Contract
Exhibit
10.5
Portions
herein identified by [***] have been omitted pursuant to a request for
confidential treatment under Rule 406 of the Securities Act of 1933, as amended.
A complete copy of this document has been filed separately with the Securities
and Exchange Commission.
BY
AND BETWEEN
HANA
PHARMACEUTICALS CORPORATION
AND
INEX
PHARMACEUTICALS CORPORATION
Table
of Contents
|
Article
1 DEFINITIONS
|
1
|
|
|
1.1
|
Definitions
|
1
|
|
1.2
|
Other
Definitions
|
13
|
|
Article
2 PROPERTY RIGHTS IN AND TO THE TECHNOLOGY
|
13 | |
|
2.1
|
University’s
Intellectual Property Rights
|
13
|
|
Article
3 GRANT OF SUBLICENCE TO HANA
|
14
|
|
|
3.1
|
Sublicense
Grant To Hana
|
14
|
|
3.2
|
License
Grant to INEX
|
14
|
|
3.3
|
Compliance
with UBC License
|
14
|
|
3.4
|
Payment
of Taxes
|
14
|
|
Article
4 SUBLICENSING BY HANA
|
15
|
|
|
4.1
|
UBC
Consent
|
15
|
|
4.2
|
Sublicenses
to Affiliates
|
15
|
|
4.3
|
Furnish
Sublicense Post Execution
|
15
|
|
4.4
|
Covenants
by Hana’s Sublicensee
|
15
|
|
4.5
|
Covenants
by Hana
|
16
|
|
4.6
|
Covenants
by Hana’s Sublicensee
|
17
|
|
4.7
|
Confirmation
from the University
|
17
|
|
Article
5 ROYALTIES AND CONSIDERATION
|
17
|
|
|
5.1
|
Assumption
of Royalty Obligations
|
17
|
|
5.2
|
Royalty
Due UBC
|
18
|
|
5.3
|
Rates
Established by UBC License
|
18
|
|
5.4
|
One
Royalty Per Product Payable to UBC
|
18
|
|
5.5
|
Payment
of Royalty Due UBC
|
19
|
|
5.6
|
Interest
Due to University
|
20
|
|
5.7
|
Sublicensing
and Royalty Payments to INEX
|
21
|
|
Article
6 PATENTS
|
31
|
|
|
6.1
|
IP
Committee
|
31
|
|
6.2
|
Responsibility
for Patent Prosecution and Maintenance
|
31
|
|
6.3
|
Identification
of Additional Process or Use
|
32
|
|
6.4
|
Issuance
of Patent
|
33
|
|
6.5
|
Improvements
|
33
|
|
6.6
|
Consultation
and Reporting
|
33
|
|
6.7
|
Reports
|
34
|
|
6.8
|
Abandonment,
Withdrawal or Discontinuance
|
34
|
|
6.9
|
Costs
of Patent Application, Prosecution and Maintenance
|
36
|
|
6.10
|
Late
Payments
|
37
|
|
6.11
|
Co-operation
|
37
|
|
6.12
|
Injunctive
Relief
|
37
|
|
Article
7 DISCLAIMERS, REPRESENTATIONS AND WARRANTIES
|
37
|
|
|
7.1
|
Disclaimer
|
37
|
|
7.2
|
International
Sale of Goods Act Not Applicable
|
38
|
|
7.3
|
No
Implied Warranties
|
38
|
|
7.4
|
Limited
Warranty
|
38
|
|
7.5
|
Conduct
of Infringement Proceedings
|
38
|
|
7.6
|
Breach
of Confidence Proceedings
|
40
|
|
7.7
|
Defense
of Infringement Proceedings
|
40
|
|
7.8
|
Co-operation
with Other Licensees
|
42
|
|
7.9
|
Hana
Representations and Warranties
|
42
|
|
7.10
|
INEX
Representations and Warranties
|
43
|
|
Article
8 INDEMNITY AND LIMITATION OF LIABILITY
|
44
|
|
|
8.1
|
Rights
of the University
|
44
|
|
8.2
|
Indemnification
by INEX
|
45
|
|
8.3
|
Indemnification
by Hana
|
45
|
|
8.4
|
Notice
of Claims
|
46
|
|
8.5
|
Consequential
Losses
|
46
|
|
8.6
|
Action
Between the Parties
|
47
|
|
Article
9 PUBLICATION AND CONFIDENTIALITY
|
47
|
|
|
9.1
|
Treatment
of Confidential Information
|
47
|
|
9.2
|
Publications
|
47
|
|
9.3
|
Objections
to Publication
|
48
|
|
9.4
|
Permitted
Disclosures
|
48
|
|
9.5
|
Liability
for Representatives
|
49
|
|
9.6
|
No
Limitation on Regulatory Compliance
|
49
|
|
9.7
|
Return
of Confidential Information
|
50
|
|
Article
10 PRODUCTION AND MARKETING
|
50
|
|
|
10.1
|
No
Use of Names and Trademarks
|
50
|
|
10.2
|
Labeling
and Patent Marking
|
50
|
|
10.3
|
Development
and Commercialization Efforts
|
50
|
|
10.4
|
Consequence
of No Sales
|
52
|
|
10.5
|
Reports
on Commercialization
|
52
|
|
10.6
|
Development
Plans
|
53
|
|
10.7
|
Reports
on Development
|
53
|
|
10.8
|
Regulatory
Compliance
|
53
|
|
Article
11 ACCOUNTING RECORDS
|
54
|
|
|
11.1
|
Documentation
|
54
|
|
11.2
|
Reporting
|
54
|
|
11.3
|
Method
of Calculation
|
54
|
|
11.4
|
Record
Retention
|
54
|
|
11.5
|
Confidential
Treatment
|
55
|
|
Article
12 INSURANCE
|
55
|
|
|
12.1
|
Insurance
|
55
|
|
Article
13 ASSIGNMENT
|
56
|
|
|
13.1
|
Assignment
|
56
|
-
2 -
|
Article
14 GOVERNING LAW AND ARBITRATION
|
57
|
|
|
14.1
|
Governing
Law
|
57
|
|
14.2
|
Jurisdiction
|
57
|
|
14.3
|
Arbitration
|
57
|
|
Article
15 NOTICES
|
58
|
|
|
15.1
|
Notices
|
58
|
|
Article
16 TERM
|
59
|
|
|
16.1
|
Term
|
59
|
|
Article
17 TERMINATION
|
59
|
|
|
17.1
|
Termination
for Bankruptcy
|
59
|
|
17.2
|
Termination
by INEX
|
61
|
|
17.3
|
Termination
for Invalidity Challenge
|
62
|
|
17.4
|
Termination
for Material Breach
|
62
|
|
17.5
|
No
Limitation on Remedies
|
62
|
|
17.6
|
Consequence
of Termination
|
62
|
|
17.7
|
Return
of Confidential Information
|
65
|
|
Article
18 MISCELLANEOUS COVENANTS REQUIRED BY UNIVERSITY
|
65
|
|
|
18.1
|
Miscellaneous
Covenants of Hana
|
65
|
|
Article
19 PRODUCT SAFETY AND REGULATORY COMPLIANCE
|
66
|
|
|
19.1
|
Regulatory
Responsibilities
|
66
|
|
19.2
|
Pharmacovigilance
|
66
|
|
19.3
|
Recalls
and Product Withdrawals
|
67
|
|
Article
20 GENERAL PROVISIONS
|
67
|
|
|
20.1
|
UBC
Requirement
|
67
|
|
20.2
|
Amendments
|
67
|
|
20.3
|
Counterparts;
Facsimile
|
68
|
|
20.4
|
Enurement
|
68
|
|
20.5
|
Exhibits
/ Schedules
|
68
|
|
20.6
|
Force
Majeure
|
68
|
|
20.7
|
Further
Assurances
|
68
|
|
20.8
|
Headings
|
68
|
|
20.9
|
Incorporation
by Reference
|
68
|
|
20.10
|
Independent
Legal Advice
|
68
|
|
20.11
|
Non-Use
of Names
|
69
|
|
20.12
|
No
Implied Rights
|
69
|
|
20.13
|
No
Solicitation or Hiring of Employees
|
69
|
|
20.14
|
No
Waiver
|
69
|
|
20.15
|
Publicity
|
69
|
|
20.16
|
Relationship
of Parties
|
69
|
|
20.17
|
Rights
and Remedies
|
70
|
|
20.18
|
Severability
|
70
|
|
20.19
|
Survival
|
71
|
|
20.20
|
Wording
|
71
|
|
20.21
|
Supremacy | 71 |
-
3 -
THIS
AGREEMENT is dated effective May 6, 2006.
BETWEEN:
INEX
PHARMACEUTICALS CORPORATION,
a
company duly incorporated under the laws of British Columbia having an office
at
#000 - 0000 Xxxxxxxx Xxxxxxx, Xxxxxxx, Xxxxxxx Xxxxxxxx, Xxxxxx X0X
0X0
(“INEX")
AND:
HANA
BIOSCIENCES, INC.,
a
company duly incorporated under the laws of Delaware having an office at 000
Xxxxxx Xxxxx Xxxxxxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, XX 00000,
X.X.X.
("Hana")
WHEREAS:
| A. |
Pursuant
to a License Agreement between INEX and the University of British
Columbia
(the “University”)
dated effective July 1, 1998, the University has exclusively licensed
to
INEX, certain patents and technology invented, developed and/or acquired
by the University relating to liposomal drug delivery
technologies.
|
| B. |
Pursuant
to an Asset Purchase Agreement between INEX and Hana dated May 6,
2006
(the “Asset
Purchase Agreement”),
INEX wishes to sublicense to Hana, certain of the patents and technology
licensed by the University to INEX relating to ionophore loading
and
sphingosome preparation, including methods and apparatus, for use
solely
within the Hana Field (as hereinafter
defined).
|
| C. |
INEX
and Hana desire to set out in this Agreement the terms and conditions
which will govern the Parties’ respective rights and obligations in
respect of the sublicensed patents and technology relating to ionophore
loading and sphingosome preparation, including methods and
apparatus.
|
NOW
THEREFORE, in consideration of the covenants, rights and obligations contained
in this Agreement and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties agree as
follows:
Article
1
DEFINITIONS
1.1 Definitions
As
used
in this Agreement, the following words and phrases shall have the following
meanings unless the context dictates otherwise:
| (a) |
“Abandoning
Party”
shall have the meaning set forth in Section 6.8.
|
| (b) |
“Accounting”
means an accounting statement setting out in detail how the amount
of
Revenue Due UBC and Sublicensing Revenue Due UBC received by Hana
and its
Sublicensees is determined.
|
| (c) |
“Affiliate”
or “Affiliated
Company”
or “Affiliated
Companies”
means with respect to any specified person, any other person that
directly
controls, is controlled by, or is under common control with, such
specified person. For the purposes of this Section, “control”
shall mean:
|
| (i) |
in
the case of corporate entities, the direct or indirect ownership
of at
least 50% of the stock or participating shares entitled to vote in
the
general meeting of shareholders,
and
|
| (ii) |
in
the case of a partnership or other legal entity, ownership of at
least 50%
interest in the income or at least a 50% interest in the power to
direct
the management or policies of such
entity.
|
For
the
purposes of this Agreement, the Parties agree that Hana and INEX are not
Affiliated Companies.
| (d) |
“Agreement”
means this Sublicense Agreement and
all Schedules attached hereto.
|
| (e) |
“Annual
Maintenance Fee” shall
have the meaning set forth in Section 5.5(k).
|
| (f) |
“Applicable
Laws”
means all applicable federal, provincial, state and local laws,
ordinances, rules and regulations of any kind whatsoever in the Territory,
including, without limitation, pharmaceutical and environmental rules
and
regulations, including cGMP Requirements, GCP Requirements, GLP
Requirements and the General Biological Products Standards of the
FDA, and
the Federal Food, Drug and Cosmetic Act, as amended, or any successor
act
thereto (“FDCA”).
|
| (g) |
“Business
Day”
means any day other than a day which is a Saturday, a Sunday or a
statutory holiday in British Columbia
or
California.
|
| (h) |
“Calendar
Quarter”
means each of the three-month periods ending on March 31,
June 30, September 30 or December
31.
|
| (i) |
"cGMP
Requirements"
means the current Good Manufacturing Practices standards required
by the
FDA (as set forth in the FDCA), the Therapeutic Products Directorate
Organization of Health Canada ("TPD"),
and the European Medicines Evaluation Agency ("EMEA")
and any other jurisdiction as mutually agreed between the Parties
together
with their applicable regulations, policies or guidelines which are
in
effect for the manufacture and testing of pharmaceutical materials,
active
ingredients, or excipients for use in Phase I, Phase II, and Phase
III
clinical trials, as applicable.
|
| (j) |
“Clinical
Activity”
and “Clinical
Activities”
mean any one or more of the activities associated with drug testing
in
humans, including trial design and execution, payment of investigators’,
institutional, and contractors’ fees, drug distribution and
accountability, analytical testing, data management, statistical
analysis,
adverse event reporting, and scientific publication, performed in
pursuit
of the Development and Commercialization of
Product.
|
-
2 -
| (k) |
“Clinical
Trial Material”
means labeled and packaged Sphingosomal Vinorelbine and/or Sphingosomal
Topotecan, and any component(s) thereof, used or to be used, in clinical
trials.
|
| (l) |
“Closing
Payment”
means an aggregate of One Million Five Hundred Thousand Dollars
($1,500,000 USD) in funds held in escrow to be paid by Hana to INEX
pursuant to the terms and conditions of the Transaction
Agreement.
|
| (m) |
“Closing
Shares”
means the number of shares of Common Stock determined by dividing
Ten
Million Dollars ($10,000,000 USD) by the FMV of the Common Stock
as of
March 16, 2006 to be paid by Hana to INEX pursuant to the terms and
conditions of the Transaction
Agreement.
|
| (n) |
“Commercialize”
and “Commercialization”
mean the activities customarily associated with sales of pharmaceutical
products including without limitation, DDMAC Activities, price and
reimbursement negotiations, pre-launch and launch activities, marketing,
sales, distribution, post-approval Clinical Activities, the development,
prosecution, registration and maintenance of trademarks, trade names
and
domain names, and Pharmacovigilance in each country in the
Territory.
|
| (o) |
“Commercially
Reasonable Efforts”
means those efforts and resources that Hana would use were it developing,
promoting and detailing its own pharmaceutical products which are
of
similar market potential as the Products, taking into account product
labeling, market potential, past performance, economic return, the
regulatory environment and competitive market conditions in the
therapeutic area, all as measured by the facts and circumstances
at the
time such efforts are due.
|
| (p) |
“Common
Stock”
means the common stock of Hana, par value $0.001 USD per
share.
|
| (q) |
“Confidential
Information” means
all information, knowledge or data:
|
| (i) |
of
an intellectual, technical, scientific or industrial nature, patentable
or
otherwise, in which a Party has a proprietary or ownership interest,
including, without limitation, technical data, drawings, photographs,
scans, specifications, standards, analytical methods, techniques,
manuals,
reports, formulas, compilations, processes, information, lists, trade
secrets, computer software, programs, devices, equipment, concepts,
inventions, designs, and know-how (including the
Technology);
|
| (ii) |
pertaining
to the business and affairs of a Party, including, without limitation,
financial information, marketing, manufacturing and commercial strategies,
patent positioning, business plans, strategies and developments,
including
any negative developments; or
|
| (iii) |
provided
or disclosed to a Party by Third Parties subject to restrictions
on use or
disclosure, whether oral or written, furnished by the disclosing
Party to
the receiving Party or any of its Representatives, whether furnished
or
prepared before or after the Effective Date of this Agreement, and
includes all analyses, compilations, data, studies, reports or other
documents based upon or including any of such information, data or
knowledge and, in all cases, all copies and tangible embodiments
thereof,
in whatever form or medium;
|
provided
that Confidential Information shall not include such information
which:
-
3 -
| (iv) |
can
be demonstrated by the receiving Party by written record to have
been
known or otherwise available to the receiving Party prior to the
disclosure by the disclosing Party;
|
| (v) |
can
be demonstrated by the receiving Party by written record to have
been in
the public domain at the time of
disclosure;
|
| (vi) |
after
disclosure, can be demonstrated by the receiving Party by written
record
to have subsequently become part of the public domain other than
as a
consequence of a breach of this Confidential Disclosure Agreement
by the
receiving Party or its
Representatives;
|
| (vii) |
after
disclosure, can be demonstrated by the receiving Party by written
record
to have been subsequently provided to the receiving Party by a Third
Party, but only to the extent the receiving Party can demonstrate
that
such disclosure does not violate any obligations of the Third Party
to the
disclosing Party; or
|
| (viii) |
the
receiving Party can demonstrate by written records results from research
and development activity conducted by the receiving Party or any
of its
Affiliates independently and in advance of disclosure by the other
Party
thereof..
|
Specific
disclosures shall not be deemed to be within the above exceptions merely because
they are embraced by general disclosures within the above exceptions, and any
combination of features shall not be deemed within the above exceptions merely
because individual features are within the above exceptions.
| (r) |
“Damages”
means any losses, liabilities, obligations, damages, penalties, fines,
claims, demands, actions, suits, costs and expenses of any nature
whatsoever, excluding indirect, special or consequential damages,
but
including, without limitation, legal fees, charges and disbursements,
and
the indirect, special or consequential damages of Third Parties for
which
a Party, Hana Indemnitees or INEX Indemnitees, as the case may be,
is
responsible.
|
| (s) |
“Date
of Commencement”
or “Commencement
Date”
means the date this Agreement will be deemed to have come into force,
which will beMay 6, 2006.
|
| (t) |
“DDMAC
Activities”
mean
all activities performed in accordance with the requirements of the
Division of Drug Marketing, Advertising and Communications, Center
for
Drug Evaluation and Research of the FDA, and the Office of the Inspector
General of the Department of Health and Human Services of the United
States.
|
| (u) |
“Definitive
Agreements”
mean the Asset Purchase Agreement, Elan Assignment and Novation Agreement,
License Agreement, Service Agreement, UBC Sublicense Agreement,
Transaction Agreement, and Registration Rights
Agreement.
|
| (v) |
“Designated
EU States”
means any one of Germany, the United Kingdom, Italy, France or
Spain.
|
| (w) |
“Develop”
and “Development”
means:
|
| (i) |
all
activities set forth in the Development Plan;
and
|
-
4 -
| (ii) |
all
activities necessary to obtain and maintain Regulatory Approvals
in each
country in the Territory, including Clinical Activities, Regulatory
Activities, Technical Transfer and Manufacturing
activities
|
| (x) |
“Development
Plan”
means the development plan for seeking Regulatory Approvals for each
Product in the Territory during the initial twelve (12) months following
the Effective Date, together with a corresponding budget accounting
for
the anticipated costs to be expended or incurred by Hana in conducting
the
Development.
|
| (y) |
“Discloser”
means a Party to this Agreement providing its Confidential Information
to
the other Party as Recipient.
|
| (z) |
“Discontinued
Patent”
shall have the meaning set forth in Section 6.8(c).
|
| (aa) |
“$
USD”
and “US
Dollars”
shall mean the lawful money of the United States of America, to be
used
for payments due to INEX.
|
| (bb) |
“$
CDN”
and “Canadian
Dollars”
shall mean the lawful money of Canada to be used for payments due
to the
University.
|
| (cc) |
“Effective
Date of Termination”
means the date on which this Agreement is terminated pursuant to
Article
17.
|
| (dd) |
“Excess
Amount”
shall have the meaning set forth in Section 7.5(g).
|
| (ee) |
“Fair
Market Value”
for the purposes of Sections 1.1(fff)
and 1.1(kkkk),
means the highest price, expressed in dollars, that an asset (whether
tangible or intangible) would bring in an open and unrestricted market,
between a willing buyer and a willing seller who are both knowledgeable,
informed, and prudent, and who are acting independently of each
other.
|
| (ff) |
“FDA”
means the Food and Drug Administration of the United States of
America.
|
| (gg) |
“FTE
Rate”
means the fully burdened rate established by INEX for the services
of an
INEX employee or consultant providing IP Services which for the first
year
of this Agreement, is $[***]
USD
based on 1,800 employee hours per year, or pro-rata portion thereof;
provided however, that on each anniversary of the Effective Date,
the FTE
Rate shall be adjusted by a percentage equal to the net change in
the
Consumer Price Index (All Items) for the province of British Columbia
for
the twelve (12) month period ending with December of the calendar
year
immediately preceding such anniversary
date.
|
| (hh) |
“FMV”
means the quotient resulting from dividing (A) the sum of the value
of all
trades for each of the twenty (20) trading days immediately preceding
the
FMV reference date, by (B) the aggregate volume of all trades of
shares of
Common Stock during such twenty trading day period, in each case
as
reported in the principal exchange or stock market on which the Common
Stock is then listed.
|
| (ii) |
“GCP
Requirements”
or “Good
Clinical Practices”
means the then current standards for clinical trials for pharmaceuticals
as required by the FDA, the TPD and the equivalent Regulatory Authority
elsewhere in the Territory, and as applicable, the policies and guidelines
of the International Conference on Harmonization in effect for the
clinical testing of pharmaceutical
materials.
|
-
5 -
| (jj) |
“GLP
Requirements”
or “Good
Laboratory Practices”
means the current Good Laboratory Practices standards required by
the FDA,
the TPD and the equivalent Regulatory Authority elsewhere in the
Territory
in effect for the testing of pharmaceutical materials as applied
to raw
materials and finished products.
|
| (kk) |
“Hana
Field”
means all uses of the Product.
|
| (ll) |
“Hana
Indemnitees”
shall have the meaning set forth in Section 8.2
|
| (mm) |
“Hana
Intellectual Property”
means:
|
| (i) |
all
Intellectual
Property Rights, patents
and patent applications (whether complete or incomplete or whether
filed
or unfiled) including
registrations, in any jurisdiction world-wide, as well as any patents
and
patent applications
assigned to or
licensed by Hana from INEX and Third Parties during the Term of
this Agreement;
and
|
| (ii) |
All
Confidential
Information owned
or controlled by Hana at any time during the Term of this
Agreement.
|
| (nn) |
“Human
Clinical Trials”
shall have the meaning set forth in Section 12.1(a).
|
| (oo) |
“Improvements”
shall have the meaning set forth in Section 6.5.
|
| (pp) |
“IND”
means an Investigational New Drug application in accordance with
the rules
and regulations of the FDA.
|
| (qq) |
“Indemnitee”
shall have the meaning set forth in Section 8.4.
|
| (rr) |
“Indemnitor”
shall have the meaning set forth in Section 8.4.
|
| (ss) |
“INEX
Indemnitees”
shall have the meaning set forth in Section 8.3.
|
| (tt) |
“Information”
means any and all Technology, the terms and conditions of this Agreement,
and any and all oral, written, electronic or other communications
and
other information disclosed or provided by the Parties including
any and
all analyses or conclusions drawn or derived therefrom regarding
this
Agreement and information developed or disclosed hereunder, or any
Party’s
raw materials, processes, formulations, analytical procedures,
methodologies, products, samples and specimens or
functions.
|
| (uu) |
“Intellectual
Property Rights”
means all
intellectual property rights subject to protection by intellectual
property laws in any country of the world, arising under statutory
or
common law, contract, or otherwise, and whether or not perfected,
including without limitation, all (a) patents, reissues of and re-examined
patents, and patent applications, whenever filed and wherever issued,
including without limitation, continuations, continuations-in-part,
substitutes and divisions of such applications and all priority rights
resulting from such applications; (b) rights associated with works
of
authorship including without limitation copyrights, moral rights,
copyright applications, copyright registrations, synchronization
rights,
mask work rights, mask work applications, mask work registrations;
(c)
rights associated with trademarks, service marks, trade names, logos,
trade dress, goodwill and the applications for registration and
registrations thereof; (d) rights relating to the protection of trade
secrets and confidential information; (e) rights analogous to those
set
forth in this Section and any and all other proprietary rights relating
to
intangible property; and (f) divisions, continuations, renewals,
reissues
and extensions of the foregoing (as and to the extent applicable)
now
existing, hereafter filed, issued or acquired.
|
-
6 -
| (vv) |
“IP
Committee”
shall have the meaning set forth in Section 6.1.
|
| (ww) |
“IP
Services”
means
services that Xxxx xxxxx reasonably necessary, desirable or helpful
to
evidence, maintain, protect or enforce Hana’s rights as set forth under
the Services Agreement.
|
| (xx) |
“License
Agreement”
shall mean the License Agreement between the Parties dated May 6,
2006.
|
| (yy) |
“Litigating
Party”
shall have the meaning set forth in Section 7.5(e).
|
| (zz) |
“Major
Markets”
means the countries of the United States of America, Germany,
the United Kingdom, Italy, France, Spain.
|
| (aaa) |
“Manufacture”
means all or a portion of the activities of Hana, INEX its Affiliates
or
their respective Third Party contractors associated with the
manufacturing, filling, sampling, testing, handling, labeling, packaging
and storage of Material and all work-in-progress. “Manufacturing” and
“Manufactured” will have comparable
meanings.”
|
| (bbb) |
“Material”
means all compounds, materials, substances, components or consumables
sourced or Manufactured by INEX, Hana or any of their respective
Third
Party contractors to produce Clinical Trial Material, and Product
for
commercial sale, but excluding machinery and
equipment.
|
| (ccc) |
“Maximum
Issuance Amount”
shall have the meaning set forth in Section 5.7(d).
|
| (ddd) |
“Method
Transfer”
means, in respect of the Services, the transfer by INEX and/or INEX’s
Third Party contractors to Hana, Hana’s Third Party contractors and/or
INEX’s Third Party contractors, of the methods for the testing of Material
pursuant to Method Transfer protocols mutually agreed between the
Parties,
and shall include without limitation, the performance of Method Transfer
qualification.
|
| (eee) |
“NDA”
means a New Drug Application in accordance with the rules and regulations
of the FDA.
|
| (fff) |
“Net
Sales”
means the aggregate US Dollar equivalent of gross revenues invoiced
by
Hana and its Affiliates and Sublicensees from or on account of the
sale of
Product to Third Parties, in any given calendar year, less deductions
actually allowed or specifically allocated to Product and actually
incurred by Hana using US GAAP and reasonable practices with respect
to
sales of all Product, consistently applied, for the
following:
|
| (i) |
credits
or allowances, if any, actually granted on account of recalls, rejection
or return of Product;
|
| (ii) |
insurance,
freight or other transportation costs incurred in shipping Product
to such
Third Parties; and
|
-
7 -
| (iii) |
excise
taxes, sales taxes, value added taxes, consumption taxes, customs
and
other duties or other taxes or other governmental charges imposed
upon and
paid or allowed with respect to the production, importation, use
or sale
of Product (excluding income or franchise taxes of any
kind);
|
(collectively,
the “Permitted
Deductions”).
