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. PRODUCT DEVELOPMENT AND COMMERCIALIZATION SUBLICENSE AGREEMENT
Exhibit
10.1
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.
PRODUCT
DEVELOPMENT AND
This
Development and Commercialization Sublicense Agreement (this “Agreement”)
is
made and entered into this 31st day of July, 2007 (the “Effective
Date”),
by
and among HANA Biosciences, Inc., a Delaware corporation (“HANA”),
PAR
Pharmaceutical, Inc., a Delaware corporation (“PAR”),
and
NovaDel Pharma, Inc., a Delaware corporation (“NovaDel”).
WHEREAS,
HANA has exclusive, restricted sublicensable rights under a license from NovaDel
, the owner of certain patents, intellectual property and know-how relating
to
lingual sprays for the metered delivery of pharmaceutical products to
humans;
WHEREAS,
HANA has commenced the development of a pharmaceutical product containing
ondansetron as an active ingredient that will be administered to humans using
the Licensed Technology (as defined below) on terms and conditions set forth
herein;
WHEREAS,
HANA
desires to sublicense to PAR the Licensed Technology, and PAR desires to accept
such sublicense on the terms and conditions set forth herein; and
WHEREAS, simultaneously
with the execution of this Agreement, the Parties are entering into that certain
Subscription Agreement that provides, on the terms and subject to the conditions
set forth therein, for a purchase by PAR of the common stock of HANA in an
amount up to $5,000,000.
NOW,
THEREFORE, in consideration of the mutual covenants and promises contained
in
this Agreement and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, HANA, PAR and NovaDel agree as
follows:
ARTICLE
1
DEFINITIONS
For
purposes of this Agreement, the following words and phrases shall have the
following meanings, unless otherwise specifically provided herein:
1.1 AAA has
the
meaning set forth in Section 15.2.1.
1.2 Affiliate shall
mean, with respect to any Person, any other Person that directly or indirectly
through one or more intermediaries, controls, is controlled by or is under
common control with such Person. For purposes of this Section 1.1 only,
“control” and, with correlative meanings, the terms “controlled by” and “under
common control with” shall mean (a) the possession, directly or indirectly, of
the power to direct the management or policies of an Person, whether through
the
ownership of voting securities, by contract or otherwise, or (b) the ownership,
directly or indirectly, of at least fifty percent (50%) of the voting securities
or other ownership interest of a Person
1
1.3 Agreement has
the
meaning set forth in the preamble.
1.4 Agreement
Related Assets has
the
meaning set forth in Section 11.3.2.
1.5 Anticipated
Filing Date has
the
meaning set forth in Section 4.2.2.
1.6 Applicable
Law shall
mean the applicable laws, rules, regulations, guidelines and requirements of
the
Regulatory Authorities in the Territory.
1.7 CGMP means
the
regulatory requirements for current good manufacturing practices promulgated
by
the FDA under the U.S. Food, Drug and Cosmetic Act and the regulations
promulgated thereunder, particularly 21 C.F.R. Section 210 et seq., and 21
C.F.R. Sections 600-610, as the same may be amended from time to
time.
1.8 Commercialization means
the
marketing, promotion, advertising, selling and/or distribution of the Licensed
Product in the Territory after Regulatory Approval therefor has been obtained;
and the term “Commercialize”
has
a
corresponding meaning.
1.9 Commercially
Reasonable Efforts shall
mean, with respect to the development or commercialization of the Licensed
Product, efforts and resources commonly used in the research-based
pharmaceutical industry for a product of similar commercial potential at a
similar stage in its lifecycle, taking into consideration its safety and
efficacy, its cost to develop, the competitiveness of alternative products,
its
proprietary position, the likelihood of regulatory approval, its profitability,
and all other relevant factors. Commercially Reasonable Efforts shall be
determined on a market-by-market basis for each Licensed Product without regard
to the particular circumstances of a Party, including any other product
opportunities of such Party.
1.10 Common
Technical Document shall
have the meaning set forth in the International Conference on Harmonization
of
the Technical Requirements for Registration of Pharmaceuticals for Human Use
(ICH) Guideline M4, Organization of the Common Technical Document, as revised
on
January 13, 2004.
1.11 Confidential
Information has
the
meaning set forth in Section 9.1.
1.12 Control shall
mean, with respect to any item of Information and Inventions, Patent Rights
or
other intellectual property right, possession of the ability, whether directly
or indirectly, and whether by ownership, license or otherwise, to assign, or
grant a license, sublicense or other right to or under, such item, Patent or
right as provided for herein without violating the terms of any agreement or
other arrangement with any Third Party.
1.13 Development
Committee has
the
meaning set forth in Section 4.1.2.
1.14 Designated
Compound
means
ondansetron.
1.15 Development
Plan
has the
meaning set forth in Section 4.1.1.
2
1.16 Effective
Date
has the
meaning set forth in the preamble.
1.17 Exploit
shall
mean to make, have made, import, use, sell, or offer for sale, including to
research, develop, register, modify, improve, manufacture, have manufactured,
store, have used, export, transport, distribute, promote, market or have sold
or
otherwise dispose of a Licensed Product or Licensed Process.
1.18 Exploitation
shall
mean the making, having made, importation, use, sale, offering for sale of
a
licensed product or process, including the research, development, registration,
modification, improvement, manufacture, storage, optimization, import, export,
transport, distribution, promotion, marketing, sale or other disposition of
a
Licensed Product or Licensed Process.
