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:


 


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


 






    1


     

    


 


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.


 


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.


 






    2


     

    

 


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.


 






    3


     

    

 


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.


 






    4


     

    

 


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.


 






    5


     

    

 


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.


 






    6


     

    

 


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;



 




    7


     

    


 


		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.





 






    8


     

    

 


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.


 


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.




 






    9


     

    

 


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.


 


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.


 






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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.





 






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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)


 


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.


 






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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.



 


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 one hundred
thousand dollars ($100,000.00) (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 two hundred fifty thousand dollars ($250,000.00), 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 two hundred fifty thousand dollars ($250,000.00), which shall be paid by OV to R- Pharm within thirty (30) days of the
Option Exercise Date.


 






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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


 


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.


 






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


 


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.


 


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.


 






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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.


 






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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





 


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).


 






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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.


 


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.


 






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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]


 




    35


     


    

 


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



 




     


     

    


 


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


 




     


     

    


 


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 information received by the complainant such as but not limited to
the Product name, lot number







 


		-	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.


 






     


     

    

 


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 submission (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);



 




     


     

    


 


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.