The
foregoing definition is subject to the following:
| (iv) |
no
deductions shall be made for any item of cost incurred by Hana, its
Affiliates or Sublicensees in preparing, Manufacturing, shipping
or
selling Product except as permitted pursuant to Sections 1.1(fff)(i),
1.1(fff)(ii)
and 1.1(fff)(iii)
inclusive;
|
| (v) |
Net
Sales shall not include transfer between any of Hana and any of its
Affiliates or Sublicensees for resale, but Net Sales shall include
the
subsequent final sales to Third Parties by such Affiliates or
Sublicensees;
|
| (vi) |
fair
market value shall be assigned to any and all non-cash consideration
such
as but not limited to any credit, barter, benefit, advantage or concession
received by Hana or its Affiliates or Sublicensees in payment for
sale of
Product;
|
| (vii) |
as
used in this definition, a “sale” shall have occurred when Product are
billed out or invoiced;
|
| (viii) |
notwithstanding
anything herein to the contrary, the following shall not be considered
a
sale of Product under this
Agreement:
|
| (A) |
the
transfer of a Product to a Third Party without consideration to Hana
in
connection with the development or testing of a Product;
or
|
| (B) |
the
transfer of a Product to a Third Party without consideration in connection
with the marketing or promotion of the Product (eg.
samples).
|
| (ggg) |
“Non-Abandoning
Party”
shall have the meaning set forth in Section 6.8(a).
|
| (hhh) |
“Non-Competition
Terms”
means the Non-Competition Terms contained in the Transaction Agreement
between the Parties dated May 6.
|
| (iii) |
“Non-litigating
Party”
shall have the meaning set forth in Section 7.5(e).
|
| (jjj) |
“Notice
of Abandonment”
shall have the meaning set forth in Section 6.8(a).
|
| (kkk) |
“Objectionable
Material”
shall have the meaning set forth in Section 9.3(b).
|
| (lll) |
“Party”
means Hana or INEX and “Parties”
means Hana and INEX.
|
| (mmm) |
“Patent(s)”
mean all Valid Claims of the following intellectual
property:
|
| (i) |
the
Canadian, United States and foreign patents and/or patent applications
listed in Schedule
"A";
|
| (ii) |
Canadian,
United States and foreign patents issued from the applications listed
in
Schedule
"A"
and from any and all divisionals and continuations of these
applications;
|
-
8 -
| (iii) |
claims
of Canadian, United States and foreign continuation-in-part applications
and of the resulting patents, which are directed to subject matter
specifically described in the Canadian, United States, and foreign
applications listed in Schedule
"A";
|
| (iv) |
claims
of all foreign patent applications, and of the resulting patents,
which
are directed to subject matter specifically described in the Canadian
and
United States patents and/or patent applications described in (i),
(ii) or
(iii) above; and
|
| (v) |
any
reissues of United States, Canadian or foreign patents described
in (i),
(ii), (iii) or (iv) above.
|
| (nnn) |
“Person”
means and includes any individual, corporation, partnership, firm,
joint
venture, syndicate, association, trust, government body, Affiliates,
Third
Parties and any other form of entity or
organisation.
|
| (ooo) |
“Pharmacovigilance”
means all the activities associated with maintaining an effective
drug
safety monitoring system and adverse events reporting system in compliance
with the requirements of Regulatory
Authorities.
|
| (ppp) |
“Prime
Rate”
means the prime or equivalent rate quoted by the Bank of Canada from
time
to time.
|
| (qqq) |
“Product”
means any one or more of Sphingosomal Vinorelbine and Sphingosomal
Topotecan.
|
| (rrr) |
“QA”
means Quality Assurance, being that part of each management system,
within
Hana and INEX separately, having responsibility for assuring the
quality
of Material and Manufacturing in respect of compliance with Regulatory
Requirements.
|
| (sss) |
“QC”
means Quality Control, being that part of each management system,
within
Hana and INEX separately, having responsibility for quality control
testing of Material in respect of compliance with Regulatory
Requirements.
|
| (ttt) |
“Recipient”
means a Party to this Agreement receiving Confidential Information
of the
other Party as Discloser.
|
| (uuu) |
“Registrational
Clinical Trial”
means any one of a Phase III clinical trial or pivotal Phase II clinical
trial conducted in furtherance of Regulatory
Approvals.
|
| (vvv) |
“Regulatory
Authorities”
means the FDA and any other like governmental authorities, whether
federal, provincial, state or municipal, regulating the manufacture,
importation, distribution, marketing, clinical testing and/or sale
of
therapeutic substances in the
Territory.
|
| (www) |
“Regulatory
Approvals”
means all necessary and appropriate regulatory approvals which must
be
obtained before placing each Product on the market in any country
in the
Territory in which such approval is required, including without
limitation, INDs, NDAs, and any other comparable terms as applicable
with
regard to any such approvals in any other country in the
Territory.
|
-
9 -
| (xxx) |
“Regulatory
Requirements” means
Applicable Laws and all rules, regulations and guidances in respect
of QC
and QA procedures and processes, manufacturing and production batch
records (including the master production record), packaging, handling,
storage, delivery and retention of raw material and finished product
samples and associated support data, and all licenses, certificates,
authorizations or requirements from Regulatory Authorities in the
Territory, including but not limited to cGMP Requirements in respect
of
the Manufacture of Material.
|
| (yyy) |
“Regulatory
Submission”
means any submission or filing made in furtherance of obtaining and
maintaining any Regulatory
Approvals.
|
| (zzz) |
“Representatives”
means, in respect of a Person, that Person’s Affiliates and their
respective directors, officers, employees, consultants, subcontractors,
sublicensees (including Sublicensees), agents, representatives and
other
persons acting under their
authority.
|
| (aaaa) |
“Revenue
Due UBC”
means all revenues, receipts, monies, and the fair market value of
all
other consideration collected or received by Hana or its Affiliates
from a
Sublicensee or other Third Party, whether by way of cash or credit
or any
barter, benefit, advantage, or concession, (but not including Sublicensing
Revenue Due UBC) from the marketing, manufacturing, sale, distribution,
or
use, of the Technology and/or any Product in any or all parts of
the world
where Hana is permitted by law and this Agreement to market, Manufacture,
sell, distribute or use the Technology and/or any Product, in such
national jurisdictions where a Valid Claim subsists, on a country
by
country basis, less the following deductions to the extent included
in the
amounts invoiced and thereafter actually allowed and
taken:
|
| (i) |
credit,
allowances or refunds given on account of returned
Products;
|
| (ii) |
transportation
charges invoiced separately and actually charged to Third
Parties;
|
| (iii) |
taxes,
duties and customs on all sales of
Product;
|
| (iv) |
agents’
commissions paid by Hana for the sale of Product;
and
|
| (v) |
bona
fide special rebates provided by Hana for Product purchased by Third
Parties.
|
Where
any
Revenue is derived from a country other than the U.S. it shall be converted
to
the equivalent in U.S. Dollars on the date Hana is deemed to have received
such
Revenue pursuant to the terms hereof at the rate of exchange set by the Federal
Reserve Bank of New York for buying such currency. The amount of U.S. Dollars
pursuant to such conversion shall be included in the Revenue.
| (bbbb) |
“Royalties”
means Royalty Due UBC, Royalty Due INEX, and Sublicensing Revenue
Due
INEX.
|
| (cccc) |
“Royalty
Due Dates”
means the last working day of March, June, September and December
of each
and every year during which this Agreement remains in full force
and
effect.
|
-
10 -
| (dddd) |
“Royalty
Due INEX”
means the royalty payable to INEX on Net Sales in the Territory as
set
forth in Section 5.7,
but excluding Sublicensing Revenue Due
INEX.
|
| (eeee) |
“Royalty
Due UBC”
means the royalties payable to UBC on Revenue Due UBC and Sublicensing
Revenue Due UBC.
|
| (ffff) |
“Service
Agreement”
means the Service Agreement entered into between INEX and Hana dated
effective May 6, 2006.
|
| (gggg) |
“Sphingosomal
Topotecan”
means a liposome that includes sphingomyelin and cholesterol and
contains
encapsulated topotecan, wherein the sphingomyelin comprises less
than 20%
dihydrosphingomyelin.
|
| (hhhh) |
“Sphingosomal
Vinorelbine”
means a liposome that includes sphingomyelin and cholesterol and
contains
encapsulated vinorelbine, wherein the sphingomyelin comprises less
than
20% dihydrosphingomyelin.
|
| (iiii) |
“Sublicense
Agreement”
means an agreement between Hana or its Affiliate and a Sublicensee
to whom
Hana has granted a further sub-sublicense of the rights granted to
Hana
hereunder.
|
| (jjjj) |
“Sublicensee”
means a Person to whom Hana or its Affiliate have granted a Sublicense
Agreement of the rights granted to Hana hereunder.
|
| (kkkk) |
"Sublicensing
Revenue Due INEX"
means
all transaction closing payments, milestone payments, license fees
and any
other pre-Commercialization
payments (excluding royalties, sales revenue, sales commissions and
any
monies and proceeds derived from the sale of sublicensed Product)
payable
to, collected or received by Hana or its Affiliates pursuant to each
Sublicense Agreement entered in respect of the Technology granted
hereunder. Except as otherwise expressly provided below, “Sublicensing
Revenue Due INEX” shall not
include:
|
| (i) |
loans
to Hana or its Affiliate by a Sublicensee relating to the Technology,
except to the extent that the interest charged for such loan is less
than
Fair Market Value (in which case only such difference between the
interest
rate charged to Hana and the interest rate at Fair Market Value shall
constitute Sublicensing Revenue Due INEX) or to the extent that the
principal of a loan is forgiven (in which case only such forgiven
amount
shall constitute Sublicensing Revenue Due INEX);
or;
|
| (ii) |
equity
investments in Hana by a Sublicensee or equity of the Sublicensee
relating
to the Technology, except to the extent that such investments are
made at
greater than Fair Market Value (in which case only the excess premium
shall constitute Sublicensing Revenue Due INEX). For the purposes
of this
subsection, if the shares of either Hana or its Sublicensee are not
listed
on any stock exchange, the Fair Market Value shall be based on the
price
at which shares of either Hana or its Sublicensee, as the case may
be,
have been issued to investors (who are not industry-related strategic
investors or collaborative research partners) in the then most recent
bona
fide arm’s length private placement financing completed within the
preceding twelve (12) months having gross proceeds of at least Ten
Million
Dollars ($10,000,000). If no such private placement financing has
been
completed, the Parties shall appoint a mutually acceptable Person
as an
independent evaluator, and if the Parties cannot agree on an evaluator,
the Fair Market Value shall be determined as provided in Section
14.3;
|
-
11 -
| (iii) |
An
exchange of rights, assets, liabilities or other interest of any
kind,
except to the extent that the economic benefit conferred upon Hana
or its
Affiliates by reason of such exchange exceeds the Fair Market Value
of the
consideration which would have been paid by Hana or its Affiliates
for
such rights, assets, liabilities or interests, as determined by:
(i) the
mutual agreement of the Parties following the application of U.S.
GAAP, or
failing mutual agreement; (ii) the binding decision of a mutually
appointed independent Third Party banker or valuator familiar with
the
pharmaceutical industry.
|
For
the
avoidance
of
doubt, and without limiting the generality of the foregoing “Sublicensing
Revenue
Due
INEX”
shall
include any Development funding in excess of Hana’s true Development costs,
whether measured: (i) as an FTE rate in excess of Hana’s actual FTE rate; (ii)
as project funding in excess of Hana’s actual project cost; (iii) as a premium
on any pass-through costs incurred by Hana; or (iv) as a premium or rate charged
in excess of any of Hana’s actual costs incurred in Development.
| (llll) |
“Sublicensing
Revenue Due UBC”
means all revenues, receipts, monies, milestone payments and research
fees
(in respect of either milestone payments or research fees, only to
the
extent that same are in excess of reimbursement for the direct costs
of
research and development or pursuit of Regulatory Approvals undertaken
by
Hana or its Affiliates pursuant to a written research or development
plan), payments, royalties, license fees and the fair market value
of all
other consideration collected or received by Hana or its Affiliates
whether by way of cash, or credit or any barter, benefit, advantage,
or
concession pursuant to each Sublicense
Agreement
relating to Valid Claims which form a part of the Technology and/or
any
Product (but not including Revenue Due UBC).
Where any Sublicensing Revenue Due UBC is derived from a country
other
than the U.S. it shall be converted to the equivalent in U.S. Dollars
on
the date Hana is deemed to have received such Sublicensing Revenue
Due UBC
pursuant to the terms hereof at the rate of exchange set by Federal
Reserve Bank of New York for buying such currency. The amount of
U.S.
Dollars pursuant to such conversion shall be included in the Sublicensing
Revenue Due UBC.]
|
| (mmmm) |
“Technical
Transfer”
means the transfer by INEX and/or INEX’s Third Party contractors to Hana,
Hana’s Third Party contractors and/or INEX’s Third Party contractors of
those aspects of the know-how encompassed by the Technology necessary
and
useful for the Manufacture of Material, and includes Method
Transfer.
|
| (nnnn) |
“Technology”
means the Patent(s) and any and all knowledge, know-how and/or technique
or techniques invented, developed and/or acquired, being invented,
developed and/or acquired by the University solely or jointly with
INEX
relating to the Patent(s) as listed in Schedule
"A"
hereto, as amended from time to time, including, without limitation,
all
research, data, specifications, instructions, manuals, papers or
other
materials of any nature whatsoever, whether written or otherwise,
relating
to same.
|
| (oooo) |
“Term”
shall have the meaning set forth in Section 16.1.
|
| (pppp) |
“Territory”
means all of the countries and territories of the world.
|
| (qqqq) |
“Third
Party(ies)”
means any Person(s) other than Hana or INEX or any of their respective
Affiliates.
|
| (rrrr) |
“UBC”
and “University”
each mean the University of British
Columbia.
|
-
12 -
| (ssss) |
“UBC
Consent”
means the consent agreement executed by the University, INEX and
Hana
dated May 6, 2006.
|
| (tttt) |
“UBC
License”
means the License Agreement between INEX and the University dated
effective July 1, 1998
|
| (uuuu) |
“UBC
Trade-marks”
means any xxxx, trade-xxxx, service xxxx, logo, insignia, seal, design,
symbol, or device used by the University in any manner
whatsoever.
|
| (vvvv) |
“University
Indemnified Parties”
shall have the meaning set forth in Section 8.1(a).
|
| (wwww) |
“US
GAAP”
means generally accepted accounting principles applied in the United
States of America.
|
| (xxxx) |
“Valid
Claim”
means either:
|
| (i) |
a
claim of an issued and unexpired patent which has not been held
unenforceable, unpatentable or invalid by a court or other governmental
agency of competent jurisdiction, and which has not been admitted
to be
invalid or unenforceable through reissue, disclaimer or otherwise;
or
|
| (ii) |
a
claim in a patent application, provided that if such pending claim
has not
issued as a claim of an issued patent within seven (7) years after
the
filing date of such patent application, such pending claim shall
not be a
Valid Claim for purposes of this
Agreement.
|
In
the
event that a claim of an issued patent is held by a court or other governmental
agency of competent jurisdiction to be unenforceable, unpatentable or invalid,
and such holding is reversed on appeal by a higher court or agency of competent
jurisdiction, such claim shall be reinstated as a Valid Claim hereunder,
effective as of the date of such reinstatement.
1.2 Other
Definitions
Any
words
defined elsewhere in this Agreement shall have the particular meaning assigned
to the words thereto.
Article
2 PROPERTY
RIGHTS IN AND TO THE TECHNOLOGY
2.1 University’s
Intellectual Property Rights
| (a) |
The
Parties hereto hereby acknowledge and agree that the University owns
any
and all right, title and interest in and to the
Technology.
|
| (b) |
Hana
shall, at the written request of INEX, enter into such further agreements
and execute any and all documents as may be required to ensure that
ownership of the Technology remains with the
University.
|
| (c) |
On
the last working day of June of each and every year during which
this
Agreement remains in full force and effect, each of Hana and INEX
shall
deliver in writing to UBC, the details of any Patents filed by each
of
them during the previous twelve month period. The delivery of reports
required pursuant to this Section 2.1(c)
is
separate and distinct from the reporting requirements established
between
each of Hana and INEX as set forth in Sections 6.6
and 6.7.
|
-
13 -
Article
3 GRANT
OF SUBLICENCE
TO HANA
3.1 Sublicense
Grant
To Hana
| (a) |
In
consideration of the Royalties reserved herein, the covenants of
Hana
contained herein, and subject to the terms of this Agreement, INEX
hereby
grants to Hana and Hana hereby accepts an exclusive sublicense under
the
Technology to make, have made, use, sell, offer for sale, sublicense,
distribute, import, and have imported Product in the Hana Field in
the
Territory.
|
| (b) |
It
is understood and agreed that the foregoing exclusive sublicenses
grant to
Hana the rights enumerated to the exclusion of all other parties,
including INEX and its Affiliates.
|
| (c) |
It
is also understood that INEX retains exclusive rights under the Technology
outside the Hana Field.
|
| (d) |
Hana
shall not sublicense or cross-license the Technology without the
prior
written consent of the University.
|
| (e) |
Notwithstanding
Section 3.1(a)
and (b) herein, the Parties acknowledge and agree that INEX and the
University may each use the Technology without charge in any manner
whatsoever for non-commercial research, scholarly publication,
educational, or other non-commercial
use.
|
3.2 License
Grant to INEX
| (a) |
Hana
hereby grants to INEX a non-exclusive license under the Technology
to
make, have made, use, import and have imported Products solely for
non-commercial research, scholarly publication, education, or other
non-commercial purposes.
|
| (b) |
Hana
hereby grants to INEX a non-exclusive license under
the Technology to carry out INEX’s activities under the Development Plan
and Services Agreement.
|
| (c) |
Hana
hereby grants to INEX a worldwide, royalty-free, non-exclusive license
under the
Hana Intellectual Property to
make, have made, use, sell, offer for sale, import, and have
imported
liposomal drug products outside the Hana
Field.
|
3.3 Compliance
with UBC License
Hana
unconditionally, absolutely and irrevocably covenants and agrees with INEX
as
primary obligor, to adopt as Hana’s own obligations every obligation of INEX
contained or set forth in the UBC License.
3.4 Payment
of Taxes
Hana
shall be responsible for the payment of any federal, provincial, state, local,
or withholding taxes which may apply to the transactions contemplated by this
Agreement. Under no circumstances will Hana be responsible for any
franchise-related taxes or taxes based on UBC’s or INEX’s gross or net
income.
-
14 -
Article
4 SUBLICENSING
BY HANA
4.1 UBC
Consent
Subject
to Hana’s agreement to assume responsibility for payment of any and all license
fees, annual fees, milestone payments and royalty obligations of INEX to UBC
as
set forth in this Agreement, Hana shall have the right to grant Sublicense
Agreements to Affiliates or Third Parties with respect to the Technology with
the prior written consent of the University not to be unreasonably withheld,
but
without the consent of INEX.
4.2 Sublicenses
to Affiliates
INEX
shall reasonably cooperate with and assist Hana in obtaining the consent of
the
University to any proposed sublicense under this Agreement, provided
that:
| (a) |
Hana
will cause the Affiliate so sublicensed to perform the terms of this
Agreement as if such Affiliate were Hana
hereunder;
|
| (b) |
any
Affiliate so sublicensed shall unconditionally, absolutely and irrevocably
covenant and agree with INEX and the University as primary obligor,
to
adopt as its own obligations every obligation of Hana contained or
set
forth in this Agreement to the extent pertinent to the scope of such
sublicense, including without limitation, the covenants in this Agreement
to pay any amounts due to the University and to INEX under the terms
of
this Agreement; and
|
| (c) |
Hana
unconditionally guarantees the performance of each Affiliate hereunder
as
if they were signatories to this Agreement to the extent the performance
or lack of performance is a breach of this
Agreement.
|
| (d) |
the
obligations and liabilities of such Affiliate and Hana under this
Agreement shall be joint and several and INEX shall not be obliged
to seek
recourse against an Affiliate before enforcing its rights against
Hana.
For greater certainty it is hereby confirmed that any default or
breach by
an Affiliate of Hana of any term of this Agreement will also constitute
a
default by Hana under this Agreement, provided, however, that Hana
shall
be entitled to written notice of any claimed default, and shall have
ninety (90) days following receipt of such notice in which to cure
any
such default pursuant to Section 17.4
hereof.
|
4.3 Furnish
Sublicense Pre and Post Execution
| (a) |
At
least thirty (30) days prior to an anticipated execution, Hana will
furnish the University with a copy of each Sublicense Agreement which
Hana
proposes to execute so as to allow the University time to review
and
comment.
|
| (b) |
Hana
will furnish each of INEX and the University with a copy of each
such
Sublicense Agreement granted within thirty (30) days after
execution.
|
4.4 Covenants
by Hana’s Sublicensee
Any
Sublicense Agreement (including any Sublicense Agreement granted to an
Affiliate) granted by Hana shall contain covenants by the Sublicensee to observe
and perform similar terms and conditions to those in this Agreement, including,
without limitation, a restriction on the grant of further sub-sub-sublicenses
without the University’s consent.
-
15 -
4.5 Covenants
by Hana
| (a) |
Hana
unconditionally guarantees the performance of each Affiliate hereunder
as
if they were signatories to this Agreement to the extent the performance
or lack of performance is a breach of this
Agreement.
|
| (b) |
Each
Sublicense Agreement shall contain covenants by the Sublicensee for
the
benefit of INEX to observe and perform similar terms and conditions
to
those in this Agreement.
|
| (c) |
All
Sublicense Agreements granted by Hana shall be further sublicensable
or
assignable with the prior written consent of the University,
but without
the prior written consent of INEX; provided, however, that
Hana shall not
sublicense any rights granted herein to any Person that in
whole or in
part, either alone or in partnership, in collaboration or in
conjunction
with any Person other than INEX, whether as principal, agent,
employee,
director, officer, shareholder, licensor or in any capacity
or manner
whatsoever, whether directly or indirectly manufactures liposomal
products
without first either: (i)
obtaining INEX’s written consent; or (ii)including in such
Sublicense Agreement a
provision requiring the Sublicensee to agree that
it will not use the Technology for any purpose other than the
Development
or Commercialization
of Products.
|
| (d) |
In
the event that Hana becomes aware of a material breach of any such
Sublicense Agreement by a Sublicensee, Hana shall promptly notify
INEX of
the particulars of same and take all commercially
reasonable steps to enforce the terms of such Sublicense
Agreement.
|
| (e) |
Within
ten (10) Business Days after execution of a Sublicense Agreement,
Hana
shall provide INEX with a copy thereof (provided that Hana shall
be
permitted to redact the financial terms of such
agreement).
|
| (f) |
All
Sublicense Agreements shall terminate upon the termination of Hana’s
rights granted herein unless events of default are cured by Hana
or its
Sublicensee within the period for the cure of default after notification
by INEX as provided by the terms of this
Agreement.
|
| (g) |
Any
Sublicensee who wishes to grant a further sublicense shall comply
with the
terms of this Section as if the further sublicense were a sublicense
hereunder, including providing to INEX, Hana and the University the
information described in this Section, and obtaining the consent
of the
University referred to in this Section, prior to any execution of
any such
sub-sub-sublicense.
|
| (h) |
All
Sublicense Agreements shall include an obligation for each Sublicensee
to
account for and report its sales of Product on the same basis as
if such
sales were sales of Hana, and INEX and the University shall receive
compensation in the same amounts as if the sales of Product by the
Sublicensee were sales of Hana; and
|
| (i) |
Hana
shall remain responsible to INEX for the compliance of each Sublicensee
with the financial and other obligations due under this
Agreement.
|
| (j) |
With
respect to the licenses granted to INEX under Section 3.2,
INEX shall have the right to grant sublicenses to its Affiliates
and to
Third Parties. All sublicenses will be consistent with the terms
of this
Agreement,
shall not relieve Hana or INEX of their obligations hereunder,
and shall incorporate terms and conditions for Hana’s benefit comparable
to those set forth in this Section 4.4
applicable to sublicenses granted by Hana.
|
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16 -
4.6 Covenants
by Hana’s Sublicensee
Any
Sublicense Agreement (including any Sublicense Agreement granted to an
Affiliate) granted by Hana shall contain covenants by the Sublicensee to observe
and perform similar terms and conditions to those in this Agreement, including,
without limitation, a restriction on the grant of further sublicenses without
the University’s consent.
