Contract
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
EXHIBIT
10.4
AMENDED
AND RESTATED LICENSE AGREEMENT
THIS
AMENDED AND RESTATED LICENSE AGREEMENT (the “Agreement”)
is
dated effective April 30, 2007.
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 0000
Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, XX 00000, X.X.X.
("Hana")
| A. |
On
May 6, 2006, INEX (as hereinafter defined) and Hana entered into
a License
Agreement (as hereinafter defined) to govern the Parties’ respective
rights and obligations in respect of Hana’s use in the Hana Field (as
hereinafter defined), of Patents (as hereinafter defined) and Technology
(as hereinafter defined).
|
| B. |
On
May 6, 2006, INEX and Hana entered into a Transaction Agreement (as
hereinafter defined). Pursuant to which Section 6.7 of the Transaction
Agreement, INEX agreed to make commercially reasonable efforts to
obtain
the consent of Aradigm (as hereinafter defined) to the assignment
by INEX
to Hana of the BCCA Patents (as hereinafter defined) licensed by
INEX to
Aradigm for use in the pulmonary delivery of Ciprofloxacin, and Hana
agreed to license the BCCA Patents back to INEX for use outside the
Hana
Field and remain liable to INEX for all milestone, royalty and
sublicensing payments which Hana would otherwise have made to INEX
in
respect of the BCCA Patents had the assignment by INEX to Hana not
taken
place.
|
| C. |
Pursuant
to Section 6.8 of the Transaction Agreement, INEX agreed to make
commercially reasonable efforts to obtain the consent of MD Xxxxxxxx
(as
hereinafter defined) to the assignment by INEX to Hana of the MD
Xxxxxxxx
License (as hereinafter defined), Xxxxxx Patents (as hereinafter
defined),
and Xxxxxx Patents (as hereinafter defined), and Hana agreed to license
the Xxxxxx Patents and Xxxxxx Patents back to INEX for use outside
the
Hana Field and remain liable to INEX for all milestone, royalty and
sublicensing payments which Hana would otherwise have made to INEX
in
respect of the Xxxxxx Patents and Xxxxxx Patents had the assignment
by
INEX to Hana not taken place.
|
| D. |
The
Parties are herewith entering into this Amended and Restated License
Agreement to: (i) to effect the termination of the license by INEX
to Hana
of the MD Xxxxxxxx Patents, and the termination of all rights,
responsibilities and obligations of Hana associated therewith; (ii)
to
affirm the continuation of the license by INEX to Hana of the Licensed
Patents (as hereinafter defined) for use in the Hana Field, and to
affirm
the continuation of all rights, responsibilities and obligations
of Hana
associated therewith; and (iii) to effect the license by Hana to
INEX of
the MD Xxxxxxxx Patents for use outside the Hana Field upon the terms
and
conditions contained herein; all as contemplated by Section 6.8 of
the
Transaction Agreement.
|
| E. |
On
even date hereof, the Parties are entering into an Assignment and
Novation
Agreement with MD Xxxxxxxx to effect the assignment by INEX to Hana
of the
MD Xxxxxxxx License and the MD Xxxxxxxx Patents as contemplated by
Section
6.8 of the Transaction Agreement.
|
Article
1 INTERPRETATION
1.1 Definitions
As
used
in this Agreement, the following terms, whether used in the singular or plural,
shall have the following meanings:
| 1.1.1 |
“Abandoning
Party”
shall have the meaning set forth in Section
8.5.1.
|
| 1.1.2 |
“Adverse
Drug Event”
means any noxious, unintended, or untoward medical occurrence in
a patient
or clinical investigation subject associated with the use of a medicinal
or investigational product, whether or not related to the medicinal
or
investigational product.
|
| 1.1.3 |
“Affiliate”
means, with respect to any Person, any Person directly or indirectly
controlled by, controlling or under common control with such Person.
For
the purposes of this definition, “control” shall mean direct or indirect
beneficial ownership of 50% or greater interest in the voting power
of
such Person or such other relationship as, in fact constitute actual
control.
|
| 1.1.4 |
“Agreement”
means this Amended and Restated License Agreement and all exhibits
attached hereto.
|
| 1.1.5 |
“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”).
|
| 1.1.6 |
“Aradigm”
means Aradigm Corporation, a company duly incorporated pursuant to
the
laws of the State of California, and having its principal place of
business at 0000 Xxxxx Xxxx Xxx, Xxxxxxx, XX 00000,
X.X.X.
|
| 1.1.7 |
“Aradigm
License”
means the license agreement dated December 8, 2004 between Aradigm
and
INEX.
|
| 1.1.8 |
“Assessed
Value”
shall have the meaning set forth in Section
3.6.6(b).
|
| 1.1.9 |
“Assigned
Patents”
mean the MD Xxxxxxxx Patents listed in Exhibit
1.1.9
attached hereto.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 1.1.10 |
“Bankruptcy
Action”
shall have the meaning set forth in Section
14.3.3.
|
| 1.1.11 |
“BCCA”
means the British Columbia Cancer
Agency.
|
| 1.1.12 |
“BCCA
Agreements”
means the Research Project Agreement between INEX (formerly Lipex
Pharmaceuticals, Inc.) and the British Columbia Cancer Agency dated
February 25, 1993 and terminated May 6, 2002.
|
| 1.1.13 |
“BCCA
Patents”
means:
|
| (a) |
the
egg sphingomyelin patents assigned by the BCCA to INEX;
and
|
| (b) |
any
and all counterparts of the foregoing, including all divisionals,
provisionals, non-provisionals, and continuations, and all patents
issuing
on any of the foregoing and any foreign counterparts thereof, together
with all registrations, reissues, re-examinations, supplemental protection
certificates, additions, renewals or extensions thereof and any foreign
counterparts thereof;
|
that
are
subject to the rights of:
| (c) |
the
BCCA (including royalty rights) under the terms and conditions of
the BCCA
Agreements;
|
| (d) |
INEX
(including milestone, Licensing/Sublicensing Revenue and royalty
rights)
under the terms and conditions of this Agreement;
and
|
| (e) |
Aradigm
under the terms and conditions of the Aradigm
License.
|
| 1.1.14 |
“Business
Day”
means any day other than a day which is a Saturday, a Sunday or a
statutory holiday in British Columbia
or
California.
|
| 1.1.15 |
“Calendar
Quarter”
means each of the three-month periods ending on March 31, June 30,
September 30 or December 31.
|
| 1.1.16 |
“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.
|
| 1.1.17 |
“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 a
Product.
|
| 1.1.18 |
“Clinical
Trial Material”
means labeled and packaged Sphingosomal Vincristine, Sphingosomal
Vinorelbine and/or Sphingosomal Topotecan, and any component(s) thereof,
used or to be used, in clinical
trials.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 1.1.19 |
“Closing
Payment”
means an aggregate of One Million Five Hundred Thousand Dollars
($1,500,000) in funds held in escrow paid by Hana to INEX pursuant
to the
terms and conditions of the Transaction
Agreement.
|
| 1.1.20 |
“Closing
Shares”
means the number of shares of Common Stock determined by dividing Ten
Million Dollars ($10,000,000) by the FMV of the Common Stock as of
March 16, 2006, paid by Hana to INEX pursuant to the terms and conditions
of the Transaction Agreement.
|
| 1.1.21 |
“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.
|
| 1.1.22 |
“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.
|
| 1.1.23 |
“Common
Stock”
means the common stock of Hana, par value $0.001 per
share.
|
| 1.1.24 |
“Confidential
Information”
means all information, knowledge or
data:
|
| (a) |
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
Technology);
|
| (b) |
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
|
| (c) |
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 the Definitive Agreements,
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:
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (a) |
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;
|
| (b) |
can
be demonstrated by the receiving Party by written record to have
been in
the public domain at the time of
disclosure;
|
| (c) |
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;
|
| (d) |
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 that the receiving Party can demonstrate
that such disclosure does not violate any obligations of the Third
Party
to the disclosing Party; or
|
| (e) |
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.
|
A
specific disclosure 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.
| 1.1.25 |
“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, INEX Indemnitees or Hana Indemnitees, as the case may be,
is
responsible.
|
| 1.1.26 |
“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.
|
| 1.1.27 |
“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.
|
| 1.1.28 |
“Designated
EU States”
means any one of Germany, the United Kingdom, Italy, France or
Spain.
|
| 1.1.29 |
“Develop”
and “Development”
means:
|
| (a) |
all
activities set forth in the Development Plan;
and
|
| (b) |
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.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 1.1.30 |
“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 of the Definitive Agreements, together with a
corresponding budget accounting for the anticipated costs to be expended
or incurred by Hana in conducting the Development. The Development
Plan
and any amendments thereto adopted in accordance with Article 4 will
form
a part of this Agreement.
|
| 1.1.31 |
“Discontinued
Patent”
shall have the meaning set forth in Section
8.5.3.
|
| 1.1.32 |
“Dispute”
shall have the meaning set forth in Section
13.1.1.
|
| 1.1.33 |
“Dollars”
or “$”
shall mean the lawful money of the United States of
America.
|
| 1.1.34 |
“Effective
Date of the Definitive Agreements”
means May 6, 2006.
|
| 1.1.35 |
“Excess
Amount”
shall have the meaning set forth in Section
9.2.6.
|
| 1.1.36 |
“Fair
Market Value”
for the purposes of Sections 1.1.69 and 1.1.56, 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.
|
| 1.1.37 |
“FDA”
means the Food and Drug Administration of the United States of
America.
|
| 1.1.38 |
“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.
|
| 1.1.39 |
“FTE
Rate”
means the fully burdened rate established by INEX for the services
of a
INEX employee or consultant providing IP Services which for the first
year
from the Effective Date of the Definitive Agreements, is $[***] based
on
1,800 employee hours per year, or pro-rata portion thereof; provided
however, that on each anniversary of the Effective Date of the Definitive
Agreements, 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.
|
| 1.1.40 |
“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.
|
| 1.1.41 |
“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.
|
| 1.1.42 |
“Hana
Field”
means all uses of the Products.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 1.1.43 |
“Hana
Indemnitees”
shall have the meaning set forth in Section
12.2.
|
| 1.1.44 |
“Hana
Intellectual Property”
means:
|
| (a) |
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 to which Hana has accepted an assignment or license
during the term of this Agreement; and
|
| (b) |
all
Confidential Information owned or controlled by Hana at any time
during
the Term of this Agreement.
|
| 1.1.45 |
“IND”
means an Investigational New Drug application in accordance with
the rules
and regulations of the FDA.
|
| 1.1.46 |
“Indemnitee”
shall have the meaning set forth in Section
12.3.
|
| 1.1.47 |
“Indemnitor”
shall have the meaning set forth in Section
12.3.
|
| 1.1.48 |
“INEX
Indemnitees”
shall have the meaning set forth in Section
12.1.
|
| 1.1.49 |
“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.
|
| 1.1.50 |
“IP
Committee”
shall have the meaning set forth in Section
8.1.
|
| 1.1.51 |
“IP
Services”
means such services as Xxxx xxxxx reasonably necessary, desirable
or
helpful to evidence, maintain, protect or enforce Hana’s rights as set
forth under the Services Agreement, and as further defined in Section
8.6.2.
|
| 1.1.52 |
“License”
means an agreement between Hana and its Affiliate or between Hana
and a
Third Party, to whom Hana has granted a license of the rights granted
by
INEX to Hana in respect of one or more of the
following:
|
| (a) |
the
Assigned Patents; and
|
| (b) |
that
portion of the Technology that relates to the Assigned
Patents.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 1.1.53 |
“License
Agreement”
means the License Agreement dated May 6, 2006 between INEX and
Hana.
|
| 1.1.54 |
“Licensed
Patents”
means all right, title and interest in and to the inventions described
in:
|
| (a) |
with
the exception of the Assigned Patents, the patents and patent applications
existing on the Effective Date of the Definitive Agreements that
were
originally assigned to INEX and are listed in Exhibit
1.1.54
attached hereto; and
|
| (b) |
any
and all patents and patent applications assigned or licensed by INEX
to
Hana after the effective date of this Agreement and during the Term
of
this Agreement that are necessary and useful in the Development or
Commercialization of the Products, subject to the terms and limitations
of
any agreement related to such patents and applications;
and
|
| (c) |
any
and all counterparts of the foregoing, including all divisionals,
provisionals, non-provisionals, and continuations, and all patents
issuing
on any of the foregoing and any foreign counterparts thereof, together
with all registrations, reissues, re-examinations, supplemental protection
certificates, additions, renewals or extensions thereof and any foreign
counterparts thereof.
|
| 1.1.55 |
“Licensee”
means an Affiliate or Third Party to whom Hana has granted a License.
