the first country in the Territory for
each such additional Indication, [***] for each such Indication.

 

7.4 Royalties.
If OV has exercised its Exclusive Option and the Parties have not executed a Re-Acquisition Agreement, the terms and conditions of this
Section 7.4 shall apply as of the Option Exercise Date.

 

a) Royalty
Rates. As further consideration for the rights granted to OV hereunder, commencing upon the First Commercial Sale of the Product in
the Territory, during the Royalty Term on a country-by-country basis, OV shall pay to R-Pharm a royalty on Net Sales of Product in the
Territory in a given Calendar Year at the applicable royalty rates set forth below:

 

	Annual Net Sales of the Product in the Territory in a given Calendar Year	 	 	Applicable Royalty Rate (Percentage of Net Sales)	 
	Portion of annual Net Sales of Product in a given Calendar Year up to and including thirty million Dollars ($30,000,000.00)	 	 	[***]	 
	Portion of annual Net Sales of Product in a given Calendar Year over thirty million Dollars ($30,000,000.00)	 	 	[***]	 

 

b)
Royalty Reductions.

 

(i) Third
Party Intellectual Property. In the event that OV enters into an agreement with a Third Party after the Effective Date in order to
obtain a license or right under a Patent, Know-How or other intellectual property right owned or controlled by such Third Party that is
necessary to Commercialize Product in a country in the Territory, then OV shall be entitled to deduct from the royalties payable hereunder
[***] of the royalties paid to such Third Party pursuant to any such agreement.

 

(ii) Generic
Products. In the event that in any country or other jurisdiction in the Territory during the Royalty Term for a Product unit
volume of all Generic Products in such country or other jurisdiction in a calendar quarter equal or exceed [***] of the sum of unit
volume of such Product and all Generic Products in such country or other jurisdiction, then, for each such country or other
jurisdiction , the royalties payable to R-Pharm for the Net Sales of such Product in such country or other jurisdiction shall be
reduced by [***] of the applicable royalty rate(s) set forth in Section 7.4a) for such Calendar
Quarter. Unless otherwise agreed by the Parties, the unit volumes of each Generic Product sold during a Calendar Quarter shall be as
reported by IMS America Ltd. or any successor or any other independent sales auditing firm reasonably agreed upon by the
Parties.

 

(iii) Cumulative
Reductions Floor. In no event will the royalty payable to R- Pharm pursuant to Section 7.4 be reduced below [***].

 

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7.5
Sublicense Income. OV shall pay to R-Pharm [***] of any Sublicense Income within ninety (90) days of the end of each calendar quarter
in which OV or any of its Affiliates receives any Sublicense Income.

 

7.6
Payments and Reports. OV shall calculate all amounts payable to R-Pharm pursuant to Section 7.4 and Section 7.5 at the end of each
Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 7.7. OV shall pay to R-Pharm the amounts due
with respect to a given Calendar Quarter within ninety (90) days after the end of such Calendar Quarter. Each payment due to R-Pharm
shall be accompanied by, at a minimum, showing on a country-by-country basis, (a) a statement of the amount of gross sales of each Product
in the Territory during the applicable Calendar Quarter (including such amounts expressed in local currency and as converted to Dollars)
and the number of each Product sold, (b) an itemized calculation of Net Sales (deductions provided for in the definition of “Net
Sales”) during such Calendar Quarter, and (c) a calculation of the amount of royalty payment due on such Net Sales for such Calendar
Quarter. Without limiting the generality of the foregoing, OV shall require its Affiliates and permitted sublicensees to account for
its Net Sales in the Territory and Sublicense Income and to provide such reports with respect thereto as if such sales were made by OV.

 

7.7
Currency Conversion. All payments to a Party hereunder shall be made in Dollars. For the purpose of calculating any sums due under,
or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales or Sublicense Income expressed in currencies
other than Dollars), a Party shall convert any amount expressed in a foreign currency into Dollar equivalents, calculated using the applicable
currency conversion as published by The Wall Street Journal, Eastern Edition, as of the last business day of the Calendar Quarter
in which such expense or revenue was recorded in accordance with generally accepted accounting principles in the United States by such
Party.

 

7.8
Withholding Taxes. Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties
shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to
take advantage of any applicable double taxation agreement or treaty. In the event there is no applicable double taxation agreement or
treaty, or if an applicable double taxation agreement or treaty reduces but does not eliminate such withholding or similar tax, the payor
shall remit such withholding or similar tax to the appropriate government authority and deduct the amount paid from the amount due to
payee and secure and send to payee the best available evidence of the payment of such withholding or similar tax. Any such amounts deducted
by the payor in respect of such withholding or similar tax shall be treated as having been paid by the payor for purposes of this Agreement.
In the event that a government authority retroactively determines that a payment made by a Party to the other pursuant to this Agreement
should have been subject to withholding or similar (or to additional withholding or similar) taxes, and such Party (the “Withholding
Party”) remits such withholding or similar taxes to the government authority, including any interest and penalties that may
be imposed thereon (together with the tax paid, the “Amount”), the Withholding Party will have the right (a) to offset
the Amount against future payment obligations of the Withholding Party under this Agreement, (b) to invoice the other Party for the Amount
(which shall be payable by the other Party within sixty (60) days of its receipt of such invoice) or (c) to pursue reimbursement of the
Amount by any other available remedy.

 

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7.9 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes
(the “Indirect Taxes”). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay
such Indirect Taxes at the applicable rate in respect of such payments following receipt, where applicable, of an Indirect Taxes invoice
in the appropriate form issued by the receiving Party in respect of those payments. The Parties shall issue invoices for all amounts
payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement
purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined
not to have been chargeable, all necessary steps will be taken by the receiving Party to receive a refund of these undue Indirect Taxes
from the applicable governmental authority or other fiscal authority and any amount of undue Indirect Taxes repaid by such authority
to the receiving Party will be transferred to the paying Party within forty-five (45) days of receipt.

 

7.10
Records and Audits. During the Term and for a period of three years thereafter, OV shall keep (and shall cause its Affiliates and
permitted sublicensees to keep) complete and accurate records pertaining to the purchase, storage, sale, or other disposition of the
Product and sublicensing in sufficient detail to permit R-Pharm to confirm the accuracy of all payments due hereunder. R-Pharm shall
have the right to audit such records to confirm payments. Such audits may be exercised during normal business hours upon reasonable prior
written notice to OV. If such audit identifies a deficiency, OV shall pay R-Pharm the amount of the deficiency plus interest per Section
7.11, within 30 days of the date R-Pharm delivers to OV a written report reflecting the results of such audit. R-Pharm shall bear the
full cost of such audit unless such audit discloses an underpayment by OV, in which case, OV shall bear the full cost of such audit and
shall remit to R-Pharm payment for the costs of such audit within 30 days of invoice receipt.