4.7 Confirmation
from the University
The
Parties acknowledge and agree that:
| (a) |
the
UBC License provides that Hana may request from the University, following
the receipt of the UBC Consent, a letter confirming that if the
University:
|
| (i) |
gives
notice of default to INEX pursuant to Article 17.3 of the UBC License,
or
|
| (ii) |
takes
any other action pursuant to Article 17.1 or 17.2 of the UBC License
to
terminate the UBC License,
|
then,
prior to any termination of the UBC License, the University will give Hana
written notice of such default or intention to terminate the UBC License and,
in
the event of any breach or default by INEX which may be cured pursuant to
Article 17.3 of the UBC License, the University will for ninety (90) days from
the date of such notice to Hana, give Hana the opportunity to cure such default
or breach on the terms provided in Article 17.3 of the UBC License, mutatis
mutandis;
and
| (b) |
if
the UBC License is terminated, and provided that this Agreement is
in good
standing at such time:
|
| (i) |
the
terms and conditions of the UBC Consent shall apply;
or
|
| (ii) |
in
the event that the terms and conditions of the UBC Consent do not
apply,
or otherwise at the option of Hana, the University and Hana may enter
into
good faith negotiations for the grant to Hana of a new license
substantially on the same terms and conditions as are contained in
the UBC
License.
|
Article
5 ROYALTIES
AND CONSIDERATION
5.1 Assumption
of Royalty Obligations
| (a) |
As
a condition of the grant of the sublicence by INEX to Hana of the
Technology, Hana shall assume and perform all payment obligations
of INEX
to the University set forth in the UBC License including all interest
and
taxes attributable thereto, arising from Hana and/or its Sublicensee(s)’
use of the Technology within the Hana Field. Without limiting the
generality of the foregoing, Hana shall assume and perform all obligations
as set forth in Sections 5.2,
5.3,
5.4,
5.5,
5.6,
and 18.1(d)
in
this Agreement.
|
| (b) |
For
avoidance of doubt, the obligations of Hana under Section 5.1(a)
are in addition to and not in substitution of any other
obligations
set forth in this Article
5.
|
-
17 -
5.2 Royalty
Due
UBC
| (a) |
Hana
covenants to pay directly to the University a royalty (the “Royalty
Due UBC”):
|
| (i) |
on
all Revenue Due UBC, calculated in accordance with the percentages
set out
in the “Royalty
Due UBC”
Column of Schedule
“A”;
and
|
| (ii) |
on
all Sublicensing Revenue Due UBC, calculated in accordance with the
percentages set out in the “UBC Sublicense Royalty” Column of
Schedule “A”;
|
all
subject to the limitation that in no event will the Royalty Due UBC payable
on
Sublicensing Revenue Due UBC and Revenue Due UBC from any Sublicensee exceed
the
amount of Royalty Due UBC that would be payable on Revenues if the Technology
and/or Product had been marketed, Manufactured, sold, distributed or used by
Hana instead of such Sublicensee.
If
Schedule“A”
is
amended at any time after the Commencement Date to add any new Technology,
patent or other intellectual property, then the Royalty Due UBC on Revenue
Due
UBC or Sublicensing Revenue Due UBC shall be calculated for any such new
Technology, patent or other intellectual property in accordance with the
provisions set out in Schedule“B”.
5.3
Rates
Established by UBC License
Hana
and
INEX agree that that the Royalty Due UBC and the formulas set out in
Schedule“A”
and
Schedule“B” are
the
royalty rates established under the UBC License, and have been agreed to by
the
Parties based on a direct flow-through of such royalties to the University.
Hana
agrees that it shall promptly remit in full to the University, without reduction
or set-off of any kind, all Royalty Due UBC pursuant to this Article
5.
5.4
One
Royalty Per Product Payable
to UBC
Hana
and
INEX understand and recognize that there are a number of Patents comprising
the
Technology and consequently it is foreseeable that a Product developed by Hana
may be subject to multiple royalty obligations as a result of more than one
Patent contributing to the development of such Product. Hana and INEX agree
that
the Royalty Due UBC payable directly by Hana to the University shall be adjusted
as follows:
| (a) |
if
more than one Patent sublicensed under this Agreement is required
in
respect of a Product, then the royalty applicable to any such specific
Product pursuant to Section 5.2
hereof may be reduced such that there shall only be one royalty payable
on
such Product and that royalty shall be the Royalty Due UBC for one
of the
Patents used (determined in accordance with Section 5.2
and Schedule“B”)
which is most favourable to the University;
and
|
| (b) |
if
it is reasonably commercially necessary for a Product to be subject
to
royalty obligations to one or more Third Parties other than the
University, or if Hana licenses or owes a royalty in respect of one
or
more patents from one or more Third Parties to be used in combination
with
the Patents sublicensed hereunder, then the Royalty Due UBC set out
in
Section 5.2
shall be adjusted by apportioning the relative value between the
Technology and said Third Party patent(s) by multiplying the Royalty
Due
UBC by the formula a/(a+b) where "a" is the value of the Patent
sublicensed under this Agreement, and "b" is the value of the Third
Party
patent(s), provided that "b" shall never be fixed at a value higher
than
"a". Values "a" and "b" shall be determined on the basis of the values
of
each patent when used separately and not used in combination with
each
other. If the Parties are unable to come to agreement on said respective
values, the issue will be determined by arbitration pursuant to
14.3
For greater certainty, notwithstanding anything in this Section,
the final
Royalty Due UBC payable by Hana to the University shall not be less
than
[***]%
of the Royalty Due UBC determined in accordance with Section 5.2.
|
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18 -
5.5
Payment
of Royalty Due UBC
| (a) |
The
Royalty Due UBC shall become due and payable by Hana to the University
within thirty (30) days of each respective Royalty Due Date and shall
be
calculated with respect to the Revenue and the Sublicensing Revenue
Due
UBC in the three (3) month period immediately preceding the applicable
Royalty Due Date.
|
| (b) |
All
payments of Royalty Due UBC made by Hana to the University hereunder
shall
be made in U.S. Dollars without any reduction or deduction of any
nature
or kind whatsoever, except as may be prescribed by
law.
|
| (c) |
Revenue
Due UBC shall be deemed to have been received by Hana or any Affiliate
of
Hana when actually received, provided that diligent efforts short
of
commencing legal action are made to collect same. Sublicensing Revenue
Due
UBC shall be deemed to have been received by Hana or any Affiliate
of Hana
with respect to each of their Sublicensees when such consideration
is
actually received.
|
| (d) |
Any
transaction, disposition, or other dealing involving the Technology,
Product or any part thereof between Hana and another Person that
is not
made at fair market value shall be deemed to have been made at fair
market
value, and the fair market value of that transaction, disposition,
or
other dealing shall be deemed to be part of the Revenue (or the
Sublicensing Revenue Due UBC, as the case may be) and shall be included
in
the calculation of Royalty Due UBC under this
Agreement.
|
| (e) |
Revenue
Due UBC shall not include and no Royalty Due UBC will be payable
on
Product used for research and development of the Product or the Technology
for which Hana does not receive consideration, such as but not limited
to
dispositions for clinical trials, marketing, research use and
compassionate use or for other similar
uses.
|
| (f) |
Sublicensing
Revenue Due UBC shall not include and no Royalty Due UBC will be
payable
on:
|
| (i) |
loans
to Hana by a Sublicensee relating to the Technology except to the
extent
that the interest charged for same is less than fair market value
(in
which case such difference shall be Sublicensing Revenue Due UBC)
or to
the extent that the principal of same is forgiven (in which case
such
forgiven amount shall be Sublicensing Revenue Due UBC);
or
|
| (ii) |
investments
in Hana by a Sublicensee relating to the Technology except to the
extent
that such investments are made at greater than fair market value
(in which
case such premium shall be Sublicensing Revenue Due UBC). For the
purposes
of this Section, if the shares are not listed on any stock exchange,
the
fair market value shall be based on the price at which shares have
been
issued to investors (who are not industry-related strategic investors
or
collaborative research partners) in the then most recent bona fide
arm’s
length private placement financing completed within the preceding
twelve
(12) months having gross proceeds of at least $500,000 CDN. If no
such
private placement financing has been completed, the Parties hereto
shall
appoint a mutually acceptable Person as an independent evaluator
and if
the Parties cannot agree on an evaluator, the appointing authority
shall
be the British Columbia International Commercial Arbitration Centre.
|
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19 -
| (g) |
If
at any time, a Third Party in any country shall, under the right
of a
compulsory license granted or ordered to be granted by a competent
governmental authority, manufacture, use or sell any Product with
respect
to which Royalty Due UBC would be payable pursuant to this Agreement,
then
Hana may reduce the Royalty Due UBC on sales in such country of such
Product to an amount no greater than the amount payable by said Third
Party to Hana as consideration for the compulsory
license.
|
| (h) |
No
Royalty Due UBC shall be payable on the sales of Product between
Hana and
its Affiliates, provided that Royalty Due UBC shall be payable on
all
Revenue received by Hana or its Affiliate(s) from any subsequent
sale of
such Product to a Sublicensee or to a Third
Party.
|
| (i) |
No
Royalty Due UBC shall be payable to the University on any revenue
paid to
Hana by its Affiliates as a consequence of a sublicense between Hana
and
its Affiliates, but Royalty Due UBC shall be payable on all Revenue
Due
UBC paid to Hana’s Affiliates by a Third Party as a consequence of a
sublicense between Hana’s Affiliates and any Third
Party.
|
| (j) |
If,
at any time, legal restrictions prevent the prompt remittance of
part or
all of the Royalty Due UBC with respect to any country where Revenue
Due
UBC or Sublicensing Revenue Due UBC is generated, Hana shall have
the
right and option, on consultation with the University, to make such
payments by depositing the amount thereof in local currency for the
benefit of the University in a bank or depository in such
country.
|
| (k) |
In
further consideration for the sublicense granted hereunder, Hana
shall pay
to the University on behalf of INEX, in addition to all other amounts
due
under this Agreement, an annual maintenance fee of [***] Dollars
($[***]
CDN) payable on or before January 2 of each year, commencing on January
2,
2007 (the “Annual
Maintenance Fee”)
during which this Agreement remains in full force and effect. Neither
all
nor any part of this Annual Maintenance Fee shall be refundable to
Hana
under any circumstances.
|
5.6 Interest
Due to University
All
amounts due and owing by Hana to the University:
| (a) |
under
this Article
5;
and
|
| (b) |
under
any other Section(s) in respect of payments to be made by Hana to
the
University;
|
-
20 -
but
not
paid by Hana on the due date thereof shall bear interest in Canadian Dollars
at
the rate of [***]
per cent
([***]%)
per
month. Such interest shall accrue on the balance of unpaid amounts from time
to
time outstanding from the date on which portions of such amounts become due
and
owing until payment thereof in full.
5.7 Sublicensing
and Royalty Payments
to INEX
| (a) |
In
consideration of the sublicense granted to Hana under this Agreement,
the
disclosure to Hana of INEX’s Confidential Information, and subject to the
provisions of this Agreement, Hana shall pay the Royalty Due INEX
and
Sublicensing Revenue Due INEX as provided herein. Hana shall also
pay to
UBC the Royalty Due UBC on Inex’s behalf. Inex shall pay to UBC the
Sublicensing Revenue Due UBC in accordance with the UBC License.
Hana and
Inex shall confirm to the other in writing the delivery of each such
payment to UBC.
|
| (b) |
Sphingosomal
Vinorelbine
|
| (i) |
Milestone
Payments:
|
Hana
shall pay to INEX milestones payments in respect
of Sphingosomal Vinorelbine as follows:
| (A) |
[***]
Dollars ($[***])
upon on the date the first patient is enrolled in any clinical trial
of
Sphingosomal Vinorelbine conducted pursuant to an IND sponsored by
Hana,
of which [***]
Dollars ($[***])
shall be paid by wire transfer to INEX of immediately available funds
and
the remaining [***]
Dollars ($[***])
shall be paid by Hana issuing to INEX a number of additional shares
of
Common Stock determined by dividing [***]
Dollars ($[***])
by the FMV as of the date of such first patient
enrolment;
|
| (B) |
[***]
Dollars ($[***])
upon the date the first patient is enrolled in a Phase II clinical
trial
of Sphingosomal Vinorelbine conducted pursuant to an IND sponsored
by
Hana, which payment shall be made by Hana issuing to INEX a number
of
additional shares of Common Stock determined by dividing [***]
Dollars ($[***])
by the FMV as of the date of such first patient enrollment;
and
|
| (C) |
[***]
Dollars ($[***])
upon the approval by the FDA of an NDA relating to Sphingosomal
Vinorelbine, which payment shall be made by Hana issuing to INEX
a number
of additional shares of Common Stock determined by dividing [***]
Dollars ($[***])
by the FMV as of the date of such FDA approval; provided however,
if a
Regulatory Submission equivalent to an NDA is approved in any of
the
Designated EU States before an NDA relating to Sphingosomal Vinorelbine
is
approved by the FDA, one half the milestone due under this Section
5.7(b)(C)
will be paid by Hana to INEX immediately upon approval of that equivalent
filing and the remaining balance will be paid by Hana to INEX immediately
upon the approval of an NDA relating to Sphingosomal Vinorelbine
by the
FDA.
|
| (D) |
For
the avoidance of doubt, each of the milestone payments described
in
subparagraphs (A) and (B) of this Section 5.7(b)(i)
above represent one-time payments to INEX, and shall be due only
upon the
first occurrence of the events described in each such subparagraph.
For
example, the milestone payment described in subparagraph (A) above
will be
due only once, following the FDA’s acceptance for review of the
Sphingosomal Vincristine NDA. No additional milestone payments to
INEX
shall be due from Hana pursuant to subparagraph (A) in connection
with any
subsequent NDA submission by Hana relating to Sphingosomal
Vincristine.
|
-
21 -
| (ii) |
Royalties:
|
Hana
shall pay to INEX royalty payments based on
cumulative Net Sales of Liposomal Vinorelbine as
follows:
| (A) |
With
respect to Net Sales of Liposomal Vinorelbine in the United States,
a
royalty equal to the sum of: (i) [***]
percent ([***]%)
of Net Sales in consideration of the Patents if the Product sold
is
embraced within any Valid Claim under the Patents in the United States;
(ii) [***]
percent ([***]%)
of Net Sales in consideration of, and during any period of product
exclusivity provided by the laws of the United States of America,
including but not limited to marketing exclusivity in the form of
data
exclusivity, pediatric exclusivity, and orphan drug designation
exclusivity; and (iii) [***]
percent ([***]%)
of Net Sales in consideration of Technology; provided, however, that
the
total royalty paid shall be limited to [***]
percent ([***]%)
of cumulative Net Sales up to [***]
Dollars ($[***]),
and limited to [***]
percent ([***]%)
of cumulative Net Sales in excess of [***]Dollars
($[***]);
and
|
| (B) |
With
respect to Net Sales of Sphingosomal Vinorelbine in each country
of the
Territory other than the United States, a royalty of [***]
percent ([***]%)
of Net Sales in consideration of Technology; provided, however, that
the
total royalty paid shall be limited to [***]
percent ([***]%)
of cumulative Net Sales up to [***]
Dollars
($[***]),
and increased to [***]
percent ([***]%)
of cumulative Net Sales in excess of [***]Dollars
($[***]).
|
| (iii) |
Generic
Competition:
If,
during a given calendar year, there is sale
of a generic Sphingosomal Vinorelbine or sale of an approved equivalent
to
Sphingosomal Vinorelbine (collectively, “Approved
Sphingosomal Vinorelbine Equivalents”)
in any country in the Territory, them, for such country, the total
amount
of Royalties Due INEX for the Net Sales of Sphingosomal Vinorelbine
in
such country during such calendar year will be reduced to [***]
percent ([***]%)
of the Royalties Due INEX pursuant to Section 5.7(b)(ii)
for such calendar year, in such
country.
|
| (iv) |
Deductions:
Notwithstanding
the schedule of royalty
payments set forth in Section 5.7(b)(ii),
Hana shall be entitled to deduct from such Sphingosomal Vinorelbine
royalty obligations owed by Hana to INEX, an amount equal to [***]
percent ([***]%)
of the research and development expenses Hana incurs in connection
with
the Development of Sphingosomal Vinorelbine (the “Sphingosomal
Vinorelbine R&D Expenses”);
provided however, that such deduction shall not exceed the lesser
of:
|
-
22 -
| (A) |
[***]
Dollars ($[***]);
or
|
| (B) |
[***]
Dollars ($[***])
per patient treated in a Registrational Clinical
Trial;
|
provided
further, however, that such deduction for Sphingosomal Vinorelbine R&D
Expenses shall not exceed [***]
percent
([***]%)
of the
royalty amount otherwise payable by Hana to INEX for Sphingosomal Vinorelbine
in
each calendar year, provided that Hana shall be entitled to carry over into
succeeding
years
any
amount of Sphingosomal Vinorelbine R&D Expenses that were ineligible for
deduction as a result of the such limitation. All Sphingosomal Vinorelbine
R&D Expenses shall be subject to audits by INEX using reasonable and
customary audit procedures in order to verify the amounts thereof.
| (c) |
Sphingosomal
Topotecan
|
| (i) |
Milestone
Payment:
Hana
shall pay to INEX milestones payments in respect of Sphingosomal
Topotecan
as follows:
|
| (A) |
[***]
Dollars ($[***])
upon the date the first patient is enrolled in any clinical trial
of
Sphingosomal Topotecan conducted pursuant to an IND sponsored by
Hana,
which payment shall be made by Hana issuing to INEX a number of additional
shares of Common Stock determined by dividing [***]
Dollars ($[***])
by the FMV as of the date of such first patient
enrollment;
|
| (B) |
[***]
Dollars ($[***])
upon the date the first patient is enrolled in a Phase II clinical
trial
of Sphingosomal Topotecan conducted pursuant to an IND sponsored
by Hana,
which payment shall be made by Hana issuing to INEX a number of additional
shares of Common Stock determined by dividing [***]
Dollars ($[***])
by the FMV as of the date of such first patient enrollment;
and
|
| (C) |
[***]
Dollars ($[***])
upon the approval by the FDA of an NDA relating to Sphingosomal Topotecan,
which payment shall be made by Hana issuing to INEX a number of additional
shares of Common Stock determined by dividing [***]
Dollars ($[***])
by the FMV as the date of such FDA approval; provided however, if
a
Regulatory Submission equivalent to an NDA is approved in any of
the
Designated EU States before an NDA relating to Sphingosomal Topotecan
is
approved by the FDA, [***]
the milestone due under this Section 5.7(c)(i)(C)
will be paid by Hana to INEX immediately upon approval of that equivalent
filing and the remaining balance will be paid by Hana to INEX immediately
upon the approval of an NDA relating to Sphingosomal Topotecan by
the
FDA.
|
| (D) |
For
the avoidance of doubt, each of the milestone payments described
in
subparagraphs (A), (B) and (C) of this Section 5.7(c)(i)
above represent one-time payments to INEX, and shall be due only
upon the
first occurrence of the events described in each such subparagraph.
For
example, the milestone payment described in subparagraph (A) above
will be
due only once, upon the date the first patient is enrolled in a clinical
trial of Sphingosomal Topotecan conducted pursuant to an IND sponsored
by
Hana. No additional milestone payments to INEX shall be due from
Hana
pursuant to subparagraph (A) in connection with any subsequent clinical
trials sponsored by Hana.
|
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23 -
| (ii) |
Royalties:
|
Hana
shall pay to INEX royalty payments
based
on cumulative Net Sales of
Sphingosomal Topotecan as
follows:
| (A) |
With
respect to Net Sales of Sphingosomal Topotecan in the United States,
a
royalty equal to the sum of: (i) [***]
percent ([***]%)
of Net Sales in consideration of the Patents if the Product sold
is
embraced within any Valid Claim under the Patents in the United States;
(ii) [***]
percent ([***]%)
of Net Sales in consideration of, and during any period of product
exclusivity provided by the laws of the United States of America,
including but not limited to marketing exclusivity in the form of
data
exclusivity, pediatric exclusivity, and orphan drug designation
exclusivity; and (iii) [***]
percent ([***]%)
of Net Sales in consideration of Technology; provided, however, that
the
total royalty paid shall be limited to [***]
percent ([***]%)
of cumulative Net Sales up to [***]
Dollars ($[***]),
and limited to [***]
percent ([***]%)
of cumulative Net Sales exceeding [***]
Dollars
($[***]);
|
| (B) |
With
respect to Net Sales of Sphingosomal Topotecan in each country of
the
Territory other than the United States, a royalty of [***]
percent
([***]%)
of Net Sales in consideration of Technology; provided, however, that
the
total royalty paid shall be limited to [***]
percent ([***]%)
of cumulative Net Sales up to [***]
Dollars
($[***]),
and increased to [***]
percent ([***]%)
of cumulative Net Sales in excess of [***]
Dollars
($[***]
).
|
| (iii) |
Generic
Competition:
|
If,
during a given calendar year, there is sale of a generic Sphingosomal Topotecan
or sale of an approved equivalent to Sphingosomal Topotecan (collectively,
“Approved
Sphingosomal Topotecan Equivalents”)
in any
country in the Territory, them, for such country, the total amount of Royalties
Due INEX for the Net Sales of Sphingosomal Topotecan in such country during
such
calendar year will be reduced to [***]
percent
([***]%)
of the
Royalties Due INEX pursuant to Section 5.7(c)(ii)
for such
calendar year, in such country.
| (iv) |
Deductions:
|
Notwithstanding
the schedule of royalty payments set forth in Section 5.7(c)(ii),
Hana
shall be entitled to deduct from such Sphingosomal Topotecan royalty obligations
owed by Hana to INEX, an amount equal to [***]
percent
([***]%)
of the
research and development expenses Hana incurs in connection with the Development
of Sphingosomal Topotecan (the “Sphingosomal
Topotecan R&D Expenses”);
provided however, that such deduction shall not exceed the lesser
of:
| (A) |
[***]
Dollars ($[***]);
or
|
-
24 -
| (B) |
[***]
Dollars ($[***])
per patient treated in a Registrational Clinical
Trial;
|
provided
further, however, that such deduction for Sphingosomal Topotecan R&D
Expenses shall not exceed [***]
percent
([***]%)
of the
royalty amount otherwise payable by Hana to INEX for Sphingosomal Topotecan
in
each calendar year, provided that Hana shall be entitled to carry over into
succeeding
years
any
amount of Sphingosomal Topotecan R&D Expenses that were ineligible for
deduction as a result of the such limitation. All Sphingosomal Topotecan R&D
Expenses shall be subject to audits by INEX using reasonable and customary
audit
procedures in order to verify the amounts thereof.
| (d) |
Limitation
on Payment Using Common Stock
|
Notwithstanding
anything to the contrary contained in Sections 5.7(b)
and
5.7(c),
at
Hana’s sole option, any milestone or other payment payable by Hana to INEX
hereunder by the issuance of shares of Common Stock to INEX may also be made
by
payment of cash to INEX. The maximum number of shares of Common Stock that
Hana
may issue to INEX in satisfaction of its obligations hereunder shall not exceed
19.99% of the total number of shares of Common Stock outstanding on the
Effective Date (the “Maximum
Issuance Amount”).
In
the event Hana issues to INEX an aggregate number of shares of Common Stock
that
equals the Maximum Issuance Amount, all amounts payable by Hana thereafter
to
INEX shall be made in cash.
| (e) |
Remuneration
Respecting Sublicensees
|
| (i) |
In
the event Hana sublicenses its rights under Sphingosomal Vincristine
before the FDA approves the Sphingosomal Vincristine NDA or a Designated
EU State approves a Regulatory Submission that is equivalent to an
NDA,
INEX shall be entitled to receive [***]
percent
([***]%)
of any Sublicensing Revenue Due INEX payable to Hana by such Sublicensee.
