Exhibit 10.1
 
Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as [***]. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.

CONFIDENTIAL
 
 

 
 
LICENSE AGREEMENT
 
by and between
 
NEUROVIVE PHARMACEUTICAL AB
 
and
 
ONCORE BIOPHARMA, INC.
 
 
 
 
 
 
 
 

--------------------------------------------------------------------------------

 
TABLE OF CONTENTS
 
ARTICLE 1 DEFINITIONS
  1    
ARTICLE 2 LICENSE AND INTELLECTUAL PROPERTY OWNERSHIP
  12
2.1
License Grant to OnCore.
12
2.2
Sublicenses.
12
2.3
Exclusivity.
13
2.4
Ownership of and Rights to Intellectual Property.
13
2.5
Option to Reserved Rights.
14
2.6
No Other Rights.
14
     
ARTICLE 3 TRANSITION ASSISTANCE; COORDINATION OF API SUPPLY
  14
3.1
Transition Assistance.
14
3.2
Coordination of Supply and Clinical Supplies.
15
     
ARTICLE 4 JOINT STEERING COMMITTEE
  15
4.1
Joint Steering Committee.
15
     
ARTICLE 5 DEVELOPMENT AND RELATED DILIGENCE
  17
5.1
Development of the Licensed Product.
17
5.2
Updates to Development Plan.
17
5.3
Regulatory Matters.
17
5.4
Third Parties.
18
     
ARTICLE 6 COMMERCIALIZATION AND RELATED DILIGENCE
  18
6.1
Diligence in Commercialization.
18
6.2
Commercialization.
18
6.3
Commercialization Plan.
18
6.4
Commercial Manufacturing and Supply.
19
6.5
Medical and Scientific Affairs.
19
     
ARTICLE 7 FINANCIAL PROVISIONS
  19
7.1
Initial License Fee.
19
7.2
Initial Public Offering.
19
7.3
Milestones
19
7.4
Royalties.
21
7.5
Payment Provisions.
 22
7.6
Maintenance of Records; Audits.
22

 
 
i

--------------------------------------------------------------------------------

 

     
ARTICLE 8 INTELLECTUAL PROPERTY PROTECTION AND RELATED MATTERS
  24
8.1
Filing, Prosecution and Maintenance of Patent Rights.
24
8.2
Enforcement of Patent Rights.
26
8.3
Claimed Infringement of Third Party Rights.
28
8.4
Product Trademarks.
30
8.5
Patent Term Extensions in the Territory.
30
     
ARTICLE 9 CONFIDENTIALITY
  30
9.1
Confidential Information.
30
9.2
Public Announcements and Use of Names.
31
     
ARTICLE 10 TERM AND TERMINATION
  31
10.1
Term.
31
10.2
Termination for Cause.
32
10.3
Termination for Convenience.
34
10.4
Termination for Clinical Failure.
35
10.5
Rights in Bankruptcy.
35
10.6
Return of Confidential Information.
36
10.7
Effect of Expiration or Termination; Survival.
36
     
ARTICLE 11 REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
  36
11.1
Mutual Representations and Warranties.
36
11.2
NeuroVive Representations and Warranties.
38
11.3
Warranty Disclaimer.
40
11.4
No Consequential Damages.
41
11.5
Indemnification and Insurance.
41

 
 
ii

--------------------------------------------------------------------------------

 

     
ARTICLE 12 MISCELLANEOUS PROVISIONS
  42
12.1
Governing Law.
42
12.2
Arbitration; Service of Process.
42
12.3
Assignment.
43
12.4
Amendments.
43
12.5
Notices.
43
12.6
Force Majeure.
44
12.7
Compliance with Export Regulations.
45
12.8
Independent Contractors.
45
12.9
Further Assurances.
45
12.1
No Strict Construction.
45
12.11
Headings.
45
12.12
No Implied Waivers; Rights Cumulative.
45
12.13
Severability.
45
12.14
No Third Party Beneficiaries.
45
12.15
Dispute Resolution.
46
12.16
Execution in Counterparts.
46
12.17
Specific Performance.
46

 
 
Schedules
 
Schedule 1.43 – NeuroVive Patent Rights
 
Schedule 1.44 – NV556 Structure
 
Schedule 9.2 – Press Release
 
 
 
 
iii

--------------------------------------------------------------------------------

 
LICENSE AGREEMENT
 
This License Agreement (this “Agreement”) dated the 8th day of September 2014
(the “Effective Date”) is by and between NeuroVive Pharmaceutical AB, a company
organized under the laws of Sweden (“NeuroVive”), and OnCore Biopharma, Inc., a
Delaware corporation  (“OnCore”).  NeuroVive and OnCore may each be referred to
herein individually as a “Party” and collectively as the “Parties”.
 
INTRODUCTION
 
WHEREAS, NeuroVive is in the business of developing and commercializing
cyclophilin inhibitors and have acquired a compound series with antiviral
activity that are encompassed in the Licensed Patents (as defined below);
 
WHEREAS, OnCore is in the business of discovering, developing and
commercializing therapies for liver and viral diseases and desires to develop
one or more compounds within the Licensed Compound Series as Licensed Products
(each as defined below) for oral treatment of Hepatitis B and at OnCore’s
option, other anti-viral indications;
 
WHEREAS, this Agreement sets forth the terms and conditions under which
NeuroVive will license the Licensed Patents and the Licensed Know-How (as
defined below) to OnCore such that OnCore can develop and, if successful,
commercialize Licensed Products in the Field (as defined below).
 
NOW, THEREFORE, in consideration of the mutual promises and covenants set forth
below and other good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the Parties hereby agree as follows:
 
 
ARTICLE 1
DEFINITIONS
 
When used in this Agreement, each of the following terms shall have the meanings
set forth in this ARTICLE 1:
 
1.1. “Acquirer Intellectual Property” means the Patent Rights and Know-How owned
or controlled by a Third Party acquirer of NeuroVive or OnCore, as the case may
be, immediately prior to a Change of Control transaction, and Improvements
thereto following the effective date of such Change of Control.
 
1.2. “Affiliate” means, with respect to any Person, any other Person which
controls, is controlled by, or is under common control with such Person.  A
Person shall be regarded as in control of another entity if it owns or controls
more than fifty percent (50%) of the equity securities of the subject entity
entitled to vote in the election of directors (or, in the case of an entity that
is not a corporation, for the election of the corresponding managing
authority).  Notwithstanding the foregoing, with respect to OnCore, “Affiliate”
does not include any stockholder of OnCore as of the Effective Date; provided
however, that for purposes of Article 9, stockholders of OnCore as of the
Effective Date (including any respective subsidiaries of such stockholders, as
applicable) shall be included as Affiliates.
 
 
- 1 -

--------------------------------------------------------------------------------

 
1.3. “API” means active pharmaceutical ingredient.
 
1.4. “Applicable Law” means the laws, rules and regulations applicable to either
Party, including any rules, regulations, guidelines or other requirements of the
Regulatory Authorities applicable to the Development, Manufacturing or
Commercialization of Licensed Products, that may be in effect from time to time
in the Territory.
 
1.5. “Asia” means China, Japan, South Korea, Taiwan and Singapore.
 
1.6. “Bankruptcy Code” means Title 11, United States Code, as amended, or
analogous provisions of Applicable Law outside the United States.
 
1.7. “Blocking Patent” means any Patent Rights owned or controlled by a Third
Party with respect to which Patent Rights an assertion is made by such Third
Party that (i) the composition of the Licensed Product, (ii) the formulation of
the Licensed Product transferred to OnCore under ARTICLE 3, or (iii) the use of
a Licensed Product in the Field infringes such Third Party’s Patent Rights in
the Territory in the Field.
 
1.8. “Business Day” means (a) in the case of OnCore, a day on which banking
institutions in New York, New York are open for business and (b) in the case of
NeuroVive, a day on which banking institutions in Stockholm, Sweden are open for
business.
 
1.9. “Change of Control” means, with respect to a Party, (a) a merger or
consolidation of such Party with a Third Party which results in the stockholders
or equity holders of such Party not owning at least fifty percent (50%) of the
combined voting power of the surviving entity immediately after such merger or
consolidation, or (b) except in the case of a bona fide equity or debt
financings, whether private or public, in which a Party issues new shares of its
capital stock or securities convertible into shares of such Party, a transaction
or series of related transactions in which a Third Party, together with its
Affiliates, becomes the beneficial owner of fifty percent (50%) or more of the
combined voting power of the outstanding securities of such Party, or (c) the
sale or other transfer to a Third Party of all or substantially all of such
Party’s business to which the subject matter of this Agreement relates.
 
1.10. “CMC” means chemistry, manufacturing and controls.
 
1.11. “Combination Product” means (a) any Licensed Product that contains a
Licensed Compound Series compound combined with one or more other APIs that are
not within the Licensed Compound Series or (b) any package containing a Licensed
Product combined with another therapeutic, prophylactic or diagnostic product or
with a measurement, monitoring or delivery device, where the package is sold as
one (1) stock keeping unit.
 
 
- 2 -

--------------------------------------------------------------------------------

 
1.12. “Commercialization” means any and all activities constituting using,
marketing, promoting, distributing, offering for sale and selling a Licensed
Product in the Field in the Territory and shall include, but not be limited to,
activities required to fulfill ongoing post-approval regulatory obligations,
including adverse event reporting and sales force training.  When used as a
verb, “Commercialize” shall mean to engage in Commercialization.
 
1.13. “Commercially Reasonable Efforts” means the efforts and resources that
would normally be exerted or employed by a similarly situated biopharmaceutical
company for a product of similar commercial or strategic importance, and at a
similar stage of its product life, based on conditions then prevailing, taking
into consideration safety and efficacy, development costs, the anticipated
prescription label and all other relevant factors; in the context of
Commercialization, marketing and sales efforts are undertaken with an aim to
maximize lawful sales of Licensed Products in the approved indication(s) in the
relevant jurisdiction.
 
1.14.  “Confidential Information” means, with respect to each Party, proprietary
data or information that belong in whole or in part to such Party, its
Affiliates or sublicensees, including, without limitation, (a) all NeuroVive
Intellectual Property and OnCore Intellectual Property, (b) any information
designated as Confidential Information of such Party hereunder, in all cases
that, if disclosed in writing, is marked with the words “Confidential,”
“Proprietary” or words of similar import, and if disclosed orally or visually,
is described in reasonable detail in a written notice sent by the Disclosing
Party to the Receiving Party within thirty (30) days of the oral or visual
disclosure requesting that such information be treated as Confidential
Information hereunder and (c) all information that a reasonable person would
understand to be confidential or proprietary in nature, whether or not marked as
such.
 
1.15. “Confidentiality Agreement” means that certain Confidentiality Agreement,
dated as of June 4, 2014, between NeuroVive and OnCore.
 
1.16. “Contract Quarters” means the successive three (3) month periods in each
Contract Year ending on March 31, June 30, September 30 or December 31.
 
1.17. “Contract Year” means the twelve (12) month period beginning on January 1
and ending on December 31 of each calendar year, provided, however, that the
first Contract Year shall be the period of time beginning on the Effective Date
and ending on December 31, 2014.  Each Contract Year, except the first Contract
Year, shall be divided into four (4) Contract Quarters.
 
1.18. “Control” or “Controlled” means with respect to any (a) material, item of
information, method, data or other Know-How, or (b) intellectual property right,
the possession (whether by ownership or license, other than pursuant to this
Agreement) by a Party or its Affiliates of the ability to grant to the other
Party access and/or a license as provided herein under such item or right
without violating any Third Party rights thereto or the terms of any agreement
or other arrangement with any Third Party existing before or after the Effective
Date.
 
 
- 3 -

--------------------------------------------------------------------------------

 
1.19. “Development” means all pre-clinical, clinical, CMC and regulatory
activities with respect to a Licensed Product in the Field and in the Territory
from the Effective Date until Regulatory Approval of such Licensed Product is
obtained for the indication under study.  When used as a verb, “Develop” shall
mean to engage in Development.
 
1.20. “Development Costs” means, with respect to a Licensed Product, the costs
and expenses incurred in conducting Development activities from the Effective
Date through the later of (a) the date of the last Regulatory Approval obtained
in the Territory for such Licensed Product, or (b) the date of termination of
Development of the final indication for which Regulatory Approval is to be
sought in the Territory.  
 
1.21. “Development Plan” means a written plan in reasonable detail covering the
period from the Effective Date through Regulatory Approval for (i) in the case
of OnCore, the Development of the first Licensed Product for the Hepatitis B
Indication, and in the case of NeuroVive, the Development of Licensed Products
outside the Field, in each case including, but not limited to, activities
designed to generate the preclinical, process
development/manufacturing/scale-up, clinical and regulatory plans and
information required for filing Regulatory Approval Applications, and (ii)
preparation and submission of Regulatory Approval Applications.
 
1.22. “EMA” means the European Medicines Agency or a successor agency in the
European Union with responsibilities comparable to those of the European
Medicines Agency.
 
1.23. “Executive Officers” means the Chief Executive Officer of OnCore (or an
executive of OnCore designated by such Chief Executive Officer) and the Chief
Executive Officer of NeuroVive (or an executive of NeuroVive designated by such
Chief Executive Officer).
 
1.24. “FD&C Act” means the U.S. Federal Food, Drug, and Cosmetic Act, as amended
from time to time (21 U.S.C. Section 301 et seq.), together with any rules and
regulations promulgated thereunder.
 
1.25. “FDA” means the United States Food and Drug Administration, or a successor
agency in the United States with responsibilities comparable to those of the
United States Food and Drug Administration.
 
1.26. “Field” means the Hepatitis B Indication and such other indications
licensed to OnCore under Section 2.5.
 
1.27. “First Commercial Sale” means, with respect to a given Licensed Product in
a country in the Territory, the first commercial sale in an arms-length
transaction of such Licensed Product to a Third Party by or on behalf of OnCore,
its Affiliate or its sublicensee in such country following receipt of applicable
Regulatory Approval of such Licensed Product in such country.
 
 
- 4 -

--------------------------------------------------------------------------------

 
1.28. “Gross Sales” for purposes of this Agreement means the amount invoiced by
OnCore or its Affiliates or sublicensees (the “Selling Party”) for sales of
Licensed Products to a Third Party purchaser, less taxes, duties or other
governmental charges imposed on the sale of Licensed Products and actually paid
or accrued by the Selling Party, to the extent billed as a separate line item by
the Selling Party to the Third Party purchaser, and calculated in accordance
with US GAAP.  To the extent such taxes, duties or governmental charges are
based on estimates, such estimates will be adjusted to actual on a periodic
basis.  A sale of a Licensed Product is deemed to occur in accordance with US
GAAP.
 
(a)           For sake of clarity and avoidance of doubt, the transfer of a
Licensed Product by a Selling Party to another Affiliate of such Selling Party
or to a sublicensee of such Selling Party for resale shall not be considered a
sale; in such cases, Gross Sales shall be determined based on the amount
invoiced or otherwise billed by such Affiliate or sublicensee to an independent
Third Party, less the Gross Sales Deductions allowed under this Section.
 
(b)           Notwithstanding the foregoing, subject to Sections 1.28(c) and
1.28(d), in the event a Licensed Product is sold as a Combination Product, Gross
Sales, for purposes of determining royalty payments on such Licensed Product,
shall be calculated by multiplying the Gross Sales of the Combination Product by
the fraction [***].
 