1.19 FDA
means
The Food and Drug Administration of the United States Department of Health
and
Human Services, or any successor agency(ies) thereof performing similar
functions.
1.20 GAAP
shall
have the meaning set forth in Section 6.8.
1.21 HANA has
the
meaning set forth in the preamble.
1.22 HANA
Indemnified Parties
has
meaning set forth in Section 12.1.
1.23 HANA
Know-How
shall
mean all Information and Inventions Controlled by HANA or an Affiliate of HANA
at any time during the Term that (a) are necessary for the use of the Licensed
Process to Exploit the Licensed Product, and (b) are not generally
known.
1.24 Improvement
shall
mean any modification, variation or revision to an apparatus, method, product
or
technology, or any discovery, technology, device, process or formulation related
to an apparatus, method, product or technology, whether or not patented or
patentable, including any enhancement in the manufacture or steps or processes
thereof, ingredients, preparation, presentation, formulation, means of delivery,
packaging or dosage of an apparatus, method, product or technology, any
discovery or development of any new or expanded indications for an apparatus,
method, product or technology, or any discovery or development that improves
the
stability, safety or efficacy of an apparatus, method, product or technology),
in each case, to the extent related to the Licensed Process, Licensed Product
or
Licensed Technology.
1.25 IND
shall
mean an investigational new drug application filed with the FDA for approval
to
commence human clinical trials, and its equivalent in other countries or
regulatory jurisdictions in the Territory.
1.26 Indemnification
Claim Notice
shall
have the meaning set forth in Section 12.4.1.
1.27 Indemnified
Party
has
meaning set forth in Section 12.4.1.
3
1.28 Information
And Invention
shall
mean all technical, scientific and other know-how and information, trade
secrets, knowledge, technology, means, methods, processes, practices, formulas,
instructions, skills, techniques, procedures, experiences, ideas, technical
assistance, designs, drawings, assembly procedures, computer programs,
apparatuses, specifications, data, results and other material, including
pre-clinical and clinical trial results, manufacturing procedures and test
procedures and techniques, (whether or not confidential, proprietary, patented
or patentable) in written, electronic or any other form now known or hereafter
developed, and all Improvements, whether to the foregoing or otherwise, and
other discoveries, developments, inventions, and other intellectual property
(whether or not confidential, proprietary, patented or patentable), in each
case, to the extent related to the Licensed Process, Licensed Product or
Licensed Technology.
1.29 Infringement
Suit
has
meaning set forth in Section 10.3.
1.30 Initial
Commercial Sale
means
the first sale for use or consumption by the general public of the Licensed
Product by PAR or its Affiliates in the Territory following Regulatory Approval
of the Licensed Product. Sales for clinical studies, compassionate use, named
patient programs, sales under a treatment IND, test marketing, any
nonregistrational studies, or any similar instance where the Licensed Product
is
supplied without charge shall not constitute an Initial Commercial
Sale.
1.31 Licensed
Process
shall
mean the proprietary lingual spray technology for the delivery of pharmaceutical
compounds through the mucosal membrane of the mouth in humans using an aerosol
or pump spray device that is under the Control of NovaDel as of the effective
date of the NovaDel-Hana License and any Improvements thereto that are conceived
and reduced to practice by NovaDel in the course of performing its obligations
under the NovaDel-Hana License.
1.32 Licensed
Product
shall
mean any dosage of pharmaceutical composition or preparation in finished form
labeled and packaged for sale by prescription, over-the-counter or any other
method only for human application that contains, as the sole active ingredient,
the Designated Compound delivered by means of the Licensed Process.
1.33 Licensed
Technology
shall
mean the NovaDel Patent Rights, the NovaDel Know-How and Improvements thereof,
and the Drug Master File, collectively, but only with respect to the
Exploitation of the Licensed Product.
1.34 Licensed
Trademark
shall
mean “ZENSANA” owned by HANA as evidenced by U.S. Trademark Application Serial
No. 78,710,181.
1.35 Lock-Up
Period
has
meaning set forth in Section 6.1.
1.36 Losses
has the
meaning set forth in Section 12.1.
1.37 NDA
means a
New Drug Application as defined in the United States Federal Food, Drug and
Cosmetic Act and applicable regulations promulgated thereunder as amended from
time to time and any equivalent application required by any Regulatory Authority
for the marketing, sale or use of the Licensed Product in the Territory for
human application.
4
1.38 Net
Sales
means
[***]
1.39 NovaDel has
the
meaning set forth in the preamble.
1.40 NovaDel-Hana
License
means
that certain License and Development Agreement originally dated October 26,
2004, by and between NovaDel and HANA, as amended and restated effective as
of
July 31, 2007.
5
1.41 NovaDel
Indemnified Parties
has
meaning set forth in Section 12.1.
1.42 NovaDel
Know-How
shall
mean all Information and Inventions Controlled by NovaDel or an Affiliate of
NovaDel as of the effective date of the NovaDel-Hana License or, from time
to
time, during the Term that (a) (i) are necessary for the use of the Licensed
Process to Exploit the Licensed Product or (ii) relate to Improvements to the
Licensed Product or Licensed Process that are conceived and/or reduced to
practice in the course of Exploiting the Licensed Product or License Process,
and (b) are not generally known, but excluding any Information and Inventions
to
the extent claimed by any NovaDel Patents.