In the event Hana sublicenses its rights to Sphingosomal Vincristine
after
the FDA approves the Sphingosomal Vincristine NDA or a Designated
EU State
approves a Regulatory Submission that is equivalent to an NDA, INEX
shall
be entitled to receive [***]
percent ([***]%)
of any Sublicensing Revenue Due
INEX
payable to Hana by such
Sublicensee;
|
| (ii) |
In
the event Hana sublicenses its rights under Sphingosomal Vinorelbine,
INEX
shall be entitled to share the Sublicensing Revenue Due
INEX
payable to Hana, if any, as
follows:
|
| (A) |
INEX’s
share of such Sublicensing Revenue Due
INEX
shall be [***]
percent ([***]%)
of any Sublicensing Revenue Due
INEX
payable to Hana by such Sublicensee during the period commencing
on the
Effective Date and ending on the date immediately preceding the date
the
first patient is enrolled in a Phase II clinical trial of Sphingosomal
Vinorelbine;
|
| (B) |
INEX’s
share of such Sublicensing Revenue Due
INEX
shall be reduced to [***]
percent ([***]%)
of
any Sublicensing Revenue Due
INEX
payable to Hana by such Sublicensee on or after the date the first
patient
is enrolled in Phase II clinical trial of Sphingosomal Vinorelbine
and
ending on the date immediately preceding the earlier to occur
of:
|
-
25 -
| (1) |
the
date the first patient is enrolled in a Phase III clinical trial
of
Sphingosomal Vinorelbine; or
|
| (2) |
the
acceptance of the NDA or its equivalent Regulatory Submission for
Sphingosomal Vinorelbine; and
|
| (C) |
INEX’s
share of such Sublicensing Revenue Due
INEX
shall be reduced to [***]
percent ([***]%)
of any Sublicensing Revenue Due
INEX
payable to Hana by such Sublicensee on or after the earlier to occur
of:
|
| (1) |
the
date the first patient is enrolled in a Phase III clinical trial
of
Sphingosomal Vinorelbine; or
|
| (2) |
the
acceptance of the NDA or its equivalent Regulatory Submission for
Sphingosomal Vinorelbine.
|
| (iii) |
In
the event Hana sublicenses its rights under Sphingosomal Topotecan,
INEX
shall be entitled to share the Sublicensing Revenue Due
INEX payable
to Hana, if any, as follows:
|
| (A) |
INEX’s
share of such Sublicensing Revenue Due
INEX shall
be [***]
([***]%)
of any Sublicensing Revenue Due
INEX payable
to Hana by such Sublicensee during the period commencing on the Effective
Date and ending on the date immediately preceding the date the first
patient is enrolled in a Phase II clinical trial of Sphingosomal
Topotecan;
|
| (B) |
INEX’s
share of such Sublicensing Revenue Due
INEX shall
be reduced to [***]
percent ([***]%)
of any Sublicensing Revenue Due
INEX payable
to Hana by such Sublicensee on or after the date the first patient
is
enrolled in Phase II clinical trial of Sphingosomal Topotecan and
ending
on the date immediately preceding the earlier to occur
of:
|
| (1) |
the
date the first patient is enrolled in a Phase III clinical trial
of
Sphingosomal Topotecan, or
|
| (2) |
the
acceptance of the NDA or its equivalent Regulatory Submission for
Sphingosomal Topotecan.
|
| (iv) |
Notwithstanding
anything to the contrary contained in this Section 5.7(e)(iii),
Hana shall have no obligation to pay to INEX its respective share
of any
such Sublicensing Revenue Due
INEX unless
and until Hana
actually
receives such Sublicensing Revenue Due
INEX from
its Sublicensee.
|
| (v) |
Where
any Sublicensing Revenue Due
INEX payable
to, collected or received by Hana or its Affiliates is in Dollars,
Hana
shall pay to INEX, INEX’s share of such Sublicensing Revenue Due
INEX within
ten
(10)
days of Hana or its Affiliate’s receipt of same. Where
any Sublicensing Revenue Due
INEX payable
to, collected or received by Hana or its Affiliates is derived from
a
country other than the United States of America, INEX’s portion of such
Sublicensing Revenue Due
INEX shall
be converted to the equivalent in Dollars on the same date that Hana
converts such Sublicensing Revenue Due
INEX to
Dollars, in which case the amount of Dollars pursuant to an actual
conversion shall be included in the Sublicensing Revenue
Due INEX
and Hana shall pay to INEX, INEX’s share of such Sublicensing
Revenue
Due INEX
within ten
(10)
days of such conversion. If at any time the Parties agree that it
is not
practical or possible for Hana to forthwith convert Sublicensing
Revenue
Due
INEX paid
in foreign currency to Dollars, or if legal restrictions prevent
the
conversion of part or all of the Sublicensing Revenue Due
INEX to
Dollars, Hana shall have the right and option, upon consultation
with
INEX, to deposit INEX’s share of such Sublicensing Revenue Due
INEX in
local currency, in an account in INEX’s sole name in a bank or depository
in the country where such Sublicensing Revenue Due
INEX is
generated. Hana
shall make such deposit within ten
(10)
days of Hana or its Affiliate’s receipt of said foreign currency. The last
date of signature of any duly executed sublicensing agreement between
Hana
and a Sublicensee shall be deemed to be the date upon which Sublicensing
Revenue
Due INEX
is
received by Hana for the purposes of determining the percentage of
Sublicensing Revenue Due
INEX payable
to INEX pursuant to Sections 5.7(b)
and 5.7(c).
Hana shall make Commercially Reasonable Efforts to inform INEX in
a timely
manner of material legislative and economic changes in such country
in
which such deposit was made so as to enable INEX to more readily
access,
convert and/or transfer from such country, INEX’s share of Sublicensing
Revenue
Due INEX
deposited in such country by Hana
|
-
26 -
| (vi) |
Notwithstanding
Section 5.7(e)(v),
if any Sublicensing Revenue
Due INEX
other than cash is payable to, collected or received by Hana or its
Affiliates,
Hana may elect to pay to INEX, INEX’s share of Sublicensing
Revenue
Due INEX
by
way of cash, common stock of Hana, common stock of another corporation
acceptable to INEX, or any combination thereof. If Hana elects to
pay INEX
using the common stock of Hana or the common stock of another corporation
acceptable to INEX, the following shall
apply:
|
| (A) |
the
last date of signature of any duly executed sublicensing agreement
between
Hana and a Sublicensee shall be deemed to be the date upon which
Sublicensing Revenue
Due INEX
is
received by Hana for the purposes of determining the percentage of
Sublicensing Revenue
Due INEX
payable to INEX pursuant to Sections 5.7(e)(i)
and 5.7(e)(ii);
|
| (B) |
the
value of the economic benefit of the Sublicensing Revenue Due
INEX
established by a Third
Party banker or valuator, measured in Dollars and applied to the
percentage entitlement of INEX determined pursuant to Section 5.7(e)(vi)(A),
shall be the assessed value (the “Assessed
Value”)
to be used in determining the number common stock of Hana or of
another corporation acceptable to INEX
payable to INEX pursuant to Section 5.7(e)(vi)(C);
and
|
| (C) |
Hana
will pay INEX using common stock of Hana or of another corporation
acceptable to INEX as follows:
|
| (1) |
the
Parties will mutually agree on the par value per share of common
stock of
Hana or of another corporation acceptable to INEX;
and
|
| (2) |
Hana
will issue or assign to INEX as applicable, a number of common stock
of
Hana or of another corporation acceptable to INEX by dividing the
Assessed
Value by the FMV as of the date upon which Sublicensing
Revenue
Due INEX
was deemed to have been received by Hana pursuant to Section 5.7(e)(vi)(A).
|
-
27 -
If
Hana
elects to pay Sublicensing Revenue
Due
INEX
using a
combination of cash and common stock as described in this Section, the Assessed
Value used to calculate the stock payable shall be reduced by the value of
Dollars actually paid to INEX in accordance with Section 5.7(e)(v).
| (D) |
Hana’s
payment of Sublicensing Revenue Due INEX in the form of stock pursuant
to
this Section shall
be
made within ten (10) days of Hana’s receipt of
same.
|
| (vii) |
Hana’s
payment of Sublicensing Revenue Due INEX under this Section 5.7(e)
shall be accompanied by an accounting setting out all Sublicensing
Revenue
Due INEX payable to, collected or received by Hana or its Affiliates,
segmented according to Product, Sublicensee identified by name, and
the
last date on which each sublicensing agreement was
executed.
|
| (f) |
Third
Party Payments
|
| (i) |
If,
during the term of this Agreement:
|
| (A) |
Hana
and INEX mutually agree that it is necessary to seek a license from
any
Third Party in the Territory in order to avoid infringement during
the
exercise of the rights herein granted;
or
|
| (B) |
if
as a result of any complaint alleging infringement or violation of
any
patent or other Intellectual Property Rights is made against Hana,
its
Affiliate or its Sublicensee with respect to the Manufacture, use
or sale
of a Product in the Hana Field, where such Manufacture, use or sale
is
encompassed by the Technology, and a settlement, consent judgement
or
award of Damages determined by a court of competent jurisdiction
requires
Hana to make payment of Damages to a Third Party in satisfaction
of such
complaint; or
|
| (C) |
if
an independent, mutually acceptable Third Party patent attorney determines
that such a license is required (in accordance with the procedure
outlined
in this Section 5.7(f)(i);
|
Hana
shall pay all royalties, Damages or other amounts to the Third Party (the
“Offset
Amount”),
and
subject
to Section 5.7(f)(ii),
Hana’s
sole remedy from INEX for such payment shall be to offset or credit [***]
percent
([***]%)
of the
Offset Amount against future payments otherwise due INEX as royalties hereunder.
Royalties due INEX shall not, however, be reduced by more than [***]
percent
([***]%)
of the
applicable royalties set forth in
Sections
5.7(b)(ii)
and
5.7(c)(ii)
during
any
given
calendar year. Any uncredited portion of the permitted Offset Amount will be
carried forward until the full permitted Offset Amount has been satisfied.
The
Offset Amount shall not include any punitive award payable to the Third Party
(the “Punitive
Amount”),
and
thus any Punitive Amount is not to be offset or credited against future royalty
payments due INEX. In the event that the Parties are unable to agree on whether
any such license is needed or on the terms of such license, the Parties shall
submit such dispute to an independent, mutually acceptable Third Party patent
attorney for a final and binding determination of such dispute, and the Parties
shall equally share the cost of engaging such patent attorney.
-
28 -
| (ii) |
Notwithstanding
the provisions of Section 5.7(f),
if the license from the Third Party or the royalty or other amount
payable
to such Third Party gives rise to an indemnification obligation under
one
or more of the Definitive Agreements in favour of Hana on the part
of
INEX, then such royalty or other amount shall be paid by INEX as
Damages
in accordance therewith; provided however, that Hana agrees to use
all
reasonable efforts to avoid a finding of wilful infringement of such
Third
Party’s rights.
|
| (g) |
Compulsory
Licenses
|
In
the
event that a government agency in any country of the Territory grants or compels
INEX,
Hana,
or either of their respective Affiliates or Sublicenses
to grant
a right to commercialize Product to any Third Party, Hana may,
at its
sole option,
either:
| (i) |
avail
itself of the royalty reduction set out in Sections 5.7(b)(iv)
and 5.7(c)(iv),
if applicable; or
|
| (ii) |
have
the benefit in such country of the same terms granted to such Third
Party
to the extent that such terms taken as a whole are more favourable
than
those of this Agreement.
|
| (h) |
Withholding
Taxes
|
Any
tax
which Hana is required to pay or withhold with respect of license fees, royalty
payments and milestone payments to be made to INEX hereunder shall be deducted
from the amount otherwise due provided that, in regard to any such deduction,
Hana shall give INEX such assistance, which shall include the provision of
such
documentation as may be required by the US Internal Revenue Service and other
revenue services, as may reasonably be necessary to enable INEX to evidence
such
payment, claim exemption therefrom or obtain a repayment thereof or a reduction
thereof and shall upon request provide such additional documentation from time
to time as is needed to confirm the payment of tax. The Parties agree
that:
| (i) |
Hana
shall be deemed to be the sole payer of payments owed to INEX under
this
Agreement and shall not have the right to substitute any domestic
or
foreign Affiliate for that purpose,
and
|
| (ii) |
in
the event that Hana takes any action, including, without limitation,
the
assignment of this Agreement, any sublicensing permitted hereby,
any
change of jurisdiction of residence or any reorganization or change
in its
business or structure so that, after such action, the withholding
tax on
the payments under this Agreement would be substantially more than
those
in effect on the Effective Date, Hana shall
either:
|
| (A) |
with
the co-operation of INEX, arrange its affairs so that the withholding
tax
consequences to INEX are not materially worse than those in effect
prior
to such action; or
|
| (B) |
gross
up the payments otherwise owed to INEX so that INEX receives net
of
withholding taxes the amount INEX would have received but for such
action.
|
| (i) |
Foreign
Payments
|
-
29 -
Where
payments are due INEX hereunder for sales of a Product in a country in the
Territory where, by reason of currency regulations or taxes of any kind, it
is
impossible or illegal for Hana, any Affiliate or Sublicensee to transfer such
payments to INEX, such payments shall be deposited in whatever currency is
allowable by the Person not able to make the transfer for the benefit or credit
of INEX in an accredited bank in that country in the Territory that is
reasonably acceptable to INEX.
| (j) |
Method
of Payment
|
Hana
shall make all payments due under this Agreement in Dollars by wire transfer
of
funds via the Federal Reserve Wire Transfer System to each of INEX’s and the
University’s account as designated in writing by each of INEX and the University
to Hana.
| (k) |
Late
Payments
|
Any
payment by Hana or INEX that is not paid on or before the date such payment
is
due under this Agreement shall bear interest at a rate equal to the lesser
of:
| (i) |
the
Prime Rate(s) during the period of late payment plus [***]
percent ([***]%)
interest compounded monthly, or
|
| (ii) |
the
maximum rate permitted by law;
|
calculated
based on the number of days that payment is delinquent until full payment has
been made.
| (l) |
Records
|
Hana
shall keep, and shall require all Affiliates and Sublicensees to keep, full,
true and accurate books of accounts and other records containing all information
and data which may be necessary to ascertain and verify the royalties payable
hereunder for a period of three (3) years after the date such royalties became
payable.
| (m) |
Audits
|
During
the Term, after the first commercial sale of Product and for a period of one
(1)
year following termination of this Agreement, INEX shall have the right from
time to time (not to exceed once during each calendar year) to have either
its
internal financial audit personnel or an independent firm of accountants (i.e.,
a certified public accountant or like person reasonably acceptable to Hana)
inspect such books, records and supporting data of Hana, provided such audit
shall not cover such records for more than the preceding five years. Such
independent firm of accountants shall perform these audits at INEX’s expense
upon reasonable prior notice and during Hana’s regular business hours, and shall
agree as a condition to such audit to maintain the confidentiality of all
information of Hana disclosed or observed in connection with such audit and
to
disclose to INEX only whether Hana has complied with its obligations under
this
Agreement with respect to the accuracy of the royalty statements, payments
and
permitted deductions. If the result of such audit demonstrates an underpayment
by Hana to INEX of [***]%
or
more, Hana shall pay for the reasonable costs of such audit, and shall
immediately pay to INEX the underpayment together with interest thereon at
the
Royal Bank of Canada prime lending rate prevailing at the time, plus
[***]
([***]%).
| (n) |
Hana
and INEX understand and recognize that there are a number of license,
sublicense and other agreements between the parties comprising the
grant
of rights by INEX to Hana. Notwithstanding that Hana’s financial
obligations to INEX may be repeated or referentially incorporated
in part
or in whole in each such agreement, the Parties agree that Hana’s
cumulative financial obligation to INEX shall comprise the
following:
|
| (i) |
the
Closing Payment;
|
-
30 -
| (ii) |
the
Closing Shares;
|
| (iii) |
Hana’s
assumption of all payment obligations of INEX
to:
|
| (A) |
the
BCCA pursuant to the BCCA Agreements as defined in the License
Agreement;
|
| (B) |
MD
Xxxxxxxx pursuant to the MD Xxxxxxxx License as defined in the License
Agreement; and
|
| (C) |
the
University pursuant to the UBC
License;
|
| (iv) |
Royalties
Due INEX pursuant to this Agreement;
and
|
| (v) |
Sublicensing
Revenue Due INEX pursuant to this
Agreement.
|
Article
6 PATENTS
6.1 IP
Committee
The
Parties will establish an IP committee (the “IP
Committee”)
comprised of an equal number of Representatives of each Party to coordinate
patent prosecution and maintenance of the Patents. The IP Committee will conduct
planning meetings as frequently as the Parties deem necessary. The primary
method of meeting will be teleconference. The cost of conducting IP Committee
meetings shall be allocated between the Parties pro-rata based on the combined
average of each Party’s percentages of responsibilities set forth in each of the
patent schedules attached to the Definitive Agreements.
6.2 Responsibility
for Patent Prosecution and Maintenance
Subject
to prior consultation with the University and to the University giving its
consent in respect of each material decision to be made concerning any Patent,
the Parties may pursue patent prosecution and maintenance as
follows:
| (a) |
In
respect of all patent and patent applications identified in Schedule
“A”,
Hana shall be responsible for:
|
| (i) |
the
continued prosecution of any such pending patent applications to
the
issuance of the resulting patents;
|
| (ii) |
the
maintenance of all such issued Patents;
and
|
| (iii) |
the
filing of additional patent applications for such Patents in any
jurisdiction world-wide, including, without limitation, any continuations,
continuations-in-part, divisionals, patents of addition, reissues,
re-examinations and extensions of or substitutes therefore, which
additional patent applications (and resulting patents) shall be
automatically included in the Patents, and the provision of this
Article
6
shall apply thereto.
|
All
reasonable costs and expenses arising from Hana’s patent prosecution and
maintenance shall be allocated between the Parties pro-rata based on the
percentages set forth in Schedule
“A”.
| (b) |
Notwithstanding
the allocation of patent prosecution and maintenance costs set forth
in
this Section 6.2,
if Hana requests IP Services from INEX in respect of any activities
which
would otherwise have been performed by Hana pursuant to Section
6.2(a)
,
INEX shall be entitled to payment of IP Services in accordance with
the
provisions of Section 6.9
herein and the applicable provisions of the Service
Agreement
|
-
31 -
| (c) |
Hana
shall be responsible for the prosecution of the pending patent
applications included in the Patents in accordance with the
responsibilities set forth in Section 6.2(a)
and cost allocations set forth in
Schedule “A”.
The cost allocations set out in Schedule
“A” shall
be subject to review and amendment by mutual agreement of the Parties
on
an annual basis on or before December 31 of each year during the
Term. In
the event that the parties cannot reach agreement on or before December
31, the matter will be resolved by arbitration in accordance with
Section
14.3.
|
| (d) |
Hana
shall diligently pursue the prosecution of all patent applications
in
accordance with the responsibilities set forth in Section 6.2(a)
and cost allocations set forth in Schedule
“A” to
issuance of the resulting patents and shall not abandon, withdraw
or
discontinue prosecution of any pending patent applications included
in the
Patents without first consulting with and obtaining the prior written
consent of INEX, which consent shall not be withheld if the Parties
agree
that the issuance of a patent from such application is
unlikely.
|
| (e) |
At
the request of INEX, Hana shall diligently pursue and prosecute additional
patent filings relating to the Patents and Technologies in any
jurisdiction worldwide in accordance with the responsibilities set
forth
in Section 6.2(a)
and cost allocations set forth in Schedule
“A”.
|
| (f) |
Either
Party may request the other Party to file new patent applications,
divisionals, provisionals, non-provisionals, continuations and
continuations-in-part to ensure that Valid Claims on Patents remain
pending. If the Party having primary responsibility for patent prosecution
and maintenance decides not to meet such request, the requesting
Party
shall be entitled to, at the requesting Party’s
election:
|
| (i) |
refer
the matter to arbitration pursuant to 14.3;
or
|
| (ii) |
perform
such filings and take such actions as it deems necessary and at its
sole
cost.
|
If
the
requesting Party elects not to refer the matter to arbitration, the other Party
shall, at the sole cost of the requesting Party:
| (iii) |
cooperate
with the requesting Party perform such filings and take such actions
as
may be required by the requesting Party if the requesting Party does
not
have standing to perform such filings and take such actions;
or
|
| (iv) |
grant
the requesting Party a power-of-attorney to perform such filings
and take
such actions as may be required by the requesting
Party;
|
to
ensure
that Valid Claims to the Patents remain pending.
6.3 Identification
of Additional Process or Use
Hana
shall have the rights, with reasonable input from INEX and the University,
to
identify any process, use or products in the Hana Field arising out of the
Technology that may be patentable and may provide written notice thereof to
INEX, upon which Hana shall take all reasonable steps to obtain a patent
assigned to the University provided that the costs of applying for, registering,
and maintaining the patent shall be shared by the Parties in accordance with
the
cost allocations set forth in Schedule
“A”
for
those jurisdictions in which Hana determines that a patent is required. In
the
event that the Parties cannot agree on an allocation of such costs within a
reasonable time, the matter will be resolved in accordance with the dispute
resolution procedure described under Section 14.3.
-
32 -
6.4 Issuance
of Patent
On
the
issuance of a patent for the Technology applied for in accordance with Section
6.3
and/or
6.5,
Hana
shall have the right to become, and shall become the sublicensee of the same
within the Hana Field, all pursuant to the terms contained herein, and
Schedule“A”
will
be
deemed to be amended to include such patents.
6.5 Improvements
For
the
purposes of this Section 6.5,
“Improvements”
means,
in respect of any Patents:
| (a) |
any
and all patents and any and all patent applications that claim priority
to
such Patents (whether complete or incomplete or whether filed or
unfilled)
including, but not limited to, provisional, non-provisional, continuations
and continuations-in-part, and divisional patent applications and
registrations in any jurisdiction world-wide;
and
|
| (b) |
any
and all inventions arising from such patents or patent applications
whether patented or not.
|
To
the
extent possible, and unless precluded by any present or future agreement of
Hana
or its Sublicensees, any Improvements made:
| (c) |
by
Hana, whether solely or jointly with any Person other than a
Sublicensee;
|
| (d) |
by
a Sublicensee, whether solely or jointly with any Person other than
Hana;
or
|
| (e) |
jointly
by Hana and a Sublicensee;
|
shall
be
solely owned by the University. Hana and/or its Sublicensees shall assign or
cause to be assigned to the University all right, title and interest in and
to
such Improvements. Such Improvements shall be added to Schedule“A”.
Hana
shall ensure that its Representatives who perform any portion of its obligations
under
this Agreement have entered into written agreements with such Hana whereby
such
Representatives assign to the University all ownership rights in any
Intellectual Property Rights made or developed by such Representatives
in the course of such work for Hana.
6.6 Consultation
and Reporting
Subject
to prior consultation with the University and to the University giving its
consent in respect of each material decision to be made concerning any Patent,
the Parties may pursue patent prosecution and maintenance as
follows:
| (a) |
On
a timely basis, Hana will consult with or instruct its patent agent(s)
and/or patent counsel(s) to consult with INEX, and INEX will consult
with
or instruct its patent agent(s) and/or patent counsel(s) to consult
with
Hana, regarding the claims and any proposed amendments thereto of:
|
| (i) |
any
Patents pending and issued; and
|
| (ii) |
any
additional patent applications to be included in the
Patents;
|
to
ensure
that the scope of patent coverage is adequate for the uses of the Patents
contemplated by each of Hana and INEX.
| (b) |
On
a timely basis, Hana shall provide INEX with copies of the material
correspondence and documents which Hana sends or receives in connection
with the application, prosecution and maintenance of Patents, and
INEX
shall provide Hana with copies of the material correspondence and
documents which INEX sends or receives in connection with the application,
prosecution and maintenance of
Patents
|
-
33
-
| (c) |
Provided
a Party has provided timely notice and copies of material correspondence
to the other Party of any matter requiring any action relating to
any
application, prosecution or maintenance of the Patents, the Party
providing timely notice shall not be found to be in breach of its
obligations under this Article
6
if
the other Party, its patent agent(s) and/or patent counsel(s) fail
to
consult with or provide written instructions to the Party providing
timely
notice, at least five (5) Business Days prior to any deadline including
an
extendible deadline, in respect of any action required for the
application, prosecution or maintenance of the Patents.
|
| (d) |
Hana
acknowledges and agrees that any report provided by Hana to INEX
in
accordance with this Article
6
may be used by INEX in INEX’s preparation of reports to the
University.
|
6.7
Reports
On
a
quarterly basis, on or before the last day of each Calendar Quarter during
the
Term, each Party shall advise the other Party and the University in writing
of
the material actions which each Party has undertaken concerning the application,
prosecution and maintenance of the Patents.
| 6.8 |
Abandonment, Withdrawal or
Discontinuance
|
| (a) |
Notwithstanding
each Party’s obligation under Section 6.2,
should either Party decide to:
|
| (i) |
discontinue
pursuing one or more patent applications, patent protection or patent
maintenance for one or more patents in relation to the Patents or
any
continuation, continuation in-part, divisional, reissue, re-examination
or
extension thereof for any reason;
|
| (ii) |
not
pursue patent protection in relation to the Patents in any specific
jurisdiction for any reason; or
|
| (iii) |
discontinue
or not pursue patent protection in relation to any further process,
use or
Product arising out of the Patents in any jurisdiction for any
reason;
|
then
such
Party (the “Abandoning
Party”)
shall
provide the other Party (the “Non-Abandoning
Party”)
with
prior written notice of its decision to discontinue or not to pursue one or
more
patent applications, patent protection, or patent maintenance, in relation
to
the Patents (the “Notice
of Abandonment”),
and
to provide sufficient detail to the other Party in sufficient time, such time
not to be less than thirty (30) Business Days, to enable the other Party to
file
a patent application or continue pursuing an existing patent application in
accordance with Sections 6.8(e)
or
6.8(g).