(c)           With respect to any Combination Product that comprises (i) a
Licensed Compound Series compound and (ii) one or more other API, where (x) the
other API is not sold separately in the applicable country during the applicable
accounting period, or (y) the Licensed Product is not sold separately in the
applicable country during the applicable accounting period, then the Gross Sales
of such Combination Product shall be determined [***].
 
(d)           With respect to any Combination Product that comprises a
monitoring device, any [***] for such monitoring device shall be fully
deductible from the Gross Sales for such Combination Product. Such deduction for
the [***] for such monitoring device shall be applied to Gross Sales before any
other deductions are taken from Gross Sales.
 
(e)           Notwithstanding the foregoing, the Parties agree that, for
purposes of this Section 1.28, (a) [***] contained in a Licensed Product shall
not be deemed to be API but (b) [***] of a Licensed Product such as, without
limitation, [***], shall not fall within the aforementioned exception and shall
be treated as APIs for purposes of this Section, provided, however, that the
Licensed Product cannot be Developed or Commercialized without such [***].
 
1.29. “Hatch-Waxman Act” means the U.S. Drug Price Competition and Patent Term
Restoration Act, as amended from time to time.
 
1.30. “Hepatitis B Indication” means all uses to treat hepatitis B virus in
humans via oral administration.
 
1.31.  “Improvements” means any and all ideas, information, Know-How, data
research results, writings, inventions, discoveries, modifications,
enhancements, derivatives, new uses, developments, techniques, materials,
compounds, products, designs, processes, or other technology or intellectual
property, whether or not patentable or copyrightable, and all Patent Rights and
other intellectual property rights in any of the foregoing.
 
 
- 5 -

--------------------------------------------------------------------------------

 
1.32. “IND” means an Investigational New Drug Application, as defined in the
FD&C Act, or similar application or submission that is required to be filed with
any Regulatory Authority before beginning clinical testing of a Licensed Product
in human subjects.
 
1.33. [***].
 
1.34. “Joint Intellectual Property” means Patent Rights, Know-How and
Improvements created, conceived or reduced to practice jointly by NeuroVive
(including its Affiliates, agents, sublicensees (other than OnCore or its
Affiliates) and Third Parties acting on their behalf) and OnCore (including its
Affiliates, agents, sublicensees (other than NeuroVive or its Affiliates) and
Third Parties acting on its behalf) while performing activities under this
Agreement.
 
1.35. “Know-How” means any non-public, proprietary invention, discovery,
process, method, composition, formula, procedure, protocol, technique, result of
experimentation or testing, information, data, material, drawings, illustrations
or other artwork, technology or other information, whether or not patentable or
copyrightable.
 
1.36. “Licensed Compound Series” means, to the extent enabled in any of the
NeuroVive Patent Rights, all sanglifehrin-based cyclophilin inhibitors together
with all possible metabolites, isomers, salts, hydrates, polymorphs, crystalline
forms, solvates and prodrugs thereof.
 
1.37. “Licensed Products” means all oral dosage forms of Licensed Compound
Series compounds, including any present and future combination products
containing a Licensed Compound Series compound as one of the active ingredients,
the making, use, offer for sale, sale or import of which would infringe a Valid
Claim of any of the NeuroVive Patent Rights in, or misappropriate any
intellectual property rights in, the NeuroVive Intellectual Property.  For the
avoidance of doubt, Licensed Products includes NVP018.
 
1.38.  “Manufacturing” means, as applicable, all activities associated with the
production, manufacture, processing, filling, finishing, packaging, labeling,
shipping, and storage of Licensed Products and its API, including process and
formulation development, process validation, stability testing, manufacturing
scale-up, pre-clinical, clinical and commercial manufacture and analytical
development, product characterization, quality assurance and quality control,
whether such activities are conducted by a Party, its Affiliates or a Third
Party contractor of such Party. When used as a verb, “Manufacture” shall mean to
engage in Manufacturing.
 
1.39. “NDA” has the meaning set forth in the definition of Regulatory Approval
Application.
 
 
- 6 -

--------------------------------------------------------------------------------

 
1.40. “NeuroVive Improvements” means any and all Improvements to the NeuroVive
Patent Rights or NeuroVive Know-How created, conceived or reduced to practice
solely by NeuroVive, or its Affiliates, agents, or sublicensees (other than
OnCore or its Affiliates) or by Third Parties acting on their behalf.
 
1.41. “NeuroVive Intellectual Property” means NeuroVive Patent Rights, NeuroVive
Know-How and NeuroVive Improvements, excluding Acquirer Intellectual Property.
 
1.42. “NeuroVive Know-How” means Know-How that is (a) Controlled by NeuroVive or
any of its Affiliates on or after the Effective Date, (b) related to the
Licensed Products, and (c) necessary or useful in connection with the
Development, Manufacture, use or Commercialization of any Licensed Product.
 
1.43. “NeuroVive Patent Rights” means (a) the patents and patent applications
listed in Schedule 1.43, (b) any Patent Rights arising from those patents and
patent applications during the Term, and (c) any other Patent Rights in the
Territory that are Controlled by NeuroVive or any of its Affiliates during the
Term (x) with claims covering any composition or method of making or method of
using Licensed Compound Series or Licensed Products or (y) that are necessary or
useful in connection with the Development, Manufacture, or Commercialization of
sanglifehrin-based cyclophilin inhibitors.
 
1.44. “NVP018” means the Licensed Product containing the Licensed Compound
Series compound designated as NV556 (the structure of which is attached to
Schedule1.43), which is currently under development by NeuroVive as of the
Effective Date.
 
1.45. “OnCore Improvements” means any and all Improvements to the NeuroVive
Intellectual Property, OnCore Patent Rights or OnCore Know-How created,
conceived or reduced to practice solely by OnCore, or its Affiliates, agents, or
sublicensees or by Third Parties acting on its behalf, while performing
activities under this Agreement.
 
1.46. “OnCore Intellectual Property” means OnCore Know-How, OnCore Patent Rights
and OnCore Improvements, excluding Acquirer Intellectual Property.
 
1.47. “OnCore Know-How” means Know-How that is (a) either (i) Controlled by
OnCore or any of Affiliates on the Effective Date, or (ii) owned by OnCore or
any of its Affiliates during the Term, (b) related to the Licensed Product, and
(c) is necessary or useful in connection with Development, Manufacture, use or
Commercialization of any Licensed Product.
 
1.48. “OnCore Patent Rights” means any Patent Rights claiming any composition or
method of making or method of use of a Licensed Product or otherwise necessary
in connection with the Development, Manufacture, use or Commercialization of any
Licensed Product, which is (a) Controlled by OnCore or any its Affiliates as of
the Effective Date, or (b) owned by OnCore or any of its Affiliates during the
Term.
 
 
- 7 -

--------------------------------------------------------------------------------

 
1.49. “Patent Rights” means all patents (including all reissues, extensions,
substitutions, confirmations, re-registrations, re-examinations, revivals or
revalidations, supplementary protection certificates and patents of addition)
and patent applications (including all provisional applications, continuations,
continuations-in-part and divisions).
 
1.50. “Person” means any natural person, corporation, firm, business trust,
joint venture, association, organization, company, partnership or other business
entity, or any government, or any agency or political subdivisions thereof.
 
1.51. “Phase Ib Clinical Trial” means a human clinical trial of a Licensed
Product, the principal purpose of which is a “proof on concept” in patients
infected with hepatitis B conducted in accordance with 21 C.F.R. § 312.21(a) or
other corresponding and similar regulatory requirements prescribed by Regulatory
Authorities outside of the US.
 
1.52. “Phase II Clinical Trial” means a human clinical trial of a Licensed
Product, the principal purpose of which is an additional determination of safety
and efficacy in the target patient population over a range of doses or patients
conducted in accordance with 21 C.F.R. § 312.21(b) or other corresponding and
similar regulatory requirements prescribed by Regulatory Authorities outside of
the US and which enables the initiation of a Phase III Clinical Trial.
 
1.53. “Phase III Clinical Trial” means a human clinical trial of a Licensed
Product that is designed to establish that the Licensed Product is safe and
efficacious for its intended use, and to define warnings, precautions, and
adverse reactions that are associated with the Licensed Product in the dosage
range to be prescribed, and to support Regulatory Approval of the
Licensed Product or label expansion of the Licensed Product conducted in
accordance with 21 C.F.R. § 312.21(c) or other corresponding and similar
regulatory requirements prescribed by  Regulatory Authorities outside of the US.
 
1.54. “Product Labels and Inserts” means (a) all labels and other written,
printed or graphic matter affixed to any container, packaging or wrapper
utilized with the Licensed Product, or (b) any written material physically
accompanying the Licensed Product, including, without limitation, product
package inserts.
 
1.55. “Product Trademarks” means the trademark(s), service mark(s), accompanying
logos, trade dress and/or indicia of origin used in connection with the
Commercialization of each Licensed Product in the Territory.  For purposes of
clarity, the term Product Trademark(s) shall not include, without limitation,
the corporate names and logos of either Party.
 
1.56. “Promotional Materials” means all written, printed or graphic material,
other than Product Labels and Inserts, and all premium items and other materials
provided by OnCore for use during details relating to a Licensed Product.
 
1.57.  “Regulatory Approval” means the approval by the applicable Regulatory
Authority for the testing, commercial manufacture, distribution, marketing,
promotion, offer for sale, use, import, export and sale of a Licensed Product in
a regulatory jurisdiction in the Territory, including, where required, separate
pricing and/or reimbursement approvals.
 
 
- 8 -

--------------------------------------------------------------------------------

 
1.58. “Regulatory Approval Application” means an application submitted to the
appropriate Regulatory Authority seeking Regulatory Approval of a Licensed
Product in the Territory including, without limitation, any type or form of New
Drug Application (“NDA”) in the United States, any type or form of marketing
authorization application in the European Union, and any similar application to
a competent drug regulatory authority in a relevant country or region in the
Territory.
 
1.59. “Regulatory Authority” means any applicable supranational, national,
regional, state or local regulatory agency, department, bureau, commission,
council or other government entity involved in granting of Regulatory Approval
for a Licensed Product in a jurisdiction within the Territory.
 
1.60. “Regulatory Materials” means regulatory applications, submissions,
notifications, communications, correspondence, registrations, Regulatory
Approvals and/or other filings made to, received from or otherwise conducted
with a Regulatory Authority that are necessary or useful in order to Develop,
Manufacture, or Commercialize any Licensed Product in a particular country or
regulatory jurisdiction in the Territory.
 
1.61. “Related Party” means OnCore’s Affiliates and permitted sublicensees.
 
1.62. “Reserved Rights” shall mean rights to Develop, have Developed,
Manufactured or have Manufactured, Commercialize or have Commercialized any
Licensed Product anywhere in the world for indications involving the treatment
of viral diseases other than hepatitis B virus.
 
1.63. “Royalty Term” means, with respect to each Licensed Product, for each
country in the Territory, the period of time commencing on the date of First
Commercial Sale of such Licensed Product in such country and extending until the
earlier of (a) the termination of this Agreement pursuant to and to the extent
set forth in ARTICLE 10, or (b) the date on which the Manufacture, use or
Commercialization of any Licensed Product is no longer covered by a Valid Claim
of NeuroVive Patent Rights in such country.
 
1.64. “Territory” means the world.
 
1.65. “Third Party” means any Person other than a Party or any of its
Affiliates.
 
1.66. “Third Party Technology” means any Patent Rights, Know-How, inventions, or
other intellectual property owned or controlled by a Third Party but not
Controlled by a Party or its Affiliates.
 
 
- 9 -

--------------------------------------------------------------------------------

 
1.67. “US” means the United States of America, including its territories and
possessions.
 
1.68. “US GAAP” means the US generally accepted accounting principles, as
consistently applied.
 
1.69. “Valid Claim” means a claim of (a) an issued and unexpired Patent Right,
which claim has not been revoked or held unenforceable, unpatentable or invalid
by a decision of a court or other governmental agency of competent jurisdiction
which is not appealable or has not been appealed within the time allowed for
appeal, and which 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 for a patent included within the Patent
Rights and which claim has not been cancelled, withdrawn or abandoned or finally
rejected by an administrative agency action from which no appeal can be taken or
pending for longer than seven (7) years in a patent application or its parent
patent applications.
 
1.70. Additional Definitions.  The following terms have the meanings set forth
in the corresponding Sections of this Agreement:
 
Defined Term
Section Reference
“Action”
12.2.1
“Agreement”
Preamble
“Anti-Bribery Laws”
11.1.5
“Audited Party”
7.6.2
“Blocking Patent Claims”
8.3.3(b)
“Breaching Party”
10.2.1
“Co-Chairperson”
4.1.1(b)
“Commercialization Plan”
6.3
“Date of Notice”
10.2.1(a)
“Disclosing Party”
9.1
“Early Termination”
10.3.1(a)
“Effective Date”
Preamble
“Efficacy Failure”
10.4.1

 
 
- 10 -

--------------------------------------------------------------------------------

 
“Generic Entry”
10.3.1
“Holdback Extension”
7.2
“Holdback Period”
7.2
“Indemnitee”
11.5.3
“Infringement Claim”
8.3.1
“Infringement Defense Costs”
8.3.2
“IP”
10.5
“JSC”
4.1.1
“Joint Steering Committee”
4.1.1
“Losses”
11.5.1
“Milestone Event”
7.3
“Milestone Payment”
7.3
“NeuroVive”
Preamble
“NeuroVive Indemnitees”
11.5.1
“OnCore”
Preamble
“OnCore Indemnitees”
11.5.2
“OnCore Securities”
7.2
“Option Notice”
2.5
“Party”
Preamble
“Prosecuting Party”
8.1.1(b)
“Receiving Party”
9.1
“Safety Failure”
10.4.1
“Sale Transaction”
7.2
“Securities Act”
11.2.8
“SPC”
8.5
“Taxes”
7.5.1
“Term”
10.1
“Transition Assistance”
3.1.2
 “Transition Term”
3.1.1

 
 
- 11 -

--------------------------------------------------------------------------------

 
ARTICLE 2
LICENSE AND INTELLECTUAL PROPERTY OWNERSHIP
 
2.1 License Grant to OnCore.
 
Subject to the terms and conditions of this Agreement, NeuroVive hereby grants
OnCore: (a) an exclusive license (even as to NeuroVive), with the right to
sublicense as provided in Section 2.2, under the NeuroVive Intellectual Property
to Develop, have Developed, Manufacture, have Manufactured, Commercialize and
have Commercialized the Licensed Products in the Field in the Territory;
provided that NeuroVive reserves for itself the right to Develop, have
Developed, Manufacture, have Manufactured, Commercialize and have Commercialized
the Licensed Products outside the Field; and (b) a non-exclusive, royalty-free
right and license and right of reference, with the right to sublicense, under
NeuroVive’s or its Affiliates rights, titles and interests in and to any
Regulatory Materials solely for OnCore to Develop, have Developed, Manufacture,
have Manufactured and Commercialize and have Commercialized the Licensed
Products in the Field.
 