 

7.11
Late Payments. If any payment due under this Agreement is not made when due, the payment shall accrue interest from the date due
until payment is received, at the rate of one-month London Inter-Bank Offering Rate plus [***] as set by the British Bankers Association
as of the due date; provided, however, that in no event shall such rate exceed the maximum annual interest rate allowable by applicable
law. The payment of such interest shall not limit either Party from exercising any other rights it may have as a consequence of the lateness
of any payment.

 

	8.	INTELLECTUAL
    PROPERTY

 

8.1
Ownership.

 

a)
Background IP. All Background IP shall be and remain exclusively the property of the Party that made or acquired such Background
IP.

 

b)
Agreement IP.

 

(i)
Compound Agreement IP. R-Pharm shall exclusively own all right, title and interest in and to all Agreement IP that is an improvement,
modification or is otherwise related to any R-Pharm Background IP or the Compound or the Product or its manufacture or use but not the
DRP Biomarker Agreement IP (“Compound Agreement IP”). OV shall promptly disclose to R-Pharm all Compound Agreement
IP that is conceived, discovered, developed or otherwise made by OV, its Affiliates, and permitted sublicensees, and its and their agents
and subcontractors. OV hereby assigns, and shall cause its Affiliates, and permitted sublicensees and its and their agent and subcontractors
to assign, to R-Pharm the entire right, title and interest in and to all Compound Agreement IP. R-Pharm shall have the exclusive right
to prepare applications for, prosecute, maintain and defend, at its own costs, the Compound Agreement IP. OV shall reasonably assist
and cooperate with R-Pharm at R-Pharm’s expense in perfecting, maintaining, defending and enforcing the rights granted to R-Pharm
in this Section 8b)(i), including the provision of any requested documentation necessary for prosecution or maintenance of patents
claiming such Compound Agreement IP, and the execution of any required documents therefor. OV shall not file any patent applications
claiming, or amend any patent applications to claim, any Compound Agreement IP.

 

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(ii)
DRP Biomarker Agreement IP. OV shall exclusively own all right, title and interest in and to all Agreement IP that is an improvement,
modification or is otherwise specifically related to the DRP Biomarker or its manufacture (“DRP Biomarker Agreement IP”).
R-Pharm shall promptly disclose to OV all DRP Biomarker Agreement IP that is conceived, discovered, developed or otherwise made by
R-Pharm, its Affiliates, and permitted sublicensees, and its and their agents and subcontractors. R-Pharm hereby assigns, and shall cause
its Affiliates, and permitted sublicensees and its and their agent and subcontractors to assign, to OV the entire right, title and interest
in and to all DRP Biomarker Agreement IP. OV shall have the exclusive right to prepare applications for, prosecute, maintain and defend,
at its own costs, the DRP Biomarker Agreement IP. R-Pharm shall reasonably assist and cooperate with OV at OV’s expense in perfecting,
maintaining, defending and enforcing the rights granted to OV in this Section 8b)(ii), including the provision of any requested documentation
necessary for prosecution or maintenance of patents claiming such DRP Biomarker Agreement IP, and the execution of any required documents
therefor. R-Pharm shall not file any patent applications claiming, or amend any patent applications to claim, any DRP Biomarker Agreement
IP.

 

(iii)
Sole Agreement IP. As between the Parties, each Party shall own and retain all right, title and interest in and to any Agreement
IP other than Compound Agreement IP or DRP Biomarker Agreement IP that is conceived, discovered, developed or otherwise made solely by
or on behalf of such Party or its Affiliates or, its permitted sublicensees, and its and their agents and subcontractors.

 

(iv)
Joint Agreement IP. As between the Parties, the Parties shall each own an equal, undivided interest in and to any Agreement IP
other than Compound Agreement IP or DRP Biomarker Agreement IP that is conceived, discovered, developed or otherwise made jointly by
or on behalf of R-Pharm or its Affiliates and its and their agents and subcontractors, on the one hand, and OV or its Affiliates, permitted
sublicensees and its and their agents and subcontractors, on the other hand (“Joint Agreement IP”). Each Party shall
promptly disclose to the other Party any Joint Agreement IP of which it becomes aware. Each Party shall have the right to make, have
made, use, sell, offer for sale, import and otherwise exploit the Joint Agreement IP without the consent of or accounting to the other
Party, subject to the exclusive license grants contemplated in this Agreement.

 

8.2
Prosecution, Maintenance and Enforcement. R-Pharm shall have the exclusive right to prepare applications for, prosecute, maintain,
defend, and enforce, at its own costs, the R-Pharm Know How, Compound Agreement IP and any other Agreement IP solely owned by R-Pharm.
OV shall have the exclusive right to prepare applications for, prosecute, maintain, defend, and enforce, at its own costs, any Agreement
IP solely owned by OV. The Parties shall work in good faith to coordinate the prosecution, maintenance, defense, and enforcement of any
Joint Agreement IP.

 

	9.	COMPLIANCE
    MATTERS

 

9.1
General. In conducting its activities hereunder, each Party shall comply in all respects with Applicable Law and accepted pharmaceutical
industry business practices, including, if and to the extent applicable to the respective Party or its activities hereunder, the FFDCA,
the Anti-Kickback Statute (42 U.S.C. § 1320a-7b), Civil Monetary Penalty Statute (42 U.S.C. § 1320a-7a), the False Claims Act
(31 U.S.C. § 3729 et seq.), comparable state statutes, the regulations promulgated under all such statutes, and the regulations
issued by the FDA or other applicable Governmental Authority. Each Party shall promptly notify the other Party in writing if it becomes
aware of any material deviations from Applicable Law with respect to activities under this Agreement.

 

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9.2 Debarment and Other Violations. OV shall not employ or subcontract with any Person that is excluded, debarred, suspended,
proposed for suspension or debarment, in Violation or otherwise ineligible for government programs for the performance of the mBC Clinical
Trial or any other activities under this Agreement. OV hereby certifies that it has not employed or otherwise used in any capacity and
will not employ or otherwise use in any capacity, the services of any Person suspended or debarred under United States law, including
21 USC 335a, or any foreign equivalent thereof, in performing any portion of the mBC Clinical Trial or other activities under this Agreement
and that OV has, as of the Effective Date, screened itself, and its officers and directors, against the Exclusions Lists and that it
has informed R-Pharm whether it or any of its officers or directors is in Violation. OV shall notify R-Pharm in writing immediately if
any such suspension debarment or Violation occurs or comes to its attention with respect to any Person performing activities under this
Agreement, and shall, with respect to any Person so suspended, debarred or in Violation, promptly remove such Person from performing
activities, function or capacity related to the mBC Clinical Trial or otherwise related to activities under this Agreement.