Without limiting the generality of the foregoing, a Licensee shall
be
deemed to include an Affiliate or Third Party who is granted a License
hereunder by Hana pursuant to the terms of the outcome or settlement
of
any infringement or threatened infringement or threatened infringement
action. Without limiting the generality of the foregoing, a Licensee
shall
be deemed to include any Affiliate or Third Party who is granted
a License
hereunder by Hana pursuant to the terms of the outcome or settlement
of
any infringement or threatened infringement
action.
|
| 1.1.56 |
“Licensing/Sublicensing
Revenue”
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 licensed or sublicensed Product) payable to, collected or
received
by Hana or its Affiliates pursuant to each License or Sublicense
entered
into in respect of:
|
| (a) |
the
Technology;
|
| (b) |
the
Licensed Patents; and/or
|
| (c) |
the
Assigned Patents.
|
Except
as
otherwise expressly provided below, “Licensing/Sublicensing Revenue” shall not
include:
| (d) |
loans
to Hana or its Affiliates by a Licensee or Sublicensee relating to
the
Patents and 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 Licensing/Sublicensing Revenue)
or
to the extent that the principal of a loan is forgiven (in which
case only
such forgiven amount shall constitute Licensing/Sublicensing Revenue);
or
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (e) |
equity
investments in Hana by a Licensee or Sublicensee, or equity of the
Licensee or Sublicensee relating to the Patents and Technology, except
to
the extent that such investment are made at greater than Fair Market
Value
(in which case only the excess premium shall constitute
Licensing/Sublicensing Revenue). For the purposes of this Section,
if the
shares of either Hana or its Licensee or 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 Licensee or 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 ($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 Article
13;
or
|
| (f) |
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,
“Licensing/Sublicensing Revenue” 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.
| 1.1.57 |
“Litigating
Party”
shall have the meaning set forth in Section
9.2.5.
|
| 1.1.58 |
“Major
Markets”
means the countries of the United States of America, Germany, the
United
Kingdom, Italy, France, Spain.
|
| 1.1.59 |
“Manufacture”,
“Manufactured”
and “Manufacturing”
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.
|
| 1.1.60 |
“Marqibo”
is Hana’s trade name for Sphingosomal
Vincristine.
|
| 1.1.61 |
“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
(including Clinical Trial Material), and Product for commercial sale,
but
excluding machinery and equipment.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 1.1.62 |
“Maximum
Issuance Amount”
shall have the meaning set forth in Section
3.4.
|
| 1.1.63 |
“MD
Xxxxxxxx”
means the University of Texas MD Xxxxxxxx Cancer
Center.
|
| 1.1.64 |
“MD
Xxxxxxxx Assignment and Novation Agreement”
means the Assignment and Novation Agreement between MD Xxxxxxxx,
INEX and
Hana to effect the assignment by INEX to Hana of the MD Xxxxxxxx
License.
|
| 1.1.65 |
“MD
Xxxxxxxx License”
means the Patent and Technology License Agreement made as of February
14,
2000 between the Board of Regents of the University of Texas System
on
behalf of the University of Texas MD Xxxxxxxx Cancer Center and INEX,
amended as of August 15, 2000.
|
| 1.1.66 |
“MD
Xxxxxxxx Patents”
means the Xxxxxx Patents and Xxxxxx Patents.
|
| 1.1.67 |
“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, performance of Method Transfer
qualification.
|
| 1.1.68 |
“NDA”
means a New Drug Application in accordance with the rules and regulations
of the FDA.
|
| 1.1.69 |
“Net
Sales”
means the aggregate United States dollar equivalent of gross revenues
invoiced by Hana and its Affiliates and Licensees 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 or its Affiliates or Licensees
or
Sublicensees using US GAAP and reasonable practices with respect
to sales
of all Product, consistently applied, for the
following:
|
| (a) |
credits
or allowances, if any, actually granted on account of recalls, rejection
or return of Product;
|
| (b) |
insurance,
freight or other transportation costs incurred in shipping Product
to such
Third Parties; and
|
| (c) |
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:
|
| (d) |
no
deductions shall be made for any item of cost incurred by Hana, its
Affiliates or Licensees or Sublicensees in preparing, Manufacturing,
shipping or selling Product except as permitted pursuant to Sections
1.1.69(a), 1.1.69(b) and 1.1.69(c)
inclusive;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (e) |
Net
Sales shall not include transfer between any of Hana and any of its
Affiliates or Licensees or Sublicensees for resale, but Net Sales
shall
include the subsequent final sales to Third Parties by such Affiliates
or
Licensees or Sublicensees;
|
| (f) |
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 Licensees or Sublicensees in
payment
for sale of Product;
|
| (g) |
as
used in this definition, a “sale” shall have occurred when Product are
billed out or invoiced;
|
| (h) |
notwithstanding
anything herein to the contrary, the following shall not be considered
a
sale of Product under this
Agreement:
|
| (i) |
the
transfer of a Product to a Third Party without consideration to Hana
in
connection with the development or testing of a Product;
or
|
| (ii) |
the
transfer of a Product to a Third Party without consideration in connection
with the marketing or promotion of the Product (e.g.,
samples).
|
| 1.1.70 |
“Non-Abandoning
Party”
shall have the meaning set forth in Section
8.5.1.
|
| 1.1.71 |
“Non-Competition
Terms”
means the terms and conditions contained in Article 7 of the Transaction
Agreement between the Parties dated May 6,
2006.
|
| 1.1.72 |
“Non-litigating
Party”
shall have the meaning set forth in Section
9.2.5.
|
| 1.1.73 |
“Notice
of Abandonment”
shall have the meaning set forth in Section
8.5.1.
|
| 1.1.74 |
“Party”
means INEX or Hana and “Parties”
means INEX and Hana.
|
| 1.1.75 |
“Patents”
means the Licensed Patents and the Assigned
Patents.
|
| 1.1.76 |
“Person”
means and includes any individual, corporation, partnership, firm,
joint
venture, syndicate, association, trust, government body, and any
other
form of entity or organization.
|
| 1.1.77 |
“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.
|
| 1.1.78 |
“Prime
Rate”
means the prime or equivalent rate quoted by the Bank of Canada from
time
to time.
|
| 1.1.79 |
“Product”
means any one or more of Sphingosomal Vincristine, Sphingosomal
Vinorelbine, and Sphingosomal
Topotecan.
|
| 1.1.80 |
“Publishing
Party”
shall have the meaning set forth in Section
10.4.1.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 1.1.81 |
“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.
|
| 1.1.82 |
“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.
|
| 1.1.83 |
“Registrational
Clinical Trial”
means any one of a Phase III clinical trial or pivotal Phase II clinical
trial conducted in furtherance of Regulatory
Approvals.
|
| 1.1.84 |
“Regulatory
Activity”
and “Regulatory
Activities”
mean any one or more of the regulatory activities to be performed
by Hana,
its Licensees, Sublicensees, or their respective Representatives
in
pursuit of the Development of each Product, including writing,
translation, compilation, notification, submission, filing, defense,
maintenance and renewal of Regulatory Approvals and payment of fees
associated therewith, and meeting with Regulatory
Authorities.
|
| 1.1.85 |
“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.
|
| 1.1.86 |
“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.
|
| 1.1.87 |
“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.
|
| 1.1.88 |
“Regulatory
Submission”
means any submission or filing made in furtherance of obtaining and
maintaining any Regulatory
Approvals.
|
| 1.1.89 |
“Representatives”
means, in respect of a Person, that Person’s Affiliates and their
respective directors, officers, employees, consultants, subcontractors,
licensees or sublicensees (including Licensees and Sublicensees)
as the
case may be, agents, representatives and other persons acting under
their
authority.
|
| 1.1.90 |
“Royalty-free
License”
means a license granted by Hana to INEX for any and all uses of the
MD
Xxxxxxxx Patents outside the Hana Field in respect of which:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (a) |
subject
to Section 1.1.90(b), a fully paid up, royalty-free license;
and
|
| (b) |
INEX
unconditionally, absolutely and irrevocably agrees with Hana to continue
to remain liable for royalty payments to MD Xxxxxxxx under the MD
Xxxxxxxx
License in respect of INEX’s use of the MD Xxxxxxxx Patents outside the
Hana Field.
|
| 1.1.91 |
“Xxxxxx
Patents”
means:
|
| (a) |
the
Xxxxxx patents and patent applications jointly owned by MD Xxxxxxxx
and
INEX, as set forth in Exhibit
1.1.91;
and
|
| (b) |
any
and all counterparts of the foregoing, including all divisionals,
provisionals, non-provisionals, and continuations, and all patents
issuing
on any of the foregoing and any foreign counterparts thereof, together
with all registrations, reissues, re-examinations, supplemental protection
certificates, additions, renewals or extensions thereof and any foreign
counterparts thereof;
|
that
are
subject to the rights of:
| (c) |
MD
Xxxxxxxx (including annual fees and royalty rights to MD Xxxxxxxx)
under
the terms and conditions of the MD Xxxxxxxx License;
and
|
| (d) |
INEX
(including milestone, Licensing/Sublicensing Revenue and royalty
rights)
under the terms and conditions of this
Agreement.
|
| 1.1.92 |
“Service
Agreement”
means the Service Agreement entered into between INEX and Hana dated
May
3, 2006 and effective as of April 3,
2006.
|
| 1.1.93 |
“Sphingosomal
Topotecan”
means a liposome that includes sphingomyelin and cholesterol and
contains
encapsulated topotecan, wherein the sphingomyelin comprises less
than 20%
dihydrosphingomyelin.
|
| 1.1.94 |
“Sphingosomal
Topotecan R&D Expenses”
shall have the meaning set forth in Section
3.3.4.
|
| 1.1.95 |
“Sphingosomal
Vincristine”
means a liposome that includes sphingomyelin and cholesterol and
contains
encapsulated vincristine, wherein the sphingomyelin comprises less
than
20% dihydrosphingomyelin.
|
| 1.1.96 |
“Sphingosomal
Vincristine NDA”
shall have the meaning set forth in Section
3.1.1.
|
| 1.1.97 |
“Sphingosomal
Vincristine R&D Expenses” shall
have the meaning set forth in Section
3.1.4
|
| 1.1.98 |
“Sphingosomal
Vinorelbine”
means a liposome that includes sphingomyelin and cholesterol and
contains
encapsulated vinorelbine, wherein the sphingomyelin comprises less
than
20% dihydrosphingomyelin.
|
| 1.1.99 |
“Sphingosomal
Vinorelbine R&D Expenses” shall
have the meaning set forth in Section
3.2.4.
|
| 1.1.100 |
“Sublicense”
means an agreement between:
|
| (a) |
a
Licensee and a Person to whom such Licensee has granted a sublicense
of
the rights granted under the License;
and
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (b) |
an
agreement between Hana and its Affiliate or between Hana and a Third
Party, to whom Hana has granted a sublicense of the rights granted
by INEX
to Hana in respect of one or more of the
following:
|
| (i) |
the
Licensed Patents; and
|
| (ii) |
that
portion of the Technology that relates to the Licensed
Patents.
|
| 1.1.101 |
“Sublicensee”
means a Person to whom a Licensee has granted a Sublicense and a
Person to
whom Hana has granted a Sublicense. Without limiting the generality
of the
foregoing, a Sublicensee shall be deemed to include any Person who
is
granted a Sublicense hereunder pursuant to the terms of the outcome
or
settlement of any infringement or threatened infringement or threatened
infringement action.
|
| 1.1.102 |
“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 Technology necessary and useful for the Manufacture
of Material, and includes Method
Transfer.
|
| 1.1.103 |
“Technology”
includes:
|
| (a) |
all
technical information and know-how relating to the technology claimed
in
the Patents in the Hana Field, including without limitation all such
information as is described in certain of the laboratory notebooks
enumerated in Exhibit
1.1.103 attached
hereto; and
|
| (b) |
all
Confidential Information possessed by INEX on the Effective Date
of the
Definitive Agreements pertaining to the Products in the Hana Field
in
data, drawings, formulae, know-how, unpatented inventions, manufacturing
information, specifications, product design histories, technical
dossiers,
regulatory records, quality system documentation, whether protectable
or
not as trade secrets or otherwise including, without limitation,
standard
operating procedures, technical reports, synthetic protocols,
manufacturing protocols, animal protocols, invention disclosures,
manufacturing records, process development data, formulation records,
biological, chemical, pharmacological, toxicological assay results,
controls, clinical testing data, IND data and histology
slides.
|
| 1.1.104 |
“Term”
shall have the meaning set forth in Section
14.1.
|
| 1.1.105 |
“Territory”
means all of the countries and territories of the
world.
|
| 1.1.106 |
“Third
Party(ies)”
means any Person(s) other than INEX or Hana or any of their respective
Affiliates.
|
| 1.1.107 |
“Xxxxxx
Patents”
means
|
| (a) |
the
Xxxxxx patent applications owned by INEX as set forth in Exhibit
1.1.9
attached hereto; and
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (b) |
any
and all counterparts of the foregoing, including all divisionals,
provisionals, non-provisionals, and continuations, and all patents
issuing
on any of the foregoing and any foreign counterparts thereof, together
with all registrations, reissues, re-examinations, supplemental protection
certificates, additions, renewals or extensions thereof and any foreign
counterparts thereof;
|
subject
to the rights of:
| (c) |
MD
Xxxxxxxx (including annual fees and royalty rights) under the terms
and
conditions of the MD Xxxxxxxx License;
and
|
| (d) |
INEX
(including milestone, Licensing/Sublicensing Revenue and royalty
rights)
under the terms and conditions of this
Agreement.
|
| 1.1.108 |
“Transaction
Agreement”
means the Transaction Agreement dated May 6, 2006 between Hana and
INEX.
|
| 1.1.109 |
“US
GAAP”
means generally accepted accounting principles applied in the United
States of America.
|
| 1.1.110 |
“Valid
Claim”
means either:
|
| (a) |
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
|
| (b) |
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 PATENT
AND TECHNOLOGY
2.1 Amendment
of License Agreement
| 2.1.1 |
Subject
to the terms and conditions of this Agreement, the Parties hereby
agree:
|
| (a) |
to
terminate:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (i) |
the
exclusive license by INEX to Hana under the MD Xxxxxxxx Patents,
subject
to the terms and conditions set forth in the MD Xxxxxxxx License,
to make,
have made, use, sell, offer for sale, import, and have imported Products
in the Hana Field within the Territory;
and
|
| (ii) |
the
exclusive license by Hana to INEX under the Hana Intellectual Property,
subject to the terms and conditions of the License Agreement, to
make,
have made, use, sell, offer for sale, import, and have imported products
outside the Hana Field; and
|
| (b) |
to
affirm INEX’s grant to Hana, and Hana’s acceptance,
of:
|
| (i) |
an
exclusive license under the Licensed Patents to make, have made,
use,
sell, offer for sale, import, and have imported Products in the Hana
Field
within the Territory; and
|
| (ii) |
an
exclusive license to the Technology to make, have made, use, sell,
offer
for sale, import, and have imported Products in the Hana Field within
the
Territory; and
|
| (c) |
to
the irrevocable and absolute grant, sale, assignment and conveyance
by
INEX to Hana, and Hana’s acceptance
of:
|
| (i) |
INEX’s
entire right, title and interest in and to the Xxxxxx Patents subject
to
the terms and conditions set forth in the MD Xxxxxxxx License;
and
|
| (ii) |
INEX’s
entire right, title and interest in and to INEX’s joint ownership of the
Xxxxxx Patents subject to the terms and conditions set forth in the
MD
Xxxxxxxx License;
|
subject
to the provisions of Sections 8.5 and 14.3.