2.2 Sublicenses.
 
2.2.1 Right to Sublicense.  OnCore may sublicense the rights granted to it under
Section 2.1 to one or more of its Affiliates or Third Parties at any
time.  OnCore shall use Commercially Reasonable Efforts to ensure that any such
Third Party to which it grants a sublicense is financially sound and able to
meet the obligations of any sublicense agreement.  OnCore shall remain
responsible for the performance of its obligations under this Agreement,
including the performance of its sublicensees, particularly with respect to all
payments due hereunder, whether or not such payments are made by the
sublicensing Party, its Affiliates or its sublicensees.  OnCore shall provide
reasonable advance notice of any such sublicense to NeuroVive and shall, upon
request, provide NeuroVive the opportunity to review the sublicense
agreement.  All such notices of sublicenses shall be deemed to be Confidential
Information of the OnCore subject to the provisions of ARTICLE 9 whether or not
so marked, and NeuroVive shall not disclose such Confidential Information to any
Third Party or use such Confidential Information for any purpose other than for
the purposes of Section 2.2.3, except (a) to the extent required under
applicable securities and other laws, and (b) to attorneys, accountants and
other advisors, and to existing and prospective investors, lenders, licensees or
collaborators, subject to commercially reasonable precautions to protect the
confidentiality of the information.  Notwithstanding the foregoing, in the event
that any such sublicense would convey substantially all rights granted to OnCore
under this Agreement, such sublicense shall not be effective without the prior
written consent of NeuroVive, such consent not to be unreasonably withheld or
delayed.
 
 
- 12 -

--------------------------------------------------------------------------------

 
2.2.2 Terms.  Each sublicense granted by OnCore under this Agreement shall be
subject and subordinate to the terms and conditions of this Agreement and shall
contain terms and conditions consistent with those in this
Agreement.  Agreements with any Commercializing sublicensee shall contain the
following provisions:  (a) a requirement that such sublicensee submit applicable
sales or other reports consistent with those required hereunder; (b) an audit
requirement similar to the requirement set forth in Section 7.6; and (c) a
requirement that such sublicensee comply with the confidentiality and non-use
provisions of ARTICLE 9 with respect to both Parties’ Confidential Information.
 
2.2.3 Effect of Termination on Sublicenses.  If this Agreement terminates for
any reason, OnCore shall use its Commercially Reasonable Efforts to assign to
NeuroVive or its designee OnCore’s rights, obligations, and interest under and
in any agreement it has with a sublicensee from the effective date of such
termination; provided, however, that such sublicensee is not in breach of its
sublicense agreement and such sublicensee agrees to comply with all of the terms
of this Agreement to the extent applicable from the rights originally
sublicensed to it by OnCore; and provided, further, that NeuroVive shall not be
liable for, and shall be indemnified and held harmless by OnCore against, any
and all liability arising under the sublicense agreement prior to the effective
date of such termination, and that the terms of the sublicense shall not apply
to NeuroVive and shall terminate to the extent that they are inconsistent with
the terms of this Agreement or impose obligations on NeuroVive beyond the
obligations set forth in this Agreement.
 
2.3 Exclusivity.
 
During the Term, NeuroVive shall not, and shall cause its Affiliates to not,
whether directly or indirectly (including via licensing), Develop, have
Developed, Manufacture, have Manufactured, Commercialize or have Commercialized
any Licensed Compound Series compound (a) in any dosage form for use involving
the treatment of hepatitis B virus in humans or (b) for use in the Field (as may
be expanded in accordance with Section 2.5 below).
 
2.4 Ownership of and Rights to Intellectual Property.
 
2.4.1 OnCore Intellectual Property.  OnCore is and shall remain the sole owner
of the OnCore Intellectual Property.  OnCore shall solely control the
prosecution of OnCore Patent Rights.
 
2.4.2 NeuroVive Intellectual Property.  NeuroVive is and shall remain the sole
owner of the NeuroVive Intellectual Property. NeuroVive shall solely control the
prosecution of NeuroVive Patent Rights.
 
2.4.3 Joint Intellectual Property.  OnCore and NeuroVive shall jointly own all
Joint Intellectual Property and neither OnCore nor NeuroVive shall endeavor to
make any use of the Joint Intellectual Property to the detriment of the other
party during the Term.  The Parties shall jointly control the prosecution of any
Patent Rights within the Joint Intellectual Property during the Term through the
Patent Steering Committee (as defined below).
 
2.4.4 Each Party shall require its employees, consultants and relevant
independent contractors to enter into a written agreement that assigns to such
Party all right, title and interest in and to all Intellectual Property created,
conceived or reduced to practice on behalf of such Party by such employees,
consultants and independent contractors.
 
 
- 13 -

--------------------------------------------------------------------------------

 
2.5 Option to Reserved Rights.
 
NeuroVive shall not, and shall cause its Affiliates not to, grant to any Third
Party any Reserved Rights, except in accordance with this
Section 2.5.  NeuroVive hereby grants to OnCore a right of first option to
obtain any Reserved Rights under this Agreement in accordance with this Section
2.5.  OnCore may, at any time during the Term, give written notice to NeuroVive
that it wishes to exercise its option to include under this Agreement any
Reserved Rights solely with respect to oral routes of administration.  Such
notice shall set forth the virus or viruses to which such option shall
apply.  As of the date of any such notice, the definition of Field shall be
deemed to include the Reserved Rights that are the subject of such notice.  In
the event NeuroVive elects to (a) grant to any Affiliate or Third Party or (b)
itself develop any Reserved Rights with respect to non-oral routes of
administration, NeuroVive shall promptly notify OnCore (each, an “Option
Notice”) and upon receipt of any such Option Notice, OnCore shall have ninety
(90) days in which to notify NeuroVive whether it wishes to exercise its option
to include such Reserved Rights under this Agreement.  Upon receipt of timely
notice given to NeuroVive that OnCore wishes to exercise such option, then the
definition of Field shall be deemed to include the Reserved Rights subject to
the applicable Option Notice as of the date of OnCore’s notice of exercise.  If
OnCore does not respond to the Option Notice within the ninety (90) day period,
then NeuroVive shall be free to grant a license to any Third Party only with
respect to the Reserved Rights that were the subject of the Option Notice.
 
2.6 No Other Rights.
 
Except as otherwise expressly provided in this Agreement, under no circumstances
shall a Party, as a result of this Agreement, obtain any ownership interest or
other right in any Know-How or Patent Rights of the other Party, including items
Controlled or developed by the other Party, or provided by the other Party to
the receiving Party at any time pursuant to this Agreement.
 
ARTICLE 3
TRANSITION ASSISTANCE; COORDINATION OF API SUPPLY
 
3.1 Transition Assistance.
 
3.1.1 Transition Term.  During the [***] period following the Effective Date
(the “Transition Term”), NeuroVive will provide Transition Assistance to
OnCore.  The Transition Term may be extended by the mutual, written consent of
both Parties upon terms including compensation to be negotiated in good faith.
 
3.1.2 Transition Assistance.  During the Transition Term, NeuroVive shall use
its Commercially Reasonable Efforts to provide assistance to OnCore, at no
out-of-pocket cost to OnCore (except as set forth below), to effect the orderly
transfer of the Licensed Product and related documentation to OnCore (the
“Transition Assistance”).  Such Transition Assistance shall include, without
limitation, within [***] after the Effective Date complete transfer of the
following: (A) in whatever medium is most efficient for the Parties (i) all
compound structures, (ii) all NeuroVive Know-How; and (B) reasonable quantities
of all available physical samples of Licensed Compound Series that exist on the
Effective Date.  For the avoidance of doubt, the scope of the information to be
transferred pursuant to this Section 3.1.2 shall be of sufficient detail to
enable a technician of ordinary skill in the art to use the information after a
reasonable period of adaptation.
 
 
- 14 -

--------------------------------------------------------------------------------

 
3.2 Coordination of Supply and Clinical Supplies.
 
3.2.1 Subject to the availability of API, OnCore may purchase from NeuroVive,
and on request of OnCore NeuroVive shall supply, such quantities of the API used
in NVP018 as OnCore may require at NeuroVive’s actual acquisition cost without
markup.  NeuroVive will supply receipts and/or invoices evidencing such
acquisition cost.  Alternatively, OnCore may purchase such API or cGMP clinical
supplies of Licensed Product directly from NeuroVive’s then-current supplier at
the same price as NeuroVive obtains from such supplier, and NeuroVive shall be
responsible to ensure that such supplier extends the same price to OnCore as it
does to NeuroVive for manufacture at that scale or batch size.  On a Calendar
Quarterly basis, the Parties will communicate to each other their estimated
requirement for such API requirements.
 
3.2.2 Notwithstanding anything to the contrary in this Agreement, OnCore may
source API, all other components of a Licensed Product, all clinical supplies of
Licensed Product and all Development activities for Licensed Product (such as
strain and process improvements) via [***], or other vendors selected by
OnCore.  However, until [***], NeuroVive shall not be required to supply a
sample of the bacterial strain used in the Manufacture of API for
NVP018.  Following [***], NeuroVive shall supply to OnCore, without cost, viable
and specification-compliant samples of the bacterial strain used in the
Manufacture of API for NVP018.
 
ARTICLE 4
JOINT STEERING COMMITTEE
 
4.1 Joint Steering Committee.
 
4.1.1 Establishment of JSC. As soon as practicable and no later than sixty (60)
days after the Effective Date, the Parties shall establish a committee to
facilitate monitoring certain activities relating to Developing and
Commercializing Licensed Products (the “Joint Steering Committee” or “JSC”) as
follows:
 
(a) Composition of the Joint Steering Committee.  The JSC shall be comprised of
three (3) representatives from each of the Parties.  Each representative shall
be an individual of suitable authority and seniority with significant experience
or expertise in biopharmaceutical drug development.  Each Party shall appoint
its respective initial representatives to the JSC within sixty (60) days after
the Effective Date, and may from time to time substitute its representatives, in
its sole discretion, effective upon written notice to the other Party of such
change.  Additional representatives or consultants may from time to time, by
mutual consent of the Parties, be invited to attend JSC meetings, subject to
such representatives’ and consultants’ being bound by confidentiality
obligations at least as strict as those contained in ARTICLE 9.  Each Party
shall bear its own expenses relating to attendance at such meetings by its
representatives and consultants.
 
 
- 15 -

--------------------------------------------------------------------------------

 
(b) Chairperson.  Each Party shall designate one of its representatives to be a
Co-Chairperson.  Each Co-Chairperson shall conduct the following activities of
the Joint Steering Committee cooperatively (the “Co-Chairperson”):  (i)
scheduling meetings of the JSC; (ii) setting agendas for meetings with solicited
input from representatives of each Party; (iii) preparing and confirming minutes
of the meetings, which shall provide a description in reasonable detail of the
discussions held at the meeting and a list of any actions, decisions or
determinations made by the JSC; and (iv) conducting effective meetings,
including ensuring that objectives for each meeting are set and achieved.
 
(c) Meetings.  The JSC shall meet in accordance with a schedule established by
mutual written agreement of the Parties, but no less frequently than twice per
Contract Year, at such locations as are determined by the JSC.  Alternatively,
the JSC may meet by means of teleconference, videoconference or other similar
communications equipment.
 
(d) Responsibilities.  The JSC shall have the following responsibilities: (i)
reviewing Development Plans and amendments and updates thereto; (ii) reviewing
regulatory strategy and clinical development strategy; (iii) monitoring
Development activities for Licensed Products undertaken by either Party,
including, without limitation, monitoring the progress in its conduct of the
Development Plans; (iv) reviewing Commercialization Plans and amendments and
updates thereto; (v) monitoring Commercialization activities for Licensed
Products undertaken by either Party; and (vi) performing such other activities
that the Parties mutually agree shall be the responsibility of the JSC.
 
4.1.2 Appointment of Subcommittees and Project Teams.  The JSC shall be
empowered to create such subcommittees of itself and other additional project
teams as it may deem appropriate or necessary and may elect to delegate
responsibilities to such subcommittees or additional project teams as it may
from time to time deem appropriate.  Each such subcommittee and project team
shall report to the JSC, which shall have authority to approve or reject
recommendations or actions proposed thereby, subject to the terms of this
Agreement.  Notwithstanding the foregoing, no subcommittee or project team shall
have authority to make any decision binding upon the JSC or the Parties.  Any
such subcommittee or project team shall be governed by the terms of this Section
4.1 as the same apply to the JSC.
 
(a) The JSC shall establish, no later than its first meeting, a subcommittee to
monitor and manage, in the mutual best interest of the Parties, the filing,
prosecution and maintenance of all Patent Rights within the Joint Intellectual
Property (the “Patent Steering Committee”).  The Patent Steering Committee shall
be composed of two (2) representatives of each of the Parties, who may or may
not also be members of the JSC.  The Patent Steering Committee shall have the
following responsibilities solely with respect to Patent Rights within Joint
Intellectual Property: (i) review, suggest revisions to and approve the filing
of draft patent applications, including the claims therein; (ii) review and
approve the non-PCT and PCT countries into which patent applications are filed;
(iii) review office actions received from the various patent offices and approve
responses thereto; (iv) approve filing strategy, including the filing of
continuations, divisionals, continuations-in-part, reissues, reexaminations,
etc.; (v) approve the payment of patent maintenance fees; and (vi) such other
duties as the Parties may agree.  The Patent Steering Committee shall meet by
phone or in person at least once each Contract Quarter.
 
 
- 16 -

--------------------------------------------------------------------------------

 
4.1.3 Decision-Making. With respect to any matter over which the JSC has
responsibility pursuant to Section 4.1.1(d), the JSC should use reasonable
efforts to reach agreement on a mutually acceptable resolution.  If the JSC is
unable to reach agreement, such matter shall be referred to the Executive
Officers to be resolved by negotiation in good faith as soon as is practicable
but in no event later than [***] after referral.  If the Executive Officers are
unable to resolve such dispute within such [***] period, OnCore shall have final
decision-making authority in the Field in the Territory and NeuroVive shall have
final decision-making authority outside the Field in the Territory.  In no event
will any disagreements within the JSC relating to the Development, Manufacture,
or Commercialization of any Licensed Product be subject to the dispute
resolution provisions of Section 12.15.
 
ARTICLE 5
DEVELOPMENT AND RELATED DILIGENCE
 
5.1 Development of the Licensed Product.
 
Subject to the terms and conditions of this Agreement, OnCore shall for each
Licensed Product use its Commercially Reasonable Efforts to Develop, obtain
Regulatory Approval for, and Commercialize each such Licensed Product in the
Field in the United States, the European Union and Asia pursuant to the
Development Plan.  Within [***] after the Effective Date, OnCore shall submit to
the JSC for review and discussion an initial Development Plan that covers all
material Development activities and their timelines believed by OnCore, as of
the date of submission, to be reasonably necessary to support the submission of
a Regulatory Approval Application for the Licensed Product in the Field.  The
Development Plan, and any updates thereto, shall contain in reasonable detail
the Development objectives to be achieved during the then-current Contract Year,
the Development activities to be performed and a timeline for performing such
Development activities.
 
5.2 Updates to Development Plan.
 
On an annual basis, OnCore shall use its Commercially Reasonable Efforts to
update the Development Plan and submit such updated Development Plan, no later
than [***] of each Contract Year, to the JSC for review and discussion.
 
5.3 Regulatory Matters.
 
5.3.1 Regulatory Strategy.  OnCore shall develop, and the JSC shall review, a
regulatory strategy for the United States consistent with the Development
Plan.  Pursuant to and in accordance with such regulatory strategy, OnCore shall
use its Commercially Reasonable Efforts to prepare and file Regulatory Approval
Applications or other submissions to Regulatory Authorities as OnCore determines
to be appropriate.
 