 

9.3
Anti-Corruption. In conducting its respective activities hereunder, OV has not taken and will not during the Term, take any action
directly or indirectly to offer, pay, or authorize such offer or payment, of money or anything of value (hereinafter collectively referred
as a “Payment”) to improperly or corruptly seek to influence any Government Official where such Payment would constitute
a violation of any Applicable Law, and has not accepted, and will not accept in the future any such Payments. In addition, regardless
of legality, OV shall not make any Payment either directly or indirectly to Government Officials if such Payment is for the purpose of
influencing decisions or actions or otherwise gaining an improper business advantage with respect to the subject matter of this Agreement.
OV shall not contact, or otherwise knowingly meet with, any Government Official for the purpose of discussing activities arising out
of or in connection with this Agreement, without the prior written approval of the other Party, except where such meeting is consistent
with the purpose and terms of this Agreement and in compliance with Applicable Law.

 

	10.	CONFIDENTIALITY

 

10.1
Confidential Information. During the Term, either Party (the “Disclosing Party”) may from time to time furnish
the other Party (the “Receiving Party”) with Confidential Information. The “R-Pharm Confidential Information”
means any and all Confidential Information for which R-Pharm is the Disclosing Party and OV the Receiving Party hereunder.
The “OV Confidential Information” means any and all Confidential Information for which OV is the Disclosing Party
and R-Pharm the Receiving Party hereunder.

 

10.2
Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, the Parties
agree that for the Term and for seven (7) years thereafter, the Receiving Party shall keep confidential and shall not publish or otherwise
disclose and shall not use for any purpose any Confidential Information of the Disclosing Party except pursuant to this Agreement.

 

10.3
Exclusions. Notwithstanding anything herein to the contrary, the obligations of confidentiality and nonuse under this Article 10
applicable to Confidential Information hereunder shall not apply to information that:

 

a)
at the time of disclosure, is known publicly or thereafter becomes known publicly through no fault of the Receiving Party, its Affiliates
or agents;

 

b)
is disclosed to the Receiving Party on a non-confidential basis by a Third Party that is not legally prohibited from disclosing such
information;

 

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c)
was developed by the Receiving Party independently of information obtained from the Disclosing Party, as shown by the Receiving Party’s
prior written records;

 

d)
was already known to the Receiving Party before receipt from the Disclosing Party, as shown by the Receiving Party’s prior written
records; provided that the foregoing shall not apply with respect to Confidential Information in possession of the Receiving Party prior
to the Effective Date, but transferred to the Disclosing Party pursuant to this Agreement; or

 

e)
is released with the prior written consent of the Disclosing Party.

 

10.4
Permitted Disclosures.

 

a)
General. Notwithstanding the provisions of Section 10.2 and subject to Section 10.4b), each Receiving Party may disclose the Disclosing
Party’s Confidential Information (a) to the Receiving Party’s employees, consultants, Affiliates, agents, or contractors
who are bound by obligations relating to confidentiality at least as restrictive of those contained herein and who have a need to know
such information in connection with the Receiving Party’s performance of its obligations or practice of its rights under this Agreement,
(b) to Regulatory Authorities or other Governmental Authorities in connection with Drug Approval Applications or Regulatory Approvals
in accordance with this Agreement, or (c) to Regulatory Authorities or other Governmental Authorities to obtain Patents in accordance
with this Agreement.

 

b)
Certain Additional Disclosures. Notwithstanding the provisions of Section 10.2, either Party may disclose mBC Clinical Trial Data
and OV Confidential Information to Third Parties as may be necessary in connection with such Party’s evaluation of a potential
or actual investment or acquisition of such Party; provided that any Third Party receiving such disclosure shall be subject to obligations
of confidentiality and non-use with respect to such mBC Clinical Trial Data and such OV Confidential Information consistent with industry
standards.

 

10.5
Terms of Agreement. The terms of this Agreement shall be deemed to be the Confidential Information of both Parties, and neither Party
may disclose such Confidential Information except as otherwise set forth in this Article 10. In addition, either Party may disclose the
terms of this Agreement on a need-to-know basis to such Party’s legal, accounting and financial advisors; provided that in each
case the Person to whom the terms of this Agreement is to be disclosed agrees in writing to be subject to obligations of confidentiality
and non-use with respect to such Confidential Information consistent with industry standards.

 

10.6
Mandatory Disclosure.

 

a)
Notification and Consultation. In the event that the Receiving Party is required by Applicable Law (including regulations applicable
to the public sale of securities) or by court order or judicial or administrative process or by the requirements of a securities exchange
on which the securities of such Party (or its Affiliate) are listed, to disclose any part of the Disclosing Party’s Confidential
Information (including the terms of this Agreement), the Receiving Party shall (a) promptly notify the Disclosing Party of each such
requirement and identify the documents so required thereby, so that the Disclosing Party may seek or request the Receiving Party to seek
an appropriate protective order, confidential treatment or other remedy or waive compliance by the Receiving Party with the provisions
of this Agreement and (b) consult with the Disclosing Party oil the advisability of taking legally available steps to resist or narrow
the scope of such requirement and cooperate in all reasonable respects with the Disclosing Party’s efforts to obtain confidential
treatment or a protective order with respect to any such disclosure.

 

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b)
Limited Disclosure. If, in the absence of such a protective order, confidential treatment request, other remedy or waiver by the
Disclosing Party, the Receiving Party is nonetheless required to disclose any part of the Disclosing Party’s Confidential Information
or any material terms or conditions of this Agreement, the Receiving Party may disclose such Confidential Information (including the
terms of this Agreement), except that the Receiving Party shall furnish only that portion of the Confidential Information (including
the terms of this Agreement) that is legally required; provided that if this Agreement is required to be publicly filed, the Parties
shall reasonably agree on a redacted version to be publicly filed.

 

10.7
Injunctive Relief. Each Party shall be entitled to seek injunctive relief to enforce the terms of this Article 10.

 

	11.	TERM
    AND TERMINATION

 

11.1
Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in
force and expire upon the later of (i) the expiration of the Option Period as extended by the R-Pharm Option Term; or (ii) if OV has
exercised its Exclusive Option and the Parties have not executed a Re-Acquisition Agreement, the expiration of the Royalty Term unless
earlier terminated pursuant to Section 11 (the “Term”).

 

11.2
Termination by OV. Upon ninety (90) days written notice to R-Pharm, OV may elect to terminate this Agreement for any reason in its
sole discretion.

 

11.3
Termination for Failure to Exercise the Exclusive Option. If OV fails to provide the Option Request Notice before the expiration
of the Option Period, then the Exclusive Option shall expire and this Agreement will terminate upon the expiration of the Option Period.