| 2.1.2 |
It
is understood and agreed that the foregoing exclusive licenses in
Section
2.2.1(b)
grant to Hana the rights enumerated to the exclusion of all other
parties,
including INEX and its Affiliates.
|
| 2.1.3 |
It
is also understood that INEX retains exclusive rights under the Licensed
Patents and Technology outside the Hana
Field.
|
2.2 License
Grant to INEX
| 2.2.1 |
Subject
to the terms and conditions of this Agreement, Hana hereby grants
to INEX
and INEX hereby accepts an, irrevocable world-wide, exclusive,
Royalty-Free License under the MD Xxxxxxxx Patents to make, have
made,
use, sell, offer for sale, import, and have imported products outside
the
Hana Field subject only to the provisions of Sections 8.5 (relating
to
abandonment, withdrawal or discontinuance of patent protection) and
14.3
(relating to termination on
bankruptcy).
|
| 2.2.2 |
In
respect of the license granted by Hana to INEX under Section 2.2.1,
the
Parties understand and agree that:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (a) |
except
as otherwise provided in the MD Xxxxxxxx License, the foregoing exclusive
licenses grant to INEX the rights enumerated to the exclusion of
all other
parties, including Hana and its Affiliates;
and
|
| (b) |
Hana
retains exclusive rights under the Assigned Patents in the Hana
Field.
|
| 2.2.3 |
Hana
hereby grants to INEX a non-exclusive license under the Patents and
Technology to make, have made, use, import and have imported Products
solely for non-commercial research, scholarly publication, education,
or
other non-commercial purposes.
|
| 2.2.4 |
Hana
hereby grants to INEX a non-exclusive license under the Patents and
Technology to carry out INEX’s activities under the Development Plan and
Services Agreement.
|
| 2.2.5 |
Hana
hereby grants to INEX a worldwide, royalty-free, non-exclusive license
under the Hana Intellectual Property to make, have made, use, sell,
offer
to sell, import, and have imported liposomes and liposomes having
an
active agent encapsulated, intercalated or entrapped therein outside
the
Hana Field, with the proviso that this grant does not extend
to:
|
| (a) |
any
Intellectual Property Rights licensed by Hana prior to the Effective
Date
of the Definitive Agreements, except to the extent that such license
permits Hana to grant such rights to INEX;
or
|
| (b) |
any
Hana Intellectual Property directed to the active agent
itself.
|
2.3 Compliance
with Third Party Agreements
| 2.3.1 |
Subject
to INEX’s performance of its obligations under this Agreement, and in
consideration for INEX’s sublicense of the BCCA Patents, 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 BCCA Agreements.
|
| 2.3.2 |
Subject
to Hana’s performance of its obligations under this Agreement, INEX
unconditionally, absolutely and irrevocably covenants and agrees
with Hana
to:
|
| (a) |
adopt
as INEX’s own obligations, the royalty obligations set forth in the MD
Xxxxxxxx License to the extent such obligations arise from INEX’s, its
licensees’ or sublicensees’ use of the MD Xxxxxxxx Patents outside the
Hana Field; and
|
| (b) |
to
continue to comply with INEX’s royalty obligations set forth in the BCCA
Agreements to the extent such obligations arise from INEX’s, its
licensees’ or sublicensees’ use of the BCCA Patents outside the Hana
Field.
|
2.4 Licensing
and Sublicensing
| 2.4.1 |
With
respect to the licenses and assignments granted to Hana under Section
2.1,
subject to the terms and conditions set out in the BCCA Agreements
and the
MD Xxxxxxxx License and Hana’s assumption of any and all license fees,
annual fees, milestone payments and royalty obligations set forth
in this
Agreement, Hana shall have the right to grant Licenses and Sublicenses
to
its Affiliates and to Third
Parties.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 2.4.2 |
All
Licenses and Sublicenses granted under this Section 2.4 shall be
subject
to the following:
|
| (a) |
Hana
will cause each Affiliate so licensed or sublicensed to perform the
terms
of this Agreement as if such Affiliate were Hana
hereunder;
|
| (b) |
each
Affiliate so licensed or sublicensed shall unconditionally, absolutely
and
irrevocably covenant and agree with INEX 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 License
or
Sublicense;
|
| (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 each 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 any term of this Agreement will also constitute a
default
by Hana under this Agreement, and INEX shall be entitled to exercise
its
rights hereunder, in addition to any other rights and remedies to
which
INEX may be entitled;
|
| (e) |
each
License and Sublicense shall contain covenants by the Third Party
Licensee
and Sublicensee, as the case may be, for the benefit of INEX to observe
and perform similar terms and conditions to those in this
Agreement;
|
| (f) |
all
Licenses and Sublicenses granted by Hana shall be further sublicensable
or
assignable without the prior written consent of INEX; provided however,
that Hana shall not license or 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 License or Sublicense,
as the
case may be, a provision requiring the Licensee or Sublicense, as
the case
may be, to agree that it will not use the Technology for any purpose
other
than the Products;
|
| (g) |
in
the event that Hana becomes aware of a material breach of any such
License
or Sublicense by a Third Party Licensee or Sublicensee, Hana shall
promptly notify INEX of the particulars of same and take all reasonable
steps to enforce the terms of such License or Sublicense, as the
case may
be;
|
| (h) |
within
ten (10) Business Days after execution of each License or Sublicense,
as
the case may be, Hana shall provide INEX with a copy thereof, provided,
however, that only if Hana is bound by by the terms of an agreement
which
predates this Agreement and prohibits Hana from disclosing the financial
terms of each License or Sublicense, then Hana shall be permitted
to
redact the financial terms thereof.
The terms of each Sublicense Agreement shall be deemed to constitute
“Confidential Information” of Hana for all purposes of this Agreement, and
INEX shall not disclose the information contained in such Sublicense
Agreement to any Third Party except as authorized pursuant to Article
10
of
this Agreement;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (i) |
all
Licenses and Sublicenses shall terminate upon the termination of
Hana’s
rights granted herein unless events of default are cured by Hana
or its
Licensee or Sublicensee, as the case may be, within the period for
the
cure of default after notification by INEX as provided by the terms
of
this Agreement;
|
| (j) |
any
Licensee who wishes to grant Sublicense or any Sublicensee who wishes
to
grant a further sub-Sublicense shall comply with the terms of this
Section
as if the further Sublicense or sub-Sublicense, as the case may be,
were a
License or Sublicense hereunder, including providing to INEX and
Hana the
information described in this Section, and obtaining the consent
referred
to in this Section, prior to any execution of any such Sublicense
or
sub-Sublicense;
|
| (k) |
all
Licenses and Sublicenses shall include an obligation for each Licensee
and
Sublicensee to account for and report its sales of Product on the
same
basis as if such sales were sales of Hana, and INEX shall receive
compensation in the same amounts as if the sales of Product by the
Licensee or Sublicensee, as the case may be, were sales of Hana;
and
|
| (l) |
Hana
shall remain responsible to INEX for the compliance of each Licensee
and
Sublicensee with the financial and other obligations due under this
Agreement.
|
| 2.4.3 |
With
respect to the licenses granted to INEX under Section 2.2, INEX shall
have
the right to grant licenses and sublicenses to its Affiliates and
to Third
Parties. All licenses and 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 each of
INEX’s
and Hana’s benefit comparable to those set forth in Section 2.4.2
applicable to Licenses and Sublicenses granted by
Hana.
|
2.5 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 INEX’s gross or net
income.
Article
3 LICENSE
FEES, MILESTONES AND ROYALTIES
In
consideration of the assignments and licenses granted to Hana under this
Agreement and the disclosure to Hana of INEX’s Confidential Information, and
subject to the provisions of this Agreement, Hana shall pay to INEX milestone
payments, license fees and royalties as provided in this Article 3.
The
payments provided under this Article 3 are in addition to the portion of the
Closing Payment and Closing Shares attributable to each of Sphingosomal
Vincristine, Sphingosomal Vinorelbine, and Sphingosomal Topotecan previously
paid to INEX by Hana pursuant to the Asset Purchase Agreement.
3.1 Sphingosomal
Vincristine.
| 3.1.1 |
Milestone
Payments:
|
Hana
shall pay to INEX milestones payments in respect of Sphingosomal Vincristine
as
follows:
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (a) |
[***]
Dollars ($[***]) within ten (10) days following the FDA’s acceptance for
review of an NDA submission by Hana relating to Sphingosomal Vincristine
(the “Sphingosomal
Vincristine NDA”),
which payment shall be satisfied by Hana issuing to INEX a number
of
additional shares of Common Stock determined by dividing [***] Dollars
($[***]) by the FMV as of the Sphingosomal Vincristine NDA filing
date;
provided however, if a Regulatory Submission equivalent to an NDA
is
accepted in any of the Designated EU States before the Sphingosomal
Vincristine NDA is accepted, then [***] (***) the milestone payment
due
under this Section 3.1.1(a) will be paid by Hana to INEX immediately
upon
the acceptance of that equivalent filing in any of the Designated
EU
States, and the remaining balance will be paid by Hana to INEX immediately
upon the acceptance of the Sphingosomal Vincristine NDA
by
the FDA; and
|
| (b) |
[***]
Dollars ($[***]) within ten (10) days following Hana’s receipt of the
approval by the FDA of the Sphingosomal Vincristine NDA, 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 approval; provided however, if a Regulatory Submission
equivalent to an NDA is approved in any of the Designated EU States
before
the Sphingosomal Vincristine NDA is approved by the FDA, [***] (***)
the
milestone payment due under this Section
3.1.1(b) will be paid by Hana to INEX immediately upon the approval
of
that equivalent filing in any of the Designated EU States, and the
remaining balance will be paid by Hana to INEX immediately upon the
approval of the Sphingosomal Vincristine NDA by the
FDA.
|
| (c) |
For
the avoidance of doubt, each of the milestone payments described
in
subparagraphs (a) and (b) of this Section 3.1.1 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.
|
3.1.2 Royalties
Hana
shall pay royalties to INEX based on cumulative Net Sales of Sphingosomal
Vincristine as follows:
| (a) |
With
respect to Net Sales of Sphingosomal Vincristine in the United States,
a
royalty equal to the sum of: (i) [***] percent ([***]%) of Net Sales
in
consideration of 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 ($[***]); and
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (b) |
With
respect to Net Sales of Sphingosomal Vincristine in each country
of the
Territory other than the United States, a royalty of [***] percent
([***]%) of Net Sales in consideration of Patents and Technology;
provided, however, that the total royalty paid shall be limited to
[***]
percent ([***]%) of cumulative Net Sales up to [***] Dollars ($[***]),
and
increased to [***] percent ([***]%) of cumulative Net Sales in excess
of
[***] Dollars ($[***]).
|
3.1.3 Generic
Competition
If,
during a given calendar year, there is sale of a generic Sphingosomal
Vincristine or sale of an approved equivalent to Sphingosomal Vincristine
(collectively, “Approved
Sphingosomal Vincristine Equivalents”)
in any
country in the Territory, then, for such country, the total amount of royalties
payable to INEX for the Net Sales of Sphingosomal Vincristine in such country
during such calendar year will be reduced to [***] percent ([***]%) of the
royalties payable to INEX pursuant to Section 3.1.2 for such calendar year,
in
such country.
3.1.4 Deductions:
Notwithstanding
the schedule of royalty payments set forth in Section 3.1.2, Hana shall be
entitled to deduct from such Sphingosomal Vincristine royalty obligations owed
by Hana to INEX, an amount equal to [***] percent ([***]%) of the research
and
development expenses Hana incurs in connection with the Development of
Sphingosomal Vincristine (the “Sphingosomal
Vincristine R&D Expenses”);
provided however, that such deduction shall not exceed the lesser
of:
| (a) |
[***]
Dollars ($[***]); or
|
| (b) |
[***]
Dollars ($[***]) per patient treated in a Registrational Clinical
Trial;
|
provided
further, however, that such deduction for Sphingosomal Vincristine R&D
Expenses shall not exceed [***] percent ([***]%) of the royalty amount otherwise
payable by Hana to INEX for Sphingosomal Vincristine in each calendar year,
provided that Hana shall be entitled to carry over into succeeding years any
amount of Sphingosomal Vincristine R&D Expenses that were ineligible for
deduction as a result of such limitation. All Sphingosomal Vincristine R&D
Expenses shall be subject to audits by INEX using reasonable and customary
audit
procedures in order to verify the amounts thereof.