1.43 NovaDel
Patents
shall
mean the Patent Rights that NovaDel Controls (a) as of the effective date of
the
NovaDel-Hana License that are listed on Exhibit A hereto and (b) from time
to
time during the Term that claim (i) the Licensed Process, (ii) the Licensed
Product, (iii) NovaDel Know-How, or (iv) any Improvements that are conceived
and/or reduced to practice in the course of Exploiting the Licensed Product
or
License Process.
1.44 Par has
the
meaning set forth in the preamble.
1.45 PAR
Indemnified Parties
has
meaning set forth in Section 12.2.
1.46 Party
or Parties
means
HANA, NovaDel and/or PAR, as applicable.
1.47 Patent
Rights
means
any of the following: (a) United States patents; (b) United States patent
applications (both provisional and non-provisional), PCT patent applications,
and divisionals, continuations and claims of continuation-in-part applications
which shall be directed to subject matter specifically described in such United
States and/or PCT patent applications, and the resulting patents (whether such
divisionals, continuations or continuation-in-part applications are based upon
a
United States patent, United States patent application or PCT application);
(c)
any patents resulting from reissues or reexaminations of the United States
patents described in (a) and (b) above; (d) foreign patents; (e) foreign patent
applications and, to the extent applicable, divisionals, continuations and
claims of continuation-in-part applications which shall be directed to subject
matter specifically described in such foreign patent applications, and the
resulting patents (whether such divisionals, continuations or
continuation-in-part applications are based upon a foreign patent application
or
a foreign patent); and (f) any foreign patents, resulting from foreign
procedures similar to United States reissues and reexaminations, of the foreign
patents and applications described in (d) and (e) above.
1.48 Person
means an
individual, partnership, joint venture, association, corporation, limited
liability company and any other form of business organization, government,
regulatory or governmental agency, commission, department or
instrumentality.
1.49 Product
Liability Claim
means a
Third Party’s assertion of a strict liability claim of actual personal injury or
death as a result of the use of the Licensed Product during the
Term.
1.50 Product
Trademarks
has
meaning set forth in Section 5.4.
6
1.51 Regulatory
Approval
means
approval by the FDA to market the Licensed Product in the United States, or
equivalent Regulatory Authority in Canada to market the Licensed Product in
Canada, including the issuance by the FDA or such other Regulatory Authority
of
an action letter indicating the approval of the NDA and the manufacturing
processes and facilities for commercial supplies of the Licensed
Product.
1.52 Regulatory
Authority
shall
mean any applicable supra-national, federal, national, regional, state,
provincial or local regulatory agencies, departments, bureaus, commissions,
councils or other government entities regulating or otherwise exercising
authority with respect to the Licensed Technology or the Licensed Product in
the
Territory.
1.53 Regulatory
Documentation
shall
mean all applications, registrations, licenses, authorizations and approvals
(including all Regulatory Approvals), all correspondence submitted to or
received from Regulatory Authorities (including minutes and official contact
reports relating to any communications with any Regulatory Authority), all
supporting documents and all clinical studies and tests, relating to the
Licensed Product, and all data contained in any of the foregoing, including
all
regulatory drug lists, advertising and promotion documents, adverse event files
and complaint files.
1.54 Subscription
Agreement
has the
meaning set forth in Section 6.1.
1.55 Term
has the
meaning set forth in Section 11.1.
1.56 Territory
means
the United States of America and Canada.
1.57 Third
Party
means
any Person other than PAR, NovaDel, HANA and their respective
Affiliates.
1.58 Third
Party Claim
shall
have the meaning set forth in Section 12.5.2.
1.59 Trademark
shall
include any word, name, symbol, color, designation or device or any combination
thereof, including any trademark, trade dress, brand xxxx, trade name, brand
name, logo or business symbol.
1.60 Valid
Claim
shall
mean, with respect to a particular country, a claim of a Patent Right in such
country that (a) has not been revoked or held unenforceable or invalid by a
decision of a court or governmental agency of competent jurisdiction from which
no appeal can be taken or has been taken within the time allowed for appeal,
and
(b) has not been abandoned, disclaimed, denied or admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise in such country, except
if a claim, or the subject matter thereof, of a pending patent application
shall
not have issued within four (4) years after the filing date from which such
claim, or subject matter thereof, takes priority, such claim shall not
constitute a valid claim for purposes of this Agreement unless and until such
claims shall issue.
ARTICLE
2
SCOPE
OF THE COLLABORATION
2.1 Objectives.
The
Parties agree, pursuant and subject to the terms of this Agreement, that HANA
intends to assign to PAR, and PAR intends to assume, all of HANA’s rights and
obligations to develop and obtain Regulatory Approval for the Licensed Product
in the Territory and to commercialize the Licensed Product in the
Territory.
7
2.2 Diligence
Obligations.
PAR
shall use Commercially Reasonable Efforts in accordance with the terms and
conditions of this Agreement, including the Development Plan, to (a) develop
and
commercialize the Licensed Product in the entire Territory; (b) file the NDA
with the FDA in PAR’s name and obtain Regulatory Approval(s) with respect to the
Licensed Product in the Territory; and (c) Exploit the Licensed Product in
the
Territory.