 
- 17 -

--------------------------------------------------------------------------------

 
5.3.2 Communications with Regulatory Authorities.  For all Licensed Products in
the Field in the Territory, OnCore shall be solely responsible for: (1) all
communications with any Regulatory Authority; (2) label development, including
negotiations with any Regulatory Authority; (3) advisory committee meetings or
their equivalent (if applicable); and (4) negotiation with any Regulatory
Authority regarding post-approval requirements/commitments.
 
5.3.3 Regulatory Approvals.  Regulatory Approval Applications for Licensed
Product in the Field shall be made in OnCore’s name, and OnCore shall be the
only Party responsible for (1) interfacing, corresponding and meeting with the
applicable Regulatory Authorities in the Territory with respect to any and all
Licensed Products in the Field, and (2) for overseeing, monitoring, coordinating
and filing Regulatory Approval Applications for such Licensed Products in the
Field.  OnCore shall hold in its name and maintain all Regulatory Approvals for
Licensed Products in the Field.
 
5.4 Third Parties.
 
OnCore and its Affiliates shall be entitled to utilize the services of Third
Parties, including Third Party contract research organizations and service
providers to perform their respective Development activities; provided, however,
that OnCore shall remain at all times fully liable for its responsibilities
under each Development Plan and this Agreement.  Any agreement with a Third
Party to perform OnCore’s Development obligations under this Agreement shall
include confidentiality and non-use provisions which are no less stringent than
those set forth in ARTICLE 9.
 
ARTICLE 6
COMMERCIALIZATION AND RELATED DILIGENCE
 
6.1 Diligence in Commercialization.
 
OnCore shall use its Commercially Reasonable Efforts to Commercialize each
Licensed Product in the Field in each country in which Regulatory Approval is
obtained.
 
6.2 Commercialization.
 
OnCore shall be solely responsible for, and shall record all revenues in
connection with, Commercialization activities relating to the Licensed Products
in the Field throughout the Territory.
 
6.3 Commercialization Plan.
 
Commencing at least [***] prior to the projected First Commercial Sale of a
Licensed Product in the Field in the Territory, OnCore shall commence preparing
a Commercialization Plan (“Commercialization Plan”) for such Licensed
Product.  No later than [***] prior to the projected First Commercial Sale of
such Licensed Product in the Field in the Territory, OnCore shall submit such
Commercialization Plan to the JSC for review.  After the launch of such Licensed
Product, on an annual basis, OnCore shall use its Commercially Reasonable
Efforts to update the Commercialization Plan and submit such updated
Commercialization Plan, no later than [***] of each Contract Year, to the JSC
for its review.
 
 
- 18 -

--------------------------------------------------------------------------------

 
6.4 Commercial Manufacturing and Supply.
 
6.4.1 OnCore shall develop a manufacturing and supply strategy for Licensed
Product (including API, drug substance and finished dosage form) consistent with
the Commercialization Plan.  Pursuant to this strategy, OnCore shall be solely
responsible for Manufacturing and supplying the API, drug substance and finished
dosage form of any Licensed Product for Commercialization in the Field
throughout the Territory.  In this role, OnCore shall identify and manage Third
Party contract manufacturers, as well as lead all supply chain management and
quality control activities.
 
6.4.2 Following OnCore’s establishment of its commercial supply of API,
NeuroVive may purchase API from OnCore’s then-current contract manufacturer at
the same price as OnCore obtains from such manufacturer, and OnCore shall be
responsible to ensure that such manufacturer extends the same price to NeuroVive
as it does to OnCore for manufacture at that scale or batch size.  On a Calendar
Quarterly basis, NeuroVive will communicate to OnCore its estimated requirement
for API.
 
6.5 Medical and Scientific Affairs.
 
OnCore shall be solely responsible for medical and scientific affairs and
programs, including professional symposia and other educational activities in
the Field in the Territory.  OnCore shall have the exclusive right to respond to
all questions or requests for information about the Licensed Products in the
Field made by any medical professionals or any other Person in the Territory.
 
ARTICLE 7
FINANCIAL PROVISIONS
 
7.1 Initial License Fee.
 
Within thirty (30) days of the Effective Date, OnCore shall pay to NeuroVive an
initial non-refundable license fee of one million dollars ($1,000,000).
 
7.2 Initial Public Offering.
 
Promptly after OnCore or an Affiliate thereof consummates a firm-commitment
underwritten initial public offering of stock, OnCore will issue to, or cause to
be issued to, NeuroVive a number of shares of common stock of the
publicly-traded entity that is equal to $[***] divided by the average of the
opening and closing price of the publicly traded stock on the first day of
trading (the “OnCore Securities”).  Upon the request of OnCore or the managing
underwriters of OnCore’s initial public offering, NeuroVive shall not sell,
transfer, make any short sale of, grant any option for the purchase of, or enter
into any hedging or similar transaction with the same economic effect as a sale
(including sales pursuant to Rule 144) (a “Sale Transaction”) of any OnCore
Securities, or any securities convertible into or exchangeable or exercisable
for any OnCore Securities, during the period beginning on the effective date of
the registration statement relating to OnCore’s initial public offering and
through the date that is [***] days after the effective date of OnCore’s initial
public offering (the “Holdback Period”).  The Holdback Period may be extended as
requested by OnCore or an underwriter to accommodate regulatory restrictions on
(a) the publication or other distribution of research reports, and (b) analyst
recommendations and opinions, including, but not limited to, the restrictions
contained in FINRA Rule 2711(f)(4) or NYSE Rule 472(f)(4), or any successor
provisions or amendments thereto (such period referred to herein as the
“Holdback Extension”).  OnCore may impose stop transfer instructions with
respect to OnCore Securities subject to the foregoing restriction until the end
of the Holdback Period and the Holdback Extension.
 
7.3 Milestones.
 
OnCore will pay to NeuroVive the amounts set forth below (each, a “Milestone
Payment”) no later than [***] after the earliest date on which OnCore or any of
its Related Parties receives written notification that the corresponding
milestone event (each, a “Milestone Event”) has first been achieved with respect
to a Licensed Product in a country in the Territory:
 
 
- 19 -

--------------------------------------------------------------------------------

 
Milestone Event
Milestone Payment
 
Clinical Development Milestones
 
Initiation of the first Phase Ib Clinical Trial of a Licensed Product in the
Field
$[***]
Initiation of the first Phase II Clinical Trial of a Licensed Product in the
Field
$[***]
Initiation of the first Phase III Clinical Trial of a Licensed Product in the
Field
$[***]
FDA accepting for filing of an NDA for a Licensed Product in the Field
$[***]
EMEA accepting for filing of a Marketing Authorization Application for a
Licensed Product in the Field
$[***]
A Regulatory Authority in Asia accepting for filing of an NDA for a Licensed
Product in the Field
$[***]
FDA approving an NDA for a Licensed Product in the Field
$[***]
EMEA approving Marketing Authorization Application for a Licensed Product in the
Field
$[***]
A Regulatory Authority in Asia approving an Regulatory Approval Application for
a Licensed Product in the Field
$[***]
   
Milestone Event
Milestone Payment
 
Milestones Applicable to Gross Sales of each Licensed Product
 
Cumulative worldwide Gross Sales equals or exceeds $[***]
$[***] upon achievement
Cumulative worldwide Gross Sales equals or exceeds $[***]
$[***] upon achievement, but no sooner than 1st day of a new fiscal year after
payment of 1st sales performance milestone
Cumulative worldwide Gross Sales equals or exceeds $[***]
$[***] upon achievement, but no sooner than 1st day of a new fiscal year after
payment of 2nd sales performance milestone
Cumulative worldwide Gross Sales equals or exceeds $[***]
$[***] upon achievement, but no sooner than 1st day of a new fiscal year after
payment of 3rd sales performance milestone

 
 
- 20 -

--------------------------------------------------------------------------------

 
7.3.1 By way of example, [***].
 
7.3.2 Once OnCore has made any particular Milestone Payment under this Section
7.3 for a particular indication, OnCore shall not be obligated to make any
payment under this Section 7.3 with respect to the re-occurrence of the same
Milestone Event for such indication, whether or not such re-occurrence is with
respect to a different or the same Licensed Product.  For the avoidance of
doubt, OnCore shall be obligated to make the Milestone Payments under this
Section 7.3 with respect to the recurrence of each Milestone Event for each
distinct indication.
 
7.3.3 Once a particular Licensed Product in a particular indication enters
clinical development, then in the event of a Change of Control transaction in
which all of the equity interests of OnCore are acquired by a Third Party,
either in an all cash transaction or in a transaction that includes both cash
and non-cash consideration, for an aggregate amount of cash consideration that
is at least [***] the sum total of the then-unpaid Milestone Payments for such
Licensed Product(s), the surviving entity immediately after such Change of
Control transaction shall pay to NeuroVive [***], within [***] after the closing
date of such Change of Control transaction.  Upon such payment, all Milestone
Payments shall be satisfied and no more Milestone Payments shall be made under
this Agreement with respect to such Licensed Product(s). Subsequent to such a
Change of Control transaction as described above, then with respect to
additional Licensed Products or indications for which Milestone Payments have
not been paid in accordance with this Section 7.3.3, Milestone Payments payable
under this Agreement shall be unaffected by such a Change of Control
transaction.
 
7.4 Royalties.
 
7.4.1 Royalty Percentages.  OnCore shall pay to NeuroVive royalties on Gross
Sales at the following rates:
 
(a) [***]of annual Gross Sales in the Territory during a Contract Year for that
portion of the cumulative Gross Sales up to [***];
 
(b) [***] of annual Gross Sales in the Territory during a Contract Year for that
portion of the cumulative Gross Sales that is greater than [***] and up to
[***]; and
 
(c) [***] of annual Gross Sales in the Territory during a Contract Year for that
portion of the cumulative Gross Sales that is greater than [***].
 
7.4.2 Royalty Term.  Notwithstanding anything to the contrary, royalties under
Section 7.4 shall be payable in respect of a particular Licensed Product in a
particular country during the Royalty Term as long as there is a Valid Claim on
such Licensed Product in such country.
 
 
- 21 -

--------------------------------------------------------------------------------

 
7.4.3 Reports and Royalty Payments.  Within [***] after the end of each Contract
Quarter commencing in the Contract Quarter immediately following the Contract
Quarter in which there was the First Commercial Sale, OnCore shall deliver to
NeuroVive a report setting forth for the previous Contract Quarter the following
information on a Licensed Product-by-Licensed Product and country-by-country
basis:  (a) the gross sales and Gross Sales of each Licensed Product, (b) the
number of units sold by OnCore and all of its Affiliates and sublicensees, (c)
the royalty due hereunder, and (d) the applicable exchange rate.  The total
royalty due to NeuroVive for the sale of Licensed Products during such Contract
Quarter shall be remitted at the time such report is made.
 
7.5 Payment Provisions.
 
7.5.1 Taxes and Withholding.  If OnCore is required to make a payment to
NeuroVive subject to a deduction of tax or withholding tax, the sum payable by
OnCore (in respect of which such deduction or withholding is required to be
made) shall be made to NeuroVive after deduction of the amount required to be so
deducted or withheld, which deducted or withheld amount shall be remitted in
accordance with Applicable Laws.  Any such withholding taxes required under
Applicable Laws to be paid or withheld shall be an expense of, and borne solely
by NeuroVive.  To the extent OnCore is required to deduct and withhold taxes on
any payments to NeuroVive, OnCore shall pay the amounts of such taxes to the
proper governmental authority in a timely manner and promptly transmit to
NeuroVive an official tax certificate or other evidence of such withholding
sufficient to enable NeuroVive to claim such payments of taxes.  NeuroVive shall
provide to OnCore any tax forms that may be reasonably necessary in order for
OnCore not to withhold tax or to withhold tax at a reduced rate under an
applicable bilateral income tax treaty.  NeuroVive shall use reasonable efforts
to provide any such tax forms to OnCore at least thirty (30) days prior to the
due date for any payments for which NeuroVive desires that OnCore apply a
reduced withholding rate.  Each Party will reasonably assist the other Party in
claiming tax refunds, deductions, or credits at the other Party’s request and
will reasonably cooperate to minimize the withholding tax, if available, under
various treaties applicable to any payment made under this Agreement.
 
7.5.2 Payment and Currency Exchange.  All amounts payable and calculations
hereunder shall be in United States dollars and shall be paid by bank wire
transfer in immediately available funds to such bank account as may be
designated in writing by NeuroVive from time to time.  Whenever for the purposes
of calculating the royalties payable under Section 7.4, conversion from any
foreign currency shall be required, all amounts shall first be calculated in the
currency of sale and then converted into United States dollars by applying the
rate of exchange quoted in the New York edition of The Wall Street Journal on
the last Business Day of the applicable Calendar Quarter.
 
7.6 Maintenance of Records; Audits.
 
7.6.1 Record-Keeping.  OnCore shall keep, and shall cause its Affiliates and
sublicensees to keep, books and accounts of record in connection with the sale
of Licensed Products and in sufficient detail to permit accurate determination
of all figures necessary for verification of royalties to be paid
hereunder.  OnCore shall maintain, and shall cause its Affiliates and
sublicensees to maintain, such records for a period of at least three (3) years
after the end of the Contract Year in which they were generated.
 
 
- 22 -

--------------------------------------------------------------------------------

 
7.6.2 Audits.  Upon [***]’ prior written notice from NeuroVive, OnCore or any of
its Affiliates or sublicensees receiving the written notice (the “Audited
Party”) shall permit an independent certified public accounting firm of
nationally recognized standing selected by NeuroVive and reasonably acceptable
to the Audited Party, to examine, at NeuroVive’s sole expense, the relevant
books and records of the Audited Party and its Affiliates as may be reasonably
necessary to verify the amounts reported in accordance with Section 7.4.3 and
the payment of royalties hereunder.  An examination by NeuroVive under this
Section 7.6.2 shall occur not more than once in any Contract Year and shall be
limited to the pertinent books and records for any Contract Year ended not more
than two (2) years before the date of the request.  The accounting firm shall be
provided access to such books and records at the Audited Party’s facility(ies)
where such books and records are normally kept and such examination shall be
conducted during the Audited Party’s normal business hours.  The Audited Party
may require the accounting firm to sign a standard non-disclosure agreement
before providing the accounting firm access to the Audited Party’s facilities or
records.  Upon completion of the audit, the accounting firm shall provide
OnCore, NeuroVive and the Audited Party a written report disclosing any
discrepancies in the reports submitted by the Audited Party or, as applicable,
the royalties paid, and in each case, the specific details concerning any
discrepancies.
 
7.6.3 Underpayments/Overpayments.  If such accounting firm correctly concludes
that additional royalties were due to NeuroVive, OnCore shall, if applicable,
pay to NeuroVive the additional royalties within [***] of the date OnCore
receives such accountant’s written report so correctly concluding.  If such
underpayment exceeds [***] of the royalties that were to be paid, OnCore also
shall reimburse NeuroVive for [***] incurred in conducting the audit.  If such
accounting firm correctly concludes that OnCore overpaid royalties to NeuroVive,
then NeuroVive shall refund such overpayments to OnCore, within [***] of the
date NeuroVive receives such accountant’s report so concluding.
 
7.6.4 Confidentiality.  All financial information of an Audited Party that is
subject to review under this Section 7.6 shall be deemed to be Confidential
Information of such Audited Party subject to the provisions of ARTICLE 9, and
NeuroVive shall not disclose such Confidential Information to any Third Party or
use such Confidential Information for any purpose other than verifying payments
to be made by OnCore to NeuroVive hereunder.
 