3.2 Sphingosomal
Vinorelbine
3.2.1 Milestone
Payments:
Hana
shall pay to INEX milestones payments in respect of Sphingosomal Vinorelbine
as
follows:
| (a) |
One
Million Dollars ($1,000,000) 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 INEX acknowledges Five
Hundred Thousand Dollars ($500,000) has been paid by wire transfer to
INEX of immediately available funds and the remaining Five Hundred
Thousand Dollars ($500,000) has been paid by Hana issuing to INEX a
number of additional shares of Common Stock determined by
dividing Five Hundred Thousand Dollars ($500,000) by the FMV as
of the date of such first patient
enrollment;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (b) |
[***]
Dollars ($[***]) 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 ($[***]) by the FMV as of the date of such first patient
enrollment; and
|
| (c) |
[***]
($[***]) 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, [***] the milestone due under this Section 3.2.1(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), (b) and (c) of this Section 3.2.1 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 Vinorelbine 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.
|
3.2.2 Royalties
Hana
shall pay to INEX royalty payments based on cumulative Net Sales of Sphingosomal
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 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
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (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 Patents and Technology; provided,
however, that the total royalty paid shall be limited to [***] percent
([***]%) of cumulative Net Sales up to [***] Dollars ($[***]), and
increased to [***] percent ([***]%) of cumulative Net Sales in excess
of
[***] Dollars ($[***]).
|
3.2.3 Generic
Competition
| (a) |
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, then, for such country, the total
amount
of royalties payable to INEX for the Net Sales of Sphingosomal Vinorelbine
in such country during such calendar year will be reduced to [***]
percent
([***]%) of the royalties payable to INEX pursuant to Section 3.2.2
for
such calendar year, in such
country.
|
3.2.4 Deductions:
Notwithstanding
the schedule of royalty payments set forth in Section 3.2.2, 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:
| (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 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.
3.3 Sphingosomal
Topotecan
| 3.3.1 |
Milestone
Payments:
|
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;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (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 3.3.1(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 3.3.1 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.
|
3.3.2 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 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 Topotecan in each country of
the
Territory other than the United States, a royalty of [***] percent
([***]%) of Net Sales in consideration of Patents and Technology;
provided, however, that the total royalty paid shall be limited to
[***]
percent ([***]%) of cumulative Net Sales up to [***] Dollars ($[***]),
and
increased to [***] percent ([***]%) of cumulative Net Sales in excess
of
[***] Dollars ($[***]).
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
3.3.3 Generic
Competition
| (a) |
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, then, for such country, the total
amount
of royalties payable to INEX for the Net Sales of Sphingosomal Topotecan
in such country during such calendar year will be reduced by [***]
percent
([***]%) of the royalties payable to INEX pursuant to Section 3.3.2
for
such calendar year, in such
country.
|
3.3.4 Deductions:
Notwithstanding
the schedule of royalty payments set forth in Section 3.3.2, 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 ($[***]); or
|
| (b) |
[***]
Dollars ($[***]) 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 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.
3.4 Limitation
on Payment Using
Common Stock
Notwithstanding
anything to the contrary contained in Sections 3.1, 3.2 and 3.3, 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 of
the
Definitive Agreements (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.
3.5 Assumption
of Milestone and Royalty Obligations
| 3.5.1 |
As
a condition of the grant of:
|
| (a) |
licence
by INEX to Hana of the Licensed Patents and Technology;
and
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (b) |
assignment
by INEX to Hana of the Assigned Patents,
|
Hana
shall assume all payment obligations of INEX to BCCA and to MD Anderson, in
respect of all license fees, annual fees, milestone payments, royalty payments
and any other like payments, including all interest and taxes attributable
thereto, arising from Hana or its Licensees’ or Sublicensees’ use of the Patents
within the Hana Field under the BCCA Agreements and the MD Xxxxxxxx
License.
| 3.5.2 |
For
avoidance of doubt, the obligations of Hana under Section 3.5.1 are
in
addition to and not in substitution of any other obligations set
forth in
this Article 3.
|
3.6 Remuneration
Respecting Sublicensees
| 3.6.1 |
In
the event Hana licenses or 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
Licensing/Sublicensing Revenue payable to Hana by such Licensee or
Sublicensee. In the event Hana licenses or 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 Licensing/Sublicensing Revenue payable to
Hana by
such Licensee or Sublicensee.
|
| 3.6.2 |
In
the event Hana licenses or sublicenses its rights under Sphingosomal
Vinorelbine, INEX shall be entitled to share the Licensing/Sublicensing
Revenue payable to Hana, if any, as
follows:
|
| (a) |
INEX’s
share of such Licensing/Sublicensing Revenue shall be [***] percent
([***]%) of any Licensing/Sublicensing Revenue payable to Hana by
such
Licensee or Sublicensee during the period commencing on the Effective
Date
of the Definitive Agreements 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 Licensing/Sublicensing Revenue shall be reduced to
[***]
percent ([***]%) of any Licensing/Sublicensing Revenue payable to
Hana by
such Licensee or Sublicensee on or after the date the first patient
is
enrolled in a Phase II clinical trial of Sphingosomal Vinorelbine
and
ending on the date immediately preceding the earlier to occur
of:
|
| (i) |
the
date the first patient is enrolled in a Phase III clinical trial
of
Sphingosomal Vinorelbine; or
|
| (ii) |
the
acceptance of the NDA or its equivalent Regulatory Submission for
Sphingosomal Vinorelbine; and
|
| (c) |
INEX’s
share of such Licensing/Sublicensing Revenue shall be reduced to
[***]
percent ([***]%) of any Licensing/Sublicensing Revenue payable to
Hana by
such Licensee or Sublicensee on or after the earlier to occur
of:
|
| (i) |
the
date the first patient is enrolled in a Phase III clinical trial
of
Sphingosomal Vinorelbine; or
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (ii) |
the
acceptance of the NDA or its equivalent Regulatory Submission for
Sphingosomal Vinorelbine.
|
| 3.6.3 |
In
the event Hana licenses or sublicenses its rights under Sphingosomal
Topotecan, INEX shall be entitled to share the Licensing/Sublicensing
Revenue payable to Hana, if any, as
follows:
|
| (a) |
INEX’s
share of such Licensing/Sublicensing Revenue shall be [***] ([***]%)
of
any Licensing/Sublicensing Revenue payable to Hana by such Licensee
or
Sublicensee during the period commencing on the Effective Date of
the
Definitive Agreements 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 Licensing/Sublicensing Revenue shall be reduced to
[***]
percent ([***]%) of any Licensing/Sublicensing Revenue payable to
Hana by
such Licensee or Sublicensee on or after the date the first patient
is
enrolled in a Phase II clinical trial of Sphingosomal Topotecan and
ending
on the date immediately preceding the earlier to occur
of:
|
| (i) |
the
date the first patient is enrolled in a Phase III clinical trial
of
Sphingosomal Topotecan, or
|
| (ii) |
the
acceptance of the NDA or its equivalent Regulatory Submission for
Sphingosomal Topotecan.
|
| 3.6.4 |
Notwithstanding
anything to the contrary contained in this Section 3.6, Hana shall
have no
obligation to pay to INEX its respective share of any such
Licensing/Sublicensing Revenue unless and until Hana actually receives
such Licensing/Sublicensing Revenue from its Licensee or
Sublicensee.
|
| 3.6.5 |
Where
any Licensing/Sublicensing Revenue payable to, collected or received
by
Hana or its Affiliates is in Dollars, Hana shall pay to INEX, INEX’s share
of such Licensing/Sublicensing Revenue within ten (10) days of Hana
or its
Affiliate’s receipt of same. Where any Licensing/Sublicensing Revenue
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 Licensing/Sublicensing Revenue shall be converted to the equivalent
in Dollars on the same date that Hana converts such Licensing/Sublicensing
Revenue to Dollars, in which case the amount of Dollars pursuant
to an
actual conversion shall be included in the Licensing/Sublicensing
Revenue
and Hana shall pay to INEX, INEX’s share of such Licensing/Sublicensing
Revenue 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 Licensing/Sublicensing Revenue paid in foreign currency to
Dollars, or if legal restrictions prevent the conversion of part
or all of
the Licensing/Sublicensing Revenue to Dollars, Hana shall have the
right
and option, upon consultation with INEX, to deposit INEX’s share of such
Licensing/Sublicensing Revenue in local currency, in an account in
INEX’s
sole name in a bank or depository in the country where such
Licensing/Sublicensing Revenue 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 License or Sublicense between Hana and a Licensee or Sublicensee
shall be deemed to be the date upon which Licensing/Sublicensing
Revenue
is received by Hana for the purposes of determining the percentage
of
Licensing/Sublicensing Revenue payable to INEX pursuant to Sections
3.6.1,
3.6.2 and 3.6.3. 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
Licensing/Sublicensing Revenue deposited in such country by
Hana.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 3.6.6 |
Notwithstanding
Section 3.6.5, if any Licensing/Sublicensing Revenue 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 Licensing/Sublicensing Revenue 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 License or Sublicense
between
Hana and a Licensee or Sublicensee, as the case may be, shall be
deemed to
be the date upon which Licensing/Sublicensing Revenue is received
by Hana
for the purposes of determining the percentage of Licensing/Sublicensing
Revenue payable to INEX pursuant to Sections 3.6.1, 3.6.2 and
3.6.3;
|
| (b) |
the
value of the economic benefit of the Licensing/Sublicensing Revenue
established by a Third Party banker or valuator, measured in Dollars
and
applied to the percentage entitlement of INEX determined pursuant
to
Section 3.6.6(a), shall be the assessed value (the “Assessed
Value”)
to be used in determining the number of shares of Common Stock of
Hana or
common stock of another corporation acceptable to INEX payable to
INEX
pursuant to Section 3.6.6(c); and
|
| (c) |
Hana
will pay INEX using Common Stock of Hana or common stock of another
corporation acceptable to INEX as
follows:
|
| (i) |
the
Parties will mutually agree on the par value per share of common
stock of
Hana or of another corporation acceptable to INEX;
and
|
| (ii) |
Hana
will issue or assign to INEX as applicable, a number of shares of
Common
Stock of Hana or common stock of another corporation acceptable to
INEX by
dividing the Assessed Value by the FMV as of the date upon which
Licensing/Sublicensing Revenue was deemed to have been received by
Hana
pursuant to Section 3.6.6(a).
|
| 3.6.7 |
If
Hana elects to pay Licensing/Sublicensing Revenue using a combination
of
cash and 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
3.6.5.
|
| (a) |
Hana’s
payment of Licensing/Sublicensing Revenue in the form of stock pursuant
to
his Section shall be made within ten (10) days of Hana’s receipt of
same.
|
| 3.6.8 |
Hana’s
payment of Licensing/Sublicensing Revenue under this Section 3.6
shall be
accompanied by an accounting setting out all Licensing/Sublicensing
Revenue payable to, collected or received by Hana or its Affiliates,
segmented according to Product, Licensee and Sublicensee identified
by
name, and the last date on which each License and Sublicense was
executed.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
3.7 Third
Party Payments
| 3.7.1 |
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 Licensee or Sublicensee with respect of the Manufacture,
use or sale of a Product in the Hana Field, where such Manufacture,
use or
sale is encompassed by one or more Patents or Technology, and a
settlement, consent judgment 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 3.7.1);
|
Hana
shall pay all royalties, Damages or other amounts to the Third Party (the
“Offset
Amount”),
and
subject
to Section 3.7.2, 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 3.1.2, 3.2.2 and
3.3.2 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.
| 3.7.2 |
Notwithstanding
the provisions of Section 3.7.1, 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 favor 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 willful infringement of such Third Party’s
rights.
|
3.8 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 licensees or
sublicensees (including Licensees and Sublicensees) to grant a right to
commercialize Product to any Third Party, Hana may, at its sole option,
either:
| 3.8.1 |
avail
itself of the royalty reduction set out in Sections 3.1.3, 3.2.3,
or
3.3.3, if applicable; or
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 3.8.2 |
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 favorable
than
those of this Agreement.
|
3.9 Reports
and Payment
Hana
shall deliver to INEX within thirty (30) days after the end of each Calendar
Quarter a written report showing its computation of royalties due under this
Agreement upon Net Sales by Hana and its Affiliates and its Licensees and
Sublicensees during such Calendar Quarter, and setting out:
| 3.9.1 |
all
Net Sales segmented in each such report according to sales by Hana,
each
Affiliate and each Licensee and Sublicensee, as well as on a
country-by-country basis, and month-by-month
basis;
|
| 3.9.2 |
deductions
from gross revenues by the categories for same set out in the definition
of Net Sales; and
|
| 3.9.3 |
the
rates of exchange used to convert such royalties to 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 Dollars
shall be
those in effect for the purchase of Dollars as certified by the noon
buying rate of the Federal Reserve Bank of New York on the first
Business
Day of the quarter with respect to which the payment is
due.
|
Hana,
simultaneously with the delivery of each such report, shall tender payment
in
Dollars of all royalties shown to be due thereon.
3.10 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:
| 3.10.1 |
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
|
| 3.10.2 |
in
the event that Hana takes any action, including, without limitation,
the
assignment of this Agreement, any licensing or 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 of
the
Definitive Agreements, 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
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (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.
|
3.11 Foreign
Payments
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 or any Affiliates or Licensees or Sublicensees,
as the case may be, 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.
3.12 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 INEX’s account as
designated in writing by INEX to Hana.
3.13 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:
| 3.13.1 |
the
Prime Rate(s) during the period of late payment plus [***] percent
([***]%) interest compounded monthly,
or
|
| 3.13.2 |
the
maximum rate permitted by law;
|
calculated
based on the number of days that payment is delinquent until full payment has
been made.
3.14 Records
Hana
shall keep, and shall require all Affiliates, Licensee 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.
3.15 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 [***] percent ([***]%) 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 [***] percent ([***]%).