2.3 Outsourcing
of MARQIBO Development.
HANA
holds the exclusive license and patent rights for the commercialization of
Sphingosomal Vincristine sulfate liposome for the therapeutic treatment of
patients with leukemia, lymphoma and solid tumors currently being developed
under the trade name “MARQIBO.” In the event that HANA in its sole discretion,
elects to grant a Third Party a right to manufacture and sell such product,
HANA
will inform PAR and, if PAR so requests, HANA will allow PAR to submit a
proposal for HANA’s consideration prior to entering into negotiations with any
other Third Party to manufacture and sell the product.
2.4 Co-Promotion
of ZENSANA.
Within
ninety (90) days following PAR’s submission of an NDA for the Licensed Product,
HANA may submit a proposal for PAR’s consideration with respect to the Parties’
joint promotion and commercialization of such Licensed Product; provided,
however,
that
any determination whether to jointly promote and commercialize the Licensed
Product with HANA will be in PAR’s sole discretion and if PAR determines to
jointly promote with HANA, then PAR and HANA will negotiate in good faith an
agreement that provides for the rights and obligations in respect
thereof.
ARTICLE
3
GRANT
OF RIGHTS
3.1 License
Grant.
Subject
to Section 3.3 and the other terms and conditions of this Agreement, HANA hereby
grants to PAR and its Affiliates and PAR accepts:
3.1.1 A
non-transferable (except as provided in Section 11.3.2), nonsublicenseable
(except as set forth in this Section 3.1 and Section 3.2), royalty-bearing,
exclusive sublicense under the Licensed Technology to Exploit the Licensed
Product in the Territory, to the full end of the Term for which the Licensed
Technology is licensed, unless sooner terminated as herein after provided;
provided, however, that PAR shall have the right to (i) utilize Third Parties
to
manufacture the Licensed Product in the Territory, and (ii) use, have used,
manufacture or have manufactured the Licensed Product outside of the Territory
solely for purposes of the distribution and sale of the Licensed Product inside
the Territory. PAR shall be entitled to use a Third Party contract sales
organization to market the Licensed Product in the Territory; provided, that
the
employees of such Third Party contract sales organization that are utilized
to
market the Licensed Product are trained and managed by PAR and carry only PAR’s
products.
8
3.1.2 In
the
event that PAR elects to use the Licensed Trademark in connection with the
Exploitation of the Licensed Product in the Territory pursuant to Section
0,
then a
non-transferable (except as provided in Article 12), nonsublicenseable,
royalty-bearing, non-exclusive right and license under the Licensed Trademark
will be granted for the sole purpose of using the Licensed Trademark to market,
distribute and sell the Licensed Product in the Territory, to the full end
of
the Term for which the Licensed Product is licensed, unless sooner terminated
as
herein after provided.
3.1.3 PAR
shall
not sell, distribute or transfer the Licensed Product to any Person that, to
PAR’s knowledge or should reasonably know, is using or intends to use the
Licensed Product outside of the Territory or is selling or transferring, or
intends to sell or transfer, the Licensed Product to a Person who is using
or
intends to use such Licensed Product outside of the Territory.
3.1.4 PAR
agrees that during the Term it will use the Licensed Technology only as
explicitly provided and in accordance with the term and conditions of this
Agreement. PAR expressly acknowledges and agrees that the only licenses granted
under this Agreement are the licenses expressly granted under this Agreement
and
that there shall be no implied license or license by estoppel.
3.2 License
Grant to NovaDel.
In the
event that NovaDel and PAR agree pursuant to Section 0
that
NovaDel is to perform certain development activities under the Development
Plan,
PAR hereby grants to NovaDel a limited, royalty-free, co-exclusive right and
license in the Territory in and to the Licensed Technology to the extent
necessary to perform such development activities.
3.3 Retained
Rights.
PAR
acknowledges that NovaDel retains all right, title and interest, including
the
right to grant licenses to Third Parties, in and to the Licensed Technology.
PAR
shall have no rights, express or implied, with respect to the Licensed
Technology except as expressly set forth in Section 3.1, and PAR covenants
to
HANA and NovaDel that none of PAR or its Affiliates shall use the Licensed
Technology, directly or indirectly, for any purpose other than for
administration of the Designated Compound in connection with the Exploitation
of
Licensed Product hereunder. Notwithstanding anything in this Agreement to the
contrary, PAR acknowledges that NovaDel retains, without any duty of accounting
or otherwise to PAR:
3.3.1 The
right
to enter into collaborations or other agreements with, and to grant licenses
and
other rights under the NovaDel Patents and NovaDel Know-How to Third Parties
to
Exploit products containing compounds other than the Designated Compound and
to
use the Licensed Process in connection therewith; and
3.3.2 The
right
to independently Exploit products containing compounds other than the Designated
Compound and to use the Licensed Process in connection therewith;
and
3.3.3 An
irrevocable, non-exclusive, royalty-free right to use the Licensed Technology
(including the Licensed Process) with respect to the Designated Compound, for
its internal, non-commercial research and development activities;
and
3.3.4 The
rights for all other territories other than the Territory and non-human uses
of
the Designated Compound.
9
3.4 Additional
Covenants and Agreements.
3.4.1 HANA
covenants and agrees that, from and after the Effective Date until the
termination of this Agreement, neither it nor any of its Affiliates shall seek
to develop (directly or indirectly) any lingual spray technology for the
delivery of anti-emetic pharmaceutical compounds.