The
Parties agree that any Notice of Abandonment must be given to the other Party
with sufficient advance notice to enable the other Party to comply with Sections
6.5, 6.6. and 6.7 of the UBC License.
| (b) |
The
Notice of Abandonment to be given by the Abandoning Party pursuant
to
Section 6.8(a)
shall clearly identify the patent applications, patent protection,
and/or
patent maintenance for the Patents to be abandoned.
|
| (c) |
Each
of the Parties agrees that notwithstanding any provision to the contrary
in this Agreement, effective upon the date of the Non-Abandoning
Party’s
receipt of the Notice of Abandonment, the Abandoning Party shall
lose all
right to any and all uses of:
|
-
34
-
| (i) |
the
patent(s) and patent application(s) to which such Party’s Notice of
Abandonment applies; and
|
| (ii) |
any
continuation, continuation-in-part, divisional, reissue, re-examination,
or extension of or to the
foregoing;
|
(any
one
of the above being the “Discontinued
Patent”).
| (d) |
Subject
to Hana having obtained the University’s prior written consent to the
abandonment of a Patent if Hana gives Notice of Abandonment to INEX
pursuant to Sections 6.8(a)
and 6.8(b),
this sublicense shall be terminated with respect solely to the
Discontinued Patent, and Hana shall forfeit the right to any and
all uses
of the Discontinued Patent and technology claimed in such Discontinued
Patent. Schedule“A” will
be deemed to be amended to exclude such Discontinued Patent and technology
claimed in such Discontinued Patent from the grant of sublicense
contained
herein.
|
| (e) |
If
Hana has given Notice of Abandonment to INEX pursuant to Sections
6.8(a)
and 6.8(b),
and INEX wishes to continue to pursue any patent applications, patent
protection and/or patent maintenance in relation to Hana’s Discontinued
Patent:
|
| (i) |
within
ten (10) Business Days of INEX’s receipt of Hana’s Notice of Abandonment,
INEX shall provide Hana with written notice of INEX’s intention to pursue
any patent applications, patent protection and/or patent maintenance
in
relation to Hana’s Discontinued
Patent;
|
| (ii) |
Hana
shall relinquish patent prosecution and maintenance of Hana’s Discontinued
Patent and INEX shall assume patent prosecution and maintenance of
same,
at INEX’s sole cost and expense;
and
|
| (iii) |
notwithstanding
the Non-Competition Terms, INEX
shall have the exclusive right to use Hana’s Discontinued Patent and
technology claimed in Hana’s Discontinued Patent, in the Hana Field.
|
| (f) |
Subject
to INEX having obtained the University’s prior written consent to the
abandonment of a Patent, If INEX gives Notice of Abandonment to Hana
pursuant to Sections 6.8(a)
and 6.8(b),
INEX shall forfeit the right to any and all uses of the Discontinued
Patent and technology claimed in any Discontinued Patent, notwithstanding
that INEX may remain the nominal owner of such Discontinued
Patent.
|
| (g) |
If
INEX has given Notice of Abandonment to Hana pursuant to Sections
6.8(a)
and 6.8(b)
and Hana wishes to continue to pursue any patent applications, patent
protection and/or patent maintenance in relation to INEX’s Discontinued
Patent:
|
| (i) |
within
ten (10) Business Days of Hana’s receipt of INEX’s Notice of Abandonment,
Hana shall provide INEX with written notice of Hana’s intention to pursue
any patent applications, patent protection and/or patent maintenance
in
relation to INEX’s Discontinued Patent, at Hana’s sole cost and expense;
and
|
| (ii) |
notwithstanding
the Non-Competition Agreement, Hana
shall have the exclusive right to use INEX’s Discontinued Patent and the
technology claimed in INEX’s Discontinued Patent, outside the Hana
Field.
|
| (h) |
INEX
may request Hana to perform Hana’s responsibilities set forth in Sections
6.2(a)
in
respect of a particular patent or patent application. If Hana is
unwilling
or unable to perform its responsibility in a timely manner, INEX
may, with
three (3) days prior written notice, perform the particular activity(ies)
requested in respect of such patent or patent application. Hana shall
pay
all reasonable costs and out-of-pocket expenses actually incurred
by INEX
to perform the particular activity(ies) requested, within thirty
(30) days
of Hana’s receipt of INEX’s invoice for such costs and out-of-pocket
expenses. For the purposes of this Section 6.8(h),
reasonable costs shall
be calculated using the FTE Rate set forth in the Service Agreement,
and
notwithstanding any termination of the Service Agreement.
|
-
35 -
6.9
Costs
of Patent Application, Prosecution and Maintenance
| (a) |
Commencing
from the date that an Abandoning Party has lost all entitlement to
a
Discontinued Patent, such Abandoning Party shall not be required
to share
in any costs (and fees for IP Services if INEX is the Abandoning
Party)
associated with the application, prosecution, and/or maintenance
of any
Patents in the Discontinued Patent.
|
| (b) |
Subject
to Section 6.8
and notwithstanding any termination of the Service Agreement, for
as long
as INEX continues to perform at Hana’s request, the activities required
for intellectual property portfolio management and all associated
activities including, without limitation, patent application, filing,
prosecution and maintenance, and payment of all government and legal
fees
required to apply for, prosecute and maintain the Patents described
in
Section 6.2(a)
(the “IP
Services”),
Hana, its successors, assigns or any Person(s) who acquires any interest
in any of the Technology will jointly and severally be responsible
for
paying INEX:
|
| (i) |
[***]
percent
([***]%)
of all reasonable out-of-pocket costs, including, without limitation,
filing fees, fees for external counsel(s), patent agent(s), contractors,
travel, and lodging expenses incurred by INEX to provide IP Services;
and
|
| (ii) |
[***]
percent
([***]%)
of the personnel costs incurred by INEX, calculated at INEX’s FTE Rate,
pro rated to reflect the actual time employees, contractors or consultants
of INEX spend providing IP Services; provided however, that on each
anniversary of the Effective Date, the FTE Rate shall be raised by
a
percentage equal to the percentage increase in the Consumer Price
Index
(All Items) for the province of British Columbia for the twelve (12)
month
period ending with December of the calendar year immediately preceding
such anniversary date; and
|
| (iii) |
[***]
percent
([***]%)
of all out-of-pocket costs and [***]
percent
([***]%)
of all personnel costs incurred by INEX to provide IP Services in
respect
of any Discontinued Patent which Hana has elected to continue pursuing
patent protection, pursuant to Section 6.8(g).
|
| (c) |
INEX
will invoice Hana monthly for all costs set forth in Section 6.9(b),
plus all applicable taxes thereon, on or before the 30th
day after the end of the month in which the IP Services were rendered
and/or expenses incurred; provided however, that any out-of-pocket
costs
incurred which are not captured in any invoice may be captured in
subsequent invoices. Hana will pay all amounts due and payable hereunder
in full in US Dollars to INEX within thirty (30) days of the date
of each
such invoice, by cheque or wire transfer to the account specified
by
INEX.
|
| (d) |
Notwithstanding
Section 6.9(c),
during the Term, INEX shall not combine Hana’s payment obligations for IP
Services under the Service Agreement together with Hana’s payment
obligations under this Section to recover from Hana, its successors,
assigns or any Person(s) who acquires any interest in any of the
Technology, more than the total monthly costs set forth in Section
6.9(b)
in
any given month.
|
-
36 -
6.10
Late
Payments
Any
payment due under Section 6.9
that is
not paid on or before the date such payment is due shall bear interest at a
rate
equal to the lesser of:
| (a) |
the
Prime Rate(s) during the period of late payment plus [***]
percent ([***]%)
interest compounded monthly; or
|
| (b) |
the
maximum rate permitted by law;
|
calculated
based on the number of days that payment is delinquent until full payment has
been made.
6.11
Co-operation
Each
Party agrees to obtain the co-operation of its Representatives in the assignment
of any Intellectual Property Rights addressed by this Agreement and the
preparation, filing, and prosecution of any patent application or registrations
which may arise under this Agreement. Such co-operation shall
include:
| (a) |
making
available to the other Party or such other Party’s Representatives whom
the other Party in its reasonable judgment deems necessary in order
to
assist it in obtaining patent protection of the Patents;
and
|
| (b) |
executing
and causing its Representatives to execute all legal documents reasonably
necessary to support the assignment, filing, prosecution and maintenance
of said Patents.
|
6.12 Injunctive
Relief
Each
Party acknowledges the competitive and technical value and the sensitive and
confidential nature of the Confidential Information and agrees that monetary
damages alone will be inadequate to protect the other Party’s interests against
any actual or threatened material breach of this Agreement. Accordingly, each
Party consents to the granting of specific performance and injunctive or other
equitable or other relief to the other Party in respect of any actual or
threatened breach of this Agreement, without proof of actual damages. These
specific remedies are in addition to any other remedy to which the Parties
may
be entitled at law or in equity.
Article
7 DISCLAIMERS,
REPRESENTATIONS AND WARRANTIES
7.1
Disclaimer
| (a) |
,The
University makes no representations, conditions, or warranties, either
express or implied, with respect to the Technology or the Product.
Without
limiting the generality of the foregoing, the University specifically
disclaims any implied warranty, condition, or representation that
the
Technology or the Product:
|
| (i) |
shall
correspond with a particular
description;
|
| (ii) |
are
of merchantable quality;
|
| (iii) |
are
fit for a particular purpose; or
|
| (iv) |
are
durable for a reasonable period of
time.
|
| (b) |
The
University shall not be liable for any Damages, or any other loss
whether
direct, indirect, consequential, incidental, or special which Hana
or its
Affiliates suffer arising from any defect, error, fault, or failure
to
perform with respect to the Technology or Product, even if the University
has been advised of the possibility of such defect, error, fault,
or
failure. Hana and its Affiliates acknowledge that they have been
advised
by the University and INEX to undertake their own due diligence with
respect to the Technology and
Product.
|
-
37 -
| (c) |
EXCEPT
FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS CONTAINED IN THIS
AGREEMENT, NEITHER INEX NOR HANA MAKES, AND EACH HEREBY EXPRESSLY
DISCLAIMS, ANY WARRANTIES OR REPRESENTATIONS, EITHER EXPRESS OR IMPLIED,
WHETHER IN FACT OR IN LAW, INCLUDING WITHOUT LIMITATION IMPLIED WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR
NON-INFRINGEMENT.
|
7.2 International
Sale of Goods Act Not Applicable
The
Parties acknowledge and agree that the International Sale of Goods Act and
the
United Nations Convention on Contracts for the International Sale of Goods
have
no application to this Agreement.
7.3 No
Implied Warranties
Nothing
in this Agreement shall be construed as:
| (a) |
a
warranty or representation by the University or INEX as to title
to the
Technology or that any Product or anything made, used, sold or otherwise
disposed of under the sublicense granted in this Agreement will not
infringe the patents, copyrights, trade-marks, industrial design
or other
intellectual property rights of any third parties, including any
patents,
copyrights, trade-marks, industrial design or other intellectual
property
rights owned, in whole or in part, by UBC, or licensed directly or
indirectly by UBC to any Person;
|
| (b) |
a
warranty or representation by UBC that Hana or its Affiliates or
any of
their Sublicensees have, or will have the freedom to operate or practice
the Technology; or
|
| (c) |
an
obligation by the University to bring or prosecute or defend actions
or
suits against any Person for infringement of patents, copyrights,
trade-marks, industrial designs or other intellectual property or
contractual rights; or
|
| (d) |
the
conferring by the University of the right to use in advertising or
publicity the name of INEX or the University or UBC
Trade-marks.
|
7.4
Limited
Warranty
INEX
warrants that to the best of its knowledge, without making any enquiry, as
of
the date of execution of this Agreement, in respect of the Technology which
is
identified in Schedule“A”
as
of
the Effective Date, the rights in the Patent(s) of all UBC inventors listed
therein have been assigned to the University, and no claims have been filed
or
served on the University or threatened in writing in respect of the
Technology.
7.5
Conduct
of Infringement Proceedings
Notwithstanding
Section 7.3,
in the
event of:
| (a) |
an
alleged infringement by a Third Party of the Technology or of any
right
with respect to the Technology by the manufacture, sale, services
or use
of products derived from the Technology in the Hana Field; or
|
-
38
-
| (b) |
any
complaint by Hana alleging any infringement by a Third Party with
respect
to the Technology or to any right with respect to the Technology
by the
manufacture, sale, services or use of product or services in the
Hana
Field;
|
subject
to first obtaining the prior written consent of the University under the UBC
License granting INEX the right to prosecute such litigation and subject further
to the University consenting to INEX granting Hana the right to prosecute such
litigation, the following shall apply:
| (c) |
Hana
shall have the first right, in its sole discretion, to prosecute
or defend
such litigation;
|
| (d) |
if
Hana does not take steps to prosecute or defend such litigation within
thirty (30) days after receipt of notice thereof, INEX may take such
legally permissible action as it deems necessary or appropriate to
prosecute or defend such litigation, but shall not be obligated to
do
so;
|
| (e) |
the
Party prosecuting or defending such litigation (in this Section,
the
“Litigating
Party”)
shall have the right to control such litigation and shall bear all
legal
expenses (including court costs and legal fees), but it shall have
no
right to settle any dispute in any manner which will restrict the
claims
in or admit any invalidity of any Patent(s) or significantly adversely
affect the rights of the other Party to this Agreement (the “Non-litigating
Party”).
By way of example and not by way of limitation, there shall be no
right of
the Litigating Party to stipulate or admit to the invalidity or
unenforceability of any Patent(s). Before any action is taken by
the
Litigating Party which could abridge the rights of the Non-litigating
Party hereunder, the Parties agree to, in good faith, consult with
a goal
of adopting a mutually satisfactory
position;
|
| (f) |
the
Parties further acknowledge that solely to the extent that any final
disposition of the litigation that will restrict the claims in or
admit
any invalidity of any Patent(s) or significantly adversely affect
the
University’s rights, any such disposition of the litigation requires the
full consultation with and approval by the University under the UBC
License;
|
| (g) |
the
Non-litigating Party agrees to co-operate reasonably in any such
litigation to the extent of executing all necessary documents, supplying
essential documentary evidence and making essential witnesses then
in its
employment available and to vest in the Litigating Party the right
to
institute any such suits, so long as all the direct or indirect costs
and
expenses of bringing and conducting any such litigation or settlement
shall be borne by the Litigating Party,
provided that INEX and Hana shall recover their respective actual
out-of-pocket expenses, or equitable proportions thereof, associated
with
any litigation or settlement thereof from any recovery made by any
Party.
Any excess amount remaining after satisfaction of the Parties’ recovery of
their respective actual out-of-pocket expenses, or equitable proportions
thereof, associated with any litigation or settlement thereof from
any
recovery made by any Party (the “Excess
Amount”)
shall be shared between
Hana and INEX
on
the same basis as set forth in Sections 5.7(b)(ii)
and 5.7(c)(ii)
with respect to Royalties from Net Sales of Product in the applicable
jurisdiction;
provided however, that any Excess Amount in the form of punitive
damages
shall be shared between Hana and INEX in proportion to each Party’s
contribution to litigation expenses. In the event a settlement or
consent
judgement does not distinguish between the forms of damages payable
by the
Third Party, and Hana and INEX cannot agree on what portion, if any,
of
the Excess Amount constitutes punitive damages, the Parties will
refer the
matter to arbitration in accordance with 14.3;
|
-
39
-
| (h) |
the
Litigating Party shall keep the Non-litigating Party and the University
fully informed of the actions and positions taken or proposed to
be taken
by the Litigating Party (on behalf of itself or a sublicensee) and
actions
and positions taken by all other parties to such
litigation;
|
| (i) |
in
the event that INEX prosecutes or defends such litigation, Hana may
elect
to participate formally in the litigation to the extent that the
court may
permit, but any additional expenses generated by such formal participation
shall be paid by Hana (subject to the possibility of recovery of
some or
all of such additional expenses as described in Section 7.5(g)
or
from such other parties to the litigation);
|
| (j) |
in
the event that Hana prosecutes or defends such litigation, Hana
acknowledges that the University may elect to participate formally
in the
litigation to the extent that the court may permit, but any additional
expenses generated by such formal participation shall be paid by
the
University (subject to the possibility of recovery of some or all
of such
additional expenses from such other parties to the litigation);
and
|
7.6
Breach
of Confidence Proceedings
In
the
event of an alleged infringement of the Technology, breach of confidentiality
respecting Confidential Information or any Third Party use of Confidential
Information, INEX and Hana agree that they shall reasonably cooperate to enjoin
such Third Party’s use of such Confidential Information
7.7
Defense
of Infringement Proceedings
Subject
to the consent of the University under the UBC License granting INEX the right
to prosecute such litigation and subject further to the University consenting
to
INEX granting Hana the right to prosecute such litigation, the following shall
apply:
| (a) |
If
any complaint alleging infringement or violation of any patent or
other
proprietary rights is made against Hana or its Sublicensee, with
respect
to the Manufacture, use or sale of a Product, the following procedure
shall be adopted:
|
| (i) |
Hana
shall promptly notify INEX upon receipt of any such complaint and
shall
keep INEX fully informed of the actions and positions taken by the
complainant and taken or proposed to be taken by Hana (on behalf
of itself
or a Sublicensee);
|
| (ii) |
if
such complaint gives rise to an indemnification obligation under
the
Definitive agreements in favor of Hana (or its Sublicensee) on the
part of
INEX, then INEX shall defend such suit and
all costs and expenses incurred by Hana (or its Sublicensee) in
investigating, resisting, litigating and settling such a complaint,
including the payment of any award of damages and/or costs to any
Third
Party, shall be paid by INEX;
|
| (iii) |
if
such complaint does not give rise to an indemnification obligation
under
the Definitive Agreements in favor of Hana on the part of INEX, then
Hana
shall have the right but not the obligation to defend such suit and
all
costs and expenses incurred by Hana (or any Sublicensee) in investigating,
resisting, litigating and settling such a complaint, including the
payment
of any award of Damages and/or costs to any Third Party, shall be
paid by
Hana (or any Sublicensee, as the case may be);
and
|
-
40
-
| (iv) |
in
any event, INEX and Hana shall assist one another and cooperate in
any
such litigation at each Party’s own
expense.
|
| (b) |
If
any complaint alleging infringement or violation of any patent or
other
proprietary rights is made against INEX, its Affiliate or sublicensee
with
respect to the Manufacture, use or sale of a Product, the following
procedure shall apply:
|
| (i) |
INEX
shall promptly notify Hana in writing
upon receipt of any such complaint setting out full details thereof
and
shall keep Hana fully informed of the actions and positions taken
by the
complainant and taken or proposed to be taken by INEX(on
behalf of itself, its Affiliate or a sublicensee);
|
| (ii) |
if
such a complaint gives rise to an indemnification obligation under
the
Definitive Agreements in favor of INEX (or
its Affiliate or sublicensee) on
the part of Hana, then Hana shall defend such suit and all costs
and
expenses incurred by INEX (or its Affiliate or sublicensee) in
investigating, resisting, litigating and settling such a complaint,
including the payment of any award of Damages and/or costs to any
Third
Party, shall be paid by Hana;
|
| (iii) |
If
such complaint does not give rise to an indemnification obligation
under
the Definitive Agreements in favor of INEX (or its Affiliate or
sublicensee) on the part of Hana, then INEX shall have the right
but not
the obligation to defend such suit and all costs and expenses incurred
by
INEX (or its Affiliate or sublicensee) in investigating, resisting,
litigating and setline such a complaint, including the payment of
any
award of Damages and/or costs to any Third Party, shall be paid by
INEX;
|
| (iv) |
In
any event, INEX and Hana shall assist one another and cooperate in
any
such litigation at each Party’s own
expense.
|
| (c) |
With
regard to costs and expenses incurred by Hana (or any Sublicensee)
under
Sections 7.7(a)(iii)
or
7.7(b)(ii)
in
investigating, resisting, litigating and settling such a complaint,
including the payment of any award of Damages and/or costs to any
Third
Party (the “Offset
Amount”),
but not including any punitive award (the “Punitive
Amount”),
Hana (or any Sublicensee) shall be entitled to offset or credit
[***]
percent ([***]%)
of the Offset Amount against future payments otherwise due INEX as
set
forth in Section 5.7(f)(i).
With regard to any Punitive Amount (eg. willful infringement), the
same is
not included in the Offset Amount and is not to be offset or credited
against future payments due INEX.
|
| (d) |
In
the event a complaint is made under either of Sections 7.7(a)
or
7.7(b),
no
settlement or consent judgment or other voluntary final disposition
may be
entered into without the consent of the other Party or the University
if
such settlement would require the other Party or the University to
be
subject to an injunction or to make a monetary payment or would restrict
the claims in or admit any invalidity of any Licensed Patents or
significantly adversely affect the rights of the other Party or the
University.
|
| (e) |
If
as a result of a proceeding alleging infringement or violation of
any
patent or other proprietary rights is made against Hana or its Sublicensee
with respect to the Manufacture, use or sale of a Product, Hana agrees
with a complainant to not pursue a Product which would otherwise
generate
a Royalty, the Parties agree that, in the event the University desires
to
acquire a co-exclusive right with Hana to the patent(s) for use of
the
Product for a specific field in the Hana Field, Hana agrees to enter
negotiations with the University for such a co-exclusive
right.
|
-
41
-
7.8
Co-operation
with Other Licensees
Hana
acknowledges that INEX may grant to its other sublicensees in respect of fields
outside the Hana Field, rights similar to those granted to Hana under Sections
7.5,
7.6,
7.7
and this
Section 7.8.
If INEX
grants such rights to its other sublicensees, in the event of any litigation
in
respect of:
| (a) |
fields
outside the Hana Field that may reasonably affect Hana’s use of the
Technology in the Hana Field or the Manufacture, use or sale of Product
by
Hana; or
|
| (b) |
the
Hana Field that may reasonably affect INEX or one or more of INEX’s
sublicensee’s use of the Technology outside the Hana Field or the
manufacture, use or sale of products outside the Hana Field by INEX
or one
or more other such sublicensee(s);
|
then
Hana, INEX and such other sublicensees (to the extent such sublicensees agree),
will use good faith efforts to determine jointly the course of action, if any,
necessary or appropriate to prosecute or defend the litigation. INEX will use
reasonable efforts to include in its Sublicense
Agreements
entered
into after the Effective Date, provisions that allow the participation of Hana
as contemplated herein.
7.9
Hana
Representations and Warranties
Hana
hereby represents and warrants to INEX and the University that, as of the
Effective Date:
| (a) |
Hana
is a corporation duly organised, existing, and in good standing under
the
laws of Delaware and has the power, authority, and capacity to enter
into
this Agreement and to carry out the transactions contemplated by
this
Agreement, all of which have been duly and validly authorised by
all
requisite corporate proceedings;
|
| (b) |
the
execution, delivery and performance by Hana of this Agreement do
not
contravene or constitute a default under any provision of applicable
law
or its articles or by-laws (or equivalent documents) or of any judgment,
injunction, order, decree or other instrument binding upon
Hana;
|
| (c) |
all
licenses, consents, authorizations and approvals, if any, required
for the
execution, delivery and performance by Hana of this Agreement have
been
obtained and are in full force and effect and all conditions thereof
have
been complied with, and no other action by or with respect to, or
filing
with, any governmental authority or any other Person is required
in
connection with the execution, delivery and performance by Hana of
this
Agreement;
|
| (d) |
this
Agreement constitutes a valid and binding agreement of Hana, enforceable
against Hana in accordance with its terms, except as such enforceability
may be limited by bankruptcy, insolvency, moratorium or creditors’ rights
generally;
|
| (e) |
the
execution, delivery and performance by Hana of this Agreement do
not and
will not conflict with or result in a material breach of any of the
terms
and provisions of any Third Party agreement of Hana entered into
as of the
Effective Date;
|
| (f) |
Hana
is not aware of any impediment, including without limitation any
Third
Party agreement of Hana, which would prevent Hana from performing
its
obligations under this Agreement;
|
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42
-
| (g) |
Hana
will not enter into any Third Party agreement after the Effective
Date
which, in any way, will prevent
Hana from performing
all of its
obligations hereunder;
|
| (h) |
the
authorized capital stock
of
Hana consists
of 100,000,000 shares of Common Stock, of which 22,658,202 shares
are
issued and outstanding as of the date of this Agreement, and 10,000,000
shares of preferred stock, par value $0.001 per share, none of which
is
issued and outstanding. All of such issued and outstanding shares
of
Common Stock
have been validly issued and are outstanding as fully paid and
non-assessable;
|
| (i) |
the
issuance of the Common Stock has been duly authorized by all necessary
action on the part of Hana and no further action is required by Hana
or
its board of directors or shareholders to complete the issuance of
the
Common Stock;
|
| (j) |
the
Common Stock, when issued, will be duly and validly issued, fully
paid and
non-assessable and will be free and clear of all liens, charges,
encumbrances and any rights of others. Hana has reserved from its
duly
authorized capital stock a number of shares sufficient to meet its
obligations to issue the Common Stock hereunder;
and
|
| (k) |
no
consent, approval, authorization or other order of any governmental
authority is required to be obtained by Hana in connection with the
authorization and issuance of Common Stock, except for such registrations,
filings or notices as have been made or as may be required to be
made
pursuant to U.S. or Canadian securities
laws.
|
7.10 INEX
Representations and Warranties
INEX
warrants and represents to Hana and the University that, as of the Effective
Date:
| (a) |
INEX
is a corporation duly organised, existing, and in good standing under
the
laws of British Columbia and has the power, authority, and capacity
to
enter into this Agreement and to carry out the transactions contemplated
by this Agreement, all of which have been duly and validly authorised
by
all requisite corporate
proceedings;
|
| (b) |
the
execution, delivery and performance by INEX of this Agreement do
not
contravene or constitute a default under any provision of applicable
law
or its articles or by-laws (or equivalent documents) or of any judgment,
injunction, order, decree or other instrument binding upon
INEX;
|
| (c) |
all
licenses, consents, authorizations and approvals, if any, required
for the
execution, delivery and performance by INEX
of
this Agreement have been obtained and are in full force and effect
and all
conditions thereof have been complied with, and no other action by
or with
respect to, or filing with, any governmental authority or any other
Person
is required in connection with the execution, delivery and performance
by
INEX
of
this Agreement;
|
| (d) |
this
Agreement constitutes a valid and binding agreement of INEX, enforceable
against INEX in accordance with its terms, except as such enforceability
may be limited by bankruptcy, insolvency, moratorium or creditors’ rights
generally;
|
| (e) |
the
execution, delivery and performance by INEX of this Agreement do
not and
will not conflict with or result in a material breach of any of the
terms
and provisions of any Third Party agreement of INEX entered into
as of the
Effective Date;
|
| (f) |
INEX
is not aware of any impediment, including without limitation any
Third
Party agreement of INEX, which would prevent INEX from performing
its
obligations under this Agreement;
|
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43
-
| (g) |
INEX
will not enter into any Third Party agreement after the Effective
Date
which, in any way, will prevent
INEX from performing
all of its
obligations
hereunder;
|
| (h) |
except
for the Intellectual Property Rights described in this Agreement,
INEX
neither owns nor controls any Intellectual Property Rights that would
be
required by Hana in order to make,
have made, use, sell, offer for sale, import, and have imported Products
in the Hana Field within the
Territory;
|
| (i) |
to
the actual knowledge of INEX,
without independent investigation or inquiry,
the rights to the Technology granted by INEX to Hana pursuant to
this
Agreement are all of the Intellectual Property Rights necessary for
Hana
to make, have made, use, sell, offer for sale, import, and have imported
Products in the Hana Field within the Territory, without any infringement
of or conflict with the Intellectual
Property Rights of Third Parties.