 

11.4
Termination for Material Breach. If either Party (the “Non-Breaching Party”) believes that the other Party
(the “Breaching Party”) has materially breached this Agreement, then the Non-Breaching Party may deliver notice
of such material breach to the Breaching Party (a “Default Notice”). If the Breaching Party does not dispute that
it has committed a material breach of this Agreement, then if the Breaching Party fails to cure such breach, or fails to take steps
as would be considered reasonable to effectively cure such breach, within ninety (90) days (or thirty (30) days payment-related
breaches) after receipt of the Default Notice (provided that if such cure cannot reasonably be achieved within such ninety- (90-)
(or thirty- (30-), as applicable) day period, then such ninety- (90-) (or thirty- (30-), as applicable) day period shall be
automatically extended for an additional ninety (90) days), the Non-Breaching Party may terminate this Agreement upon written notice
to the Breaching Party. If the Breaching Party disputes that it has materially breached this Agreement, the dispute shall be
resolved pursuant to Section 14.14. If, as a result of the application of such dispute resolution procedures, the Breaching Party is
finally determined to be in material breach of this Agreement (an “Adverse Ruling”), then if the Breaching Party
fails to cure such material breach within ninety (90) days (or thirty (30) days payment-related breaches) after such Adverse Ruling
(or such longer period as established by the courts in such final determination), then the Non-Breaching Party may terminate this
Agreement upon written notice to the Breaching Party.

 

11.5
Termination for Insolvency. In the event that either Party (a) files for protection under bankruptcy or insolvency laws or files
a request for bankruptcy under any bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints
or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within ninety (90) days
after such filing, (d) proposes or is a party to any dissolution or liquidation, (e) files a petition under any bankruptcy or insolvency
act or has any such petition filed against that is not discharged within ninety (90) days of the filing thereof, or (f) admits in writing
its inability generally to meet its obligations as they fall due in the general course (each of the foregoing (a) through (f), an “Insolvency
Event”), then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such
Party.

 

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11.6
Effects of Termination. In the event of any termination of this Agreement, then:

 

a)
all rights and licenses granted by each Party to the other Party hereunder shall immediately terminate;

 

b)
each Party and its Affiliates shall promptly return to the other Party or destroy any Confidential Information of the other Party furnished
to the receiving Party by the other Party, except that the receiving Party shall have the right to retain one copy for record keeping
purposes; and

 

c)
in the event that this Agreement is terminated by R-Pharm pursuant to Section 11.4 or 11.5 or by OV pursuant to Section 11.2, at the
written request of R-Pharm, which must be delivered within ninety (90) days after the termination of this Agreement:

 

(i)
OV shall and hereby does assign to R-Pharm, to the extent it is legally permitted to do so, any material Regulatory Documentation and
any other Regulatory Approvals for the Product, in each case, owned by OV (or any of its Affiliates) as of the effective date of termination
and that are solely and exclusively related to the Product, and to the extent it is not legally permitted to do so, OV shall and hereby
does grant to R-Pharm an exclusive “right of reference” (as defined in US FDA 21 CFR 314.3(b)) or similar “right of
reference” (as defined in applicable regulations in the relevant jurisdiction) with respect to such Regulatory Documentation and
other Regulatory Approvals. OV shall and hereby does grant to R-Pharm a non-exclusive “right of reference” (as defined in
US FDA 21 CFR 314.3(b)) or similar “right of reference” (as defined in applicable regulations in the relevant jurisdiction)
with respect to such Regulatory Documentation and other Regulatory Approvals that are necessary for R-Pharm’s development and commercialization
of the Product but that are not solely and exclusively related to the Product;

 

(ii)
OV shall and hereby does grant to R-Pharm a non-exclusive, world-wide, fully paid-up, royalty-free license, with the right to grant and
authorize sublicenses, under the Patents and Know-How Controlled by OV as of the effective date of termination that (i) were actually
used by OV in the Development of the Product hereunder, (ii) are solely and exclusively related to Product, and (iii) are necessary for
the continued Development of such Product (in the form that such Product was being Developed by OV as of the effective date of termination)
for use in the Field (collectively, the “Terminated Product Technology”), to research, develop, make, have made, use,
offer to sell, sell, import, export or otherwise exploit Product (in the form that such Product was being Developed by OV as of the effective
date of termination) in the Field in the Territory; and

 

(iii)
If OV was conducting (i) an ongoing clinical trial of the Product or (ii) the mBC Clinical Trial as of the effective date of termination,
then R-Pharm may notify OV in writing (prior to the effective date of termination of this Agreement) that it will continue such clinical
trial, in which case, the Parties shall negotiate in good faith and mutually agree on an agreement setting forth the terms and conditions,
under which R-Pharm will continue such clinical trial.

 

11.7
Remedies. Except as otherwise expressly provided herein, termination of this Agreement in accordance with the provisions hereof shall
not limit remedies that may otherwise be available in law or equity.

 

11.8
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 a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations
that are expressly indicated to survive the termination or expiration of this Agreement. Without limiting the foregoing, Sections 7.7,
7.8, 7.9, 7.10, 7.11, 11.6, and 11.7 and this Section 11.8, and Articles l (to the extent used in any surviving provisions), and 8, 10,
13 and 14 of this Agreement shall survive the termination or expiration of this Agreement for any reason.

 

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	12.	 REPRESENTATIONS,
    WARRANTIES, AND COVENANTS

 

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

 

a)
it is a corporation duly organized, validly existing, and in good standing under the laws of its jurisdiction of formation;

 

b)
it has full corporate power and authority to execute, deliver, and perform this Agreement, and has taken all corporate actions required
by law and its organizational documents to authorize the execution and delivery of this Agreement and the consummation of the transactions
contemplated by this Agreement;

 

c)
this Agreement constitutes a valid and binding agreement enforceable against it in accordance with its terms;

 

d)
all consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such Party
in connection with this Agreement have been obtained;

 

e)
the execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement,
and the consummation of the transactions contemplated hereby, do not and shall not (i) conflict with or result in a breach of any provision
of its organizational documents; (ii) result in a breach of any other agreement to which it is a party; or (iii) violate any law; and

 

f)
except as otherwise provided herein, neither Party nor any of its respective Affiliates has, and neither will during the Term, enter
into agreements or grant any right, title or interest to any Person that is inconsistent with the rights and licenses granted to the
other Party under this Agreement.

 

12.2
Additional Representations, Warranties and Covenants of R-Pharm. R-Pharm further warrants and represents to OV as of the Effective
Date as follows: R-Pharm owns, Controls, and/or has the right to provide the copies of the Existing Regulatory Documentation and transfer
the Compound to OV hereunder and it not aware of any pending, imminent, or threatened litigation or dispute relating to such Existing
Regulatory Documentation and Compound;

 

	13.	INDEMNIFICATION.

 

13.1
Indemnification Obligations of R-Pharm. R-Pharm shall indemnify and hold OV, its Affiliates and its respective officers, directors,
agents and employees (“OV Indemnitees”) harmless from and against any and all losses, damages, liabilities, penalties,
costs, and expenses (collectively, “Losses”) arising out of or resulting from any claim, demand, action, suit or proceeding
of Third Parties (collectively, “Third Party Claims”) against or incurred by the OV Indemnitees to the extent arising
or resulting from:

 

a)
any breach of any representation or warranty of R-Pharm set forth in this Agreement;

 

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b)
any breach of any covenant, agreement or undertaking made by R-Pharm in this Agreement; or

 

c)
the willful misconduct of R-Pharm or its Affiliates or its or their respective directors, officers, employees and agents, in connection
with R-Pharm’s performance of its obligations or exercise of its rights under this Agreement;

 

d)
provided however that, such indemnity shall not apply (i) to any actual violation by OV or its Affiliates of Applicable Law after the
Effective Date, or (ii) to the extent OV has an indemnification obligation pursuant to Section 13.2.