3.4.2 Promptly
after the Effective Date, each of NovaDel and HANA shall at its cost and
expense, use good faith reasonable efforts to disclose to PAR in writing, or
via
mutually acceptable electronic media, copies or reproductions of all HANA
Know-How and NovaDel Know-How, not previously disclosed to PAR, reasonably
necessary in order to enable PAR to exploit its rights granted under this
Article 3. In addition, during the Term, each of HANA and NovaDel shall promptly
disclose to PAR in writing, or via mutually acceptable electronic media, on
an
ongoing basis, copies or reproductions of all new HANA Know-How and NovaDel
Know-How that is reasonably necessary to market, sell or have sold the Licensed
Product. Such HANA Know-How and NovaDel Know-How and other information shall
be
automatically deemed to be within the scope of the licenses granted herein
without payment of any additional compensation.
3.5 Manufacturing.
3.5.1 Subject
to the other provisions of this Section 3.5.1, PAR shall be solely responsible
for the manufacture of the Licensed Product, both for clinical development
and
following receipt of Regulatory Approval of the Licensed Product; provided
that
PAR may contract with a Third Party to perform such manufacturing services.
PAR
shall share all data and other information relating to the manufacturing process
and shall consult with NovaDel with respect thereto. Without limiting the
generality of the foregoing, NovaDel shall have the opportunity to review,
prior
to execution, all agreements with Third Parties relating to the manufacture
of
the Licensed Product; provided, however, that PAR shall have the ultimate
decision making authority in the event of any dispute between NovaDel and PAR
relating to the terms of any such manufacturing agreement (or the choice of
such
Third Party manufacturer). NovaDel and its Extraterritorial Licensees (as
defined in the NovaDel-Hana License) retain the right to purchase product from
said Third Party, if applicable, at the same costs as PAR with the exception
of
an increase of cost due to a modification to the packaging/labeling by NovaDel
or any Extraterritorial Licensee.
3.5.2 PAR
agrees that, at all times during the performance of the development activities,
it, or its designee, will act in accordance with all Applicable
Laws.
3.5.3 To
the
extent PAR contracts with a Third Party to manufacture the Licensed Product,
such Third Party shall agree in writing to be bound by the obligations of
confidentiality and non-use at least equivalent in scope to those set forth
in
Article 9 of this Agreement.
3.5.4 PAR
shall
not object to permitting any Third Party manufacturer from selling NovaDel
and
its Extraterritorial Licensees Licensed Product under Section 3.5.1 in the
identical packaging and labeling as PAR purchases such Licensed Product for
sale
in the United States, subject to the requirement by NovaDel and Sublicensees
to
have such Licensed Product uniquely identified by a separate batch record
identification or other indicia sufficient to distinguish sales by NovaDel,
or
its Extraterritorial Licensees, from those of PAR.
10
3.5.5 PAR
shall
use Commercially Reasonable Efforts to obtain any required licenses, permissions
needed and documentation (e.g., Certificate of Pharmaceutical Product) in order
for NovaDel and its Extraterritorial Licensees to buy and export Licensed
Product from the United States. NovaDel shall reimburse all reasonable expenses
incurred by PAR for obtaining such licenses or permissions within thirty (30)
days of an Extraterritorial Licensee’s receipt of an invoice from PAR itemizing
such expenses
3.5.6 NovaDel
warrants, covenants and agrees that any license agreement that NovaDel enters
into with an Extraterritorial Licensee regarding Licensed Product that are
subject to this Agreement shall contain an indemnity clause requiring the
Extraterritorial Licensee to indemnify PAR and its Affiliates against any and
all claims, proceedings, demands, liability and expenses of any kind, including
legal expenses and attorneys’ fees (collectively, “Claims”),
arising out of or in connection with the manufacture, sale, use, consumption,
advertisement or other disposition of Licensed Product by the Extraterritorial
Licensee, its Affiliates or any end user, or arising from any violation of
law,
negligence, willful or reckless misconduct, or from any breach of any material
obligation of such Extraterritorial Licensee under its agreement with NovaDel,
other than Claims resulting from the gross negligence or willful misconduct
of
PAR; provided, however, that in no event shall the scope of the indemnification
to PAR be any less than the scope of the Extraterritorial Licensee’s
indemnification obligations to NovaDel.
ARTICLE
4
DEVELOPMENT
PROGRAM
4.1 Development
Plan; Responsibility and Control.
4.1.1 Within
sixty (60) days after the Effective Date, PAR will adopt a development plan,
and
provide such development plan to NovaDel, describing its strategy and principal
activities in seeking Regulatory Approval for the Licensed Product and
commercializing the Licensed Product in accordance with the terms of this
Agreement (the “Development
Plan”),
which
may be amended by PAR in its commercially reasonable discretion. PAR will use
its Commercially Reasonable Efforts to execute the Development Plan. Subject
to
the Development Plan and the other terms and conditions contained in this
Agreement, PAR shall have control over and responsibility for executing all
aspects of the Development Plan, including planning, strategy, administrative
management, and fiscal control; provided, however, that PAR shall include the
Development Committee in such efforts in a consultative capacity. In the event
that PAR desires, PAR may request NovaDel to conduct certain development
activities, and, if NovaDel agrees, NovaDel and PAR shall negotiate in good
faith the scope of such development activities to be undertaken by NovaDel,
appropriate amendments to the Development Plan and the amounts to be paid to
NovaDel for the provision of such development activities; provided that it
is
understood that PAR shall not be entitled to amend the Development Plan to
include the performance of any activities by NovaDel without the prior written
consent of NovaDel.