|
Article
8 INDEMNITY
AND LIMITATION OF LIABILITY
8.1
Rights
of the University
| (a) |
Hana
hereby indemnifies, holds harmless and defends the University, its
Board
of Governors, officers, employees, faculty, students, invitees and
agents
(collectively, in this Article
8,
the “University
Indemnified Parties”)
against any and all claims (including all legal fees and disbursements
incurred in association therewith) arising out of the exercise of
any
rights under this Agreement, the UBC License or the UBC Consent,
including, without limiting the generality of the foregoing, against
any
damages or losses, consequential or otherwise, arising from or out
of the
use of the Technology or Product sublicensed under this Agreement
by Hana,
its Affiliates or its Sublicensees, or their customers or end-users
howsoever the same may arise, or any injury or death to any Person
or
damage to any property caused by any Product, whether claimed by
reason of
breach of warranty, negligence, product defect or otherwise, and
regardless of the form in which any such claim is made.
|
| (b) |
Hana
agrees and acknowledges that subject to Section 8.1(c):
|
| (i) |
the
University’s total liability, whether under the express or implied terms
of this Agreement, the UBC License or the UBC Consent, in tort (including
negligence), or at common law, for any loss or damage suffered by
Hana or
its Affiliates, whether direct, indirect, special, or any other similar
or
like damage, to the extent that such losses or damage may arise or
does
arise from any breaches of the UBC License, this Agreement or the
UBC
Consent, by the University Indemnified Parties, shall be limited
to the
sum of $[***]
CDN;
and
|
| (ii) |
INEX’s
total liability, whether under the express or implied terms of this
Agreement, in tort (including negligence), or at common law, for
any loss
or damage suffered by Hana, whether direct, indirect, special, or
any
other similar or like damage, to the extent that such losses or damage
may
arise or does arise from any breaches of the UBC License by the University
Indemnified Parties, shall be limited to the sum of $[***]
CDN.
|
| (c) |
In
no event shall the University be liable for consequential or incidental
damages arising from any breach or breaches of the UBC License, this
Agreement or the UBC Consent.
|
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44
-
8.2
Indemnification
by INEX
Subject
to limit set forth in Section 8.1(b)(ii),
INEX
hereby agrees that it shall be responsible for, indemnify, hold harmless and
defend Hana, its Representatives, and their respective heirs, successors and
assigns (collectively, the “Hana
Indemnitees”),
from
and against any and all Damages suffered or incurred by any Hana Indemnitee
arising out of, relating to, resulting from or in connection with any Third
Party claims arising out of or relating to:
| (a) |
the
breach of any representation or warranty made by INEX
herein;
|
| (b) |
the
default by INEX in the performance or observance of any of its obligations
to be performed or observed hereunder;
and
|
| (c) |
the
breach by INEX of any Regulatory Requirements, regulations and guidelines
in connection with any Technology.
|
The
foregoing shall not apply to the extent that such Damages are due
to:
| (d) |
the
breach of any representation or warranty made by Hana
herein;
|
| (e) |
the
default by Hana in the performance or observance of any of its obligations
to be performed or observed
hereunder;
|
| (f) |
the
breach by Hana or its Sublicensees, of any Regulatory Requirements,
regulations and guidelines in connection with any Product;
and
|
| (g) |
any
injury or death to any Person or damage to any property caused by
any
Product provided by Hana or its Sublicensees, whether claimed by
reason of
breach of warranty, negligence, product defect or otherwise, and
regardless of the form in which any such claim is
made.
|
8.3
Indemnification
by Hana
In
addition to Hana’s obligations set forth in Section 8.1(a),
Hana
hereby agrees that it shall be responsible for, indemnify, hold harmless and
defend INEX, its Representatives and their respective heirs, successors and
assigns (collectively, the “INEX
Indemnitees”),
from
and against any and all Damages suffered or incurred by any INEX Indemnitee
arising out of, relating to, resulting from or in connection with any Third
Party claims arising out of or relating to:
| (a) |
the
breach of any representation or warranty made by Hana
herein;
|
| (b) |
the
default by Hana in the performance or observance of any of its obligations
to be performed or observed
hereunder;
|
| (c) |
the
breach by Hana, or its Sublicensees, of any Regulatory Requirements,
regulations and guidelines in connection with any Product;
|
| (d) |
any
complaint alleging infringement or violation of any patent or other
proprietary rights is made against INEX or its Affiliates with respect
to
Hana’s Manufacture, use or sale of a Product; and
|
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45
-
| (e) |
any
injury or death to any Person or damage to any property caused by
any
Product provided by Hana or its Sublicensees, whether claimed by
reason of
breach of warranty, negligence, product defect or otherwise, and
regardless of the form in which any such claim is
made.
|
The
foregoing shall not apply to the extent that such Damages are due
to:
| (f) |
the
breach of any representation or warranty made by INEX
herein;
|
| (g) |
the
default by INEX in the performance or observance of any of its obligations
to be performed or observed hereunder;
and
|
| (h) |
the
breach by INEX of any Regulatory Requirements, regulations and guidelines
in connection with any Technology.
|
8.4
Notice
of Claims
In
the
event that a claim is made pursuant to Section 8.2
or
8.3
against
any Person which seeks indemnification hereunder (the “Indemnitee”),
the
Indemnitee shall give the indemnifying Party (the “Indemnitor”)
prompt
notice of any claim or lawsuit or other action for which it seeks to be
indemnified under this Agreement and agrees that the Indemnitor shall not have
any obligation under Section 8.2
or
8.3
as
applicable, unless:
| (a) |
the
Indemnitor is granted, subject to the provisions of this Section
8.4
and the relevant provisions of Sections 7.5,
7.7
and 7.8,
full authority and control over the defense, including settlement,
against
such claim or law suit or other action,
and
|
| (b) |
the
Indemnitee cooperates fully with the Indemnitor and its agents in
defense
of the claims or law suit or other
action.
|
The
Indemnitee shall have the right to participate in the defense of any such claim,
complaint, suit, proceeding or cause of action referred to in this Section
utilizing attorneys of its choice, at its own expense, provided however, that
the Indemnitor shall, subject to the provisions of this Section 8.4
and the
relevant provisions of Sections 7.5,
7.7
and
7.8,
have
full authority and control to handle any such claim, complaint, suit proceeding,
or cause of action, including any settlement or other disposition thereof,
for
which the Indemnitee seeks indemnification under this Section; provided however,
subject to the following sentence, that no settlement or consent judgment or
other voluntary final disposition may be entered into without the consent of
the
Indemnitee if such settlement would require the Indemnitee to be subject to
an
injunction or to make a monetary payment or would restrict the claims in or
admit any invalidity of any Patent(s) or significantly adversely affect the
rights of the Indemnitee.
8.5
Consequential
Losses
EXCEPT
FOR EACH PARTY’S LIABILITY TO THE OTHER PARTY FOR INFRINGEMENT OF THE OTHER
PARTY’S INTELLECTUAL PROPERTY RIGHTS OR BREACH OF THE OBLIGATIONS RESPECTING
CONFIDENTIAL INFORMATION, NO PARTY WILL BE LIABLE FOR CONSEQUENTIAL OR
INCIDENTAL DAMAGES OF ANY NATURE ARISING FROM SUCH PARTY'S ACTIVITIES UNDER
THIS
AGREEMENT; PROVIDED, HOWEVER, THAT THIS LIMITATION SHALL NOT LIMIT THE
INDEMNIFICATION OBLIGATION OF SUCH PARTY UNDER SECTIONS 8.2
OR
8.3
FOR
CONSEQUENTIAL OR INCIDENTAL DAMAGES RECOVERED BY A THIRD PARTY.
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46
-
8.6
Action
Between the Parties
For
the
avoidance of doubt, in connection with actions brought by one Party hereto
against the other (whether for breach of any provisions hereof, any
representation or warranty made herein or otherwise), each Party expressly
reserves all of its rights and remedies under applicable law, including, without
limitation, the right to xxx for breach of contract.
Article
9 PUBLICATION
AND CONFIDENTIALITY
9.1 Treatment
of Confidential Information
| (a) |
The
Discloser’s Confidential Information shall be developed, received, and
used by the Recipient solely in furtherance of the purposes set forth
in
this Agreement subject to the terms and conditions set forth in this
Article
9.
|
| (b) |
The
Recipient shall keep and use all of the Discloser’s Confidential
Information in confidence and will not, without the Discloser’s prior
written consent, disclose any of the Discloser’s Confidential Information
to any person or entity, except those of the Recipient’s officers,
employees, consultants, professional advisors, agents and assigns
who
require said Confidential Information in performing their obligations
under this Agreement. The Recipient covenants and agrees that it
will
initiate and maintain an appropriate internal program limiting the
internal distribution of the Discloser’s Confidential
Information.
|
| (c) |
The
Recipient shall not use, either directly or indirectly, any of the
Discloser’s Confidential Information for any purpose other than as
contemplated herein without the Discloser’s prior written
consent.
|
| (d) |
If
the Recipient is required by judicial or administrative process to
disclose any or all of the Discloser’s Confidential Information, the
Recipient shall promptly notify the Discloser and, when available,
allow
the Discloser reasonable time to oppose such process before disclosing
any
Confidential Information as provided in Section 9.4(b).
|
| (e) |
Notwithstanding
any termination or expiration of this Agreement, the obligations
created
in this Article
9
shall survive and be binding upon the Recipient, its successors and
assigns.
|
9.2
Publications
Hana
acknowledges that the policies of the University require that the results of
the
University’s research be publishable, subject to Article
9
of the
UBC License. Hana and INEX therefore agree that any UBC inventors of the
Technology shall not be restricted from presenting at symposia, national, or
regional professional meetings, or from publishing in abstracts, journals,
theses, or dissertations, or otherwise, whether in printed or in electronic
media, methods and results of the University’s research regarding the
Technology, provided however that:
| (a) |
INEX
provides to Hana within five (5) days after receipt from the University,
copies of any proposed publication or presentation provided to INEX
by the
University; and
|
| (b) |
Hana
has not, within twenty-one (21) days after receipt of said copies,
objected to INEX in writing to such proposed presentation or proposed
publication in accordance with Section 9.3
of
this Agreement.
|
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47 -
9.3
Objections
to Publication
| (a) |
Either
Party may object to the University’s proposed presentation or proposed
publication on the grounds that:
|
| (i) |
it
contains Confidential Information that was disclosed to the University
by
Hana or INEX; or
|
| (ii) |
it
discloses patentable subject matter which needs protection.
|
| (b) |
If
either Party makes an objection under Section 9.3(a)(i),
the Party so objecting shall specify the portions of the presentation
or
publication considered objectionable (the “Objectionable
Material”).
INEX shall forward all objections to the University within four (4)
days
of issuing or receiving an objection. Upon receipt of notification
from
Hana that any proposed publication or disclosure contains Objectionable
Material, the University and INEX shall work together to revise the
proposed publication or presentation to remove or alter the Objectionable
Material in a manner acceptable to Hana, in which case Hana shall
withdraw
its objection. INEX shall co-operate in all reasonable respects in
making
revisions to any proposed disclosures if considered by Hana to contain
Objectionable Material. Hana acknowledges that the University shall
not be
restricted from publishing or presenting the proposed disclosure
as long
as the Objectionable Material has been removed. In respect of any
disclosures by the University pursuant to Section 9.7 of the UBC
License,
upon Hana’s request, INEX shall request that Hana’s Confidential
Information shall be deleted therefrom prior to disclosure by the
University.
|
| (c) |
If
Hana makes an objection under Section 9.3(a)(i),
thereafter Hana and/or INEX may file a patent application and the
Parties
acknowledge that the University is obligated under the UBC License
to
ensure that its researchers refrain from making such publication
or
presentation until one or more patent applications have been filed
with
one or more patent offices directed to such patentable subject matter,
or
until three (3) months have elapsed from date of receipt of the written
objection by the University, whichever is sooner, after which the
University and its researchers may proceed with said presentation
or
publication. For greater certainty, a provisional patent application
shall
be considered to be a patent application in the United States of
America
for the purposes of this Agreement.
|
9.4
Permitted
Disclosures
| (a) |
Each
Party requires of the other, and each Party agrees insofar as it
may be
permitted to do so at law, that this Agreement, and each part of
it, is
confidential and shall not be disclosed to Third Parties. Notwithstanding
the foregoing, Hana hereby consents to the disclosure by INEX of
the terms
and conditions of this Agreement to the University, solely for the
purpose
of obtaining the consent of the University in accordance with the
UBC
License, and INEX shall use reasonable efforts to ensure that the
University is informed of the confidential nature of this Agreement,
and
each part of it, insofar as it may be permitted to do so at law,
shall not
be disclosed by the University to Third Parties, as Hana claims that
such
disclosure would or could reveal commercial, scientific or technical
Information and would significantly harm Hana’s competitive position
and/or interfere with Hana’s negotiations with prospective Sublicensees.
Notwithstanding anything contained in this Section, the Parties hereto
acknowledge and agree that the University may identify the title
of this
Agreement, the Parties to this Agreement, the inventors of the Technology
and the term of this Agreement.
|
-
48 -
| (b) |
Notwithstanding
Section 9.1(b),
either Party may disclose:
|
| (i) |
the
content of this Agreement to Third Party contractors or collaborators
to
facilitate or carry out research, development or commercialization
activities under this Agreement or to carry out financing arrangements;
and
|
| (ii) |
the
University’s Confidential Information to Third Parties in the exercise of
each of Hana and INEX’s rights under this
Agreement;
|
provided
that such Third Parties enter into an agreement with the Party disclosing
Confidential Information which contains confidentiality provisions substantially
the same as those set forth herein. Each Party may also disclose Confidential
Information received from the other Party where in the reasonable and
unqualified opinion of the Recipient’s legal counsel, disclosure is required to
be made under
| (iii) |
the
securities laws of any relevant jurisdiction, including the Recipient’s
jurisdiction of incorporation or a jurisdiction in which the Recipient’s
securities are traded on a stock exchange;
or
|
| (iv) |
such
disclosure is required to be made by the Recipient or its Representatives
under the terms of a valid and effective subpoena or order issued
by a
court of competent jurisdiction or by an administrative body or government
authority;
|
provided
that:
| (v) |
the
Recipient shall immediately notify the Discloser prior to any such
disclosure and the Discloser shall have been given the opportunity
where
possible to oppose such disclosure by the Recipient by seeking a
protective order or other appropriate remedy, or to waive compliance
with
the provisions of this Agreement;
|
| (vi) |
the
Recipient or its Representatives, as the case may be, shall disclose
only
that portion of the Information legally required to be disclosed;
and
|
| (vii) |
the
Recipient or its Representatives, as the case may be, will exercise
all
reasonable efforts to maintain the confidential treatment of the
Information.
|
9.5
Liability
for Representatives
Each
Party will maintain a list of all Representatives to whom it has disclosed
Confidential Information and will be responsible for the failure by any of
its
Representatives to maintain the confidence of any Confidential Information
of
the other Party in accordance with the terms of this Article.
9.6 No
Limitation on Regulatory Compliance
Nothing
in this Agreement shall be construed as preventing or in any way inhibiting
Hana
from complying with statutory and regulatory requirements governing the
Development, Manufacture, use and sale or other distribution of Product in
the
Territory in any manner which it reasonably deems appropriate, including, for
example, by disclosing to regulatory authorities confidential or other
information received from INEX.
-
49 -
9.7
Return
of Confidential Information
Except
as
required to comply with regulatory requirements or the Definitive Agreements,
within thirty (30) days of receipt of a written request from the Discloser,
the
Recipient will return to the Discloser or destroy, at the Discloser’s sole
discretion, all Confidential Information of the Discloser, including all such
information that is electronically stored by the Recipient, all reproductions
thereof and all samples of materials (including Materials) in the form provided
by the Discloser to the Recipient, in the Recipient’s possession or control and
confirm such destruction or delivery to the Discloser in writing, as
applicable.
Article
10 PRODUCTION
AND MARKETING
10.1
No
Use of Names and Trademarks
| (a) |
Hana
shall not use any of the UBC Trade-marks or make reference to the
University or its name or to INEX in any advertising or publicity
whatsoever, without the prior written consent of the University or
INEX,
respectively, except as required by law. INEX shall not make reference
to
Hana in any advertising or publicity whatsoever, without the prior
written
consent of Hana, except as required by law. Without limiting the
generality of the foregoing, neither Party shall issue a press release
with respect to this Agreement or any activity contemplated herein
without
the prior review and approval of same by the other Party, except
as
required by law. If either Party is required by law to act in
contravention of this Section, such Party shall provide the other
Party
with sufficient advance notice in writing to permit the other Party
to
bring an application or other proceeding to contest the
requirement.
|
| (b) |
Hana
at its sole cost and expense, shall be responsible for the selection,
registration and maintenance of all trademarks which it employs in
connection with Sphingosomal Vinorelbine and Sphingosomal Topotecan
in the
Territory and shall own and control such trademarks during the term
of
this Agreement and following its termination or expiration.
|
10.2
Labeling
and Patent Marking
The
Product shall be packaged by Hana and labeled in a manner consistent with the
requirements of the Regulatory Authorities in the country in which it will
be
sold, and where legally permissible, shall identify any applicable Patents
consistent with any patent marking requirements.
10.3
Development
and Commercialization Efforts
| (a) |
In
each country in the Territory in which a Product has received Regulatory
Approval, Hana, directly or through its permitted Representatives,
shall
use Commercially Reasonable Efforts to Commercialize the Product
and to
meet or cause to be met the market demand for the
Product.
|
| (b) |
If
the University is of the view that Hana is in breach of Section
10.3(a),
INEX shall notify Hana and the Parties hereto shall appoint a mutually
acceptable person as an independent evaluator (the “Evaluator”)
to conduct the evaluation set forth in Section 10.3(c).
If the Parties cannot agree on such an evaluator, the appointing
authority
shall be the British Columbia International Commercial Arbitration
Centre.
|
-
50 -
| (c) |
Unless
the Parties mutually agree otherwise, the following rules and procedures
shall govern the conduct of the Parties and the Evaluator before
and
during the investigation by the
Evaluator:
|
| (i) |
within
thirty (30) days of the appointment of the Evaluator, each Party
shall
provide to the Evaluator and the other Party copies of all documents,
statements and records on which the Party intends to rely in presenting
its position to the Evaluator;
|
| (ii) |
within
forty-five (45) days of the appointment of the Evaluator, Hana shall
provide to the Evaluator and INEX a written summary of its position.
On
receipt of Hana's summary, INEX shall have fifteen (15) days to prepare
and submit to Hana and the Evaluator its own summary in reply to
the
summary submitted by Hana; and
|
| (iii) |
on
receipt of the documents, statements, records and summaries submitted
by
the Parties the Evaluator shall have thirty (30) days within which
to
conduct such further inquiries as he or she may deem necessary for
the
purpose of reviewing the efforts made by Hana with respect to the
promotion, marketing and sale of the Product in compliance with the
requirements of Section 10.3(a).
For the purpose of conducting such an inquiry, the Evaluator shall
have
the right to:
|
| (A) |
require
either Party to disclose any further documents or records which the
Evaluator considers to be relevant;
|
| (B) |
interview
or question either orally (or by way of written questions) one or
more
Representatives of either Party on issues deemed to be relevant by
the
Evaluator;
|
| (C) |
make
an "on
site"
inspection of Hana’s facilities;
|
| (D) |
obtain
if necessary, the assistance of an independent expert to provide
technical
information with respect to any area in which the Evaluator does
not have
a specific expertise.
|
| (d) |
The
Evaluator shall within thirty (30) days of starting the inquiry,
prepare a
report setting out his or her findings and conclusions as to whether
or
not Hana has used Commercially Reasonable Efforts as specified in
Section
10.3(a).
If the Evaluator determines that Hana has failed to use Commercially
Reasonable Efforts as specified in Section 10.3(a),
then the Evaluator shall specify in the report his or her conclusions
as
to what would constitute such efforts, and Hana shall thereafter
make the
efforts so specified. If Hana fails to make such efforts, after notice
of
termination for breach provided in accordance with the terms of Section
17.4,
then INEX’s sole remedy for failure to make the efforts specified in
Section 10.3(a)
and 10.3(d)
shall be that this Agreement may be terminated in accordance with
Section
17.4.
|
| (e) |
The
report and conclusions of the Evaluator shall be delivered to Hana
and
INEX, and shall be accepted by both Parties as final and
binding.
|
| (f) |
INEX
may not call for more than one evaluation pursuant to Section 10.3(b)
in
any two (2) calendar year period. The cost of an evaluation hereunder
shall be borne [***]%
by Hana and [***]%
by INEX. At the request of Hana, INEX will consent to the participation
in
any evaluation made pursuant hereto of Hana’s Sublicensee(s). At the
request of INEX, Hana will participate in an evaluation made pursuant
to
Article 10 of the UBC License.
|
-
51 -
| (g) |
Hana
agrees that it shall deliver to INEX an annual report, due on December
31
of each year during the term of this Agreement, which summarizes
the major
activities Hana has undertaken in the course of the preceding twelve
(12)
months to develop and commercialize and/or market the Technology
in the
Hana Field. The report will include an outline of the status of any
Product in clinical trials and the existence of any sublicenses of
the
Technology.
|
10.4 Consequence
of No Sales
| (a) |
In
addition to the terms of Section 10.3,
Hana shall be deemed to have breached its obligation to use Commercially
Reasonable Efforts in conducting marketing of a Product in any country
in
the Major Markets if, for a continuous period of one hundred and
eighty
(180) days at any time following launch of commercial sales of the
Product
in any such country in the Major Markets, no sales of the Product
are made
in the ordinary course of business in such country by Hana, an Affiliate
or a Sublicensee, unless:
|
| (i) |
the
Parties mutually agree it is to their mutual benefit to delay commercial
sales of Product in such country;
or
|
| (ii) |
Hana
is prevented, restricted, interfered with or delayed in making such
sales
by reason of a cause beyond Hana’s reasonable control and can demonstrate
same to INEX;
|
in
which
event such period shall be extended by (i) the period of delay mutually agreed
upon or (ii) by the period of Hana’s inability, provided that Hana uses its
Commercially Reasonable Efforts to avoid or remove the cause of such
inability.
| (b) |
If
Hana breaches its obligation set forth in Section 10.4(a):
|
| (i) |
INEX
shall be entitled to terminate all rights granted to Hana in the
Definitive Agreements in respect of such Product in such country
in the
Major Markets by written notice to Hana in the event that Hana is
in
default of its obligations under Section 10.4(a)
and fails to remedy such default within sixty (60) days after notice
thereof by INEX;
|
| (ii) |
All
sublicenses granted by Hana in respect of such Product in such country
in
the Major Markets shall forthwith terminate upon the effective date
of
termination in Section 10.4(b)(i);
and
|
| (iii) |
Hana
shall continue to be bound by and shall comply with Sections 17.6,
17.7
and any other Sections which are intended to survive any termination
of
rights under this Agreement.
|
10.5 Reports
on Commercialization
Hana
shall report to INEX on the status and progress of Hana’s efforts under this
Section 10.5
as
follows and shall permit INEX to forward to UBC, copies of all reports provided
by Hana to INEX hereunder:
| (a) |
Hana
shall deliver to INEX within thirty (30) days after the end of each
Calendar Quarter reports setting forth in general terms, reasonably
sufficient for evaluation of the diligence obligations contained
herein,
the efforts Hana has made to Commercialize the Product during the
year,
including any significant adverse developments, and any plans for
or
occurrences of any commercial sales of the Product in any jurisdiction
and
a summary of the efforts it intends to make in the upcoming year(s)
on
these matters.
Hana agrees to appropriately consider any INEX input and comments
related
to Hana’s plan for the upcoming year(s), provided that it is understood
that Hana shall have final decision making responsibility for such
plans.
|
-
52 -
| (b) |
To
the extent that such could not be appropriately communicated to INEX
in
accordance with Section 10.5(a),
Hana shall keep INEX informed in a timely manner of significant
developments in Hana’s (and its Affiliates and Sublicensees where
relevant) progress of its efforts to Commercialize the Product, including
without limitation, any significant adverse developments, and any
plans
for or occurrences of any commercial sales of the Product in any
jurisdiction.
|
10.6 Development
Plans
| (a) |
Hana,
with INEX’ assistance, shall prepare for the Parties’ review and
discussion, a detailed Development Plan for the Development of each
Product.
|
| (b) |
The
Development Plan shall describe the specific Clinical Activities,
Regulatory Activities, Technical Transfer activities, and Manufacturing
activities to be performed in the Territory for the
twelve (12) month period
following the Effective Date. The
Development Plan will be reviewed from time to time as the Parties
reasonably determine to be necessary or
useful.
|
| (c) |
The
Development Plan shall be incorporated herein by reference and all
Development shall be conducted by Hana
in
compliance with Regulatory
Requirements.
|
10.7 Reports
on Development
| (a) |
Hana
shall use Commercially Reasonable Efforts to Develop each Product
in the
Territory (including carrying out its responsibilities under the
Development Plan) to:
|
| (i) |
conduct
or cause to be conducted the necessary and appropriate clinical trials
as
necessary to obtain and maintain Regulatory Approvals for each Product;
and
|
| (ii) |
prepare,
file and prosecute or cause to be prepared, filed and prosecuted
the
Regulatory Submission for each
Product.
|
| (b) |
Hana
will provide INEX with written reports to keep INEX fully informed
of the
progress of the Development of each Product as
follows:
|
| (i) |
at
the close of each Calendar Quarter during the first twenty-four (24)
months following the Effective Date;
and
|
| (ii) |
on
or before June 31 and December 31 of each and every calendar year
thereafter.
|
| (c) |
Hana
shall permit INEX to forward to UBC, copies of all reports provided
by
Hana to INEX pursuant to this Section 10.5, 10.6 and 10.7(b).
|
10.8 Regulatory
Compliance
All
Development and Commercialization activities in respect of each Product shall
be
conducted by Hana in compliance with Regulatory Requirements.