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
Article
4 DEVELOPMENT
OBLIGATIONS
4.1 Development
Plans
| 4.1.1 |
The
Parties acknowledge having executed a detailed Development Plan for
the
Development of each Product, which describes the specific Clinical
Activities, Regulatory Activities, Technical Transfer activities,
and
Manufacturing activities to be performed in the Territory for a twelve
(12) month period following the Effective Date of the Definitive
Agreements.
|
| 4.1.2 |
The
Development Plan will be reviewed from time to time as the Parties
reasonably determine to be necessary or
useful.
|
| 4.1.3 |
The
Development Plan shall be incorporated herein by reference and all
Development undertaken thereunder shall be conducted by Hana in compliance
with Regulatory Requirements.
|
4.2 Development
Efforts
| 4.2.1 |
Hana
shall use Commercially Reasonable Efforts to Develop each Product
in the
Territory (including carrying out its responsibilities under the
Development Plan) to:
|
| (a) |
conduct
or cause to be conducted the necessary and appropriate clinical trials
as
necessary to obtain and maintain Regulatory Approvals for each Product;
and
|
| (b) |
prepare,
file and prosecute or cause to be prepared, filed and prosecuted
the
Regulatory Submission for each
Product.
|
| 4.2.2 |
Hana
will provide INEX with written reports to keep INEX fully informed
of the
progress of the Development of each Product as
follows:
|
| (a) |
at
the close of each Calendar Quarter during the first twenty-four (24)
months following the Effective Date of the Definitive Agreements;
and
|
| (b) |
on
or before June 31 and December 31 of each and every calendar year
thereafter.
|
4.3 Transition
Committees
The
Parties will establish working committees to actively manage the transition
by
INEX to Hana of the responsibilities for Development of each Product during
the
initial twelve (12) months following the Effective Date of the Definitive
Agreements. Such working committees will conduct periodic planning and review
meetings as well as ad hoc meetings as necessary. The primary method of meeting
will be teleconference. Responsibilities of the working committees may include
overseeing the planning and monitoring of the clinical and regulatory
Development process and Technical Transfer process. All such meetings of the
working committees shall be conducted at Hana’s sole cost and expense.
4.4 Subcontractors
Hana
may
subcontract to any of its Representatives any of its obligations in respect
of
the Development with the consent of INEX, such consent not to be unreasonably
withheld or delayed; provided however, that Hana shall be responsible for the
performance of its Representatives and shall remain fully responsible and
obligated to INEX for all activities undertaken by its
Representatives.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
Article
5 COMMERCIALIZATION
OBLIGATIONS
5.1 Regulatory
Compliance
All
Commercialization activities in respect of each Product shall be conducted
by
Hana in compliance with Regulatory Requirements.
| 5.2 |
Marqibo
Trade-xxxx
|
| 5.2.1 |
The
Parties acknowledge that INEX has taken all necessary, and has
caused
its wholly owned Affiliate
to
take all steps necessary to
assign to Hana all applications for trade-xxxx and all registered
trade-marks for Marqibo in all jurisdictions within the Territory.
|
| 5.2.2 |
Except
as provided herein, Hana at its sole cost and expense, shall be
responsible for the selection, registration and maintenance of all
other
trademarks which it employs in connection with each Product in the
Territory and shall own and control such trademarks during the term
of
this Agreement and following its termination or
expiration.
|
| 5.3 |
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.
| 5.4 |
Commercialization
Efforts
|
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.
| 5.5 |
Consequence
of No Sales
|
| 5.5.1 |
In
addition to the terms of Section 5.4, 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, a Licensee or
a
Sublicensee, unless:
|
| (a) |
The
Parties mutually agree it is to their mutual benefit to delay commercial
sales of Product in such country;
or
|
| (b) |
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.
| 5.5.2 |
If
Hana breaches its obligation set forth in Section
5.5.1:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (a) |
INEX
shall be entitled to terminate all rights granted to Hana in the
Definitive Agreements in respect of each 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 5.5.1 and fails to remedy
such
default within sixty (60) days after notice thereof by INEX;
|
| (b) |
All
Licenses and 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 5.5.2(a);
and
|
| (c) |
Hana
shall continue to be bound by and shall comply with Sections 14.6,
14.8,
and any other Sections which are intended to survive any termination
of
rights under this Agreement.
|
5.6 Reports
Hana
shall report to INEX on the status and progress of Hana’s efforts under this
Section 5.6 as follows:
| 5.6.1 |
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 shall 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.
|
| 5.6.2 |
To
the extent that such could not be appropriately communicated to INEX
in
accordance with Section 5.6.1, Hana shall keep INEX informed in a
timely
manner of significant developments in Hana’s (and its Affiliates’,
Licensees’ and Sublicensees’, as the case may be) 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.
|
Article
6 PRODUCT
SAFETY AND REGULATORY COMPLIANCE
6.1 Regulatory
Responsibilities
| 6.1.1 |
Hana
shall use its Commercially Reasonable Efforts to ensure that none
of its
Representatives who participate in any Development
activities:
|
| (a) |
is
or has been suspended, debarred or disqualified by the
FDA;
|
| (b) |
has
been convicted of any offence that would form the basis for any
suspension, disqualification or debarment;
or
|
| (c) |
is
or has been subject to any proceedings for the suspension,
disqualification or debarment.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 6.1.2 |
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.
|
| 6.1.3 |
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.
|
| 6.1.4 |
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 documents submitted to Regulatory Authorities to meet new Regulatory
Requirements and guidelines in the
Territory.
|
6.2 Pharmacovigilance
| 6.2.1 |
Upon
the transfer, by INEX to Hana of the INDs for Sphingosomal Vinorelbine
and
Sphingosomal Topotecan, and the NDA for Sphingosomal Vincristine,
Hana
shall be responsible for, in respect of each such Product, performing
Pharmacovigilance in respect of all pre-Regulatory Approval Clinical
Activities and all post-Regulatory Approval Product safety monitoring
in
accordance with Regulatory Requirements, in addition to all other
Regulatory Activities for which Hana is
responsible.
|
| 6.2.2 |
For
as long as Material sourced, Manufactured or quality released by
INEX
remains available for use in approved clinical trials, Hana
shall:
|
| (a) |
inform
INEX within five (5) Business Days of any complaint received or regulatory
action taken in respect of such Material and shall seek INEX’s opinion
before passing judgment on the quality of such Material to any Third
Party; and
|
| (b) |
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.
|
6.3 Recalls
and Product Withdrawals
| 6.3.1 |
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:
|
| (a) |
the
Party in whose name the applicable IND file is registered will be
responsible for coordinating such recall or product
withdrawal;
|
| (b) |
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 6.3.2;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (c) |
Unless
INEX is liable for such costs and expenses in accordance with the
terms of
Section 6.3.2, Hana will remain responsible to INEX for payment of
all
services in respect of the Manufacture and supply of Material;
and
|
| (d) |
Both
Parties will cooperate fully with one another in connection with
any such
recall or product withdrawal.
|
| 6.3.2 |
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.
|
| 6.3.3 |
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.
|
| 6.3.4 |
Notwithstanding
any expiration or early termination of this Agreement, the provisions
of
Sections 6.2 and 6.3 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
7 INTELLECTUAL
PROPERTY RIGHTS
7.1 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 Article 10 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 Article 10 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.
7.2 INEX
Title
The
Parties hereby acknowledge and agree that to the best of the knowledge of INEX,
INEX owns any and all right, title and interest in and to the Patents and
Technology subject only to:
| 7.2.1 |
the
assignments granted to Hana under this
Agreement;
|
| 7.2.2 |
the
license granted to Hana under this
Agreement;
|
| 7.2.3 |
the
rights of the BCCA (including royalty obligations) under the BCCA
Agreements, in respect of the BCCA Patents;
and
|
| 7.2.4 |
the
rights of MD Xxxxxxxx (including annual fee and royalty obligations)
under
the MD Xxxxxxxx License in respect of the MD Xxxxxxxx
Patents.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
7.3 Ownership
of Pre-existing Intellectual Property Rights
The
Parties hereby acknowledge and agree that, except as otherwise provided in,
and
subject to the terms and conditions of the Definitive Agreements and this
Agreement, any Intellectual Property Rights owned by either Party and by MD
Xxxxxxxx prior to the Effective Date of the Definitive Agreement shall remain
owned by such Party and by MD Xxxxxxxx.
7.4 Ownership
of Future Intellectual Property Rights
| 7.4.1 |
Subject
to the Non-Competition Terms and any Notice of Abandonment that INEX
or
Hana may issue in respect of any Intellectual Property Rights related
to
the Products, all right, title and interest in and to any and all
Intellectual Property Rights that arise after the effective date
of this
Agreement and are related to the Products shall be owned as
follows:
|
| (a) |
MD
Xxxxxxxx and Hana shall be the joint owners of any patents and patent
applications filed after the effective date of this Agreement that
claim
priority to the Xxxxxx Patents;
|
| (b) |
Hana
shall be the exclusive owner of any patents and patent applications
filed
after the effective date of this Agreement that claim priority to
the
Xxxxxx Patents; and
|
| (c) |
INEX
shall be the exclusive owner of any patents and patent applications
filed
after the Effective Date of the Definitive Agreements that claim
priority
to the Licensed Patents.
|
regardless
of which Person(s) created or invented the same.
| (d) |
All
Intellectual Property Rights of INEX existing before the effective
date of
this Agreement and all Intellectual Property Rights developed by
employees
or agents of INEX or its Affiliate solely or joint with a Third Party
after the effective date of this Agreement shall be and will remain
the
exclusive property of INEX, and subject to the grants of Sections
2.1 and
2.2. Notwithstanding any provisions to the contrary, this Agreement
does
not grant to Hana any right, title, or interest in or to any part
or whole
of the DHSM Patents referenced in Section 6.10 of the Transaction
Agreement, for which an option to license has been granted to
Hana;
|
| (e) |
Subject
to Section 2.2, 7.4.1(a), 7.4.1(b), 7.4.1(c) and 7.4.1(d), all
Intellectual Property Rights conceived and reduced to practice solely
by
employees or agents of Hana or its Affiliate relating to the Products
shall be and remain the exclusive property of Hana and subject to
the
license grant of Section 2.2;
|
| (f) |
Subject
to Sections 7.4.1(a), 7.4.1(b), 7.4.1(c) and 7.4.1(d), any Intellectual
Property Rights developed jointly by one or more employees or agents
of
each of INEX and Hana or their Affiliates relating to the Products
shall
be owned exclusively by Hana, and subject to the license grant of
Section
2.2; and
|
| (g) |
Each
Party shall ensure that its Representatives who perform any portion
of its
obligations under this Agreement have entered into written agreements
with
such Party whereby such Representatives assign to such Party all
ownership
rights in any Intellectual Property Rights made or developed by such
Representatives in the course of such work for such
Party.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 7.4.2 |
Each
Party further agrees to execute, acknowledge and deliver to the requesting
Party such other instruments of conveyance and transfer and will
take such
other actions and execute, acknowledge and deliver such other documents,
certifications and further assurances as the requesting Party may
reasonably require in order to: (i) vest more effectively in the
requesting Party any rights transferred hereby, including but not
limited
to, obtaining registration or regulatory approval of any assets acquired
or rights granted hereunder or derivative works thereof; or (ii)
better
enable the requesting Party to exercise the rights acquired by such
Party
hereunder. Each of the Parties hereto will cooperate with the other
and
execute and deliver to the other Party such other instruments and
documents and take such other actions as may be reasonably requested
from
time to time by any other Party as necessary to carry out, evidence
and
confirm the intended purposes of this
Agreement.
|
| 7.4.3 |
Hana
agrees that in negotiating any joint venture, collaborative research,
development, Commercialization or other agreement(s) it may have
with any
Person other than INEX under which any Intellectual Property Rights
related to the Products may arise after the effective date of this
Agreement, Hana shall include in such agreements, provisions that
provide
for the assignment or license, as the case may be, of such Intellectual
Property Rights by such Person(s) and their Representatives to INEX
in
accordance with Sections 7.4.1(a), 7.4.1(b), 7.4.1(c) and
7.4.1(d).
|
7.5 BCCA
Patents
| 7.5.1 |
The
Parties acknowledge that INEX has made Commercially Reasonable Efforts
to
obtain Aradigm’s consent to the assignment by INEX to Hana of the BCCA
Patents and has discharged its obligation under Section 6.7(a) of
the
Transaction Agreement. If Aradigm indicates its willingness to consent
to
such assignment and if Aradigm and the Parties are able to agree
upon the
terms and conditions for such assignment, the Parties will amend
this
Agreement and enter into such other legal documents reasonably necessary
to support the assignment of BCCA Patents to
Hana.
|
| 7.5.2 |
Notwithstanding
any expiration or termination of the Service Agreement dated April
3, 2007
between the Parties and notwithstanding that the assignment of BCCA
Patents do not constitute IP Services as defined herein, Hana shall
reimburse INEX’s out of pocket expenses, at cost, and INEX’s internal
costs at the FTE Rate, for all activities agreed between Hana and
INEX to
facilitate the assignment of the BCCA Patents to
Hana.
|
Article
8 PATENT
PROSECUTION AND MAINTENANCE
8.1 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.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 8.2.1 |
In
respect of all patents and patent applications that are listed in
Exhibits
1.1.9 and 1.1.54,
Hana shall be responsible for:
|
| (a) |
the
continued prosecution of any such pending patent applications to
the issuance of the resulting
patents;
|
| (b) |
the
maintenance of all such issued Patents;
and
|
| (c) |
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 8
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 Exhibits
1.1.9 and 1.1.54.
| 8.2.2 |
Notwithstanding
the allocation of patent prosecution and maintenance costs set forth
in
this Section 8.2, if Hana requests IP Services from INEX in respect
of any
activities which would otherwise have been performed by Hana pursuant
to
Section 8.2.1, INEX shall be entitled to payment of IP Services in
accordance with the provisions of Section 8.6 and the Service
Agreement.
|
| 8.2.3 |
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 8.2.1 and cost allocations
set forth
in Exhibits
1.1.9 and 1.1.54.