 

13.2
Indemnification Obligations of OV. OV shall indemnify and hold R-Pharm, its Affiliates and their respective officers, directors,
agents and employees (“R-Pharm Indemnitees”) harmless from and against any and all Losses arising out of or resulting
from any Third Party Claims against or incurred by the R-Pharm Indemnitees to the extent arising or resulting from:

 

a)
any breach of any representation or warranty ofOV set forth in this Agreement;

 

b)
any breach of any covenant, agreement or undertaking made by OV in this Agreement; or

 

c)
the willful misconduct of OV or its Affiliates or its or their respective directors, officers, employees and agents, in connection with
OV’s performance of its obligations or exercise of its rights under this Agreement;

 

d)
provided however that, such indemnity shall not apply (i) to any actual violation by R-Pharm or its Affiliates of Applicable Law after
the Effective Date, (ii) to the extent R-Pharm has an indemnification obligation pursuant to Section 13.1.

 

13.3
Indemnification Procedure.

 

a)
For the avoidance of doubt, all Third Party Claims in respect of a R-Pharm Indemnitee or OV Indemnitee shall be made solely by R-Pharm
or OV, respectively.

 

b)
A Party seeking indemnification hereunder (“Indemnified Party”) shall give the other Party (“Indemnifying
Party”) prompt written notice (“Indemnification Claim Notice”) of any Losses or discovery of fact upon which
such Indemnified Party intends to base a request for indemnification under this Article 13, but the failure or delay to so notify the
Indemnifying Party shall not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party,
except to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve the relevant claims is adversely
affected thereby. The Indemnification Claim Notice shall contain a description of the claim and the nature and amount of such Loss (to
the extent that the nature and amount of such Loss is known at such time). Upon the request of the Indemnifying Party, the Indemnified
Party shall furnish promptly to the Indemnifying Party copies of all correspondence, communications and official documents (including
court documents) received or sent in respect of any Third Party Claims and Losses.

 

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c)
If the Litigation Conditions are satisfied, then the Indemnifying Party shall have the right to assume and control the defense of the
Third Party Claim, at its own expense with counsel selected by it and reasonably acceptable to the Indemnified Party, by delivering written
notice of its assumption of such defense to the Indemnitee within twenty (20) days of its receipt of notice of such Third Party Claim
from the Indemnified Party (but the Indemnifying Party shall in any event have the right to assume and control the defense of a Third
Party Claim that initially sought injunctive relief (including a declaratory judgment) when the only remaining dispute in such matter
is the determination of non-injunctive relief or when the only remaining relief sought by the Third Party in such matter is non-injunctive
relief, whichever is first); provided, however, that the Indemnified Party shall have the right to retain its own counsel, with the reasonable
fees and expenses to be paid by the Indemnifying Party, if (a) representation of the Indemnified Party by the counsel retained by the
Indemnifying Party would be inappropriate due to actual or potential conflict of interests between such Indemnified Party and Indemnifying
Party, (b) the Indemnifying Party has failed within a reasonable time to retain counsel, (c) the Indemnified Party shall have reasonably
concluded that there may be legal defenses available to it that are different from or in addition to those available to the Indemnifying
Party, or (d) at any time the Litigation Conditions are not satisfied with respect to such Third Party Claim.

 

d)
Subject to the provisions of paragraph (g) below, the Indemnified Party shall not make any admission of liability, conclude any agreement
in relation to such liability or make any compromise with any Person, body or authority in relation to such liability without the prior
written consent of the Indemnifying Party.

 

e)
Subject to the provisions of paragraph (c) above and paragraphs (f) and (g) below, the Indemnifying Party shall have the right, upon
written notice given to the Indemnified Party within thirty (30) days after receipt of the Indemnification Claim Notice to assume
the defence and handling of any Third Party Claim, at the Indemnifying Party’s sole expense, in which case the provisions of
paragraph (f) below shall govern. The assumption of the defence of a Third Party Claim by the Indemnifying Party shall not be
construed as acknowledgement that the Indemnifying Party is liable to indemnify any indemnitee in respect of the Third Party Claim,
nor shall it constitute a waiver by the Indemnifying Party of any defences it may assert against any Indemnified Party’s claim
for indemnification. In the event that it is ultimately decided that the Indemnifying Party is not obligated to indemnify or hold an
Indemnitee harmless from and against the Third Party Claim, the Indemnified Party shall reimburse the Indemnifying Party for any and
all reasonable and justifiable costs and expenses (including attorneys’ fees and costs of suit) incurred by the Indemnifying
Party in its defence of the Third Party Claim. If the Indemnifying Party does not give written notice to the Indemnified Party,
within thirty (30) days after receipt of the Indemnification Claim Notice, of the Indemnifying Party’s election to assume the
defence and handling of such Third Party Claim, the provisions of paragraph (g) below shall govern.

 

f)
Upon assumption of the defence of a Third Party Claim by the Indemnifying Party: (i) the Indemnifying Party shall have the right to
and shall assume sole control and responsibility for dealing with the Third Party Claim; (ii) the Indemnifying Party may, at its own
cost, appoint as counsel in connection with conducting the defence and handling of such Third Party Claim any law firm or counsel
reasonably selected by the Indemnifying Party; (iii) the Indemnifying Party shall keep the Indemnified Party informed of the status
of such Third Party Claim; and (iv) the Indemnifying Party shall have the right to settle the Third Party Claim on any terms the
Indemnifying Party chooses; provided, however, that it shall not, without the prior written consent of the Indemnified Party, agree
to a settlement of any Third Party Claim which could lead to liability or create any financial or other obligation on the part of
the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder or which admits any wrongdoing or
responsibility for the claim on behalf of the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party
and shall be entitled to participate in, but not control, the defence of such Third Party Claim with its own counsel and at its own
expense. In particular, the Indemnified Party shall, at the Indemnifying Party’s expense furnish such records, information and
testimony, provide witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably
requested in connection therewith. Such cooperation shall include access during normal business hours by 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 the Indemnified Party, the indemnitees and its and their employees and agents available on a mutually convenient
basis to provide additional information and explanation of any records or information provided.

 

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g)
If the Indemnifying Party does not give written notice to the Indemnified Party as set forth in paragraph (d) or fails to conduct the
defence and handling of any Third Party Claim in good faith after having assumed such, the Indemnified Party may, at the Indemnifying
Party’s expense, select counsel reasonably acceptable to the Indemnifying Party in connection with conducting the defence and handling
of such Third Party Claim and defend or handle such Third Party Claim in such manner as it may deem appropriate. In such event, the Indemnified
Party shall keep the Indemnifying Party timely apprised of the status of such Third Party Claim and shall not settle’ such Third
Party Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld. If the Indemnified
Party defends or handles such Third Party Claim, the Indemnifying Party shall cooperate with the Indemnified Party, at the Indemnified
Party’s request but at no expense to the Indemnified Party, and shall be entitled to participate in the defence and handling of
such Third Party Claim with its own counsel and at its own expense.