11
4.1.2 PAR
and NovaDel
shall establish a development committee (the “Development
Committee”),
which
shall confer at least on an annual basis to coordinate PAR’s and NovaDel’s
performance of their respective responsibilities under this Agreement. PAR
and NovaDel
each shall appoint an equal number of representatives with the requisite
experience and seniority to enable them to make decisions on behalf of the
Parties. From time to time, PAR and NovaDel
each may substitute its representatives on written notice to the
other.
The
Development Committee shall not have the power to amend or modify the
Development Plan, which may only be amended or modified as provided in Section
4.1.1.
4.1.3 By
no
later than November 1 of each calendar year during the Term, PAR shall prepare
and deliver to NovaDel an updated Development Plan for the following calendar
year. NovaDel shall have the right to comment on the Development Plan (including
the initial Development Plan delivered pursuant to Section 4.1.1), and PAR
shall
consider such comments in good faith; provided that nothing contained herein
is
intended to limit PAR’s sole discretion with respect to the development of the
Licensed Product in the Territory.
4.2 Clinical
and Regulatory Approval.
4.2.1 Subject
to the terms of the Development Plan, in the Territory, PAR shall (a) use its
Commercially Reasonable Efforts to conduct required clinical trials of the
Licensed Product and obtain Regulatory Approval, and (b) be responsible for
all
activities related to the toxicology, formulation, process development, quality
assurance/quality control, and regulatory affairs for the Licensed Product
and
(c) include HANA and NovaDel in such efforts in a consultative capacity;
provided, however, that, as and to the extent requested by PAR and agreed to
by
NovaDel pursuant to Section 4.1.1, NovaDel may collaborate with PAR in executing
the Development Plan; provided further, however, for purposes of clarity,
neither HANA nor NovaDel shall have the right to direct or control PAR’s conduct
of such activities.
4.2.2 Subject
to the terms of the Development Plan, PAR shall use its Commercially Reasonable
Efforts to prepare any required application(s) for Regulatory Approval,
including the filing of the NDA with the FDA in PAR’s name, and shall have
responsibility for: (a) all clinical data and reports related to Licensed
Product studies, including clinical trials for the Licensed Product; and (b)
all
NDAs and other Regulatory Approvals for the Licensed Product in the Territory.
PAR shall inform HANA and NovaDel of all communications with the FDA, and shall
provide copies of all FDA submissions and other written communication with
the
FDA as soon as reasonably practicable. The Parties shall cooperate in good
faith
with respect to all such submissions and meetings with the FDA relating to
regulatory approval of the Licensed Product. In addition, and without limiting
PAR’s obligations under Section 0
or this
Section 0,
PAR
shall file the NDA with the FDA on or before the last day of the thirty-second
(32nd) month after the Effective Date (the “Anticipated
Filing Date”);
provided, however, that PAR may extend the Anticipated Filing Date by four
(4)
months by delivering, at any time after the second (2nd) anniversary of the
Effective Date, written notice of such extension to NovaDel. The Anticipated
Filing Date, as extended, may thereafter be extended only upon the mutual
agreement of PAR and NovaDel.
12
4.2.3 PAR
shall, and shall cause its Affiliates to, promptly disclose to NovaDel all
Regulatory Documentation and all other Information and Inventions in the
possession or Control of PAR or its Affiliates that relate to the Exploitation
of the Licensed Product. NovaDel and NovaDel’s Extraterritorial Licensees shall
have a perpetual, royalty-free, irrevocable, worldwide right to use and
reference the Regulatory Documentation and any data included or referenced
therein for all purposes. PAR agrees to utilize the Common Technical Document
format for its marketing applications in order to facilitate any subsequent
submissions filed by NovaDel or its Extraterritorial Licensees outside of the
Territory.
4.2.4 PAR
will
be the primary contact for Chemistry, Manufacturing and Control matters in
all
relevant regulatory applications except to regulatory bodies outside
the United States and
Canada. PAR will keep NovaDel reasonably informed of all such communications,
if
any, between PAR and the Regulatory Authorities in the United States and
Canada.
4.2.5 PAR
agrees to keep the Common Technical Document, except for those sections in
the
Summary Basis of Approval and available through the Freedom of Information
Act,
strictly confidential in accordance with Article 9.
4.3 Development
Program Reporting.
PAR
shall provide HANA and NovaDel at least quarterly with updates regarding the
progress of the Development Program and Regulatory Approval process, including
all planned and ongoing clinical trials for the Licensed Product, planned and
ongoing formulation and stability studies, interaction with Regulatory
Authorities, planned and ongoing promotional advertising and other marketing
efforts, rolling forecasts of projected sales of each Licensed Product for
the
upcoming twelve (12) months, and also shall advise HANA and NovaDel of any
unforeseen material problems or delays encountered since the date of its last
such report and any other information reasonably requested by HANA or NovaDel
with respect to the development activities related to the Licensed Product
undertaken by PAR in such calendar quarter.
4.4 Development
Costs.