ARTICLE 8
INTELLECTUAL PROPERTY PROTECTION AND RELATED MATTERS
 
8.1 Filing, Prosecution and Maintenance of Patent Rights.
 
8.1.1 NeuroVive Patent Rights
 
 
- 23 -

--------------------------------------------------------------------------------

 
(a) Primary Responsibility.  OnCore, through counsel of its choosing and
reasonably acceptable to NeuroVive, shall have primary responsibility for and
control over obtaining, prosecuting (including any interferences, reissue
proceedings and re-examinations), and maintaining throughout the Territory the
NeuroVive Patent Rights that relate specifically to hepatitis B in NeuroVive’s
name, all at OnCore’s sole cost and expense.  NeuroVive, through counsel of its
choosing and reasonably acceptable to OnCore, shall have primary responsibility
for and control over obtaining, prosecuting (including any interferences,
reissue proceedings and re-examinations), and maintaining throughout the
Territory all other NeuroVive Patent Rights all at NeuroVive’s sole cost and
expense.  If necessary, OnCore and NeuroVive will enter into a Client and
Billing Agreement with counsel for each Party to allow such counsel to interact
with both parties and take direction from the Party with the right to control
prosecution and maintenance of the applicable NeuroVive Patent Rights.
 
(b) Notwithstanding the foregoing, the Party with responsibility for prosecuting
a NeuroVive Patent Right (the “Prosecuting Party”) shall keep the other Party
fully informed of patent prosecution activities and shall provide the other
Party with copies of material correspondence (including, but not limited to,
applications, office actions, responses, etc.) relating to prosecution and
maintenance of any NeuroVive Patent Rights under this Agreement.  The other
Party may provide comments and suggestions with respect to any material actions
to be taken by the Prosecuting Party and the Prosecuting Party shall reasonably
consider all comments, suggestions and prosecution actions recommended by the
other Party.
 
(c) In order to facilitate a Party’s right to comment, the Prosecuting Party
shall provide copies of all such official correspondence and any proposed
responses by the Prosecuting Party at least thirty (30) days prior to any filing
or response deadlines, or within five (5) Business Days of the Prosecuting
Party’s receipt of any official correspondence if such correspondence only
allows for thirty (30) days or less to respond, and the other Party shall
provide any comments promptly and in sufficient time to allow the Prosecuting
Party to meet applicable filing requirements.  In no event shall the Prosecuting
Party be required to delay any submission, filing or response past any deadline
that is not extendable.  The Prosecuting Party agrees to use its Commercially
Reasonable Efforts to avoid extension fees, unless agreed to in advance by the
Parties, and to take such action as deemed reasonably necessary to preserve
pendency of the NeuroVive Patent Rights, including, but not limited to, the
filing of any new or continuing patent application and/or payment of any fee
necessary to preserve pendency of a pending application.
 
(d) Common Interest.  All information exchanged between the Parties regarding
preparation, filing, prosecution or maintenance of the NeuroVive Patent Rights
shall be deemed Confidential Information.  In addition, the Parties acknowledge
and agree that, with regard to such preparation, filing, prosecution and
maintenance of the NeuroVive Patent Rights, the interests of the Parties as
licensor and licensee are to obtain the strongest patent protection possible,
and as such, are aligned and are legal in nature.  The Parties agree and
acknowledge that they have not waived, and nothing in this Agreement constitutes
a waiver of, any legal privilege concerning the NeuroVive Patent Rights,
including, without limitation, privilege under the common interest doctrine and
similar or related doctrines.
 
 
- 24 -

--------------------------------------------------------------------------------

 
(e) Election Not to Continue Prosecution; Abandonment.  If the Prosecuting Party
elects (i) not to continue the prosecution (including any interferences and
post-grant proceedings) or maintenance of a NeuroVive Patent Right in a
particular country in the Territory, or (ii) not to file and prosecute patent
applications for the NeuroVive Patent Rights in a particular country following a
written request from the other Party to file and prosecute in such country, then
the Prosecuting Party shall so notify the other Party promptly in writing of its
intention in good time to enable the other Party to meet any deadlines by which
an action must be taken to establish or preserve any such rights in such patent
in such country and the other Party shall have the right to file for, or
continue to prosecute, maintain or enforce, or otherwise pursue such NeuroVive
Patent Rights in such country.  If OnCore is the Prosecuting Party and NeuroVive
so elects to continue to prosecute, maintain or enforce, or otherwise pursue
such NeuroVive Patent Rights in such country, such Patent Rights will no longer
be considered NeuroVive Patent Rights licensed to OnCore in such country as of
the date of OnCore’s notice to NeuroVive.  If NeuroVive is the Prosecuting Party
and OnCore so elects to continue to prosecute, maintain or enforce, or otherwise
pursue such NeuroVive Patent Rights in such country, OnCore may setoff all its
costs of prosecution and maintenance of the applicable NeuroVive Patent Rights
in such country against any amounts payable by OnCore under this Agreement.
 
8.1.2 Cooperation.  Each Party hereby agrees: (a) to make its and its
Affiliates' employees, agents and consultants reasonably available to the other
Party (or to the other Party’s authorized attorneys, agents or representatives),
to the extent reasonably necessary to enable such Party to undertake patent
prosecution as contemplated by this Agreement; (b) to cooperate, if necessary
and appropriate, with the other Party in gaining patent term extensions wherever
applicable to Patent Rights that are subject to this Agreement; and (c) to
endeavor in good faith to coordinate its efforts with the other Party to
minimize or avoid interference with the prosecution and maintenance of the other
Party’s patent applications that are subject to this Agreement.
 
8.2 Enforcement of Patent Rights.
 
8.2.1 Notification.  Each Party shall promptly report in writing to the other
Party during the Term any (a) known or suspected infringement of any NeuroVive
Patent Rights or (b) unauthorized use or misappropriation of any Confidential
Information, including NeuroVive Intellectual Property, by a Third Party of
which it becomes aware, and shall provide the other Party with all available
evidence supporting such infringement or unauthorized use or misappropriation.
 
8.2.2 Rights to Enforce.  In respect of Licensed Products in the Field in the
Territory, OnCore shall have the first right, but not the obligation, to take
any reasonable measures it deems appropriate to stop infringing activities in
the Field in the Territory, including (a) initiating or prosecuting an
infringement or other appropriate suit or action against or (b) granting
adequate rights and licenses necessary for continuing such activities in the
Territory to any Third Party who at any time has infringed, or is suspected of
infringing, any NeuroVive Patent Rights, or of using without proper
authorization any NeuroVive Know-How claiming or relating to Licensed Products
in the Field.  In the event that OnCore elects not to take action pursuant to
this Section 8.2.2, OnCore shall so notify NeuroVive in writing of its intention
within ninety (90) days of OnCore’s notice of such infringement activities to
enable NeuroVive to meet any deadlines by which an action must be taken to
establish or preserve any enforcement rights, and NeuroVive shall have the
right, but not the obligation, to take any such reasonable measures to stop such
infringing activities by such alleged infringer.
 
 
- 25 -

--------------------------------------------------------------------------------

 
8.2.3 Procedures; Expenses and Recoveries.  The Party having the right to
initiate any infringement suit under Section 8.2.2 shall have the sole and
exclusive right to select counsel for any such suit and shall pay all expenses
of the suit, including attorneys’ fees and court costs and reimbursement of the
other Party’s reasonable out-of-pocket expenses in rendering assistance
requested by the initiating Party.  If required under Applicable Law in order
for the initiating Party to initiate and/or maintain such suit, or if either
Party is unable to initiate or prosecute such suit solely in its own name or it
is otherwise advisable to obtain an effective legal remedy, in each case, the
other Party shall join as a party to the suit and will execute and cause its
Affiliates to execute all documents necessary for the initiating Party to
initiate litigation to prosecute and maintain such action.  Notwithstanding the
foregoing, if OnCore is the initiating Party and so requests, then NeuroVive
shall join as a party to the suit and will execute and cause its Affiliates to
execute all documents necessary for OnCore to initiate litigation to prosecute
and maintain such action.  In addition, at the initiating Party’s request, the
other Party shall provide reasonable assistance to the initiating Party in
connection with an infringement suit at no charge to the initiating Party except
for reimbursement by the initiating Party for reasonable out-of-pocket expenses
incurred in rendering such assistance.  The non-initiating Party shall have the
right to participate and be represented in any such suit by its own counsel at
its own expense. If the Parties obtain from a Third Party, in connection with
such suit, any damages, license fees, royalties or other compensation (including
any amount received in settlement of such litigation), such amounts shall be
allocated as follows:
 
(a) in all cases, to reimburse each Party for all expenses of the suit,
including attorneys’ fees and disbursements, court costs and other litigation
expenses; and
 
(b) any of the remaining amount that relates to Licensed Product shall be [***].
 
8.2.4 Other Infringement Resolutions.  In the event of a dispute or potential
dispute that has not ripened into a demand, claim or suit of the types described
in this Section 8.2 (e.g., actions seeking declaratory judgments and revocation
proceedings), the same principles governing control of the resolution of the
dispute, consent to settlements of the dispute, and implementation of the
settlement of the dispute (including sharing in and allocating the payment or
receipt of damages, license fees, royalties and other compensation) set forth in
this Section 8.2 shall apply.  Each Party shall immediately notify the other
Party of any certification of which it becomes aware filed pursuant to 21 U.S.C.
§ 355(b)(2)(A) or § 355(j)(2)(A)(vii) (or any amendment or successor statute
thereto) claiming that a NeuroVive Patent Right or a OnCore Patent Right is
invalid or that infringement of such Patent Right will not arise from the
development, manufacture, use or sale of any product by a Third Party.  The
provisions of this Section 8.2 shall thereafter apply as if such Third Party
were an infringer or suspected infringer; provided that in the event that OnCore
elects not to take action, OnCore shall so notify NeuroVive in writing of its
intention within fifteen (15) Business Days of OnCore’s notice of such
infringement activities to enable NeuroVive to meet any deadlines by which an
action must be taken to establish or preserve any enforcement rights.
 
 
- 26 -

--------------------------------------------------------------------------------

 
8.3 Claimed Infringement of Third Party Rights.
 
8.3.1 Notice.  In the event that a Third Party at any time provides written
notice of a claim to, or brings an action, suit or proceeding against, any
Party, or any of such Party’s respective Affiliates or sublicensees, claiming
infringement of its Patent Rights (including with respect to a Blocking Patent)
or unauthorized use or misappropriation of its Know-How, based upon an assertion
or claim arising out of the Development, Manufacture or Commercialization of a
Licensed Product in the Territory (“Infringement Claim”), such Party shall
promptly notify the other Party of the Infringement Claim or the commencement of
such action, suit or proceeding, enclosing a copy of the Infringement Claim and
all papers served.  Each Party agrees to make available to the other Party its
advice and counsel regarding the technical merits of any such claim at no cost
to the other Party and to offer reasonable assistance to the other Party at no
cost to the other Party.
 
8.3.2 Obligation to Defend. OnCore shall have the obligation to defend all
Infringement Claims brought against either Party or any of its Affiliates or
sublicensees arising out of the Development, Manufacture or Commercialization of
a Licensed Product in the Field in the Territory; provided that the foregoing
shall not be construed to require OnCore to defend (i) NeuroVive against a
breach of NeuroVive’s representations and warranties set forth herein, or (ii)
NeuroVive, its Affiliates or sublicensees with respect to Manufacturing
activities by such parties in the Territory.
 
8.3.3 Procedure.
 
(a) To the extent that the Infringement Claim, whether in the form of an
assertion by a Third Party or a filed litigation (or other formal dispute
resolution procedure), directly relates to a Blocking Patent (a “Blocking Patent
Claim”), NeuroVive shall have the first right to control any negotiations and
discussions with the Third Party to resolve the Blocking Patent Claim by
acquiring a license under the Blocking Patent.  If NeuroVive is unable to
resolve the Blocking Patent Claim by acquiring a license under the Blocking
Patent on terms that are commercially reasonable to NeuroVive, in NeuroVive’s
discretion at no expense to OnCore, then OnCore may negotiate a license with the
Third Party under the Blocking Patent in the Territory in the Field and include
any royalties or other payments payable thereunder as Infringement Defense Costs
under Section 8.3.3(c).
 
(b) OnCore shall have the sole and exclusive right to select counsel to defend
any Infringement Claim brought via litigation or other formal dispute resolution
procedure; provided that it shall consult with NeuroVive with respect to
selection of counsel for such defense.  OnCore shall keep NeuroVive informed,
and shall from time to time consult with NeuroVive regarding the status of any
such claims and shall provide NeuroVive with copies of all material documents
filed in, and all material written communications relating to, any suit brought
in connection with such claims.  NeuroVive shall also have the right to
participate and be represented in any such claim or related suit, at its own
expense.  OnCore shall not settle any Infringement Claims that would adversely
impact any of the NeuroVive Patent Rights (such as invalidation of or narrowing
the scope of any claim of any of the NeuroVive Patent Rights) or purport to
impose any obligations on NeuroVive, without obtaining the prior written consent
of NeuroVive or its Affiliate, as applicable, which consent shall not be
unreasonably withheld.
 
 
- 27 -

--------------------------------------------------------------------------------

 
(c)  All litigation costs and expenses incurred by OnCore in connection with
such Infringement Claim, and all damages payable by OnCore to the Third Party in
respect of such Infringement Claims (“Infringement Defense Costs”) shall be
borne by OnCore; provided that, subject to Section 8.3.3(d):
 
(i) to the extent the Infringement Claim and related Infringement Defense Costs
are directly related to a Blocking Patent, OnCore may deduct such Infringement
Defense Costs as incurred against the royalties and milestones that become
payable to NeuroVive under Sections 7.3 or 7.4; or
 
(ii) to the extent the Infringement Claim and related Infringement Defense Costs
related to any other allegation, OnCore may deduct half of such Infringement
Defense Costs as incurred against the royalties and milestones that become
payable to NeuroVive under Sections 7.3 or 7.4.
 
(d) For any given Contract Quarter, the royalties payable to NeuroVive under
Section 7.4 shall not be reduced by the application of Section 8.3.3(c) by more
than [***] of the royalties otherwise payable to NeuroVive under Section 7.4
(with the undeducted balance of Infringement Defense Costs applied against
royalties and milestones payable to NeuroVive under Sections 7.3 or 7.4 in
successive Contract Quarters until fully recovered by OnCore).
 
8.3.4 Limitations.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN SECTION 11.5, THE
FOREGOING STATES THE ENTIRE RESPONSIBILITY OF NEUROVIVE AND ONCORE, AND THE SOLE
AND EXCLUSIVE REMEDY OF NEUROVIVE OR ONCORE, AS THE CASE MAY BE, IN THE CASE OF
ANY CLAIMED INFRINGEMENT OF ANY THIRD PARTY PATENT RIGHTS OR UNAUTHORIZED USE OR
MISAPPROPRIATION OF ANY THIRD PARTY’S KNOW-HOW.
 
 
- 28 -

--------------------------------------------------------------------------------

 
8.4 Product Trademarks.
 
OnCore and/or its Affiliates or sublicensees, as applicable, shall select and
own the Product Trademarks for each Licensed Product in the Field in the
Territory and shall be solely responsible for filing and maintaining the Product
Trademarks in the Field in the Territory (including payment of costs associated
therewith).  OnCore shall assume full responsibility, at its sole cost and
expense, for any infringement of a Product Trademark for a Licensed Product in
the Field in the Territory by a Third Party, and shall defend and indemnify
NeuroVive for and against any claims of infringement of the rights of a Third
Party by the use of a Product Trademark in connection with a Licensed Product in
the Field in the Territory.
 