 

	14.	MISCELLANEOUS

 

14.1
Further Action. Each Party agrees, without the necessity of any further consideration, to execute, acknowledge, and deliver any and
all such further instruments, and do all further similar acts, as may be necessary or appropriate to carry out the purposes and intent
of this Agreement.

 

14.2
Press Releases. No Party shall issue any other press release, trade announcement or make any other public announcement or statement
with regard to the transactions contemplated by this Agreement without the other Parties’ prior written consent, which shall not
be unreasonably withheld. Where consent is forthcoming, the Parties agree to consult with each other regarding the content of any such
press release or other announcement. The aforementioned restriction shall not apply to announcements required by any Regulatory Authority
or Governmental Entity under Applicable Law, provided that in such event the Parties shall coordinate the wording and OV shall take into
consideration any requests of R-Pharm. Each Party hereto acknowledges that OV and R-Pharm shall have the right to disclose a brief summary
of the transaction, including the amounts payable by OV under this License Agreement, in its official financial reports.

 

14.3
Notices and Other Communications. All notices, consents, waivers, and other communications under this Option Agreement must be in
writing and will be deemed to have been duly given when: (a) delivered by hand (with written confirmation of receipt); (b) sent by fax
(with written confirmation of receipt), provided that a copy is immediately sent by an internationally recognized overnight delivery
service (receipt requested); or (c) when received by the addressee, if sent by an internationally recognized overnight delivery service
(receipt requested), in each case to the appropriate addresses and fax numbers set forth below (or to such other addresses and fax numbers
as a Party may designate by written notice):

 

If
to OV:

 

Oncology
Venture ApS

Venlighedsvej 1

DK-2970
Hoersholm, Denmark

Attention: Chief Executive Officer

Email:
pbj@oncologyventure.com

 

    	34

     

    

 

With a copy to:

 

DechertLLP
1900 K St., N.W.

Washington,
D.C. 20006

Attention:
David E. Schulman

Telephone: (202) 261-3440

 

Ifto
R-Pharm:

 

R-Pharm
US Operating, LLC

3120 Princeton Pike, Suite 201

Lawrence, N.J. 08648 U.S.A.

Attn:
Chief Executive Officer

 

With a copy to:

 

Morgan,
Lewis & Bockius LLP

502 Carnegie Center

Princeton,
NJ 08540

Attention: David Glazer, Esq.

 

Each
Party may change its address for purposes of this License Agreement by written notice to the other Party.

 

14.4
Amendments. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives
of each Party.

 

14.5
Assignment. No Party may assign its rights and obligations under this Agreement without the other Party’s prior written
consent, which consent shall not be unreasonably withheld, except that either Party may assign its rights and obligations under this
Agreement without the consent of the other Party to (i) one or more of its Affiliates (provided that such Party shall remain
responsible for such Affiliate’s performance of this Agreement); or (ii) in connection with the transfer or sale of all or
substantially all of its assets related to the subject matter of this Agreement, or in the event of its merger or consolidation or
change in control or similar transaction. The assignor shall remain liable notwithstanding any assignment hereunder.

 

14.6
Third Party Rights. The provisions of this Option Agreement are for the sole benefit of the Parties and their successors and permitted
assigns, and they shall not be construed as conferring any rights to any Third Party.

 

14.7
Entire Agreement. This Agreement (together with the Exhibits hereto) sets forth and constitutes the entire agreement and understanding
between the Parties relating to subject matter hereof and in relation to such subject matter supersedes all earlier understandings and
agreements, whether written or oral, between the Parties (including that certain Mutual Non-Disclosure and Confidentiality Agreement
by and between R-Pharm US LLC and OV dated October 11, 2017).

 

14.8
No Additional Representations or Warranties. Each Party acknowledges that it has not entered into this Agreement in reliance upon
any representation or warranty other than as set out in this Agreement. No representation, warranty, condition or any other term is to
be implied into this Agreement whether by virtue of any usage or course of dealing or otherwise except as expressly set out in it. This
clause shall not exclude the liability of a Party for fraud or fraudulent misrepresentation.

 

    	35

     

    

 

14.9
Relationship. Nothing contained in this Agreement shall be deemed to constitute a partnership, joint venture, or legal entity of
any type between R-Pharm and OV, or to constitute one as the agent of the other. Moreover, each Party agrees not to construe this Agreement,
or any of the transactions contemplated hereby, as a partnership for any tax purposes. Each Party shall act solely as an independent
contractor, and nothing in this Agreement shall be construed to give any Party the power or authority to act for, bind, or commit the
other.

 

14.10
Waiver of Rights. No failure or delay by a Party to exercise any right or remedy provided under this Agreement or by law or to insist
upon compliance with any term or condition of this Agreement will constitute a waiver of that (or any other) right or remedy or excuse
a similar subsequent failure to perform any such term or condition by the other Party. No waiver shall be effective unless it has been
given in writing and signed by the Party giving such waiver. No single or partial exercise of such right or remedy will preclude or restrict
the further exercise of that (or any other) right or remedy.

 

14.11
Severability. Every provision of this Agreement is intended to be severable. If any provision of this Agreement shall be invalid
or unenforceable, such invalidity or unenforceability shall not affect the other provisions of this Agreement, which shall remain in
full force and effect. The Parties hereto agree to consult each other and to agree upon a new stipulation which is permissible under
Applicable Law and which comes as close as possible to the original purpose and intent of the invalid, void or unenforceable provision.

 

14.12
Counterparts. This Agreement may be executed in any number of counterparts, each of which is an original but all of which together
will constitute one and the same instrument.

 

14.13
Governing Law and Venue. This Agreement and the performance, enforcement, breach or termination hereof shall be interpreted, governed
by and construed in accordance with the laws of the State of New York, United States, without giving effect to the conflicts of Laws
provision thereof, and with the exclusion of the International Sale of Goods Vienna Convention on the International Sale of Goods. Except
for decisions that are subject to the decision-making authority of a given Party (or mutual agreement of the Parties, as applicable)
or the JDC, as expressly set forth in this Agreement, in the event of any controversy, claim or counterclaim arising out of or relating
to this Agreement, the Parties shall first attempt to resolve such controversy or claim through good faith negotiations for a period
of not less than thirty (30) days following notification of such controversy or claim to the other Party. If such controversy or claim
cannot be resolved by means of such negotiations during such period, then such controversy or claim (excepting preliminary injunctions)
shall be submitted by the parties for binding arbitration under rules of the International Chamber of Commerce (ICC) to be held in New
York City, New York. The Parties shall bear their own costs of arbitration, unless otherwise awarded by arbitrator(s).