PAR
shall be solely responsible for all costs and expenses incurred by it after
the
Effective Date relating to the development of the Licensed Products for
Exploitation in the Territory, including costs and expenses, if any, incurred
by
NovaDel at in accordance with Section 4.1.1.
4.5 Regulatory
Records.
PAR
shall
maintain records of its development activities in sufficient detail and in
good
scientific manner appropriate for patent and regulatory purposes, which shall
be
complete and accurate and shall fully and properly reflect all work done and
results achieved in the performance of its development activities, and which
shall be retained by PAR for at least five (5) years after the termination
of
this Agreement, or for such longer period as may be required by Applicable
Law.
NovaDel shall have the right, during normal business hours and upon reasonable
notice, to inspect and copy any such records; provided,
however, that NovaDel shall not have the right to conduct more than one such
inspection in any twelve (12)-month period.
13
ARTICLE
5
COMMERCIALIZATION
OBLIGATIONS
5.1 Regulatory
Compliance.
All
Commercialization activities in respect of the Licensed Product in the Territory
shall be conducted by PAR in compliance with Applicable Laws and the Regulatory
Approval in the country of sale.
5.2 Labeling
and Patent Marking.
The
Licensed Product shall be packaged by PAR and labeled in a manner consistent
with the requirements of the Regulatory Authorities and all Applicable Laws
in
the country in which it will be sold, and where legally permissible, shall
identify any applicable Patent Rights consistent with any patent marking
requirements.
5.3 Commercialization
Efforts.
Following receipt of Regulatory Approval of the Licensed Product by the FDA,
PAR
shall use Commercially Reasonable Efforts to Exploit the Licensed Product in
the
United States. PAR shall have the right to Exploit the Licensed Product in
Canada; provided, however, that if PAR does not use Commercially Reasonable
Efforts to Commercialize the Licensed Product in Canada within one hundred
eighty (180) days following Regulatory Approval by Health Canada, then HANA
may
Commercialize the Licensed Product in Canada, provided further, that, in such
case, PAR shall be entitled to a royalty of [***]
percent
([***]%)
of the
Net Sales in Canada. In addition, and without limiting PAR’s obligations under
Section 0
or this
Section 0,
PAR
shall consummate the Initial Commercial Sale in the United States within nine
(9) months after receipt of Regulatory Approval from the FDA for the Licensed
Product. PAR shall have responsibility for all advertising, marketing,
promotion, distribution, selling and other commercialization activities,
including developing strategies and tactics related to such activities for
the
Licensed Product. PAR shall, at all times during the Term after receipt of
Regulatory Approval, use efforts, including but not limited to appropriate
promotional campaigns and materials, and qualified commercial personnel,
consistent with those typically used in the pharmaceutical industry and equal
to
those committed to products of similar size and expected value to seek to
commercialize the Licensed Product in the Territory for those formulations
and
indications for which PAR is commercializing the Licensed Product. Should PAR
fail to meet the above 'standard', the NovaDel and PAR will discuss PAR’s
continued commitment to commercialize the Licensed Product and the termination
of this Agreement.
5.4 Trademarks.
PAR
shall have the right and obligation to determine the trademark and any other
related logos, trade names, and similar source identifiers that are created
or
selected for use to be used on and with the Licensed Product, including the
whether to use the Licensed Trademark (collectively, the “Product
Trademarks”).
With
the exception of the Licensed Trademark, the Product Trademarks shall not
include any trademarks, logos, trade names or similar source identifiers that
are owned or licensed by HANA or NovaDel as of the Effective
Date.
14
ARTICLE
6
ROYALTIES
AND OTHER CONSIDERATIONS
6.1 License
Fee and Equity.
Simultaneously with the execution of this Agreement, PAR shall purchase Five
Million Dollars ($5,000,000) worth of shares of newly issued HANA common stock
at a price per share that reflects a twenty-five percent premium to the then
current market price of HANA’s common stock pursuant to the terms and conditions
of that certain Stock Purchase Agreement between the Parties of even date
herewith (the “Subscription
Agreement”).
The
number of shares of HANA’s common stock issued to PAR will be determined by
dividing the sum of Five Million Dollars ($5,000,000) by one hundred twenty-five
percent (125%) of the weighted average closing price per share of HANA’s common
stock on the NASDAQ Global Market during the ten (10) business days prior to
the
Effective Date. PAR represents that it is acquiring the shares of common stock
of HANA for investment purposes only and covenants that it will not sell,
transfer or otherwise dispose of any such shares until the earliest of: (a)
the one (1) year anniversary of the Effective Date, (b) the filing of an NDA
for
the Licensed Product, and (c) the termination of this Agreement. PAR shall
pay HANA for such shares by wire transfer of immediately available funds upon
execution and delivery of this Agreement (the “Lock-Up
Period”).
Following the expiration of the Lock-Up Period, the Investor further agrees
that, without the prior written consent of the Company, it will not sell more
than fifty percent (50%) of the aggregate number of Shares purchased hereunder
in any ninety (90) day period until the first anniversary of the end of the
Lock-Up Period, at which time this further restriction shall no longer be
applicable.
6.2 Milestone
Payments.