8.5 Patent Term Extensions in the Territory.
 
The Parties shall use reasonable efforts to obtain all available supplementary
protection certificates (“SPC”) and other extensions of Patent Rights (including
those available under the Hatch-Waxman Act).  Each Party shall execute such
authorizations and other documents and take such other actions as may be
reasonably requested by the other Party to obtain such extensions.  The Parties
shall cooperate with each other in gaining patent term restorations, extensions
and/or SPCs wherever applicable to Patent Rights. The Party first eligible to
seek patent term restoration or extension of any such Patent Rights or any SPC
related thereto shall have the right to do so; provided that if in any country
the first Party has an option to extend the patent term for only one of several
patents, the first Party shall consult with the other Party before making the
election.  If more than one patent is eligible for extension or patent term
restoration, the Parties shall select, in good faith, a strategy that shall
maximize patent protection and commercial value for each Licensed Product.
 
ARTICLE 9
CONFIDENTIALITY
 
9.1 Confidential Information.
 
All Confidential Information disclosed by a Party (together with its Affiliates,
the “Disclosing Party”) to the other Party (together with its Affiliates, the
“Receiving Party”) before or during the Term shall be used by the Receiving
Party solely in connection with the activities contemplated by this Agreement,
shall be maintained in confidence by the Receiving Party and shall not otherwise
be disclosed by the Receiving Party to any other Person, firm, or agency,
governmental or private (other than a Party’s Affiliates), without the prior
written consent of the Disclosing Party, except to the extent that the
Confidential Information (as determined by competent documentation):
 
9.1.1 was known or used by the Receiving Party prior to its date of disclosure
to the Receiving Party; or
 
9.1.2 either before or after the date of the disclosure to the Receiving Party,
is lawfully disclosed to the Receiving Party by sources other than the
Disclosing Party rightfully in possession of the Confidential Information; or
 
9.1.3 either before or after the date of the disclosure to the Receiving Party,
becomes published or generally known to the public (including information known
to the public through the sale of products in the ordinary course of business)
through no fault or omission on the part of the Receiving Party or its
sublicensees; or
 
 
- 29 -

--------------------------------------------------------------------------------

 
9.1.4 is independently developed by or for the Receiving Party without reference
to or reliance upon the Confidential Information.
 
9.1.5 If any of the forgoing 9.1.1 – 9.1.5 are relied upon by the Receiving
Party, it is understood and agreed that only the individual elements of
Confidential Information subject to any of the foregoing exceptions may be
disclosed and not the combination or integration of such elements, unless and
until such combination or integration of elements is also subject to any such
exception.
 
9.1.6 In addition, the provisions of this Section 9.1 shall not preclude the
Receiving Party from disclosing Confidential Information to the extent such
Confidential Information is required to be disclosed by the Receiving Party to
comply with Applicable Laws, to defend or prosecute litigation or to comply with
governmental regulations, provided that the Receiving Party provides prior
written notice of such disclosure to the Disclosing Party and takes reasonable
and lawful actions to avoid and/or minimize the degree of such
disclosure.  NeuroVive and OnCore each agree that they shall provide
Confidential Information received from the other Party only to their respective
employees, consultants and advisors, and to the employees, consultants and
advisors of such Party’s Affiliates, who have a reasonable need to know and are
bound by confidentiality obligations at least as strict as this ARTICLE 9.  In
addition, each Party may not disclose the terms of this Agreement (to the extent
such terms are confidential) to any Third Party except as required by law and
except to actual or prospective investors, acquirers, licensees or strategic
partners or to a Party’s accountants, attorneys and other professional advisors;
provided that such disclosures shall be subject to continued confidentiality
obligations at least as strict as this ARTICLE 9.
 
9.2 Public Announcements and Use of Names.
 
No public disclosure of the existence of, or the terms of, this Agreement may be
made by either Party, and no Party shall use the name, trademark, trade name or
logo of the other Party in any publicity, news release or public disclosure
relating to this Agreement or its subject matter without the prior express
written permission of the other Party, except as may be required by law or
expressly permitted by the terms hereof.  A press release, agreed upon by the
Parties, is attached to this Agreement as Schedule 9.2.  If a public disclosure
is required by any Applicable Law, including in a filing with a governmental
authority or stock exchange, the disclosing Party shall provide copies of the
disclosure reasonably in advance of such filing or other disclosure, but not
later than three (3) Business Days prior to the filing, for the non-disclosing
Party’s prior review and comment and to allow the other Party a reasonable time
to object to any such disclosure or to request confidential treatment thereof.
 
ARTICLE 10
TERM AND TERMINATION
 
10.1 Term.
 
This Agreement shall commence on the Effective Date and on a country-by-country
and Licensed Product-by-Licensed Product basis, shall be in full force and
effect until the expiration of the last-to-expire Royalty Term of such Licensed
Product in such country in the Territory (the “Term”).  After expiration of the
Royalty Term in accordance with 1.63(b) for a Licensed Product in a given
country, no further royalties shall be payable in respect of sales of such
Licensed Product in such country, and the license granted to OnCore under
Section 2.1 shall be a fully paid-up, perpetual, irrevocable, royalty-free
license with respect to such Licensed Product in the Field in such country.
 
 
- 30 -

--------------------------------------------------------------------------------

 
10.2 Termination for Cause.
 
10.2.1 Cause for Termination.
 
(a) This Agreement may be terminated in its entirety or on a Licensed Product
-by-Licensed Product or country-by-country basis at any time during the Term
upon [***] prior written notice by a Party if the other Party (the “Breaching
Party”) is in breach of its material obligations under this Agreement as a whole
or on a Licensed Product-by-Licensed Product or country-by-country basis and has
not cured such breach for [***], measured from the date written notice of such
material breach is given to the Breaching Party (“Date of Notice”); provided,
however, that if such alleged material breach is not reasonably susceptible of
cure within such [***] period and the Breaching Party uses reasonable and
diligent good faith efforts to cure such alleged material breach, such [***]
period shall be extended as long as is reasonably necessary (but no more than
[***] from the Date of Notice) and no such termination shall occur for so long
as such efforts continue or if such breach is cured (but in each case for no
longer than [***] from the Date of Notice).
 
(b) This Agreement may be terminated at any time during the Term by a Party upon
the filing or institution of bankruptcy, reorganization (other than a voluntary
corporate reorganization), liquidation or receivership proceedings, or upon an
assignment of a substantial portion of the assets for the benefit of creditors
by the other Party; provided, however, that in the event of any involuntary
bankruptcy or receivership proceeding, such right to terminate shall only become
effective if the Party consents to the involuntary bankruptcy or receivership,
or such proceeding is not dismissed within [***] after the filing thereof.
 
(c) In the event that NeuroVive believes that OnCore has failed to use its
Commercially Reasonable Efforts to Develop, Manufacture, and/or Commercialize
any Licensed Product at any time in a given country or countries in the
Territory, prior to providing a notice of breach under Section 10.2.1(a),
NeuroVive shall raise such issue by written notice to OnCore, which shall not
constitute a notice of breach.  If within [***] following OnCore’s receipt of
such notice from NeuroVive, NeuroVive believes that OnCore has not remedied the
issues identified by NeuroVive in such notice, then (i) OnCore shall provide
NeuroVive with a written response specifying, in reasonable detail, how it is
using or has begun to use such Commercially Reasonable Efforts, and (ii) the
Parties shall discuss such response.  Thereafter, if NeuroVive continues to
believe that OnCore has not used its Commercially Reasonable Efforts, it may
then pursue the remedies provided to it under this Agreement, including Section
10.2.1.  Nothing in this Section 10.2.1(c) shall be construed to limit OnCore’s
ability to dispute, cure or defend against any such issue, including under
Section 10.2.1(a).
 
10.2.2 Effect of Termination by NeuroVive for Cause.  Without limiting any other
legal or equitable remedies that NeuroVive may have, if OnCore is the Breaching
Party with respect to the applicable Licensed Product(s) in the applicable
country(ies) and NeuroVive terminates this Agreement in accordance with Section
10.2.1(a):
 
 
- 31 -

--------------------------------------------------------------------------------

 
(a) With respect to the applicable Licensed Product(s) in the applicable
country(ies), NeuroVive may elect to terminate all related licenses granted
under this Agreement;
 
(b) With respect to the applicable Licensed Product(s) in the applicable
country(ies), OnCore shall grant an exclusive license in the Field in the
applicable countries, with the right to sublicense, and promptly transfer to
NeuroVive, or its Affiliates as requested by NeuroVive, and NeuroVive shall
assume and thereafter be fully responsible and liable for all of OnCore’s right,
title and interest in and to:
 
(i)      all Regulatory Materials, Regulatory Approvals, drug master files and
clinical trial agreements (to the extent assignable and not cancelled) to the
extent related solely to the applicable Licensed Product(s) in the applicable
country(ies), including INDs, NDAs and their foreign equivalents;
 
(ii)      OnCore Know How and all other data, including preclinical and clinical
data, preclinical and clinical study protocols, all CMC data, standard operating
procedures, materials and information of any kind or nature whatsoever, in
OnCore’s possession or in the possession of its Related Parties to the extent
related solely to the applicable Licensed Product(s) in the applicable
country(ies);
 
(iii)                  all trademarks and product logos related solely to
applicable Licensed Product(s) in the applicable country(ies);
 
(iv)                  all Licensed Products in its inventory and all unused
samples of the applicable Licensed Product and all API then in possession or
control of OnCore, each at OnCore's actual cost;
 
(v) all material information related solely to Commercialization of the Licensed
Product(s), provided, however, that NeuroVive shall not use any Promotional
Materials containing OnCore’s name in connection with the sale of any Licensed
Product(s) at any time, including after the termination of this Agreement.
 
(c) To the extent OnCore or its Affiliates had, prior to such termination, been
directly Manufacturing Licensed Product(s), OnCore and NeuroVive shall negotiate
in good faith the terms of a supply arrangement pursuant to which OnCore will
supply Licensed Product(s) to NeuroVive for [***] following the effective date
of such termination, and OnCore shall reasonably assist, at NeuroVive's expense,
in the transfer of Manufacturing processes to NeuroVive or NeuroVive’s
designated new manufacturers.  In the event that a Third Party Manufactures the
Licensed Product(s) on OnCore’s behalf, OnCore will use its Commercially
Reasonable Efforts to facilitate the assignment of OnCore’s contract
manufacturing agreement with such Third Party to NeuroVive; provided that OnCore
shall not be required to pay any amounts to facilitate such assignment.
 
 
- 32 -

--------------------------------------------------------------------------------

 
(d) NeuroVive may elect to have any agreements to which OnCore is a party
providing solely for Development, Commercialization or Manufacturing services
for the applicable Licensed Product(s) in the applicable country(ies), such as
contract research organization contracts and contract manufacturing organization
contracts, assigned to NeuroVive to the extent permitted by such agreements and
not cancelled, and thereafter NeuroVive shall indemnify and hold harmless OnCore
from any liabilities arising under such agreements from and after the applicable
date of assignment and assumption, except to the extent caused by OnCore’s
actions.
 
(e) OnCore shall provide to NeuroVive, at no expense to NeuroVive, such
additional appropriate technology transfer, transition assistance and
post-termination services not otherwise specified in this Section 10.2.2 and
reasonably requested by NeuroVive, including, without limitation, such
assistance with technology transfer as required to prevent disruptions in
Development and Manufacture of Licensed Product.
 
10.2.3 Effect of Termination by OnCore for Cause.  Without limiting any other
legal or equitable remedies that OnCore may have, if NeuroVive is the Breaching
Party with respect to the applicable Licensed Product(s) in the applicable
country(ies) and OnCore terminates this Agreement in accordance with Section
10.2.1(a) solely in the event of a breach by NeuroVive of Article 2, 3 or 9 or
Section 8.2 or 11.5, then OnCore may terminate any agreements to which OnCore is
a party providing for Development, Commercialization or Manufacturing services
for the applicable Licensed Product(s) in the applicable country(ies), such as
contract research organization contracts and contract manufacturing organization
contracts, and NeuroVive shall indemnify and hold harmless OnCore from any
liabilities or obligations arising under such agreements as a result of such
terminations.
 
10.3 Termination for Convenience.
 
10.3.1 OnCore’s Termination for Convenience.
 
(a) OnCore shall have the right to terminate this Agreement, in its entirety or
on a Licensed Product-by-Licensed Product or country-by-country basis, upon
[***] advance written notice to NeuroVive (such termination, an “Early
Termination”).  In the event OnCore terminates this Agreement with respect to
any Licensed Product on a country-by-country basis in any of (i) the United
States; (ii) the European Union as a whole; or (iii) any country in Asia (as
defined in Article 1), and provided that such Licensed Product is covered by a
Valid Claim in such terminated country at the time of termination, then this
Agreement will be deemed to have been terminated by OnCore in its entirety.
 
(b) OnCore shall have the right to terminate this Agreement upon a Generic Entry
(as defined below) after providing [***] written notice NeuroVive.  A “Generic
Entry” shall be deemed to have occurred if any Licensed Product is sold in a
country of the Territory and OnCore's Gross Sales of such Licensed Product in
such country during any Calendar Quarter following entry of a generic product is
reduced by at least [***] from the Gross Sales of the Licensed Product in such
country in the Calendar Quarter immediately prior to the entry of such generic
product into the market.
 
 
- 33 -

--------------------------------------------------------------------------------

 
10.3.2 Effect of Termination for Convenience.  If OnCore effects an Early
Termination pursuant to Section 10.3.1(a), or (b), the effects of termination
set forth in Section 10.2.2 shall apply with OnCore exerting at least the same
level of efforts during the notice period as it was expending on Development and
Commercialization of Licensed Product prior to a convenience termination
consistent with the transition of items to NeuroVive.  In addition, if OnCore
terminates this Agreement in its entirety under Section 10.3.1(a) prior to the
First Commercial Sale of any Licensed Product, OnCore shall pay NeuroVive two
million dollars ($2,000,000).
 
10.4 Termination for Clinical Failure.
 
10.4.1 Clinical Failure.  Notwithstanding Section 10.3, OnCore may terminate
this Agreement in its entirety or on a Licensed Product-by-Licensed Product or
country-by-country basis by providing written notice to NeuroVive if, (i) prior
to Regulatory Approval of a Licensed Product in the Field in such country,
OnCore determines in good faith, using reasonable clinical judgment with the
input of the relevant drug safety monitoring board, that there are material
concerns regarding the safety of any Licensed Product (a “Safety Failure”) or
(ii) a Licensed Product fails to substantially achieve any of the primary or
secondary efficacy endpoints of any clinical trial involving the Licensed
Product (an “Efficacy Failure”), provided that OnCore acts in good faith in
making such determination and reasonably consults with NeuroVive prior to
terminating this Agreement due to an Efficacy Failure.  NeuroVive shall have the
right engage a neutral arbiter with the requisite expertise to provide an
opinion regarding the reasonableness of any determination by OnCore of the
existence of a Safety Failure, such opinion to be provided to and considered in
good faith by OnCore.  The costs and expenses of such arbiter shall be borne
initially by NeuroVive; however, if the arbiter finally concludes that OnCore’s
determination of the existence of an Efficacy Failure was not made in good
faith, then OnCore shall reimburse NeuroVive for the reasonable costs and
expenses of such arbiter.
 