The cost allocations set out in Exhibits
1.1.9 and 1.1.54 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
Article
13.
|
| 8.2.4 |
Hana
shall diligently pursue the prosecution of all patent applications
in
accordance with the responsibilities set forth in Section 8.2.1 and
cost
allocations set forth in Exhibits
1.1.9 and 1.1.54 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.
|
| 8.2.5 |
At
the request of INEX, Hana shall diligently pursue and prosecute additional
patent filings relating to the Patents and Technology in any jurisdiction
worldwide in accordance with the responsibilities set forth in Section
8.2.1 and cost allocations set forth in Exhibits
1.1.9 and 1.1.54.
|
| 8.2.6 |
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:
|
| (a) |
refer
the matter to arbitration pursuant to Article 13;
or
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (b) |
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:
| (c) |
cooperate
with the requesting Party to 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
|
| (d) |
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 Patents remain pending.
| 8.3.1 |
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:
|
| (a) |
any
Patents pending and issued; and
|
| (b) |
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.
| 8.3.2 |
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.
|
| 8.3.3 |
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 8 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.
|
8.4 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 in writing of the material actions
which each Party has undertaken concerning the application, prosecution and
maintenance of the Patents.
| 8.5.1 |
Notwithstanding
each Party’s obligation under Section 8.2, should either Party decide
to:
|
| (a) |
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;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (b) |
not
pursue patent protection in relation to the Patents in any specific
jurisdiction for any reason; or
|
| (c) |
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 Section 8.5.5 or 8.5.7.
| 8.5.2 |
The
Notice of Abandonment to be given by the Abandoning Party pursuant
to
Section 8.5.1 shall clearly identify the patent applications, patent
protection, and/or patent maintenance for the Patents to be
abandoned.
|
| 8.5.3 |
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
rights under:
|
| (a) |
the
patent(s) and patent application(s) to which such Party’s Notice of
Abandonment applies; and
|
| (b) |
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”).
| 8.5.4 |
If
Hana gives Notice of Abandonment to INEX pursuant to Sections 8.5.1
and
8.5.2 in respect of:
|
| (a) |
one
or more of the Licensed Patents, this license shall be terminated
with
respect solely to such Discontinued Patent(s), and Hana shall forfeit
the
right to any and all uses of the Discontinued Patent(s) and Technology
claimed in such Discontinued Patent(s). Exhibits
1.1.54 and
1.1.103 will
be deemed to be amended to exclude such Discontinued Patent and Technology
claimed in such Discontinued Patent from the grant of license contained
herein
|
| (b) |
one
or more of the Assigned Patents and INEX elects to continue to pursue
any
patent applications, patent protection and/or patent maintenance
in
relation to such Discontinued Patent in accordance with Section 8.5.5,
Hana shall forfeit the right to any and all uses of such Discontinued
Patent(s) and of the inventions and Technology claimed in such
Discontinued Patent(s), and assign such Discontinued Patent(s) to
INEX.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 8.5.5 |
If
Hana has given Notice of Abandonment to INEX pursuant to Sections
8.5.1
and 8.5.2, and INEX wishes to continue to pursue any patent applications,
patent protection and/or patent maintenance in relation to Hana’s
Discontinued Patent:
|
| (a) |
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;
|
| (b) |
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
|
| (c) |
notwithstanding
the Non-Competition Terms, INEX shall have the exclusive right to
use
Hana’s Discontinued Patent and inventions claimed in Hana’s Discontinued
Patent, in the Hana Field.
|
| 8.5.6 |
If
INEX gives Notice of Abandonment to Hana pursuant to Sections 8.5.1
and
8.5.2 in respect of:
|
| (a) |
one
or more of the Licensed Patents, and Hana elects to continue to pursue
any
patent applications, patent protection and/or patent maintenance
in
relation to such Discontinued Patent in accordance with Section 8.5.7,
INEX shall forfeit the right to any and all uses of the Discontinued
Patent(s) and inventions claimed in any Discontinued Patent(s), and
shall
assign such Discontinued Patent(s) to
Hana.
|
| (b) |
one
or more of the Assigned Patents, Hana’s grant of a license to INEX shall
be terminated with respect solely to the Discontinued Patent(s),
and INEX
shall forfeit the right to any and all uses of the Discontinued Patent(s)
and Technology claimed in such Discontinued Patent(s). Exhibits
1.1.9 and
1.1.103
will
be deemed to be amended to exclude such Discontinued Patent(s) and
Technology claimed in such Discontinued Patent(s) from the grant
of the
license to INEX contained herein.
|
| 8.5.7 |
If
INEX has given Notice of Abandonment to Hana pursuant to Sections
8.5.1
and 8.5.2 and Hana wishes to continue to pursue any patent applications,
patent protection and/or patent maintenance in relation to INEX’s
Discontinued Patent:
|
| (a) |
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
|
| (b) |
notwithstanding
the Non-Competition Terms, Hana shall have the exclusive right to
use
INEX’s Discontinued Patent and the inventions claimed in INEX’s
Discontinued Patent, outside the Hana
Field.
|
| 8.5.8 |
Either
Party may request the other Party to perform such other Party’s
responsibilities set forth in Sections 8.2.1 or 8.2.2, as the case
may be,
in respect of a particular patent or patent application. If the Party
bearing such responsibility is unwilling or unable to perform its
responsibility in a timely manner, the Party requesting performance
in
respect of such patent or patent application may, with three (3)
days
prior written notice, perform the particular activity(ies) requested
in
respect of such patent or patent application. The Party unwilling
or
unable to perform its responsibility shall pay all reasonable costs
and
out-of-pocket expenses actually incurred by the requesting Party
to
perform the particular activity(ies) requested, within thirty (30)
days of
the non-performing Party’s receipt of the performing Party’s invoice for
such costs and out-of-pocket expenses. For the purposes of this Section
8.5.8, reasonable costs shall
be calculated using the FTE Rate set forth in the Service Agreement,
regardless of the Party performing the activity(ies), and notwithstanding
any termination of the Service
Agreement.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
8.6 Costs
of Patent Application, Prosecution and Maintenance
| 8.6.1 |
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 services fees if INEX is the Abandoning Party)
associated with the application, prosecution, and/or maintenance
of any
Patents in the Discontinued License
Patent.
|
| 8.6.2 |
Subject
to Section 8.6.1, 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 8.2.1 (the “IP
Services”),
Hana, its successors, assigns or any Person(s) who acquires any interest
in any of the Patents and Technology will jointly and severally be
responsible for paying INEX:
|
| (a) |
[***]
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
|
| (b) |
[***]
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 of the Definitive
Agreements, the FTE Rate shall be adjusted by a percentage equal
to the
percentage 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;
and
|
| (c) |
[***]
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
8.5.5.
|
| 8.6.3 |
INEX
will invoice Hana monthly for all costs set forth in Section 8.6.2,
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 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.
|
| 8.6.4 |
Notwithstanding
Section 8.6.3, 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 8.6 to recover from Hana,
its successors, assigns or any Person(s) who acquires any interest
in any
of the Patents and Technology, more than the total monthly costs
set forth
in Section 8.6.2 in any given
month.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 8.6.5 |
Hana
shall be responsible for prosecuting and maintaining the MD Xxxxxxxx
Patents and for payment of all costs associated therewith. If INEX
exercises its rights under Section 2.2.1
to
either the Xxxxxx Patents and/or the Xxxxxx Patents, INEX shall be
responsible for ten percent (10%) of the cost of Hana’s prosecution and
maintenance of the Xxxxxx Patents and/or the Xxxxxx Patents, as
applicable.
|
8.7 Late
Payments
Any
payment due under Section 8.6 that is not paid on or before the date such
payment is due shall bear interest at a rate equal to the lesser
of:
| 8.7.1 |
the
Prime Rate(s) during the period of late payment plus [***] percent
([***]%) interest compounded monthly;
or
|
| 8.7.2 |
the
maximum rate permitted by law;
|
calculated
based on the number of days that payment is delinquent until full payment has
been made.
8.8 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, as well as
in
the preparation, filing, and prosecution of any patent application or
registrations which may arise under this Agreement. Such co-operation shall
include:
| 8.8.1 |
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
|
| 8.8.2 |
executing
and causing its Representatives to execute all legal documents reasonably
necessary to support the assignment, filing, prosecution and maintenance
of said Patents.
|
Article
9 INFRINGEMENT
PROCEEDINGS
9.1 Limits
Except
as
expressly set out in this Agreement, nothing in this Agreement shall be
construed as:
| 9.1.1 |
an
obligation by Hana or INEX to bring or prosecute or defend actions
or
suits against Third Parties for infringement of patents, copyrights,
trade-marks, industrial designs or other intellectual property or
contractual rights; or
|
| 9.1.2 |
the
conferring by Hana or INEX of the right to use in advertising or
publicity
the name of Hana or INEX or their respective
trademarks.
|
9.2 Conduct
of Infringement Proceedings
Notwithstanding
Section 9.1, in the event of:
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 9.2.1 |
an
alleged infringement by a Third Party of the Patents or Technology
or of
any right with respect to the Patents or Technology by the manufacture,
sale, services or use of products derived from the Patents or Technology
in the Hana Field; or
|
| 9.2.2 |
any
complaint by Hana alleging any infringement by a Third Party with
respect
to the Patents or Technology or to any right with respect to the
Patents
or Technology by the manufacture, sale, service or use of products
derived
from the Patents or Technology in the Hana
Field;
|
the
following shall apply:
| 9.2.3 |
Hana
shall have the first right, in its sole discretion, and at its sole
expense, to prosecute or defend such
litigation;
|
| 9.2.4 |
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 such litigation or defend such litigation at its own expense,
but shall not be obligated to do
so;
|
| 9.2.5 |
the
Party prosecuting or defending such litigation (in this Article,
the
“Litigating
Party”)
shall have the right to control such litigation and shall bear all
legal
expenses (including court costs and legal fees), including settlement
thereof provided however that no settlement or consent judgment or
other
voluntary final disposition of any suit defended or action brought
by a
Party pursuant to this Section 9.2 may be entered into without the
consent
of the other Party if such settlement would require the other Party
to be
subject to an injunction or to make a monetary payment or would restrict
the claims in or admit any invalidity of any Patents 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 Patents. 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;
|
| 9.2.6 |
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 3.1, 3.2 and 3.3 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 Article 13;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 9.2.7 |
the
Litigating Party shall keep the Non-litigating Party fully informed
of the
actions and positions taken or proposed to be taken by the Litigating
Party on behalf of itself or a licensee or sublicense (including
Licensee
or Sublicensee) and actions and positions taken by all other parties
to
such litigation; and
|
| 9.2.8 |
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 9.2.6 or
from such
other parties to the litigation).
|
9.3 Breach
of Confidence Proceedings
In
the
event of an alleged breach of confidentiality respecting Confidential
Information or any Third Party use of Confidential Information, Hana and INEX
agree that they shall reasonably cooperate to enjoin such Third Party’s use of
such Confidential Information, and take such other action as a Party with regard
to its own Confidential Information may deem appropriate, at law or in
equity.
9.4 Defense
of Infringement Proceedings
| 9.4.1 |
If
any complaint alleging infringement or violation of any patent or
other
proprietary rights is made against Hana, its Affiliate, Licensee
or
Sublicensee with respect to the Manufacture, use or sale of a Product,
the
following shall apply:
|
| (a) |
Hana
shall promptly notify INEX in writing upon receipt of any such complaint
setting out full details thereof 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, a Licensee or a
Sublicensee);
|
| (b) |
if
such complaint gives rise to an indemnification obligation under
any of
the Definitive Agreements in favor of Hana (or its Affiliate or Licensee
or Sublicensee) on the part of INEX, then INEX shall defend such
suit and
all costs and expenses incurred by Hana (or any Affiliate or Licensee
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
INEX;
|
| (c) |
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 Affiliate or Licensee
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 (or any Affiliate or Licensee
or
Sublicensee, as the case may be);
and
|
| (d) |
in
any event, INEX and Hana shall assist one another and cooperate in
any
such litigation at each Party’s own
expense.
|
| 9.4.2 |
If
any complaint alleging infringement or violation of any patent or
other
proprietary rights is made against INEX, its Affiliate, licensee
or
sublicensee with respect to the Manufacture, use or sale of a Product,
the
following procedure shall apply:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (a) |
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;
|
| (b) |
if
such a complaint gives rise to an indemnification obligation under
the
Definitive Agreements in favor of INEX on the part of Hana, then
Hana
shall defend such suit and all costs and expenses incurred by INEX
(or its
Affiliate) 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;
|
| (c) |
if
such complaint does not give rise to an indemnification obligation
under
the Definitive Agreements in favor of INEX 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) in investigating,
resisting, litigating and settling such a compliant, including the
payment
of any award of Damages and/or costs to any Third Party, shall be
paid by
INEX;
|
| (d) |
in
any event, INEX and Hana shall assist one another and cooperate in
any
such litigation at each Party’s own
expense.
|
| 9.4.3 |
With
regard to costs and expenses incurred by Hana (or any Licensee or
Sublicensee) under Sections 9.4.1(c) or 9.4.2(b) 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 Licensee or Sublicensee) shall be entitled to offset
or
credit [***] percent ([***]%) of the Offset Amount against future
payments
otherwise due INEX as set forth in Section 3.7.1. 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.
|
| 9.4.4 |
In
the event a complaint is made under either of Sections 9.4.1 or 9.4.2,
no
settlement or consent judgment or other voluntary final disposition
may be
entered into without the consent of the other Party if such settlement
would require the other Party to be subject to an injunction or to
make a
monetary payment or would restrict the claims in or admit any invalidity
of any Patents or significantly adversely affect the rights of the
other
Party.