-
53 -
Article
11 ACCOUNTING
RECORDS
11.1
Documentation
Hana
shall maintain at its principal place of business, or such other place as may
be
most convenient, separate accounts and records of business done pursuant to
this
Agreement, such accounts and records to be in sufficient detail to enable proper
returns to be made under this Agreement and Hana shall cause its Sublicensees
to
keep similar accounts and records.
11.2
Reporting
| (a) |
Hana
shall deliver the Accounting to the University on the date sixty
(60) days
after each and every Royalty Due Date, together with the Royalty
Due UBC
payable hereunder and the Accounting (and a report identifying each
Sublicensee and the principal location of the business of each
Sublicensee); and
|
| (b) |
Hana
shall
deliver to INEX within thirty (30) days after the end of each Calendar
Quarter a written report showing its computation
of Royalty Due INEX under this Agreement upon Net Sales by Hana and
its
Affiliates and its Sublicensees during such Calendar Quarter, and
setting
out:
|
| (i) |
all
Net Sales segmented in each such report according to sales by Hana,
each
Affiliate and each Sublicensee, as well as on a country-by-country
basis,
and month-by-month basis;
|
| (ii) |
deductions
from gross revenues by the categories for same set out in the definition
of Net Sales; and
|
| (iii) |
the
rates of exchange used to convert such royalties to US Dollars from
the
currency in which such sales were made. For the purposes hereof,
such
conversion calculations are to be made on a monthly basis and the
rates of
exchange to be used for converting royalties hereunder to US Dollars
shall
be those in effect for the purchase of US Dollars as certified by
the noon
buying rate of the Federal Reserve Bank of New York on the first
Business
Day of the Calendar Quarter with respect to which the payment is
due;
|
together
with the Royalty Due INEX payable hereunder.
Hana
shall permit INEX to forward to UBC, copies of all reports provided by Hana
to
INEX hereunder.
| (c) |
Hana’s
payment of Sublicensing Revenue Due INEX and all Royalty Due UBC
under
this Agreement shall be accompanied by an accounting setting out
all
Sublicensing Revenue Due INEX and Sublicensing Revenue Due UBC payable
to,
collected or received by Hana or its Affiliates, segmented according
to
Product, Sublicensee identified by name, and the last date on which
each
Sublicense Agreement was executed..
|
11.3 Method
of Calculation
The
calculation of Royalties shall be carried out in accordance with US GAAP,
applied on a consistent basis.
11.4 Record
Retention
Hana
shall retain the accounts and records referred to in Section 11.1
for at
least three (3) years after the date upon which they were made and shall permit
any duly authorized representative of INEX on reasonable notice no more than
once every year, except for just cause in which case inspection may be conducted
more frequently, to inspect such accounts and records during normal business
hours of Hana at INEX’s expense. Hana shall furnish such reasonable evidence as
such Representative will deem necessary to verify the Accounting and will permit
such Representative to make copies of or extracts from such accounts, records
and agreements at INEX’s expense.
-
54 -
11.5 Confidential
Treatment
During
the term of this Agreement and thereafter INEX agrees that all Information
provided by Hana to INEX or its Representatives pursuant to this Article remains
confidential and is treated as such by INEX.
Article
12 INSURANCE
12.1 Insurance
| (a) |
Prior
to or immediately upon the start of any human clinical trials or
other
product testing involving human subjects by Hana or its Sublicensee
(“Human
Clinical Trials”)
and for a period of five (5) years after the expiration of this Agreement
or the earlier termination thereof, Hana shall obtain and/or maintain,
respectively, at its sole cost and expense, public liability and
product
liability insurance in not less than the following amounts, with
a
reputable and financially secure insurance
carrier:
|
| (i) |
Each
Occurrence: $5,000,000
Dollars
|
| (ii) |
General
Aggregate: $5,000,000
Dollars
|
Such
product liability insurance shall insure against all liability, including
personal injury, physical injury, or property damage arising out of Human
Clinical Trials, the Manufacture, sale, distribution, or marketing in the
Territory, by Hana, its Affiliate or its Sublicensee, of Product. Hana shall
provide written proof of the existence of such insurance to INEX upon
request.
| (b) |
At
all times during the term of this Agreement and for a period of five
(5)
years after the expiration of this Agreement or the earlier termination
thereof, INEX shall obtain and/or maintain, respectively, at its
sole cost
and expense, comprehensive or commercial form general liability coverage,
including contractual liability, and public liability insurance in
not
less than the following amounts, with a reputable and financially
secure
insurance carrier:
|
| (i) |
Each
Occurrence: $4,000,000
(Canadian dollars)
|
| (ii) |
General
Aggregate: $4,000,000
(Canadian dollars)
|
| (c) |
INEX
shall, at Hana’s request, provide Hana with certificates of insurance and
copies of the policies of insurance reflecting the coverage and amounts
set forth in this Section 12.6.2. Each certificate of insurance shall
contain a provision that the coverage afforded under the policy(s)
will
not be cancelled without thirty (30) days prior written notice (hand
delivered or certified mail, return receipt requested) to
Hana.
|
| (d) |
Hana’s
insurance shall include the University, its Board of Governors, faculty,
officers, employees, students and agents as additional insureds,
and shall
provide primary coverage with respect to the activities contemplated
by
this Agreement. Such policy shall not be cancelled or materially
altered
except upon at least thirty (30) days’ written notice to INEX and UBC.
Failing the Parties’ agreeing on the appropriate terms or the amount of
coverage, then the matter shall be determined as provided in Section
14.3
herein. Hana shall provide INEX with certificates of insurance evidencing
such coverage thirty (30) days before commencement of Human Clinical
Trials and thirty (30) days prior to the sales of any Product, and
Hana
covenants not to start Human Clinical Trials, or sell any Product
before
such certificate is provided and approved by INEX, or to start any
Human
Clinical Trials or sell any Product at any time unless the insurance
outlined in this Article
12
is
in effect.
|
-
55 -
| (e) |
Each
Party shall require that such Party’s Representatives and Hana’s
Sublicensee under this Agreement shall
either:
|
| (i) |
demonstrate
to the other Party’s reasonable satisfaction that such Representative or
Hana’s Sublicensee has a program of self insurance no less adequate than
that which a reasonable and prudent businessperson carrying on a
similar
line of business would require; or
|
| (ii) |
sixty
(60) days prior to the earlier of the start of Human Clinical Trials
or
the first sale of any Product by Hana’s Sublicensee, procure and maintain
public liability, and product liability insurance in reasonable amounts,
with a reputable and financially secure insurance carrier. Hana shall
ensure that any and all such policies of insurance required pursuant
to
this Article
12
shall contain a waiver of subrogation against the University, its
Board of
Governors, faculty, officers, employees, students, and
agents.
|
| (f) |
Notwithstanding
anything to the contrary contained in this Section 12.1,
before
the first date of commercial sale of any Product in the U.S., Hana
and its
Affiliate and Sublicensee of each such Product will maintain in full
force
and effect, with reputable insurers or pursuant to a self-insurance
program, product liability insurance to a minimum value of Five Million
Dollars ($5,000,000) per each occurrence and in the
aggregate.
|
Article
13 ASSIGNMENT
13.1 Assignment
| (a) |
Except
as expressly permitted hereby, Hana will not assign, transfer, mortgage,
charge or otherwise dispose of any or all of the rights, duties or
obligations granted to it under this Agreement without the prior
written
consent of the University and INEX, the consent of INEX not to be
unreasonably withheld or delayed. INEX shall reasonably co-operate
with
and assist Hana in obtaining the consent of the University to any
proposed
assignment of this Agreement by Hana. Notwithstanding the foregoing,
Hana
shall have the right to assign to an Affiliated Company or an entity
that
acquires all or substantially all of the assets related to the Technology
and the Product.
|
| (b) |
Hana
acknowledges that the University shall have the right to assign its
rights, duties and obligations under the UBC License to a company
or
society of which the University is the sole shareholder in the case
of a
company or of which the University controls the membership, in the
case of
a society.
|
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56 -
Article
14 GOVERNING
LAW AND ARBITRATION
14.1 Governing
Law
This
Agreement shall be governed by and construed in accordance with the laws of
the
Province of British Columbia and the laws of Canada in force therein without
regard to its conflict of law rules.
14.2 Jurisdiction
Both
Parties agree that by executing this Agreement they have attorned to the
jurisdiction of the Supreme Court of British Columbia. Subject to Section
14.3,
the
courts of British Columbia shall have exclusive jurisdiction over this
Agreement.
14.3 Arbitration
In
the
event of any dispute arising between the Parties concerning this Agreement,
its
enforceability, or its interpretation, the following procedure shall
apply:
| (a) |
Prior
to engaging in any formal dispute resolution with respect to any
dispute,
controversy or claim arising out of or in relation to this Agreement
or
the breach, termination or invalidity of this Agreement (each, a
“Dispute”),
the Chief Executive Officers of the Parties shall attempt to resolve
the
Dispute for a period not less than thirty (30)
days.
|
| (b) |
Except
for any Dispute with respect to Intellectual Property Rights, which
may,
at the option of the other Party, be dealt with by commencing an
action in
a court of competent jurisdiction, any Dispute that cannot be settled
amicably by agreement of the Parties pursuant to Section 14.3(a)
may, on mutual agreement of the Parties, be finally settled by a
single
arbitrator appointed [pursuant to the provisions of the CPR
International Institute for Conflict Prevention & Resolution] [in
accordance with the rules of the American Arbitration
Association].
|
| (c) |
The
place of arbitration shall be Vancouver and the language to be used
in the
arbitration proceedings shall be
English.
|
| (d) |
The
award rendered in any arbitration shall be final and binding upon
both
Parties. The judgment rendered by the arbitrator(s) shall include
costs of
arbitration, reasonable legal fees and reasonable costs for any expert
and
other witnesses.
|
| (e) |
Notwithstanding
the provisions of Sections 14.3(a),
14.3(b),
14.3(c),
14.3(d)
and 14.3Error!
Reference source not found.,
either Party shall be free to submit any Dispute relating to Intellectual
Property Rights to any court having jurisdiction over the Parties
and the
subject matter of the Dispute and to seek such relief and remedies
as are
available in that court.
|
| (f) |
Each
Party is required to continue to perform its obligations under this
Agreement pending final resolution of any
Dispute.
|
| (g) |
Notwithstanding
any provision of this Article
14,
if a ruling by a court or arbitral authority on any dispute between
INEX
and Hana regarding the interpretation of this Agreement could reasonably
affect the interpretation of the UBC License, the Parties acknowledge
that
under the UBC License, on receipt of notice of such a dispute from
INEX,
the University may elect to apply to join in such proceeding in accordance
with the UBC License.
|
-
57 -
| (h) |
Notwithstanding
any provision of this Article
14,
if a ruling by a court or arbitral authority on any dispute between
Hana
and its Sublicensee regarding the interpretation of the Sublicensee's
Sublicense
Agreement
could reasonably affect the interpretation of this Agreement, on
receipt
of notice of such a dispute from Hana, INEX may elect to apply to
join in
such proceeding.
|
| (i) |
If
INEX is permitted to join in such proceeding it shall be bound by
the
decision of such court or arbitral authority, in so far as the
interpretation of such decision could reasonably affect the interpretation
of this Agreement.
|
| (ii) |
If
INEX elects not to join in such proceeding (for reasons other than
not
being permitted to join) then INEX hereby agrees to be bound by the
decision of such court or arbitral authority, in so far as the
interpretation of such decision could reasonably affect the interpretation
of this Agreement.
|
| (iii) |
If
INEX is not permitted to join in such proceeding, then INEX shall
not be
bound by the decision of such court or arbitral
authority.
|
Article
15 NOTICES
15.1 Notices
All
payments, reports and notices or other documents that any of the Parties hereto
are required or may desire to deliver to any other Party hereto may be delivered
only by personal delivery or by registered or certified mail, or fax, all
postage and other charges prepaid, at the address for such Party set forth
below
or at such other address as any Party may hereinafter designate in writing
to
the others. Any notice personally delivered or sent by fax shall be deemed
to
have been given or received at the time of delivery, or transmission of the
fax.
Any notice mailed as aforesaid shall be deemed to have been received on the
expiration of five (5) days after it is posted, provided that if there shall
be
at the time of mailing or between the time of mailing and the actual receipt
of
the notice a mail strike, slow down or labour dispute which might affect the
delivery of the notice by the mail, then the notice shall only be effected
if
actually received.
|
If
to INEX:
Inex
Pharmaceuticals Corporation
#000
- 0000 Xxxxxxxx Xxxxxxx
Xxxxxxx,
X.X.
Xxxxxx
X0X 0X0
Attention:
President
and CEO
Tel: (000)
000-0000
Fax: (000)
000-0000
|
With
a copy to:
Lang
Xxxxxxxx LLP
1500
- 0000 Xxxx Xxxxxxx Xxxxxx
Xxxxxxxxx,
X.X.
X0X
0X0
Attention:
Xxx Xxxxxx
Tel:
(000)
000-0000
Fax: (000)
000-0000
|
-
58 -
|
If
to Hana:
Hana
BioSciences, Inc.
000
Xxxxxx Xxxxx Xxxxxxxxx, Xxxxx 000,
Xxxxx
Xxx Xxxxxxxxx, XX 00000
U.S.A
Attention:
President
and/or CEO
Tel:
Fax:
|
With
a copy to:
Attention:
Tel:
Fax:
|
Any
Party
may, at any time, give notice of any change of address to the other and the
address specified therein shall be such Party's address for the purpose of
receiving notices.
Article
16 TERM
16.1 Term
| (a) |
In
respect of any Royalty Due UBC, this Agreement and the sublicense
granted
hereunder shall terminate on the expiration of a term of twenty (20)
years
from July 1, 1998 or the expiration of the last patent obtained pursuant
to Article
6
herein, whichever event shall last occur unless earlier terminated
pursuant to Article
17
herein. Upon expiry of the Term of this Agreement (but not on termination
in accordance with Article
17)
Hana shall thereafter have, in perpetuity, a fully paid-up worldwide
license to use and sublicense the Technology in the Hana Field and
to
Manufacture, have made, distribute, import, use and sell Products,
without
further payment of Royalty Due UBC.
|
| (b) |
Notwithstanding
the termination or expiration of the Term of this Agreement, Hana
shall
continue to make payment to INEX in accordance with the principles
set
forth in the Definitive Agreements.
|
Article
17 TERMINATION
17.1
Termination
for Bankruptcy
| (a) |
This
Agreement may be terminated by INEX by providing notice to Hana
upon:
|
| (i) |
the
bankruptcy, liquidation or dissolution of
Hana;
|
| (ii) |
the
filing of any voluntary petition for bankruptcy, dissolution, liquidation
or winding-up of the affairs of Hana;
or
|
| (iii) |
the
filing of any involuntary petition for bankruptcy, dissolution,
liquidation or winding-up of the affairs of Hana which is not dismissed
within one hundred twenty (120) days after the date on which it is
filed
or commenced.
|
| (b) |
This
Agreement may be terminated by Hana by providing written notice to
INEX
upon:
|
| (i) |
the
bankruptcy, liquidation or dissolution of
INEX;
|
-
59 -
| (ii) |
the
filing of any voluntary petition for bankruptcy, dissolution, liquidation
or winding-up of the affairs of INEX;
or
|
| (iii) |
the
filing of any involuntary petition for bankruptcy, dissolution,
liquidation or winding-up of the affairs of INEX which is not dismissed
within one hundred twenty (120) days after the date on which it is
filed
or commenced. Notwithstanding
the bankruptcy of INEX, or the impairment of performance by INEX
of its
obligations under this Agreement as a result of bankruptcy of INEX,
to the
extent that INEX retains the rights necessary to grant the sublicenses
granted in this Agreement, Hana
shall be entitled to retain the sublicenses granted herein, subject
to
INEX’s rights to terminate this Agreement as provided in this
Agreement.
|
| (c) |
Effect
of INEX Bankruptcy. In
the event INEX shall: (1) make an assignment for the benefit of creditors,
or petition or apply to any tribunal for the appointment of a custodian,
receiver, or trustee for all or a substantial part of its assets;
(2)
commence any proceeding under any bankruptcy, dissolution,
or liquidation law or statute of any jurisdiction whether now or
hereafter
in effect; (3) have had any such petition or application filed or
any such
proceeding commenced against it in which an order for relief is entered
or
an adjudication or appointment is made, and which remains undismissed
for
a period of one hundred twenty (120) calendar days or more; (4) take
any
corporate action indicating its consent to, approval of, or acquiescence
in any such petition, application, proceeding, or order for relief
or the
appointment of a custodian, receiver, or trustee for all or substantial
part of its assets; or (5) permit any such custodianship, receivership,
or
trusteeship to continue undischarged for a period of one hundred
twenty
(120) calendar days or more (each, a “Bankruptcy Action: and the
occurrence of any of the foregoing causes the
applicable Party or any third party, including, without limitation,
a
trustee in bankruptcy, to be empowered under state or federal law
to
reject this Agreement or any Agreement supplementary hereto,
then
Hana shall have the following
rights:
|
| (i) |
In
the event of a rejection of this Agreement or any Agreement supplementary
hereto, Hana shall be permitted to receive and use any INEX Technology
and
Confidential Information for the purpose of enabling it to mitigate
damages caused to Hana because of the rejection of this
Agreement;
|
| (ii) |
In
the event of a rejection of this Agreement or any agreement supplementary
hereto, Hana may elect to retain its rights under this Agreement
or any
agreement supplementary hereto as provided in Section 365(n) of the
United
States Bankruptcy Code or comparable provision of the laws of any
other
country in the Territory. Upon Hana’s written request to INEX or the
bankruptcy trustee or receiver, INEX or such bankruptcy trustee or
receiver shall not interfere with the rights of Hana as provided
in this
Agreement or in any agreement supplementary
hereto;
|
| (iii) |
In
the event of a rejection of this Agreement or any agreement supplementary
hereto, Hana may elect to retain its rights under this Agreement
or any
agreement supplementary hereto as provided in Section 365(n) of the
United
States Bankruptcy Code or comparable provision of the laws of any
other
country in the Territory without prejudice to any of its rights of
setoff
and/or recoupment with respect to this Agreement under the Bankruptcy
Code
or applicable non-bankruptcy law;
or
|
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60 -
| (iv) |
In
the event of a rejection of this Agreement or any agreement supplementary
hereto, Hana may retain its rights under this Agreement or any agreement
supplementary hereto as provided in Section 365(n) of the United
States
Bankruptcy Code or comparable provision of the laws of any other
country
in the Territory without prejudice to any of its rights under Section
503(b) of the Bankruptcy Code or comparable provision of the laws
of any
other country in the Territory.
|
Notwithstanding
anything to the contrary in this Section 17.1(c):
| (v) |
INEX
will provide Hana with thirty (30) days prior written notice of INEX’s
regulatory filings in respect of any reorganization or arrangement
proposed by INEX;
|
| (vi) |
any
reorganization or arrangement involving INEX, its affiliates and/or
its
wholly owned subsidiaries which does not prejudice the rights of
Hana
shall not constitute a Bankruptcy Action for the purposes of this
Section
17.1(c)and
shall not give rise to the remedies set forth in this Section 17.1(c);
and
|
| (vii) |
if
Hana asserts any rights under Sections 17.1(c)(i),
17.1(c)(ii),
17.1(c)(iii)
or
17.1(c)(iv),
Hana shall continue to be bound by all liabilities and obligations
imposed
upon Hana, its Affiliates and Sublicensees under this Agreement,
and
INEX’s custodian, receiver or trustee in bankruptcy shall be entitled
to
exercise against Hana, its Affiliates and Sublicensees, any remedies
available to INEX under this
Agreement
|
17.2
Termination
by INEX
INEX
may,
at its option, terminate this Agreement immediately on the happening of any
one
or more of the following events by delivering notice in writing to that effect
to Hana:
| (a) |
if
any execution, sequestration, or any other process of any court becomes
enforceable against Hana or if any such process is levied on the
rights
under this Agreement or upon any of the monies due to INEX and is
not
released or satisfied by Hana within sixty (60) days
thereafter;
|
| (b) |
if
any resolution is passed by Hana or voluntary order made or other
steps
taken by Hana for the winding up, liquidation or other termination
of the
existence of Hana;
|
| (c) |
if
Hana ceases to carry on its business, other than as a result of a
disposition of substantially all of Hana’s business to a Third
Party;
|
| (d) |
if
Hana commits any breach of Section 4.1
or
any material breach of Article
12;
|
| (e) |
Hana
notifies INEX in writing that it intends to discontinue pursuing
all
Patent protection for the Technology hereof;
or
|
| (f) |
if
any Sublicensee of Hana is in material breach of its Sublicense
Agreement
with Hana which breach would be a breach of this Agreement if committed
by
Hana and Hana fails to use reasonable efforts to cause such Sublicensee
to
cure such breach within sixty (60) days of receipt of written notice
from
INEX requiring that Hana cause such Sublicensee to cure such
breach.
|
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17.3
Termination
for Invalidity Challenge
INEX
shall be entitled to terminate this Agreement immediately upon written notice
to
Hana, if Hana or any of its Affiliates or Sublicensees, directly or indirectly,
contests or otherwise disputes the ownership, scope, or validity of any of
the
Patents, or supports such attack by a Third Party.
17.4
Termination
for Material Breach
| (a) |
Either
Party shall be entitled to terminate this Agreement by written notice
to
the other Party in the event that the other Party is in material
default
of any of its obligations hereunder and fails to remedy any such
breach of
its obligations within ninety (90) days after notice thereof by the
Party
alleging breach. Any such notice
shall:
|
| (i) |
specifically
state that the Party not in default intends to terminate this Agreement
in
the event that the other Party fails to remedy the breach;
and
|
| (ii) |
expressly
set forth the actions required of the other Party to remedy the
breach.
|
If
such
breach is not corrected, the Party not in breach shall have the right to
terminate this Agreement or the license(s) hereunder in respect of such Product
or such country as to which a breach remains unremedied by giving written notice
to the other Party, by giving written notice to the other Party provided the
notice of termination is given within six (6) months of one Party’s discovery of
the other Party’s breach and prior to correction of the breach.
| (b) |
Either
Party shall be entitled to terminate this Agreement or the licenses
granted to the other Party hereunder by written notice to such other
Party
in the event that such other Party is in material breach of the
Non-Competition Terms, and fails to remedy any such breach within
ninety
(90) days after notice thereof.
|
| (c) |
If
a dispute arises as to whether either Party is in material breach
of its
obligations hereunder, or as to whether such Party has cured any
such
breach, either Party may invoke the dispute resolution procedure
described
in Section 14.3
to
resolve such Dispute.
|
17.5
No
Limitation on Remedies
Upon
any
termination of this Agreement or the license(s) hereunder in respect of such
Product or such country pursuant to this Article
17,
neither
Party shall be relieved of any obligations incurred prior to such termination.
Termination of the Agreement in accordance with the provisions hereof shall
not
limit remedies that may be otherwise available in law or equity.
17.6
Consequence
of Termination
| (a) |
If
this Agreement or the license(s) granted by INEX to Hana in respect
of a
particular Product in a particular country(ies) is terminated pursuant
to
Sections 17.1(a),
17.2,
17.3
for invalidity challenge or a breach by Hana as set forth in Section
10.4
for lack of sales, or 17.4
for material breach, Hana shall make payments to each of INEX and
the
University in the manner specified in Article
5,
and each of INEX and the University, may proceed to enforce payment
of:
|
| (i) |
all
outstanding Royalty Due INEX, Sublicensing Revenue Due INEX and other
monies owed to INEX; and
|
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62 -
| (ii) |
all
outstanding Royalty Due UBC;
|
and
to
exercise any or all of the rights and remedies contained herein or otherwise
available to INEX by law or in equity, successively or concurrently at the
option of INEX.
| (b) |
Upon
any such termination of this Agreement or of the license(s) granted
by
INEX to Hana, all sublicenses granted hereunder shall forthwith terminate,
and Hana shall:
|
| (i) |
except
as required by law or expressly permitted by Section 17.7,
deliver up to INEX within a reasonable time, not to exceed six (6)
months
from the Effective Date of Termination, all Technology in its possession
or control and shall thereafter have no further right of any nature
whatsoever in the Technology. On failure by Hana to so deliver up
the
Technology, INEX may take action against Hana to enforce such delivery
and
Hana will pay all charges or expenses incurred by INEX in the enforcement
of such rights or remedies against Hana including, without limitation,
INEX’s legal fees and disbursements on an indemnity
basis;
|
| (ii) |
deliver
to INEX within thirty (30) days of the Effective Date of Termination
a
written Accounting and plan specifying, in such terms as INEX may
in its
reasonable discretion require, the inventory of Product remaining
unsold
on the Effective Date of Termination, and Hana’s plan for the disposition
of same. Following the delivery of such accounting and plan, Hana
shall
then have a reasonable time to liquidate such inventory of Product,
provided that such period shall not exceed six (6) months from the
Effective Date of Termination. Hana shall continue to make all payments
to
INEX on all such Product sold in the same manner as specified in
this
Agreement, notwithstanding anything contained in, or any exercise
of
rights by INEX under this Article
17;
|
| (iii) |
provided
that INEX shall be responsible for any reasonable associated out-of-pocket
costs associated with the following activities, Hana shall promptly
deliver to INEX a copy of all data (including animal and human data)
and
such other information, Material, materials (including biological
materials) and documents in Hana’s possession or control arising from the
Development of Product under this Agreement that INEX may reasonably
require in order to obtain and/or maintain Regulatory Approvals.