10.4.2 Effect of Termination for Clinical Failure.  In the event OnCore
terminates this Agreement pursuant to this Section 10.4, the effects of
termination set forth in Section 10.2.2 (b), (c), (d), and (e) shall apply.
 
10.5 Rights in Bankruptcy.
 
All rights and licenses granted under or pursuant to this Agreement, including
without limitation ARTICLE 2, are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the Bankruptcy Code or analogous provisions of
Applicable Law outside the United States, licenses of right to “intellectual
property” as defined under Section 101 of the Bankruptcy Code or analogous
provisions of Applicable Law outside the United States (hereinafter “IP”).  The
Parties agree that a Party, as licensee of such rights under this Agreement,
shall retain and may fully exercise all of its rights and elections under the
Bankruptcy Code or any other provisions of Applicable Law outside the United
States that provide similar protection for IP.  Each Party hereby grants to the
other Party and its Affiliates a right to obtain possession of and to benefit
from a complete duplicate of (or complete access to, as appropriate) any such IP
and all embodiments of intellectual property, which, if not already in the other
Party’s possession, shall be promptly delivered to it upon the other Party’s
written request therefor.  The term “embodiments of intellectual property”
includes all tangible, electronic or other embodiments of rights and licenses
hereunder, including all Licensed Products, all Regulatory Approval Applications
and Regulatory Approvals and rights of reference therein, and all Information
related to Licensed Products, NeuroVive Patent Rights and NeuroVive Know-How, or
OnCore Patent Rights and OnCore Know-How, as applicable.  Neither Party shall
interfere with the exercise by the other Party or its Affiliates of rights and
licenses to IP and embodiments of intellectual property licensed hereunder in
accordance with this Agreement, and each Party agrees to reasonably assist the
other Party and its Affiliates to obtain the IP and embodiments of intellectual
property in the possession or control of Third Parties as reasonably necessary
or desirable for the other Party or its Affiliates to exercise such rights and
licenses in accordance with this Agreement.
 
 
- 34 -

--------------------------------------------------------------------------------

 
10.6 Return of Confidential Information.
 
Except to the extent otherwise required by Applicable Law, upon termination of
this Agreement, each Party shall promptly return to the other Party, delete or
destroy all relevant records and materials in such Party’s possession or control
containing Confidential Information of the other Party; provided that such Party
may keep one copy of such materials for archival purposes only or to determine
its continuing rights and/or obligations under this Agreement.
 
10.7 Effect of Expiration or Termination; Survival.
 
Expiration or termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to such expiration or termination.  The provisions of
ARTICLE 9  (Confidentiality), ARTICLE 11 (Representations and Warranties;
Indemnification) and ARTICLE 12 (Miscellaneous Provisions) and Sections 2.2.3
(Effect of Termination on Sublicenses), Section 10.2.2 (Effect of Termination by
NeuroVive for Cause), Section 10.2.3 (Effect of Termination by OnCore for
Cause), Section 10.3.2 (Effect of Termination for Convenience) and Section
10.4.2 (Effect of Termination for Clinical Failure) shall survive any expiration
or termination of this Agreement.  Except as set forth in this ARTICLE 10, upon
termination or expiration of this Agreement all other rights and obligations
cease.  Any expiration or early termination of this Agreement shall be without
prejudice to the rights of either Party against the other accrued or accruing
under this Agreement before termination.
 
ARTICLE 11
REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
 
11.1 Mutual Representations and Warranties.
 
Each Party represents, warrants and covenants to the other Party that as of the
Effective Date of this Agreement:
 
11.1.1 Corporate Existence and Authority.  It is a corporation (in the case of
OnCore) and a company (in the case of NeuroVive) duly organized, validly
existing and in good standing (or its foreign equivalent) under the laws of its
jurisdiction of organization, and has full power and authority to enter into
this Agreement and to carry out the provisions hereof.
 
11.1.2 Authorized Execution; Binding Obligation.
 
(a) The execution, delivery, and performance of this Agreement and the
consummation of the transactions contemplated hereby have been duly authorized
and approved by all necessary corporate or company action on its part; and
 
 
- 35 -

--------------------------------------------------------------------------------

 
(b) This Agreement has been duly executed and delivered by it and constitutes a
legal, valid, and binding obligation enforceable against it in accordance with
this Agreement’s terms, except as the same may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium or other laws relating to or
affecting creditors’ rights generally and by general equity principles,
including judicial principles affecting the availability of injunction and
specific performance.
 
11.1.3 No Conflicts.  The execution, delivery and performance of this Agreement
by it does not conflict with any agreement, instrument or understanding, oral or
written, to which it is a party and by which it or its assets may be bound.
 
11.1.4 All Consents and Approvals Obtained.  Except as otherwise described in
this Agreement, (a) all necessary consents, approvals and authorizations of, and
(b) all notices to, and filings by such Party with, all governmental authorities
and other Persons required to be obtained or provided by such Party in
connection with the execution, delivery and performance of this Agreement have
been obtained and provided, except for those government approvals, if any, not
required at the time of execution of this Agreement.
 
11.1.5 Compliance with Law.  It shall at all times comply with Applicable Laws
in all material respects with respect to the Licensed Products.  Neither it nor
any of its Affiliates nor any director, officer, agent, employee, consultant of,
or other person associated with, or acting on behalf of, it or its Affiliates
has (a) made, authorized, offered or promised to make any payment or transfer of
anything of value, directly, indirectly or through a third party, to any foreign
government official, employee or other representative (including employees of a
government owned or controlled entity or public international organization and
including any political party or candidate for public office), in violation of
any Anti-Bribery Laws, or any law of similar effect in any jurisdiction to which
such Person is subject or (b) otherwise taken any action in violation of any
Anti-Bribery Laws, or any law of similar effect in any jurisdiction to which
such Person is subject.  For the purposes of this Section 11.1.5, the acts
specified include (x) the making or payment of any illegal contributions,
commissions, fees, gifts, entertainment, travel or other unlawful expenses
relating to political activity, (y) the direct or indirect payment, gift, offer,
promise or authorization to make a payment, gift, offer or promise of, anything
of material value to any foreign government representative and (z) the making of
any bribe, illegal payoff, influence payment, kickback or other unlawful
payment.  “Anti-Bribery Laws” means the United States Foreign Corrupt Practices
Act of 1977 or any other anti-bribery laws, statutes, rules or regulations of
any country that may be applicable to a Party, including the United Kingdom
Bribery Act 2010 and any anti-bribery and related prohibitions implemented under
the Organization for Economic Cooperation and Development Convention on
Combating Bribery of Foreign Public Officials in International Business
Transactions.
 
 
- 36 -

--------------------------------------------------------------------------------

 
11.1.6 Representations Regarding Debarment and Compliance.  Each Party
represents, warrants and covenants that neither it nor any of its Affiliates nor
any of their respective directors, officers, employees, or consultants, and, to
its knowledge based upon reasonable inquiry, any Third Party (and its directors,
officers, employees and consultants), in each case who were responsible for the
development or whose responsibilities involve the Development or
Commercialization of the Product as authorized by this Agreement:
 
(a) are debarred under Section 306(a) or 306(b) of the FD&C Act;
 
(b) have been charged with, or convicted of, any felony or misdemeanor under
Applicable Laws related to any of the following: (A) the development or approval
of any drug product or the regulation of any drug product under the FD&C Act;
(B) a conspiracy to commit, aid or abet the development or approval of any drug
product or regulation of any drug product; (C) health care program-related
crimes (involving Medicare or any state health care program); (D) patient abuse,
controlled substances, bribery, payment of illegal gratuities, fraud, perjury,
false statement, racketeering, blackmail, extortion, falsification or
destruction of records; (E) interference with, obstruction of an investigation
into, or prosecution of, any criminal offense; or (F) a conspiracy to commit,
aid or abet any of these listed felonies or misdemeanors; and
 
(c) is excluded, suspended or debarred from participation, or otherwise
ineligible to participate, in any United States federal or state health care
programs (including convicted of a criminal offense that falls within the scope
of 42 U.S.C. §1320a-7 but not yet excluded, debarred, suspended, or otherwise
declared ineligible), or excluded, suspended or debarred from participation, or
otherwise ineligible to participate, in any United States federal procurement or
nonprocurement programs.
 
11.2 NeuroVive Representations and Warranties.
 
NeuroVive represents and warrants to OnCore that as of the Effective Date of
this Agreement:
 
11.2.1 NeuroVive Intellectual Property.  NeuroVive Controls the NeuroVive
Intellectual Property existing as of the Effective Date and is entitled to grant
the licenses specified herein.  The NeuroVive Patent Rights existing as of the
Effective Date constitute all of the Patent Rights Controlled by NeuroVive as of
the Effective Date that are necessary or useful to practice the NeuroVive
Intellectual Property.  NeuroVive has not previously licensed, assigned,
transferred, conveyed or otherwise encumbered its right, title and interest in
the NeuroVive Intellectual Property in a manner that conflicts with any rights
granted to OnCore hereunder.
 
11.2.2 Infringement.  To the knowledge of NeuroVive, there is no actual or
threatened infringement of the NeuroVive Patent Rights in the Field in the
Territory by any Third Party or any other infringement or threatened
infringement that would adversely affect OnCore’s rights under this Agreement.
 
 
- 37 -

--------------------------------------------------------------------------------

 
11.2.3 NeuroVive Patent Rights.  To the knowledge of NeuroVive, the NeuroVive
Patent Rights existing as of the Effective Date are subsisting and are not
invalid or unenforceable, in whole or in part.  There are no claims, judgments
or settlements against or amounts with respect thereto owed by NeuroVive or any
of its Affiliates relating to the NeuroVive Patent Rights.  No claim or
litigation has been brought or threatened by any Third Party alleging that (a)
the NeuroVive Patent Rights are invalid or unenforceable or (b) the NeuroVive
Patent Rights or the licensing or exploiting of the NeuroVive Patent Rights
violates, infringes or otherwise conflicts or interferes with any intellectual
property or proprietary right of any Third.
 
11.2.4 Claims; Judgments.  To the knowledge of NeuroVive, there are no claims,
judgments or settlements against or owed by NeuroVive or pending or threatened
claims or litigation relating to the NeuroVive Intellectual Property.
 
11.2.5 Product Liability.  NeuroVive represents and warrants that there is no
actual, pending, alleged or, to the knowledge of NeuroVive, threatened product
liability action with respect to any Licensed Product anywhere in the world and
NeuroVive is not aware of any facts or circumstances that would cause NeuroVive
to believe that there is a basis for such a product liability claim.
 
11.2.6 License Agreements.
 
(a) Attached to this Agreement as Schedule 11.2.6 are all of the agreements
pursuant to which NeuroVive has acquired the NeuroVive Intellectual Property and
pursuant to which NeuroVive has any ongoing or future obligations (the “License
Agreements”).  The License Agreements are valid, binding and in full force and
effect and are enforceable by NeuroVive in accordance with their
terms.  NeuroVive has performed all obligations required to be performed by it
to date under the License Agreements and is not in breach of or in default under
the License Agreements, and no event has occurred which with the passage of time
or giving of notice or both would constitute such a breach or default, and to
NeuroVive's knowledge, there is no existing breach or default by any
counterparty to a License Agreement and to NeuroVive's knowledge, no event has
occurred which with the passage of time or giving notice of or both would
constitute such a breach or default by such a counterparty.  NeuroVive has not
received any notice of breach under any License Agreement, whether or not cured
or disputed.
 
(b) NeuroVive will not at any time during the Term take any action that it knows
or should know will result in a breach of any License Agreement and will
throughout the Term comply with the terms and provisions of License Agreements
in all material respects.  NeuroVive will not at any time during the Term
terminate any License Agreement without the prior written consent of
OnCore.  NeuroVive will not agree to any amendment, waiver of rights, or
modification of any License Agreement that has, or would reasonably be expected
to have, a material negative effect on the rights granted to OnCore under this
Agreement or the obligations imposed on OnCore under this Agreement without the
prior written consent of OnCore.
 
 
- 38 -

--------------------------------------------------------------------------------

 
11.2.7 Disclosure.  NeuroVive has disclosed to OnCore all material information
and data (including without limitation all communications with or from the FDA
or any other Regulatory Authority) relating to the results of all preclinical
studies of any Licensed Product.  NeuroVive has provided to OnCore all reports
and data collections containing information about adverse safety issues
(including adverse drug experiences) related to any Licensed Product of which
NeuroVive has knowledge.  NeuroVive represents that it has not failed to furnish
OnCore with any information requested by OnCore, or intentionally concealed from
OnCore any information in NeuroVive's possession which would be reasonably
likely to be material to OnCore's decision to enter into this Agreement and
undertake the commitments and obligations set forth herein.
 
11.2.8 Securities.
 
(a) NeuroVive acknowledges and understands that an investment in OnCore
Securities involves substantial risks and that NeuroVive could lose all or a
portion of the investment in OnCore Securities.
 
(b) NeuroVive has such knowledge and experience in financial and business
matters so as to be capable of evaluating the merits and risks of its investment
in OnCore Securities and NeuroVive is able to bear the economic risk of its
investment in OnCore Securities for an indefinite period of time because OnCore
Securities are subject to the transfer restrictions contained in the
Stockholders Agreement and have not been registered under the Securities Act of
1933 and the rules and regulations promulgated thereunder (as amended from time
to time, the “Securities Act”) or the securities laws of any state of the United
States or other applicable jurisdiction.
 
(c) NeuroVive has had an opportunity to ask questions and receive answers
concerning the terms and conditions of the offering of OnCore Securities and has
had access to such other information concerning OnCore as NeuroVive has
requested.  NeuroVive has reviewed, or has had an opportunity to review, copies
of (i) the Amended and Restated Certificate of Incorporation of OnCore (ii) the
Amended and Restated By-laws of OnCore, (iii) the Amended and Restated
Stockholders’ Agreement, and (iv) such other documents and instruments as
NeuroVive deems necessary in evaluating the purchase of OnCore Securities.
 
(d) NeuroVive is an “accredited investor” within the meaning of Rule 501(a) of
Regulation D under the Securities Act and OnCore Securities to be acquired by it
pursuant to this Agreement are being acquired for its own account and not with a
view to any distribution thereof or with any present intention of offering or
selling any of OnCore Securities in a transaction that would violate the
Securities Act or the securities laws of any state of the United States of
America or any other applicable jurisdiction.
 
11.3 Warranty Disclaimer.
 
EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES
ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR
IMPLIED, TO THE OTHER PARTY WITH RESPECT TO ANY TECHNOLOGY OR OTHER SUBJECT
MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS ALL IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH
RESPECT TO ANY AND ALL OF THE FOREGOING.  EACH PARTY HEREBY DISCLAIMS ANY
REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE OR
COMMERCIALIZATION OF ANY LICENSED PRODUCT UNDER THIS AGREEMENT WILL BE
SUCCESSFUL.
 
 
- 39 -

--------------------------------------------------------------------------------

 
11.4 No Consequential Damages.
 
NEITHER PARTY HERETO WILL BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL
DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER,
INCLUDING WITHOUT LIMITATION LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH
OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.  NOTHING IN THIS
SECTION 11.4 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR
OBLIGATIONS OF EITHER PARTY OR TO LIMIT A PARTY’S LIABILITY FOR BREACHES OF ITS
OBLIGATION REGARDING CONFIDENTIALITY UNDER ARTICLE 9.
 