|
9.5 Co-operation
with Other Licensees
Hana
acknowledges that INEX may grant rights to its other sublicensees in respect
of
fields outside of the Hana Field similar to those granted to Hana under Sections
9.2, 9.3, 9.4 and this Section 9.5. If INEX grants such rights to its other
sublicensees, in the event of any litigation in respect of:
| 9.5.1 |
fields
outside of the Hana Field that may reasonably affect Hana’s use of the
Patents or Technology in the Hana Field or the Manufacture, use or
sale of
Product by Hana; or
|
| 9.5.2 |
the
Hana Field that may reasonably affect INEX or one or more of INEX’s
sublicensee’s use of the Patents or 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
INEX, Hana and such other sublicensees 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, provisions that allow the participation of Hana as
contemplated herein.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
Article
10 CONFIDENTIAL
INFORMATION AND PUBLICATION
10.1 Treatment
of Confidential Information
Each
Party agrees:
| 10.1.1 |
to
keep and use in strict confidence all Confidential Information of
the
other Party that each Party acquires, sees, or is informed of, as
a direct
or indirect consequence of this Agreement and to not, without the
prior
written consent of the other Party, disclose any such Confidential
Information or recollections thereof to any Person other than its
Representatives who are under an obligation of confidentiality on
terms
substantially similar to those set out in this Agreement, who have
been
informed of the confidential nature of the Confidential Information
and
who require such information in connection with the performance of
this
Agreement;
|
| 10.1.2 |
that
all copies, duplicates, reproductions, translations or adaptations
of any
Confidential Information of the other Party made hereunder shall
be
clearly labeled as confidential;
and
|
| 10.1.3 |
to
take all reasonable steps to prevent material in its possession that
contains or refers to Confidential Information of the other Party
from
being discovered, used or copied by Third Parties and that it shall
use
reasonable steps to protect and safeguard all Confidential Information
of
the other Party in its possession from all loss, theft or
destruction.
|
10.2 Permitted
Disclosures
Notwithstanding
anything to the contrary contained in this Agreement, each Party will be
permitted to disclose Confidential Information received from the other
Party:
| 10.2.1 |
where
in the reasonable and unqualified opinion of the receiving Party’s legal
counsel, disclosure is required to be made
under:
|
| (a) |
the
securities laws of any relevant jurisdiction, including the receiving
Party’s jurisdiction of incorporation or a jurisdiction in which the
receiving Party’s securities are traded on a stock exchange;
or
|
| (b) |
such
disclosure is required to be made by the receiving Party 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:
| (c) |
the
receiving Party shall immediately notify the disclosing Party prior
to any
such disclosure and the disclosing Party shall have been given the
opportunity where possible to oppose such disclosure by the receiving
Party by seeking a protective order or other appropriate remedy,
or to
waive compliance with the provisions of this
Agreement;
|
| (d) |
the
receiving Party or its Representatives, as the case may be, shall
disclose
only that portion of the information legally required to be disclosed,
and
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (e) |
the
receiving Party or its Representatives, as the case may be, will
exercise
all reasonable efforts to maintain the confidential treatment of
the
information; and
|
| 10.2.2 |
to
Third Party contractors or collaborators to facilitate or carry out
the
Parties’ performance of their respective activities under this Agreement,
provided that such Third Parties enter into an agreement with such
Party
which contains confidentiality provisions substantially the same
as those
set forth herein.
|
10.3 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.
10.4 Publications
Generally
The
following restrictions shall apply with respect to the disclosure in
conferences, scientific journals or publications by any Party or Representative
of any Party relating to the inventions contained in the Patents and the
Technology or to the activities or results of the Development by Hana of any
Product:
| 10.4.1 |
at
least thirty (30) days before any proposed submission is submitted
and any
proposed publication is published by a Party (the “Publishing
Party”),
such Publishing Party shall provide the other Party with an advance
copy
of any such proposed submission or proposed publication, as the case
may
be, before any other disclosure of same and such other Party shall
have a
reasonable opportunity to recommend any changes it reasonably believes
are
necessary to preserve Intellectual Property Rights or Confidential
Information belonging in whole or in part to INEX or Hana, and the
incorporation of such recommended changes shall not be unreasonably
refused; and
|
| 10.4.2 |
if
such other Party informs the Publishing Party, within thirty (30)
days
after receipt of an advance copy of a proposed publication, that
such
publication in its reasonable judgment could be expected to have
a
material adverse effect on any Intellectual Property Rights or
Confidential Information belonging in whole or in part to INEX or
Hana,
the Publishing Party shall delay or prevent such publication as proposed.
In the case of inventions, the delay shall be sufficiently long to
permit
the timely preparation and filing of a patent application(s) or
application(s) for a certificate of invention on the information
involved
but not more than ninety (90) days.
|
10.5 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 Information or
other information received from INEX.
10.6 Return
of Confidential Information
Except
as
required to comply with Regulatory Requirements, within thirty (30) days of
receipt of a written request from the disclosing Party, the receiving Party
will
return to the disclosing Party or destroy, at the disclosing Party’s sole
discretion, all Confidential Information of the disclosing Party, including
all
such information that is electronically stored by the receiving Party, all
reproductions thereof and all samples of materials in the form provided by
the
disclosing Party to the receiving Party, in the receiving Party’s possession or
control and confirm such destruction or delivery to the disclosing Party in
writing, as applicable.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
Article
11 REPRESENTATIONS
AND WARRANTIES
11.1 Hana
Representations and Warranties
Hana
hereby represents and warrants to INEX that, as of the effective date of this
Agreement:
| 11.1.1 |
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;
|
| 11.1.2 |
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;
|
| 11.1.3 |
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;
|
| 11.1.4 |
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;
|
| 11.1.5 |
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 of this Agreement;
|
| 11.1.6 |
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;
|
| 11.1.7 |
Hana
will not enter into any Third Party agreement after the effective
date of
this Agreement which, in any way, will prevent Hana from performing
all of
the obligations hereunder;
|
| 11.1.8 |
the
authorized capital of Hana consists of 100,000,000 shares of Common
Stock,
of which 29,295,117 shares
are issued and outstanding as of March 30, 2007, 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;
|
| 11.1.9 |
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;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 11.1.10 |
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;
|
| 11.1.11 |
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;
|
| 11.1.12 |
subject
to: (i) INEX’s representation and warranty set forth in Section 11.2.8;
and (ii) the completion of the assignment of the MD Xxxxxxxx Patents
by
INEX to Hana, and to the best of the knowledge of Hana without independent
investigation or inquiry of any kind, Hana holds the entire right
title
and interest in and to the Assigned Patents, free and clear of all
encumbrances and Hana has the right and power to grant on an exclusive
and
non-exclusive basis, as the case may be, the licences granted to
INEX
under this Agreement without consent of any Third Party that may
claim any
such interest through Hana, including, without limitation, any secured
creditor of Hana
|
| 11.1.13 |
subject
to INEX’s representation and warranty set forth in Section 11.2.9; and
subject to the completion of the assignment of the MD Xxxxxxxx Patents
by
INEX to Hana, to the best of the knowledge of Hana without independent
investigation or inquiry of any kind, all the Assigned Patents are
validly
subsisting and all maintenance fees and similar annuity payments
have been
made in each of the jurisdictions requiring such payments;
and
|
| 11.1.14 |
Subject
to INEX’s representation and warranty set forth in Section 11.2.12, and
without independent investigation or inquiry of any kind, except
for the
Intellectual Property Rights described in this Agreement, Hana neither
owns nor controls any Intellectual Property Rights that would be
required
by INEX in order to make, have made, use, sell, offer for sale, import,
and have imported Products outside the Hana Field in the
Territory.
|
11.2 INEX
Representations and Warranties
INEX
warrants and represents to Hana that, as of the effective date of this
Agreement:
| 11.2.1 |
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;
|
| 11.2.2 |
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;
|
| 11.2.3 |
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;
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 11.2.4 |
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;
|
| 11.2.5 |
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 of this Agreement;
|
| 11.2.6 |
INEX
is not aware of any impediment, including without limitation any
Third
Party agreement, which would prevent INEX from performing its obligations
under this Agreement;
|
| 11.2.7 |
INEX
will not enter into any Third Party agreement after the effective
date of
this Agreement which, in any way, will limit its ability to perform
all of
the obligations hereunder;
|
| 11.2.8 |
to
the best of the knowledge of INEX, INEX holds the entire right title
and
interest in and to the Patents and Technology, free and clear of
all
encumbrances and INEX has the right and power to
grant:
|
| (a) |
on
an exclusive basis, the licences granted to Hana under this Agreement
without consent of any Third Party that may claim any such interest
through INEX, including, without limitation, any secured creditor
of INEX;
and
|
| (b) |
the
assignments granted to Hana under this Agreement, and INEX has obtained
the consent of all Third Parties from whom consent to such assignments
is
required;
|
| 11.2.9 |
to
the best of the knowledge of INEX, all the Patents are validly subsisting
and all maintenance fees and similar annuity payments have been made
in
each of the jurisdictions requiring such
payments;
|
| 11.2.10 |
to
the best of the knowledge of INEX, all statements contained in any
applications for the registration of the Patents were true and correct
as
of the date of such applications;
|
| 11.2.11 |
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 in the Territory;
and
|
| 11.2.12 |
to
the actual knowledge of INEX, without independent investigation or
inquiry, the rights to the Patents and Technology granted by INEX
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.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
11.3 DISCLAIMER
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.
Article
12 INDEMNIFICATION
AND LIABILITY LIMITATIONS
12.1 Indemnification
by Hana
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:
| 12.1.1 |
the
breach of any representation or warranty made by Hana
herein;
|
| 12.1.2 |
the
default by Hana in the performance or observance of any of its obligations
to be performed or observed
hereunder;
|
| 12.1.3 |
the
breach by Hana of any Regulatory Requirements, regulations and guidelines
in connection with any Product;
|
| 12.1.4 |
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
|
| 12.1.5 |
any
injury or death to any Person or damage to any property caused by
any
Product provided by Hana or a Licensee or Sublicensee, 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:
| 12.1.6 |
the
breach of any representation or warranty made by INEX
herein;
|
| 12.1.7 |
the
default by INEX in the performance or observance of any of its obligations
to be performed or observed hereunder;
and
|
| 12.1.8 |
the
breach by INEX of any Regulatory Requirements, regulations and guidelines
in connection with any Patents and
Technology.
|
12.2 Indemnification
by INEX
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:
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 12.2.1 |
the
breach of any representation or warranty made by INEX
herein;
|
| 12.2.2 |
the
default by INEX in the performance or observance of any of its obligations
to be performed or observed hereunder;
and
|
| 12.2.3 |
the
breach by INEX of any Regulatory Requirements, regulations and guidelines
in connection with any Patents and
Technology;
|
The
foregoing shall not apply to the extent that such Damages are due
to:
| 12.2.4 |
the
breach of any representation or warranty made by Hana
herein;
|
| 12.2.5 |
the
default by Hana in the performance or observance of any of its obligations
to be performed or observed
hereunder;
|
| 12.2.6 |
the
breach by Hana of any Regulatory Requirements, regulations and guidelines
in connection with any Product; and
|
| 12.2.7 |
any
injury or death to any person or damage to any property caused by
any
Product provided by Hana or its Licensee or 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.
|
12.3 Notice
of Claims
In
the
event that a claim is made pursuant to Section 12.1 or 12.2 against any Person
who 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 12.1 or 12.2 as applicable, unless:
| 12.3.1 |
the
Indemnitor is granted, subject to the provisions of this Section
12.3 and
the relevant provisions of Article 9, full authority and control
over the
defense, including settlement, against such claim or law suit or
other
action, and
|
| 12.3.2 |
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 12.3 and the
relevant provisions of Article 9, 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 Patents or significantly adversely affect the rights of the
Indemnitee.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
12.4 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 12.1 OR 12.2 FOR
CONSEQUENTIAL OR INCIDENTAL DAMAGES RECOVERED BY A THIRD PARTY.
12.5 Actions
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.