INEX
may, directly or through a licensee, exploit such data, other information,
Materials, materials (including biological materials) and documents
to
develop, make, have made, import, use, offer for sale and sell Product
in
such country(ies);
|
| (iv) |
Hana
shall also, within thirty (30) days after the effective date of such
termination, use all reasonable endeavors to take all steps and execute
all documents reasonably necessary to assign and/or transfer or permit
reference to (to the extent legally permissible in the relevant country)
all Regulatory Submissions and Regulatory Approvals arising from
the
Development of Product under this Agreement in Hana’s name or in the name
of Hana’s Representatives to INEX or its designee, provided that INEX
shall be responsible for any reasonable associated out-of-pocket
costs of
transfer;
|
| (v) |
In
the event that no such assignment and/or transfer and/or reference
pursuant to Section 17.6(b)(iv)
may legally be made, then Hana shall forthwith surrender to INEX
or its
designee such Regulatory Submissions and Regulatory Approvals for
cancellation;
|
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63 -
| (vi) |
Upon
INEX’s request, Hana shall within thirty (30) days after the effective
date of such termination, deliver to INEX or its designee any and
all
documents relating to applications, correspondences with Regulatory
Authorities, Regulatory Submissions, Regulatory Approvals, and
post-Regulatory Approval Pharmacovigilance in its possession or control
arising from the Development of Product that are reasonably required
for
commercialization of Product, provided that INEX shall be responsible
for
any reasonable associated out-of-pocket costs of
transfer.
|
Except
to
the extent set out in the last sentence of Section 17.6(b)(iii),
Hana’s
transfer to INEX of any data, other information, Materials, materials (including
biological materials) or documents shall not grant INEX any license or right
(whether express, implied or by estoppel) in any Intellectual Property Rights
owned or controlled by Hana.
| (c) |
Upon
any termination by INEX of the licenses granted
hereunder:
|
| (i) |
Hana
shall not be relieved of any obligations incurred prior to such
termination; and
|
| (ii) |
each
Party shall promptly return to the other Party all written Confidential
Information, and all copies thereof (except for one archival copy
to be
retained solely for the purpose of confirming which information to
hold in
confidence hereunder); and
|
| (d) |
The
termination of the license granted hereunder will be without prejudice
to:
|
| (i) |
INEX’s
right to receive all payments accrued from Hana pursuant to Section
6.9
as
of the effective date of such termination including, without limitation,
payment for all out-of-pocket costs and personnel costs which INEX
has
properly and reasonably incurred in providing IP Services and in
following
instructions received from Hana up to the date of such termination.
For
greater certainty, such costs shall include INEX’
reasonable and necessary non-cancelable obligations to
Third Parties actually incurred by INEX in the performance of its
obligations under this Agreement
prior to the date of notice of termination, but arising after the
date of
notice of termination; and
|
| (ii) |
any
or all of the rights and remedies contained herein or otherwise available
to either Party by law or in equity, successively or concurrently,
at the
option of either Party.
|
| (e) |
Notwithstanding
the termination of this Agreement, Article
11
shall remain in full force and effect until three (3) years
after:
|
| (i) |
all
payments of Royalties required to be made by Hana under this Agreement
have been made by Hana to each of INEX and the University;
and
|
| (ii) |
any
other claim or claims of any nature or kind whatsoever of INEX against
Hana has been settled.
|
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64 -
17.7 Return
of Confidential Information
Except
as
required by law, upon any termination of this Agreement, each Party shall cease
to use the Confidential Information of the other Party, and upon written request
and at the option of the other Party, shall deliver or destroy and certify
the
destruction of all copies of same, except for a single copy to be retained
solely for the purpose of compliance with the terms of this
Agreement.
Article
18 MISCELLANEOUS
COVENANTS REQUIRED BY UNIVERSITY
18.1
Miscellaneous
Covenants of Hana
| (a) |
Hana
hereby represents and warrants to INEX that Hana is a corporation
duly
organized, existing, and in good standing under the laws of Canada
and has
the power, authority, and capacity to enter into this Agreement and
to
carry out the transactions contemplated by this Agreement, all of
which
have been duly and validly authorized by all requisite corporate
proceedings.
|
| (b) |
Hana
represents and warrants that it has the expertise necessary to handle
the
Technology in the Hana Field with care and without danger to Hana,
its
employees, agents, or the public. Hana shall not accept delivery
of the
Technology until it has requested and received from INEX all necessary
information and advice to ensure that it is capable of handling the
Technology in a safe and prudent
manner.
|
| (c) |
Hana
shall comply with all laws, regulations and ordinances, whether Federal,
Provincial, Municipal or otherwise with respect to the Technology
and/or
this Agreement.
|
| (d) |
Upon
the presentation of itemized bills to Hana by INEX or the University,
Hana
shall pay to INEX or the University, as the case may be:
|
| (i) |
all
reasonable legal expenses and costs incurred by the University in
respect
of the negotiation and preparation of this Agreement, and of any
amendments of this Agreement; and
|
| (ii) |
all
reasonable legal expenses and costs in excess of $[***]
CDN
incurred by the University in respect of any consents or approvals
required from the University, including but not limited to expenses
and
costs in respect of the University’s review of each sublicense to be
granted by Hana.
|
| (e) |
Hana
shall pay all taxes and any related interest or penalty howsoever
designated and imposed as a result of the existence or operation
of this
Agreement, including, but not limited to, tax which Hana is required
to
withhold or deduct from payments to INEX and to the University. Hana
will
furnish to INEX and to the University such evidence as may be required
by
American and Canadian authorities to establish that any such tax
has been
paid. The Royalties specified in this Agreement are exclusive of
taxes. If
INEX or the University is required to collect a tax to be paid by
Hana (or
any of its Sublicensees), Hana shall pay such tax to INEX or to the
University, as the case may be, on demand. Under
no circumstances will Hana be responsible for any franchise-related
taxes
or taxes based on the University’s or INEX’s gross or net
income
|
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65 -
Article
19 PRODUCT
SAFETY AND REGULATORY COMPLIANCE
19.1 Regulatory
Responsibilities
| (a) |
Hana
shall ensure
that
none of its Representatives who participate in any Development
activities:
|
| (i) |
is
or has been suspended, debarred or disqualified by the
FDA;
|
| (ii) |
has
been convicted of any offence that would form the basis for any debarment;
or
|
| (iii) |
is
or has been subject to any proceedings for the suspension,
disqualification or debarment.
|
| (b) |
Upon
the re-activation and/or transfer by INEX to Hana of the NDA or IND,
as
the case may be, in respect of each Product, Hana shall be responsible
for
using
Commercially Reasonable Efforts to maintain and fulfill
all Regulatory Requirements with respect to such Product that are
imposed
upon Hana as the holder of Regulatory Submissions and Regulatory
Approvals.
|
| (c) |
Hana
and/or its Representatives’ Manufacturing, shipping and distribution of
Material for clinical and commercial use shall be done in accordance
with
applicable specifications and Regulatory Requirements. Hana shall
maintain
and shall require its Representatives who receive, handle, store,
ship or
distribute Product to maintain a record retention policy consistent
with
cGMP and Regulatory Requirements, and to maintain records with sufficient
detail to facilitate traceability in the event of recalls or voluntary
withdrawals of Product.
|
| (d) |
In
respect of each Product, Hana will use Commercially
Reasonable Efforts
to
make such changes as reasonably necessary to the master production
record,
specifications, procedures, processes, Materials, facilities, equipment
or
any matter utilized by Hana under this Agreement or contained or
reference
in and documents submitted to Regulatory Authorities to meet new
Regulatory Requirements and guidelines in the
Territory.
|
19.2 Pharmacovigilance
| (a) |
Upon
the transfer
|
| (b) |
For
as long as Material sourced, Manufactured or quality released by
INEX
remains available for use in approved clinical trials, Hana
shall:
|
| (i) |
inform
INEX within five (5) Business Days of any complaint received or regulatory
action taken in respect of such Material and shall seek INEX’ opinion
before passing judgment on the quality of such Material to any Third
Party; and
|
| (ii) |
provide
INEX with a copy(ies) of all documentation provided to and received
from
Regulatory Authorities in respect of such complaint or Adverse Drug
Event,
within one (1) Business Day of sending or receiving
same.
|
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19.3 Recalls
and Product Withdrawals
| (a) |
If
either Party is required or requested by any Regulatory Authority
to
recall or withdraw any Clinical Trial Material for any reason, or
should
either Party decide voluntarily to withdraw any Clinical Trial
Material:
|
| (i) |
the
Party in whose name the applicable IND file is registered will be
responsible for coordinating such recall or product
withdrawal;
|
| (ii) |
Hana
shall pay the costs and expenses of such recall or product withdrawal,
subject to recovery of some or all of same in accordance with the
terms of
Section 19.2;
|
| (iii) |
Unless
INEX is liable for such costs and expenses in accordance with the
terms of
Section 19.2,
Hana will remain responsible to INEX for payment of all Services
in
respect of the Manufacture and supply of Material;
and
|
| (iv) |
Both
Parties will cooperate fully with one another in connection with
any such
recall or product withdrawal.
|
| (b) |
If
a recall or product withdrawal is due to INEX’s negligence, willful
misconduct or breach of this Agreement or of the Service Agreement,
INEX
will reimburse Hana for all of Hana’s reasonable costs and expenses
actually incurred by Hana in connection with the recall or product
withdrawal, including any Service fees and expenses associated with
the
supply of the Product recalled or withdrawn, costs of retrieving
Product
already delivered to customers, costs and expenses Hana is required
to pay
for notification, shipping and handling charges, destruction or return
of
the defective Product or otherwise and such other reasonable costs
as may
be reasonably related to the recall or product
withdrawal.
|
| (c) |
If
the Parties are unable to agree on whether or not a recall or product
withdrawal is due to INEX’s negligence, willful misconduct or breach of
this Agreement, either Party may refer the matter for resolution
pursuant
to Article 13.
|
| (d) |
Notwithstanding
any expiration or early termination of this Agreement, the provisions
of
Sections 19.2
and 19.3
shall continue to apply for as long as any Product containing Material
that was sourced, Manufactured or quality released by INEX remains
available for use in approved clinical
trials.
|
Article
20 GENERAL
PROVISIONS
20.1 UBC
Requirement
On
reasonable notice, Hana shall permit any duly authorized Representative of
the
University and of INEX, jointly or separately, during normal business hours
and
at each of the University’s and INEX’s sole risk and expense to enter upon and
into any premises of Hana for the purpose of inspecting the Products and the
manner of this Manufacture and generally of ascertaining whether or not the
provisions of this Agreement have been, are being, or will be complied with
by
Hana.
20.2 Amendments
No
amendment, modification, supplement, termination or waiver of any provision
of
this Agreement will be effective unless in writing signed by the Parties and
then only in the specific instance and for the specific purpose given.
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67 -
20.3 Counterparts;
Facsimile
This
Agreement may be executed in any number of counterparts (either originally
or by
facsimile), each of which shall be deemed to be an original, and all of which
taken together shall be deemed to constitute one and the same instrument, and
it
shall not be necessary in making proof of the agreement to produce or account
for more than one such counterpart.
20.4 Enurement
This
Agreement shall enure to the benefit of and be binding upon the Parties hereto
and their respective successors and permitted assigns.
20.5 Exhibits
/ Schedules
The
Schedules attached hereto shall be deemed to form an integral part of this
Agreement.
20.6 Force
Majeure
In
the
event that either Party is prevented from performing or is unable to perform
any
of its obligations under this Agreement due to any act of God; fire; casualty;
flood; war; strike; lockout; failure of public utilities; injunction or any
act,
exercise, assertion or requirement of governmental authority; epidemic;
destruction of production facilities; riots; insurrection; failure of
transportation; inability to procure or use materials (including Materials),
or
any other cause beyond the reasonable control of the Party invoking this Section
20.6
if such
Party shall have used its reasonable efforts to avoid such occurrence, such
Party shall give notice to the other Party in writing promptly, and thereupon
the affected Party’s performance shall be excused and the time for performance
shall be extended for the period of delay or inability to perform due to such
occurrence.
20.7 Further
Assurances
Each
Party shall co-operate with the other, and execute and deliver, or cause to
be
executed and delivered, all such other documents and instruments and take all
such other actions as such Party may be reasonably requested by the other Party
to take from time to time, consistent with the terms of this Agreement in order
to implement the provisions and purposes of this Agreement.
20.8 Headings
The
headings in this Agreement are solely for convenience of reference and shall
not
be used for purposes of interpreting or construing the provisions hereof.
20.9 Incorporation
by Reference
Notwithstanding
any expiration or termination of the License Agreement or any other agreement
between the Parties, any part of the UBC License or any other agreement between
the Parties which are expressly incorporated herein by reference, mutatis
mutandis,
shall
continue to apply to this Agreement during the Term of this
Agreement.
20.10 Independent
Legal Advice
Both
Parties sought external legal counsel representation in the preparation of
this
Agreement, and neither Party shall be construed to be the drafter
hereof.
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68 -
20.11 Non-Use
of Names
Neither
Party shall use the name of the other Party, nor any adaptation thereof, in
any
advertising, promotional or sales literature without prior written consent
obtained from such other Party in each case (which consent shall not be
unreasonably withheld or delayed).
20.12 No
Implied Rights
Nothing
in this Agreement will be deemed or implied to be the grant by one Party to
the
other of any right, title or interest in any product or Product, Confidential
Information, trade xxxx, trade dress or any other intellectual property or
any
other proprietary right of the other, except as is expressly provided for
herein.
20.13 No
Solicitation
or Hiring of Employees
The
Parties agree that, during the Term of this Agreement and for a period of twelve
(12) months thereafter, it will not directly or indirectly induce any employee
of the other Party to terminate their employment with the other Party without
the prior written consent of the other Party.
This
Section shall not prevent or prohibit any employee from one Party directly
contacting the other Party for employment or employment opportunities or from
responding to published employment advertisements, and under these limited
circumstances, this restriction shall not prevent either Party from interviewing
and/or hiring such an employee.
20.14 No
Waiver
No
condoning, excusing or overlooking by any Party of any default or breach by
the
another Party in respect of any terms of this Agreement shall operate as a
waiver of such Party's rights under this Agreement in respect of any continuing
or subsequent default or breach, and no waiver shall be inferred from or implied
by anything done or omitted by such Party, save only an express waiver in
writing.
20.15 Publicity
Except
as
required by law, stock exchange or regulatory authority:
| (a) |
neither
Party, nor any of its Affiliates, shall originate any publicity,
news
release or other public announcement, written or oral, relating to
this
Agreement or the existence of an arrangement between the Parties,
without
the prior written approval of the other Party and agreement upon
the
nature and text of such announcement or disclosure, which approval
shall
not be unreasonably withheld or delayed;
and
|
| (b) |
the
Party desiring to make any such public announcement or other disclosure
shall inform the other Party of the proposed announcement or disclosure
in
reasonably sufficient time prior to public release, and shall provide
the
other Party with a written copy thereof, in order to allow such other
Party to comment upon such announcement or
disclosure.
|
20.16 Relationship
of Parties
It
is not
the intent of the Parties hereto to form any partnership or joint venture.
Each
Party shall, in relation to its obligations hereunder, be deemed to be and
shall
be an independent contractor, and nothing in this Agreement shall be construed
to give such Party the power or authority to act as agent for the other Party
for any purpose, or to bind or commit the other Party in any way whatsoever.
-
69 -
20.17 Rights
and Remedies
The
rights and remedies available under this Agreement shall be cumulative and
not
alternative and shall be in addition to and not a limitation of any rights
and
remedies otherwise available to the Parties at law or in equity. No exercise
of
a specific right or remedy by any Party precludes it from or prejudices it
in
exercising another right or pursuing another remedy or maintaining an action
to
which it may otherwise be entitled either at law or in equity.
20.18 Severability
If
any
one or more of the provisions contained in this Agreement is found by any court
or arbitrator for any reason, to be invalid, illegal or unenforceable in any
respect in any jurisdiction:
| (a) |
such
provision shall be severable from the remainder of the Agreement
in the
jurisdiction in which such provision was found to be invalid, illegal
or
unenforceable;
|
| (b) |
the
validity, legality and enforceability of such provision will not
in any
way be affected or impaired thereby in any other jurisdiction and
the
validity, legality and enforceability of the remaining provisions
contained herein will not in any way be affected or impaired thereby,
unless in either case as a result of such determination this Agreement
would fail in its essential purpose;
and
|
| (c) |
the
Parties will use their best efforts to substitute for any provision
that
is invalid, illegal or unenforceable in any jurisdiction a valid,
legal
and enforceable provision which achieves to the greatest extent possible
the economic, legal and commercial objectives of such invalid, illegal
or
unenforceable provision and of this
Agreement.
|
-
70 -
20.19 Survival
Notwithstanding
any termination of the sublicense granted hereunder, the provisions of
Article
1,
Sections 2.1,
3.4,
4.2(d) 5.5,
5.6,
5.7,
6.2(b),
6.5,
6.6(c),
6.6(d),
6.8(c),
6.9(c),
6.10,
6.12,
Article
7,
Article
8,
Article
9,
10.1(a),
Section
11.4,
11.5,
Article
12,
Article
13,
Article
14,
Article
15,
Article
16,
Article
17,
Article
18,
Article
19
and
Article
20,
as well
as under any other provisions which by their nature are intended to survive
any
such termination, will survive the termination of this Agreement or of any
rights sublicensed hereunder.
20.20 Wording
Wherever
the singular or masculine form is used in this Agreement, it will be construed
as the plural or feminine or neuter form, as the case may be, and vice versa,
as
the context or the Parties require.
20.21 Supremacy
Solely,
as between Inex and Hana, in the event of any conflict between the terms of
this
Agreement and the License Agreement, and solely with regards to obligations
of
Inex and Hana under the License Agreement, the terms of the License Agreement
will govern. For greater clarity it is confirmed that the provision in the
forgoing sentence will not apply with regards to any provision of this Agreement
that the University may rely on, or enforce against either Inex or Hana under
the terms of the UBC Consent.
IN
WITNESS WHEREOF,
each of
the Parties has caused this Agreement to be executed on its behalf by a duly
authorized officer as of the date first written above.
|
INEX
PHARMACEUTICALS
CORPORATION
by
its authorized signatory:
/s/ Xxxxxxx
Xxxxx
Xxxxxxx
Xxxxx
President
& C.E.O.
|
HANA
PHARMACEUTICALS
CORPORATION
by
its authorized signatory:
/s/ Xxxx X.
Xxx
Xxxx
X. Xxx
President
and C.E.O.
|
-
71 -
Schedule
“A” to Sublicense Agreement
NOTES:
| · |
The
Assignment of existing licences is not captured in this schedule,
which is
exclusive to IP rights only
|
-
72 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense Royalty
|
|
Group
4 (XXX-2300 and XXX-2700 families): liposome manufacturing and
loading;
covers all three products
|
||||||||
|
XXX-2300-NP
|
Ionophore-Mediated
Liposome Loading
|
U.S.
Patent Application No. 08/741,622
US
Patent Number 5,837,282
ISSUED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-PCT
|
Ionophore-Mediated
Liposome Loading
|
International
Patent Application No. PCT/CA97/00821
International
Patent Publication No.
WO
98/18450
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-AT
|
Ionophore-Mediated
Liposome Loading
|
Austrian
Patent No.
AT
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-AU
|
Ionophore-Mediated
Liposome Loading
|
Australian
Patent No.
AU
000000
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
73 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense Royalty
|
|
XXX-2300-BE
|
Ionophore-Mediated
Liposome Loading
|
Belgium
Patent No.
BE
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-CA
|
Ionophore-Mediated
Liposome Loading
|
Canadian
Patent Application No.
2,269,921
PENDING
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-CH
|
Ionophore-Mediated
Liposome Loading
|
Switzerland
Patent No.
CH
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-DE
|
Ionophore-Mediated
Liposome Loading
|
German
Patent No.
DE
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
74 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense
Royalty
|
|
XXX-2300-DK
|
Ionophore-Mediated
Liposome Loading
|
Danish
Patent No.
DE
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-EP
|
Ionophore-Mediated
Liposome Loading
|
European
Patent Application No. 97911086.3
European
Patent No.
EP
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-ES
|
Ionophore-Mediated
Liposome Loading
|
Spanish
Patent No.
ES
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-FR
|
Ionophore-Mediated
Liposome Loading
|
French
Patent No.
FR
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
75 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense
Royalty
|
|
XXX-2300-GB
|
Ionophore-Mediated
Liposome Loading
|
United
Kingdom Patent No.
GB
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-IE
|
Ionophore-Mediated
Liposome Loading
|
Irish
Patent No.
IE
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-IT
|
Ionophore-Mediated
Liposome Loading
|
Italian
Patent No.
IT
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-JP
|
Ionophore-Mediated
Liposome Loading
|
Japanese
Patent Application No.
10-519843
PENDING
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
76 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense
Royalty
|
|
XXX-2300-NL
|
Ionophore-Mediated
Liposome Loading
|
Netherlands
Patent No.
NL
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2300-SE
|
Ionophore-Mediated
Liposome Loading
|
Swedish
Patent No.
SE
0941065
GRANTED
|
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
X.
Xxxxxxxxx,
X.
Xxxxxx,
X.
Xxxxx,
N.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-PSP
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
U.S.
Provisional Patent Application No. 60/143,978
EXPIRED
- July 15, 2000
|
Xxxxxx,
V.
Dzubanov,
X.
Xxxxxx,
X.
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-PCT
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
International
Patent Application No. PCT/CA00/00843
International
Publication No.
WO
01/05374
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-AU
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Australian
Patent No.
AU
000000
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
77 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense
Royalty
|
|
XXX-2700-BR
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Brazilian
Patent Application No.
0012624-1
PENDING
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-CA
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Canadian
Patent Application No.
2,378,438
PENDING
|
Maurer,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-CN
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Chinese
Patent No.
ZL
00810355.0
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-DE
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
German
Patent No.
DE
1194122
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-EP
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
European
Patent Application No. 00949026.9
European
Patent No.
EP
1194122
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-ES
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Spanish
Patent No.
ES
1194122
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
78 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense
Royalty
|
|
XXX-2700-FR
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
French
Patent No.
FR
1194122
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-GB
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
United
Kingdom Patent No.
GB
1194122
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-IE
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Irish
Patent No.
IE
1194122
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-IL
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Israeli
Patent Application No.
147,089
PENDING
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-IS
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Icelandic
Patent Application No.
PCT/CA00/00843
ABANDONED
- OCTOBER 19, 2004
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-IT
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Italian
Patent No.
IT
1194122
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
79 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense Royalty
|
|
XXX-2700-JP
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Japanese
Patent Application No. 2001-510431
PENDING
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-SG
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
Xxxxxxxxx
Xxxxxx Xx.
XX
00000
GRANTED
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-US
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
U.S.
Patent Application No. 10/019,199
PENDING
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-PCT1
|
Method
and Apparatus for Preparation of Lipid Vesicles
|
International
Patent Application No. PCT/CA00/00842
International
Publication No.
WO
01/05373
|
Xxxxxx,
V.
Dzubanov,
X. Xxxxxx, X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-AU1
|
Method
and Apparatus for Preparation of Lipid Vesicles
|
Australian
Patent No.
AU
000000
GRANTED
|
Xxxxxx,
V.
Dzubanov,
X. Xxxxxx, X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-CA1
|
Method
and Apparatus for Preparation of Lipid Vesicles
|
Canadian
Patent Application No.
2,378,430
PENDING
|
Xxxxxx,
V.
Dzubanov,
X. Xxxxxx, X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-EP1
|
Method
and Apparatus for Preparation of Lipid Vesicles
|
European
Patent Application No. 00949025.1
PENDING
|
Xxxxxx,
V.
Dzubanov,
X. Xxxxxx, X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
80 -
|
Inex
File Number
|
Title
|
Serial/
Patent Numbers
|
Inventors
|
Origin
|
Ownership
of Prosecution
|
Hana
Cost Allocation
|
UBC
Royalty
|
UBC
Sublicense
Royalty
|
|
XXX-2700-JP1
|
Method
and Apparatus for Preparation of Lipid Vesicles
|
Japanese
Patent Application No. 2001-510430
PENDING
|
Xxxxxx,
V.
Dzubanov,
X. Xxxxxx, X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-US1
|
Method
and Apparatus for Preparation of Lipid Vesicles
|
U.S.
Patent Application No. 10/019,200
PENDING
|
Xxxxxx,
V.
Dzubanov,
X. Xxxxxx, X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
|
XXX-2700-CNT1
|
Methods
for Preparation of Lipid-Encapsulated Therapeutic Agents
|
U.S.
Patent Application No. 11/359,999
PENDING
|
Xxxxxx,
X.
Xxxx,
X.
Xxxxxx,
P.
|
UBC
|
INEX
|
[***]%
|
[***]%
|
[***]%
|
-
81 -
Schedule
“B” to Sublicense Agreement
ROYALTIES
In
each case where:
|
A
|
=
|
Number
of UBC credited inventors who have not signed waivers of interest
in
royalties received by UBC, and
|
|
B
|
=
|
Total
Number of UBC credited inventors.
|
Neither
INEX, Hana nor UBC will require that any graduate student becomes a party
to a
waiver agreement pursuant to their activities and studies while at
UBC.
Royalties
on Revenues Due UBC
[***]%
x
Number
of UBC credited inventors
x
(1
+
A/B)
x
Revenue Due UBC
Total
Number of Inventors 2
For
the
avoidance of doubt, where there are no UBC credited inventors, no Royalties
will
be payable
-
82 -
Royalties
on Sublicensing Revenues Due UBC
[***]%
x
Number
of UBC credited inventors
x
(1
+
A/B)
x
Sublicensing Revenue Due UBC
Total
Number of Inventors 2
For
the
avoidance of doubt, where there are no UBC credited inventors, no Royalties
will
be payable.
-
83 -