 

14.14
Dispute Resolution. The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate
to either Party’s rights or obligations hereunder. It is the objective of the Parties to establish under this Section 14.14 procedures
to facilitate the resolution of disputes arising under this Agreement (other than any disputes relating to matters with respect to which
under this Agreement a Party has sole decision-making authority or discretion, in which case, such matter shall be determined by such
Party and shall not be part of the dispute resolution procedure set forth in this Section 14.14) in an expedient manner by mutual cooperation
and without resort to litigation. In the event that the Parties are unable to resolve such dispute through diligent review and deliberation
by the Parties within thirty (30) days from the date either Party had designated such matter as a dispute in written notice to the other
Party, then, at any time after such thirty (30) day period, either Party may proceed to enforce any and all of its rights with respect
to such dispute. For clarity, such thirty (30) day period shall not extend any other time periods provided in this Agreement, including
those set forth in Section 11.4.

 

    	36

     

    

 

14.15
English Language. This Agreement is written and executed in the English language. Any translation into any other language shall not
be an official version of this Agreement and in the event of any conflict in interpretation between the English version and such translation,
the English version shall prevail.

 

14.16
Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition
to any other remedy referred to in this Agreement or otherwise available under law.

 

14.17
Expenses. Except as otherwise expressly provided in this Agreement, each Party shall pay the fees and expenses of its respective
lawyers and other experts and all other expenses and costs incurred by such Party incidental to the negotiation, preparation, execution
and delivery of this Agreement.

 

14.18
Special, Indirect and Other Losses. EXCEPT (A) FORA PARTY’S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 10 AND SECTION 2.8, OR
(B) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A THIRD PARTY CLAIM FOR WHICH A PARTY PROVIDES
INDEMNIFICATION UNDER ARTICLE 13, NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY
DUTY OR OTHERWISE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR FOR ANY ECONOMIC LOSS OR LOSS OF PROFITS
SUFFERED BY THE OTHER PARTY.

 

14.19
No Exclusion. Neither Party excludes any liability for death or personal injury caused by its negligence or that of its employees,
agents or sub-contractors.

 

14.20
Compliance with Law. Each Party shall perform its obligations under this Agreement in accordance with all Applicable Law. No Party
shall, or shall be required to, undertake any activity under or in connection with this Agreement which violates, or which it believes,
in good faith, may violate, any Applicable Law.

 

14.21
Force Majeure. If and to the extent that any Party is prevented or delayed from performing any of its obligations under this Agreement
by any unavoidable and unforeseeable event which is beyond the reasonable control of the Party affected, including but not limited to
the following events: earthquake, storm, flood, fire or other acts of nature, epidemic, war (whether or not declared), riot, public disturbance,
strike or lockouts, government actions, terrorist attack or the like (a “Force Majeure”), and promptly so notifies
in writing the other Party, specifying the matters constituting Force Majeure together with such evidence in verification thereof as
it can reasonably give and specifying the period for which it is estimated that the prevention or delay will continue, then the Party
so affected shall be relieved of liability to the other for failure to perform or for delay in performing such obligations (as the case
may be), but shall nevertheless use its Commercially Reasonable Efforts to resume full performance thereof.

 

14.22
Construction.

 

a)
The definitions of the terms herein will apply equally to the singular and plural forms of the terms defined and where a word or
phrase is defined herein, each of its other grammatical forms will have a corresponding meaning. Whenever the context may require,
any pronoun will include the corresponding masculine, feminine, and neuter forms. The word “shall” will be construed to
have the same meaning and effect as the word “will.” The word “any” means “any and all” unless
otherwise clearly indicated by context. The words “including,” “includes,” “include,” “for
example,” and “e.g.” and words of similar import will be deemed to be followed by the words “without
limitation.” The word “or” is disjunctive but not necessarily exclusive. The words “hereof,”
“herein” and “herewith” and words of similar import will, unless otherwise stated, be construed to refer to
this Agreement as a whole and not to any particular provision of this Agreement.

 

b)
The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall
be applied against either Party hereto.

 

c)
Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated
in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption
will apply against the Party which drafted such terms and provisions.

 

[SIGNATURES
FOLLOW ON NEXT PAGE]

 

    	37

     

    

 

The
Parties have executed this Agreement as of the Effective Date to evidence their agreement to the terms and provisions set forth herein.

 

	 	Oncology Venture ApS
	 	 	 
	 	By:	 
		Name: 	Peter
Buhl Jensen, M.D.
	 	Title:	Chief
Executive Officer
	 	 	 
	 	R-Pharm US Operating, LLC
	 	 	 
	 	By:	 
	 	Name: 	
	 	Title:	

 

[Signature Page to Development,
Option and License Agreement]

  

    	 

     

    

 

EXHIBIT
A: CLINICAL DEVELOPMENT PLAN

 

	●	To be agreed by the Parties and attached within ninety (90)
days after the Effective Date

 

    	A-1

     

    

 

EXHIBIT
B: THE COMPOUND

 

IXEMPRA®
(ixabepilone) a cancer medicine. IXEMPRA is used alone or with another cancer medicine called capecitabine. IXEMPRA is used to treat
breast cancer, when certain other medicines have not worked or no longer work.

 

DOSAGE
FORMS AND STRENGTHS

 

IXEMPRA
for injection, 15 mg supplied with DILUENT for IXEMPRA, 8 ml

 

IXEMPRA for injection, 45 mg supplied with DILUENT for IXEMPRA, 23.5 ml

 

    	B-1

     

    

 

EXHIBIT
C: FORM OF PHARMACOVIGILANCE AGREEMENT

 

PHARMACOVIGILANCE
AGREEMENT

 

This
Pharmacovigilance Agreement (hereinafter the “Agreement”) as a part of Distribution Agreement NQ from_/_/_______ has been entered
by and between:

 

R-Pharm
US, LLC, a legal entity having its registered address at 3120 Princeton Pike, Lawrence, NJ (hereinafter “R-Pharm US”), and
______________., a legal entity having its registered address at ____________(hereinafter Partner), each hereinafter referred to as a “Party” and collectively
as the “Parties”, for the purposes of division of the Parties’ ·rights and obligations regarding monitoring
of the Product effectiveness and safety aimed at identification, assessment and prevention of undesirable effects of the Product use
in accordance with the laws applicable to relations between the Parties.

 

Definitions

 

Adverse
Event/Adverse Drug Experience/ADE: any untoward medical occurrence in a patient or clinical investigation subject administered a
Product and which does not necessarily have to have a causal relationship with the Product.

 

Product:
medicinal product or medical device where a Marketing Authorization Holder is R-Pharm US in the USA and Partner in the market.

 

Territory(s)
shall mean 

 

Effective
Date means the date of this Agreement as designated on the first page of this Agreement.

 

Year
has the meaning from January 1st until December 31st.

 

Agreement
shall mean this Agreement.