12.6 Insurance
| 12.6.1 |
Prior
to or immediately upon the start of any human clinical trials or
other
product testing involving human subjects by Hana or its Licensee
or
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:
|
| (a) |
Each
Occurrence:$5,000,000
Dollars
|
| (b) |
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 the
Manufacture, sale, distribution, or marketing in the Territory, by Hana or
its
Licensee or Sublicensee, of Product. Hana shall provide written proof of the
existence of such insurance to INEX upon request.
| 12.6.2 |
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:
|
| (a) |
Each
Occurrence:$4,000,000
(Canadian dollars)
|
| (b) |
General
Aggregate:$4,000,000
(Canadian dollars)
|
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(ies) will not be canceled without
thirty (30) days prior written notice (hand delivered or certified mail, return
receipt requested) to Hana.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 12.6.3 |
Each
Party shall require that such Party’s Representatives and Hana’s Licensee
and Sublicensee under this Agreement shall
either:
|
| (a) |
demonstrate
to the other Party’s reasonable satisfaction that such Representative or
Hana’s Licensee or 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
|
| (b) |
sixty
(60) days prior to the earlier of the start of Human Clinical Trials
or
the first sale of any such Product by Hana’s Licensee or Sublicensee,
procure and maintain public liability and product liability insurance
in
reasonable amounts, with a reputable and financially secure insurance
carrier.
|
| 12.6.4 |
Notwithstanding
anything to the contrary contained in this Section 12.6, before the
first
date of commercial sale of any Product in the U.S., Hana and its
Affiliate
and Licensee 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 DISPUTE
RESOLUTION
13.1 Negotiation
and Arbitration
In
the
event of any dispute arising between the Parties concerning this Agreement,
its
enforceability, or its interpretation, the following procedure shall
apply:
| 13.1.1 |
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.
|
| 13.1.2 |
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 13.1.1 may,
on
mutual agreement of the Parties, be finally settled by a single arbitrator
appointed pursuant to the rules of The Center for Public Resource’s
Institute for Dispute Resolution.
|
| 13.1.3 |
The
place of arbitration shall be Seattle, Washington and the language
to be
used in the arbitration proceedings shall be
English.
|
| 13.1.4 |
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.
|
| 13.1.5 |
Nothing
in this Agreement shall be deemed as preventing either Party from
seeking
specific performance, injunctive relief (or any other equitable relief),
in respect of any actual or threatened breach of this Agreement,
without
proof of actual damages, from any court having jurisdiction over
the
Parties and the subject matter of the Dispute as necessary to protect
either Party’s name, Confidential Information or Intellectual
property.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 13.1.6 |
Notwithstanding
the provisions of Subsections 13.1.2 through 13.1.5 inclusive, 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.
|
| 13.1.7 |
Each
Party is required to continue to perform its obligations under this
Agreement pending final resolution of any
Dispute.
|
Article
14 TERM
& TERMINATION
14.1 Term
| 14.1.1 |
The
license grant by INEX to Hana in this Agreement shall become effective
on
the effective date of this Agreement and, unless earlier terminated
in
accordance with this Article 14, shall expire, on a country-by-country
basis, in respect of each Product upon the later
of:
|
| (a) |
expiration
of the last to expire of the Patents containing Valid Claims covering
such
Product in such country in the Territory;
|
| (b) |
expiration
of the last to expire period of product exclusivity covering such
Product
that is provided by the laws of such country in the Territory;
and
|
| (c) |
on
the date that all Technology cease to be Confidential Information
under
the circumstances set out in Section
1.1.24.
|
(the
“Term”
of
this
Agreement).
14.2 Termination
for Invalidity Challenge
If
Hana
or one of its Affiliates intends to assert or actually asserts in any court
or
other governmental agency of competent jurisdiction (but excluding any Dispute
governed by Article 13 herein) that a Patent is invalid, unenforceable, or
that
no issued Valid Claim embodied in such patent excludes a Third Party from
making, having made, using, selling, offering for sale, importing or having
imported a Product in such jurisdiction:
| 14.2.1 |
Hana
will not less than sixty (60) days prior to making any such assertion,
provide to INEX a complete written disclosure of each and every basis
then
known to Hana or its Affiliate for such assertion and, with such
disclosure, will provide INEX with a copy of any document or publication
upon which Hana or its Affiliate intends to rely in support of such
assertion; and.
|
| 14.2.2 |
INEX
shall be entitled, upon not less than thirty (30) days prior written
notice to Hana, to terminate the license granted to Hana under Article
2
or require an assignment by Hana to INEX of such Assigned Patent
(as the
case may be) for such Product(s) covered by the patent under challenge
in
the applicable jurisdiction; provided however, that INEX shall not
terminate such license or require assignment of such Assigned Patent
(as
the case may be) if within thirty (30) days of Hana’s receipt of INEX’s
notification hereunder, Hana has:
|
| (a) |
confirmed
by written notice to INEX that Hana no longer intends to challenge
the
validity or enforceability of any Patent;
or
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (b) |
provided
to INEX, documentation to confirm Hana’s withdrawal of its filing,
submission or other process commenced in any court or other governmental
agency of competent jurisdiction to challenge the validity or
enforceability of any Patent.
|
14.3 Termination
on Bankruptcy
| 14.3.1 |
This
Agreement may be terminated by INEX by providing written notice to
Hana
upon:
|
| (a) |
the
bankruptcy, liquidation or dissolution of
Hana;
|
| (b) |
the
filing of any voluntary petition for bankruptcy, dissolution, liquidation
or winding-up of the affairs of Hana;
or
|
| (c) |
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.
|
| 14.3.2 |
This
Agreement may be terminated by Hana by providing written notice to
INEX
upon:
|
| (a) |
the
bankruptcy, liquidation or dissolution of
INEX;
|
| (b) |
the
filing of any voluntary petition for bankruptcy, dissolution, liquidation
or winding-up of the affairs of INEX;
or
|
| (c) |
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 licenses granted in this Agreement, Hana shall be entitled
to
retain the licenses granted herein, subject to INEX’s rights to terminate
this Agreement as provided in this
Agreement.
|
| 14.3.3 |
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:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (a) |
in
the event of a rejection of this Agreement or any agreement supplementary
hereto, Hana shall be permitted to receive and use any Technology
and
Confidential Information for the purpose of enabling it to mitigate
damages caused to Hana because of the rejection of this
Agreement;
|
| (b) |
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
thereto;
|
| (c) |
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
|
| (d) |
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 465(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 14.3.3:
| (e) |
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;
|
| (f) |
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
14.3.3 and shall not give rise to the remedies set forth in this
Section
14.3.3; and
|
| (g) |
if
Hana asserts any rights under Section 14.3.3(a), 14.3.3(b), 14.3.3(c)
or
14.3.3(d), Hana shall continue to be bound by all liabilities and
obligations imposed upon Hana, its Affiliates, Licensees and Sublicensees,
any remedies available to INEX under this
Agreement.
|
14.4 Termination
for Material Breach
| 14.4.1 |
Except
as otherwise provided in this Agreement, 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 breach of its obligations hereunder
and fails to remedy any such breach within ninety (90) days after
notice
thereof by the Party alleging breach. Any such notice
shall:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| (a) |
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
|
| (b) |
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 the license hereunder in respect of such Product or such country
as to
which a breach remains unremedied] (to the extent such license is revocable
or
otherwise subject to termination as provided herein) 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 default and prior to
correction of the default.
Either
Party shall be entitled to terminate the licenses granted hereunder (to the
extent such license is revocable or otherwise subject to termination as provided
herein) by written notice to the other Party in the event that the other Party
is in material default of the Non-Competition provisions of the Asset Purchase
Agreement, and fails to remedy any such default within ninety (90) days after
notice thereof.
| 14.4.2 |
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 Article 13 to resolve such
Dispute.
|
14.5 No
Limitation on Remedies
Upon
any
termination of this Agreement pursuant to this Article 14, 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.
14.6 Consequences
of Termination
| 14.6.1 |
Notwithstanding
anything to the contrary herein, if INEX terminates this Agreement
pursuant to this Article 14, within thirty (30) days following the
effective date of such termination, Hana shall assign to
INEX:
|
| (a) |
Hana’s
entire right, title and interest in and to the Xxxxxx Patents subject
to
the terms and conditions set forth in the MD Xxxxxxxx License;
and;
|
| (b) |
Hana’s
entire right, title and interest in and to Hana’s joint ownership of the
Xxxxxx Patents subject to the terms and conditions set forth in the
MD
Xxxxxxxx License.
|
| 14.6.2 |
Upon
any termination by INEX of the licenses granted by INEX or of this
Agreement:
|
| (a) |
Hana
shall not be relieved of any obligations incurred prior to such
termination;
|
| (b) |
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
|
| (c) |
all
Licenses and Sublicenses granted hereunder shall forthwith
terminate.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 14.6.3 |
The
termination by INEX of the licenses granted by INEX or of this Agreement
will be without prejudice to:
|
| (a) |
INEX’s
right to receive all payments accrued from Hana pursuant to Section
8.6 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’s reasonable and
necessary non-cancelable obligations to Third Parties actually incurred
by
INEX in the performance if its obligations under this Agreement prior
to
the date of notice of termination, but arising after the date of notice of
termination; and
|
| (b) |
any
other legal, equitable or administrative remedies as to which either
Party
may then or thereafter become
entitled.
|
14.7 Disposition
of Product
Upon
any
termination of this Agreement pursuant to Sections 14.3 and 14.4, Hana shall
within thirty (30) days after the effective date of such termination notify
INEX
in writing of the amount of each Product which Hana, its Affiliates, Licensees
and Sublicensees then have completed on hand, the sale of which would, but
for
the termination, be subject to royalty. At INEX’s sole election, evidence by
written consent, INEX may xxxxx Xxxx, its Affiliates, and their respective
Licensees and/or Sublicensees written permission during the one (1) year
following such termination to sell that amount of Product, provided that Hana
shall pay the aggregate royalty thereon at the conclusion of the earlier of
the
last such sale or such one (1) year period. Except as provided under this
Section 14.7, all sublicenses granted by Hana shall forthwith terminate upon
the
termination of this Agreement.
14.8 Delivery
of Data and Materials and License
Upon
termination of the license granted by INEX to Hana in respect of a particular
Product in a particular country(ies) under Section 14.4 by INEX for Hana’s
uncured material default, or Section 14.3.1 for invalidity challenge, or Section
5.5 for lack of sales:
| 14.8.1 |
Provided
that INEX shall be responsible for any reasonable associated out-of-pocket
costs associated with the following activities, Hana shall deliver
to INEX
a copy of all data (including animal and human) and such other
information, Materials, 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 for such Product in the
applicable country(ies). 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
countries.
|
| 14.8.2 |
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.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
| 14.8.3 |
In
the event that no such assignment and/or transfer and/or reference
pursuant to Section 14.8.2 may legally be made, then Hana shall forthwith
surrender to INEX or its designee such Regulatory Submissions and
Regulatory Approvals for
cancellation.
|
| 14.8.4 |
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 in such country(ies), 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 14.8.1, 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.
Article
15 GENERAL
PROVISIONS
15.1 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.
15.2 Assignment
Neither
Party may assign this Agreement in whole or in part without the prior written
consent of the other Party, provided that either Party may assign this Agreement
to an Affiliate or a successor in interest on written notice to the other Party.
Any permitted assignee shall assume all obligations of its assignor under this
Agreement. No assignment shall relieve any Party of responsibility for the
performance of any accrued obligation that such Party then has under this
Agreement.
15.3 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.
15.4 Entire
Agreement
This
Agreement (including Exhibits) constitutes the entire agreement between the
Parties concerning the subject matter hereof, and supersedes all written or
oral
prior agreements or understandings with respect thereto.
15.5 Enurement
This
Agreement shall enure to the benefit of and be binding upon the Parties hereto
and their respective successors and permitted assigns.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
15.6 Exhibits
The
Exhibit attached hereto shall be deemed to form an integral part of this
Agreement.
15.7
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; inability to procure
or use materials, labor, equipment, transportation or energy; or any other
cause
beyond the reasonable control of the Party invoking this Section 15.7 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.
15.8 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.
15.9 Governing
Law
This
Agreement shall be governed by and construed in accordance with the laws of
the
State of Washington and the laws of the United States of America applicable
therein..
15.10 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.
15.11 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.
15.12 International
Sale of Goods Act
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.
15.13 Jurisdiction
Subject
to Article 13, the Parties agree that the courts of the State of Washington
will
have exclusive jurisdiction to determine all disputes and claims arising between
the Parties.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
15.14 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).
15.15
Notices
Notices
provided under this Agreement to be given or served by either Party on the
other
will be given in writing and served personally, by prepaid registered mail
return receipt requested, by a reputable courier company or by means of
facsimile, to the following respective addresses or to such other addresses
as
the Parties may hereafter advise each other in writing. Each such notice shall
be deemed delivered (i) on the date delivered if by personal delivery, (ii)
on
the date telecommunicated if by facsimile, and (iii) on the date upon which
the
return receipt is signed or delivery is refused, as the case may be, if
mailed:
|
If
to Hana:
Hana
BioSciences, Inc.
0000
Xxxxxxxxx Xxxxx, Xxxxx 000,
Xxxxx
Xxx Xxxxxxxxx, XX 00000
U.S.A
Attention:
President and/or C.E.O.
Tel:
Fax:
|
|
|
If
to INEX:
Inex
Pharmaceuticals Corporation
#000
- 0000 Xxxxxxxx Xxxxxxx
Xxxxxxx,
X.X.
Xxxxxx
X0X 0X0
Attention:
President
and/or C.E.O.
Tel: (000)
000-0000
Fax: (000)
000-0000
|
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.
15.16 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 (including 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.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
15.17 No
Solicitation
or Hiring of Employees
The
Parties agree that, during the Term 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.
15.18 No
Third-Party Rights
No
provision of this Agreement will be deemed or construed in any way to result
in
the creation of any rights or obligation in any Person not a party to this
Agreement.
15.19 No
Waiver
No
condoning, excusing or overlooking by any Party of any default or breach by
the
other 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.
15.20 Publicity
Except
as
required by law, stock exchange or regulatory authority:
| 15.20.1 |
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
|
| 15.20.2 |
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.
|
15.21 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.
15.22 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.
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
15.23 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:
| 15.23.1 |
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;
|
| 15.23.2 |
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
|
| 15.23.3 |
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.
|
15.24 Survival
Notwithstanding
any termination of this Agreement, the provisions of Article 1, Sections
2.4.2(c), 2.4.2(d), 2.5, Article 3, Sections 5.5.2(c), 6.2, 6.3, 7.1, 7.3,
7.4.1, 7.4.2, 8.3.3, 8.5.3, 8.5.4, 8.5.6, 8.6.2, 8.6.3, 8.7, 8.8, Article 9,
Article 10, Article 11, Article 12, Article 13, Article 14, Article 15, 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.
15.25 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.
| HANA | INEX PHARMACEUTICALS |
| BIOSCIENCES, INC. | CORPORATION |
| by its authorized signatory: | by its authorized signatory: |
| /s/ Xxxx X. Xxx | /s/ Xxxxxxx Xxxxx |
| Xxxx X. Xxx | Xxxxxxx Xxxxx |
|
President
and Chief Executive Officer
|
President
and Chief Executive Officer
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.