11.5 Indemnification and Insurance.
 
11.5.1 Indemnification by OnCore.  OnCore shall indemnify, hold harmless, and
defend NeuroVive, its Affiliates, and their respective equity holders, partners
(general and/or limited), managers, directors, officers, employees and agents
(“NeuroVive Indemnitees”) from and against any and all Third Party claims,
suits, losses, liabilities, damages, costs, fees and expenses (including
reasonable attorneys’ fees) (collectively, “Losses”) arising out of or resulting
from, directly or indirectly, (a) any material breach of, or inaccuracy in, any
representation or warranty made by OnCore in this Agreement, or any breach or
violation of any covenant or agreement of OnCore or any of its Affiliates or
sublicensees in or pursuant to this Agreement, (b) the negligence or willful
misconduct by or of OnCore or its Affiliates, and their respective directors,
officers, employees and agents, and (c) the Development, Manufacturing and/or
Commercialization of the Licensed Product by OnCore or its Affiliates or
sublicensees (including product liability) during the Term.  Furthermore, OnCore
shall have no obligation to indemnify the NeuroVive Indemnitees to the extent
that the Losses arise out of or result from, directly or indirectly, any
material breach of, or inaccuracy in, any representation or warranty made by
NeuroVive in this Agreement, or any breach or violation of any covenant or
agreement of NeuroVive in or pursuant to this Agreement, or the negligence or
willful misconduct by or of any of the NeuroVive Indemnitees, or the
Development, Manufacturing and/or Commercialization of any Licensed Product by
NeuroVive at any time.
 
11.5.2 Indemnification by NeuroVive.  NeuroVive shall indemnify, hold harmless,
and defend OnCore, its Affiliates and their respective equity holders, partners
(general and/or limited), directors, managers, officers, employees and agents
(“OnCore Indemnitees”) from and against any and all Losses arising out of or
resulting from, directly or indirectly, (a) any material breach of, or
inaccuracy in, any representation or warranty made by NeuroVive in this
Agreement, or any breach or violation of any covenant or agreement of NeuroVive
in or pursuant to this Agreement, (b) the negligence or willful misconduct by or
of NeuroVive, its Affiliates, and their respective directors, officers,
employees and agents, and (c) the Development, Manufacture, and/or
Commercialization of any Licensed Product other than by or on behalf of OnCore
or its Affiliates or sublicensees.  Furthermore, NeuroVive shall have no
obligation to indemnify the OnCore Indemnitees to the extent that the Losses
arise out of or result from, directly or indirectly, any material breach of, or
inaccuracy in, any representation or warranty made by OnCore in this Agreement,
or any breach or violation of any covenant or agreement of OnCore in or pursuant
to this Agreement, or the negligence or willful misconduct by or of any of the
OnCore Indemnitees.
 
 
- 40 -

--------------------------------------------------------------------------------

 
11.5.3 Indemnification Procedure.  In the event of any such claim against any
OnCore Indemnitee or NeuroVive Indemnitee (individually, an “Indemnitee”), the
indemnified Party shall promptly notify the other Party in writing of the claim
and the indemnifying Party shall manage and control, at its sole expense, the
defense of the claim and its settlement; provided that the failure to so notify
promptly shall not relieve the indemnifying Party of its obligations under this
Section 11.5 except to the extent of the actual prejudice suffered by such Party
as a result of such failure; and further provided that the indemnifying Party
shall not have the right to assume the defense of such claim if such claim
relates to an Infringement Claim.  The Indemnitee shall cooperate with the
indemnifying Party and may, at its option and expense, be represented in any
such action or proceeding.  The indemnifying Party shall not be liable for any
settlements, litigation costs or expenses incurred by any Indemnitee without the
indemnifying Party’s written authorization.  Notwithstanding the foregoing, if
the indemnifying Party believes that any of the exceptions to its obligation of
indemnification of the Indemnitees set forth in Section 11.5.1 or Section 11.5.2
may apply, the indemnifying Party shall promptly notify the Indemnitees, which
shall then have the right to be represented in any such action or proceeding by
separate counsel at their expense; provided that the indemnifying Party shall be
responsible for payment of such expenses if the Indemnitees are ultimately
determined to be entitled to indemnification from the indemnifying Party.  The
indemnifying Party shall not effect any settlement of any such claims without
the consent of the Indemnitee, which consent shall not be unreasonably withheld
or delayed.
 
11.5.4 Insurance.  OnCore shall use its Commercially Reasonable Efforts to
maintain insurance, including product liability insurance, with respect to its
activities hereunder, which may include self-insurance.  Such insurance shall be
in such amounts and subject to such deductibles as OnCore may reasonably
determine based upon standards prevailing in the industry at the time.
 
ARTICLE 12
MISCELLANEOUS PROVISIONS
 
12.1 Governing Law.
 
This Agreement shall be construed and the respective rights of the Parties
determined according to the substantive laws of England and Wales
notwithstanding the provisions governing conflict of laws of any jurisdiction.
 
12.2 Arbitration; Service of Process.
 
12.2.1 Jurisdiction.  Each Party by its execution hereof, hereby irrevocably
agrees to binding arbitration under the auspices of the International Chamber of
Commerce to resolve all disputes under or in respect of this Agreement that are
not resolved pursuant to Section 12.15 (“Action”).  The arbritral panel shall be
made of a panel of three (3) members, all of whom shall be independent of both
of the Parties and shall be knowledgeable in licensing, Development and
Commercialization of pharmaceutical products.  Each of the Parties shall select
one of the members of the arbitral panel (subject to the foregoing
qualifications) and the two (2) members selected by the Parties shall select the
third (3rd) member of the arbitral panel.  The Action shall be held in London,
England.  Any award made by the arbitrators shall may be entered as a judgment
in and enforced by any court of competent jurisdiction
worldwide.  Notwithstanding the previous sentence, a Party may commence any
Action in court to obtain emergency or temporary injunctive relief.
 
 
- 41 -

--------------------------------------------------------------------------------

 
12.2.2 Service of Process.  Each Party hereby (a) consents to service of process
in any Action between the parties arising in whole or in part under or in
connection with this Agreement in any manner permitted by the laws of England
and Wales, (b) agrees that service of process made in accordance with clause (a)
or made by registered or certified mail, return receipt requested, at its
address specified pursuant to Section 12.5 (Notices), shall constitute good and
valid service of process in any such Action and (c) waives and agrees not to
assert (by way of motion, as a defense, or otherwise) in any such Action any
claim that service of process made in accordance with clause (a) or (b) does not
constitute good and valid service of process.
 
12.3 Assignment.
 
This Agreement may not be assigned or otherwise transferred, nor may any right
or obligation hereunder be assigned or transferred, by either Party without the
prior, written consent of the other Party.  Notwithstanding the foregoing, (a)
NeuroVive may monetize the value of its royalty stream, Milestone Payments and
other payments under this Agreement by assigning to a Third Party the right to
receive royalties, Milestone Payments and other payments and the right to
receive royalty reports from OnCore; provided that NeuroVive gives sixty (60)
days’ prior written notice to OnCore, and (b) either Party may, without the
other Party’s consent, assign this Agreement and its rights and obligations
hereunder in whole or in part to an Affiliate or pursuant to a Change of
Control.  The assigning Party shall remain responsible for the performance by
its assignee of this Agreement or any obligations hereunder so assigned to such
assignee.
 
12.4 Amendments.
 
This Agreement and the Schedules and Exhibits referred to in this Agreement
constitute the entire agreement between the Parties with respect to the subject
matter hereof, and supersede all previous arrangements with respect to the
subject matter hereof, whether written or oral, including the Confidentiality
Agreement.  Any amendment or modification to this Agreement shall be made in
writing signed by both Parties.
 
12.5 Notices.
 
Any consent, notice or report required or permitted to be given or made under
this Agreement by one of the Parties hereto to the other shall be in writing and
(a) delivered by hand, (b) sent by internationally recognized delivery service,
(c) sent by registered or certified mail, return receipt requested, postage
prepaid, or (d) sent by facsimile transmission confirmed by prepaid, registered
or certified mail letter, and shall be deemed to have been properly served to
the addressee upon receipt of such written communication, in any event to the
following addresses:
 
 
- 42 -

--------------------------------------------------------------------------------

 
If to OnCore:
OnCore Biopharma, Inc.
 
3805 Old Easton Road
Doylestown, PA 18902
 
Attention: Chief Legal Officer
   
 
with a copy (which shall not constitute notice) to:
   
[***
 
***
 
***
 
***
 
***
 
***]
   
If to NeuroVive:
NeuroVive Pharmaceutical AB
 
Medicon Village
Scheelevägen 2
223 81 Lund
SWEDEN
 
Attention: Chief Executive Officer
 
with a copy (which shall not constitute notice) to:
   
NeuroVive Pharmaceutical AB
Karolinska Institutet Science Park
Fogdevreten 2
SE-171 65 Solna
SWEDEN
 
Attention: Chief Operating Officer

 
Either Party may change its address to which notices shall be sent by giving
notice to the other Party in the manner herein provided.
 
12.6 Force Majeure.
 
The failure of either Party to timely perform any obligation under this
Agreement by reason of epidemic, earthquake, riot, civil commotion, fire, act of
God, war, terrorist act, strike, flood, or governmental act or restriction, or
other cause that is beyond the reasonable control of the respective Party, shall
not be deemed to be a material breach of this Agreement, but shall be excused to
the extent and for the duration of such cause, and the affected Party shall
provide the other Party with full particulars thereof as soon as it becomes
aware of the same (including its best estimate of the likely extent and duration
of the interference with its activities) and shall use its Commercially
Reasonable Efforts to avoid or remove such cause.  If the performance of any
such obligation under this Agreement is delayed owing to such a force majeure
for any continuous period of more than one hundred eighty (180) days, the
Parties hereto shall consult with respect to an equitable solution.
 
 
- 43 -

--------------------------------------------------------------------------------

 
12.7 Compliance with Export Regulations.
 
Neither Party shall export any technology licensed to it by the other Party
under this Agreement except in compliance with US export laws and regulations.
 
12.8 Independent Contractors.
 
It is understood and agreed that the relationship between the Parties is that of
independent contractors and that nothing in this Agreement shall be construed as
authorization for either NeuroVive or OnCore to act as agent for the
other.  Nothing herein contained shall be deemed to create an employment,
agency, joint venture or partnership relationship between the Parties or any of
their agents or employees for any purpose, including tax purposes, or to create
any other legal arrangement that would impose liability upon one Party for the
act or failure to act of the other Party.  Neither Party shall have any express
or implied power to enter into any contracts or commitments or to incur any
liabilities in the name of, or on behalf of, the other Party, or to bind the
other Party in any respect whatsoever.
 
12.9 Further Assurances.
 
Each Party hereto agrees to execute, acknowledge and/or deliver such further
instruments, and to do all other acts, as may be necessary or appropriate in
order to carry out the purposes and intent of this Agreement.
 
12.10 No Strict Construction.
 
This Agreement has been prepared jointly and shall not be strictly construed
against either Party.
 
12.11 Headings.
 
The captions or headings of the sections or other subdivisions hereof are
inserted only as a matter of convenience or for reference and shall have no
effect on the meaning of the provisions hereof.
 
12.12 No Implied Waivers; Rights Cumulative.
 
No failure on the part of NeuroVive or OnCore to exercise, and no delay in
exercising, any right, power, remedy or privilege under this Agreement, or
provided by statute or at law or in equity or otherwise, shall impair, prejudice
or constitute a waiver of any such right, power, remedy or privilege or be
construed as a waiver of any breach of this Agreement or as an acquiescence
therein, nor shall any single or partial exercise of any such right, power,
remedy or privilege preclude any other or further exercise thereof or the
exercise of any other right, power, remedy or privilege.
 
12.13 Severability.
 
If any provision hereof should be held invalid, illegal or unenforceable in any
respect in any jurisdiction, the Parties hereto shall substitute, by mutual
consent, valid provisions for such invalid, illegal or unenforceable provisions,
which valid provisions in their economic effect are sufficiently similar to the
invalid, illegal or unenforceable provisions that it can be reasonably assumed
that the Parties would have entered into this Agreement with such valid
provisions.  In case such valid provisions cannot be agreed upon, the
invalidity, illegality or unenforceability of one or several provisions of this
Agreement shall not affect the validity of this Agreement as a whole, unless the
invalid, illegal or unenforceable provisions are of such essential importance to
this Agreement that it is to be reasonably assumed that the Parties would not
have entered into this Agreement without the invalid, illegal or unenforceable
provisions.
 
 
- 44 -

--------------------------------------------------------------------------------

 
12.14 No Third Party Beneficiaries.
 
No Person, other than OnCore, NeuroVive and their respective Affiliates and the
Indemnitees under ARTICLE 11 and any permitted assignees hereunder, shall be
deemed an intended beneficiary hereunder or have any right to enforce any
obligation of this Agreement.
 
12.15 Dispute Resolution.
 
With respect to any disputes between the Parties concerning this Agreement, the
dispute shall be submitted to escalating levels of OnCore and NeuroVive senior
management for review.  If the dispute cannot be resolved despite such
escalation, then the matter may be referred by either Party to the Executive
Officers to be resolved by negotiation in good faith as soon as is practicable
but in no event later than [***] after referral.  Such resolution, if any, by
the Executive Officers shall be final and binding on the Parties.  If the
Executive Officers are unable to resolve such dispute within such [***] period,
each Party will be free to pursue all rights available to it under law or
equity, provided that it has complied with this Section 12.15.  Notwithstanding
the foregoing, either Party may seek emergency or temporary injunctive relief in
any court of competent jurisdiction.
 
12.16 Execution in Counterparts.
 
This Agreement may be executed in any number of counterparts and by facsimile
signature, each of which counterparts, when so executed and delivered, shall be
deemed to be an original, and all of which counterparts, taken together, shall
constitute one and the same instrument.
 
12.17 Specific Performance.
 
In addition to any and all other remedies that may be available at law or in
equity, in the event of any breach or threatened breach of Section 2.5 or
ARTICLE 9 of this Agreement NeuroVive and OnCore shall be entitled to seek,
without the requirement of a bond be posted, specific performance of the
agreements and obligations of the parties hereunder and to such other injunctive
or other equitable relief as may be granted by a court of competent
jurisdiction.
 
[Signature page follows]
 
 
- 45 -

--------------------------------------------------------------------------------

 
IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of the date
first set forth above.
 
 

   
NEUROVIVE PHARMACEUTICAL AB
            By: /s/ Mikael Brönnegård     Name:
Mikael Brönnegård
    Title: Chief Executive Officer                     By: /s/ Greg Batcheller  
  Name:
Greg Batcheller
    Title:
Executive Chairman
                   
ONCORE BIOPHARMA, INC.
            By: /s/ Patrick T. Higgins     Name:
Patrick T. Higgins
    Title:
Chief Executive Officer

 
 
        
         

 
 

--------------------------------------------------------------------------------

 
Schedule 1.43

NeuroVive Patent Rights

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

--------------------------------------------------------------------------------

 

Schedule 1.44

NV556 Structure
 
 
 
 
 

 
 
 

--------------------------------------------------------------------------------

 
[***]
Schedule 9.2

Press Release

 

 
 
 

--------------------------------------------------------------------------------