 

Product
Technical Complaints and Adverse Drug Experiences

 

1.
Hereby R-Pharm US authorizes Partner to act as a holder and owner of marketing authorization for the Product in terms of collecting,
processing, registration and analysis of information on side effects, ADE and in terms of submission to the authorized federal executive
body of the Territory for control and supervision in healthcare of a Product pharmacovigilance report as stipulated by the laws of the
Territory in force.

 

2.
Product technical complaints (hereinafter - “PTC”) related to the quality of Product that are received by Partner shall be
notified to R-Pharm US (or its designee agent) as soon as received but in not more than forty-eight (48) hours. Partner will include
in the notification to R-Pharm US any

 

    	C-1

     

    

 

-
Details of the patient (sex or age);

-
Details of the event including outcome;

-
Details of the reporter (name, title and contact information).

 

The
first communication from Partner to R-Pharm US should be communicated in writing by email (and confirmed by fax) to the contact point
of the Pharmacovigilance contact person of R-Pharm US.

 

4.
Partner is responsible for medical assessment of all cases of Adverse Experiences/events, relevant for Product within the Territory(s).

 

Partner
shall provide R-Pharm US with CIOMS forms for Adverse Experiences/Events relevant to Product originated in the Territory within fourteen
(14) days from the date of initial receipt (day one (1) begins when Partner receives the report about ADE).

 

R-Pharm
US (or its designee agent) shall provide Partner with CIOMS forms for all relevant Suspected Unexpected Serious Adverse Reactions (hereinafter
- “SUSARS”) originated outside of the Territory within fourteen (14) from the date of initial receipt.

 

R-PHARM
US PHARMACOVIGILANCE CONTACT

 

Pro
Pharma Group

 

Regulatory
/ Medical / Pharmacovigilance/ Safety information exchange

Name: Tim Smith, Director of Pharmacovigilance

e-mail DrugSafety@propharmaroup.com

e-mail Tim.Smith@propharmagroup.com phone US 1-844-586-8953

R-Pharm
US will contact Partner for further information on an as needed basis.

 

Partner pharmacovigilance contact person:

 

 

 

5.
Partner shall serve as an expert in the Territory reporting regulations and shall be responsible for submission of safety information
reports to local regulatory authorities (single reports and periodic reports) based on local regulations.

 

    	C-2

     

    

 

6.
R-Pharm US (or designee agent) shall provide Partner with periodic safety update reports that were prepared for US regulatory reporting.
Partner shall determine whether each report needs to be submitted to local regulatory authorities based on its regulations, Partner may
modify the format of the report (without modification of content) based on local regulatory requirements; if modification of content
is necessary, R-Pharm US must review and approve the report prior to (expiration date), complainant name (in case of legal entity), number
of units involved, and a complete description of the complaint. Partner will include any documents related to the PTC that could permit
R-Pharm US investigate the PTC including but not limited to images or photos, and samples if available. The PTC information should be
communicated in writing by email (and confirmed by fax) to the Quality persons indicated in this Annex:

 

QUALITY
CONTACT PERSONS:

 

R-Pharm
US PTC contact person

 

Name:
Jignesh Shah

 

Title:
VP, Global Supply Chain, Manufacturing and Quality

 

E-Mail: jignesh.shah@rpharm-us.com

 

Phone:
+1 (609) 512-7211

 

Fax:
+1 (609) 512-7198

 

PTC
contact person

 

Name: Verena Grimm

 

Title:
Manager Contract QA Biopharmaceuticals

 

E-Mail:
Verena.Grimm(ivr-pharm.com

 

Phone:
+49-7303-12-9122

 

Fax:
+49-7303-12-387

 

<Partner
contact information>

 

3.
Partner is obliged to communicate to R-Pharm US (or designee agent), within the maximum time period of forty-eight (48) hours, any communication
received from a client, hospital or health authority in relation with the potential adverse drug events and/or any other safety issue
relevant for the Product that could potentially affect the safety of the Product.

 

The
first communication from Partner to R-Pharm US shall contain the following elements:

 

-
Product name;

-
Lot number (if applicable);

 

    	C-3

     

    

 

7.
In consideration of the expenses incurred by Partner in performance of this Agreement, R-Pharm US shall pay to Partner the fees as set
out in Distribution Agreement.

 

The
Parties agree and acknowledge that the Fees set out in Distribution Agreement shall be valid throughout the first two (2) Years of the
term of this Agreement, it being understood that the Year of the Effective Date counts as the first Year. For all subsequent Years during
the term of this Agreement, the Parties agree to meet not later than thirty (30) days prior to the end of each Year to review and agree
new fees for the following Year. Subject to the parties agreeing new fees, the Fees will be replaced with the newly agreed amounts and
Distribution Agreement will be deemed to be amended accordingly.

 

Other
Exchanged Information (as described below)

 

Certain
information or reports, while not meeting the definition of an Adverse Drug Event (ADE) shall also be exchanged. This information includes:

 

	 	●
    	A
    case involving pregnancy/lactation exposure to the Product(s) either maternal or paternal
	 	 	 
	 	●	Lack
    of effect, misuse, product confusion, abuse, overdose, inadvertent or accidental exposure without an associated ADE, occupational
    exposure without an associated ADE
	 	 	 
	 	●	An
    unexpected therapeutic or clinical benefit from use of the Product(s)
	 	 	 
	 	●	Any
    actions due to safety issues including Product recall (Note: notification of such between the Parties must be immediate)
	 	 	 
	 	●	Actual
    or Potential medication errors, suspected transmission by a medicinal Product of an infectious agent, “off-label” use
    (including “off-label” pediatric use)
	 	 	 
	 	●	events
    possibly or probably related to biomedical research, animal research that may potentially cause significant risk for human subjects
    including mutagenicity, teratogenicity, or carcinogenicity
	 	 	 
	 	●	Any
    Product quality complaint for pharmaceuticals and biologicals related to ADE has to be reported.

 

Partner
shall send all Other Exchanged Information described above to R-Pharm US, regardless of an associated ADE unless otherwise stated, utilizing
the terms of ADE reporting set forth in this Agreement.

 

Other
Exchanged Information described above should be reported by Partner to R-Pharm US in accordance with same timelines and contact details
as Adverse Experience/Event reports.

 

Product recall due to safety issues shall also be handled as an ADE and the notification between the Parties will be immediate.

 

Product
recall due to safety issues shall also be handled as an ADE and the notification between the Parties will be immediate.

 

Monthly
Reconciliation

 

On
a monthly basis, Partner shall provide R-Pharm US with a listing of all reports sent to R- Pharm US in the course of the previous month.
This listing shall be sent to R-Pharm US contact above and will be used by R- Pharm US to confirm that all reports sent by Partner to
R-Pharm US were received by R-Pharm US in the course of the previous month. All ADE reports, initial and follow-up reports, shall be
included on the listing. Should there be discrepancies on the list Partner shall be notified. In the event no reports were sent by Partner
to R-Pharm US in a particular month, a notification will be sent to R-Pharm US indicating zero (0) reports were sent that month.

 

C-4

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