In
addition to the preceding amounts, PAR shall also pay milestone payments to
HANA
as follows:
6.2.1 [***]
Dollars
($[***])
within
ten (10) days following PAR’s receipt of Regulatory Approval from the FDA of the
NDA for the Licensed Product; plus
6.2.2 If
Net
Sales during a specified fiscal year equal at least $[***]
in the
Territory, then PAR will pay to HANA [***]
Dollars
($[***])
within
60 days following the end of such year; plus
6.2.3 If
Net
Sales during a specified fiscal year equal at least $[***]
in the
Territory, then PAR will pay to HANA [***]
Dollars
($[***])
within
60 days following the end of such year; plus
6.2.4 If
cumulative Net Sales of the Licensed Product reaches [***]
Dollars
($[***])
within
five (5) years following Regulatory Approval by the FDA of the NDA, then PAR
will pay to HANA [***]
Dollars
($[***])
within
60 days after obtaining such Net Sales threshold; plus
6.2.5 If
cumulative Net Sales of the Licensed Product reaches [***]
Dollars
($[***])
within
five (5) years following Regulatory Approval by the FDA of the NDA, then PAR
will pay to HANA [***]
Dollars
($[***])
within
60 days after obtaining such Net Sales threshold.
6.3 Royalty
Payments.
In
addition to the milestone payments described above, PAR shall pay to HANA
royalty payments based on Net Sales of the Licensed Product as follows:
6.3.1 PAR
shall
pay to HANA amounts due to NovaDel as royalties under the NovaDel-Hana License
as follows:
15
6.3.1.1 [***]
percent
([***]%)
of up
to the first $[***]
of Net
Sales by PAR or any Affiliate during each fiscal year in the Territory;
plus
6.3.1.2 [***]
percent
([***]%)
of Net
Sales greater than $[***]
and up
to $[***]
by PAR
or any Affiliate during each fiscal year in the Territory; plus
6.3.1.3 [***]
percent
([***]%)
of Net
Sales greater than $[***]
by PAR
or any Affiliate during each fiscal year in the Territory.
6.3.2 After
cumulative Net Sales exceed [***]
Dollars
($[***])
within
five (5) years following Regulatory Approval by the FDA of the NDA, PAR shall
pay to HANA royalty payments based on Net Sales equal to [***]
percent
([***]%)
of Net
Sales in excess of [***]
Dollars
($[***])
per
Contract Year (in addition to the [***]
percent
([***]%)
royalty provided in Section 6.3.1.3).
6.3.3 All
royalties shall be payable to HANA on a calendar quarterly basis, within
forty-five (45) days after the end of each calendar quarter. The conversion
rate
for payments under this section, as it pertains to sales in Canada, shall be
calculated by using the conversion rate on the last day of the calendar quarter
for which the sales apply. The conversion rate to be used will be taken from
the
currency converter at xxx.xxxxx.xxx. Canadian dollar sales will be converted
into U.S. dollars and then the royalty rates outlined in this section will
apply.
6.3.4 Notwithstanding
anything to the contrary contained herein, any and all amounts to be received
by
HANA
from
PAR
pursuant to Section 6.3.1 shall be paid to a lock-box account. Accordingly,
the
Parties agree that, within thirty (30) days after the Effective Date, the
Parties will take such actions reasonably requested by NovaDel, and enter into
documentation in form and substance reasonably satisfactory to NovaDel
(including, without limitation, a security agreement, lockbox agreement and
irrevocable payment instructions), in order to (i) grant to NovaDel a first
priority, perfected security interest in all of HANA’s right, title and interest
under this Agreement (including without limitation its right to receive payments
of the sublicense fees and other amounts payable by PAR hereunder) and in and
to
any lockbox account(s) to which payments thereunder may be made, (ii) perfect
NovaDel’s security interest in such lockbox account(s) and provide for
remittances therefrom in accordance with the terms in the NovaDel-Hana License
and (iii) irrevocably instruct PAR to make all payments under this Agreement
directly to such lockbox account(s); provided, however, that any payment
obligation owed by PAR to HANA pursuant to Section 6.3.1 shall be deemed paid
immediately upon delivery of such amount to the agreed-to lock box
account.
6.4 Royalty
Term.
PAR’s
royalty obligations under Section 6.3 shall terminate, on a country-by-country
basis, with respect to the Licensed Product upon the later of (a) the expiration
or invalidation in such country of the last NovaDel Patent that includes at
least one Valid Claim covering the Licensed Product in such country and (b)
the
twentieth (20th) anniversary of the Effective Date; provided, however, if (i)
the last NovaDel Patent that includes at least one Valid Claim covering the
Licensed Product in such country expires or is invalidated prior to the
twentieth (20th) anniversary of the Effective Date and (ii) no regulatory
exclusivity with respect to such Licensed Product exists in such country
(whether as a result of expiration of the exclusivity period or otherwise),
then
the royalty obligations under Section 6.3 in such country shall be reduced
in
accordance with the terms of Section 6.7.
16
6.5 Mode
of Payment.
All
payments to HANA under this Agreement shall be paid in United States Dollars
by
wire transfer of immediately available funds to a bank account in the United
States as HANA may reasonably designate.
6.6 Non-Refundable,
Non-Creditable.
Subject
to Sections 6.8 and
8.2,
the amounts paid or payable under this Article 6 shall be non-refundable
and non-creditable against any other amounts due NovaDel or HANA under this
Agreement.
6.7 Reduction
of Royalty.
In the
event that, or from and after the date on which, (a) no Valid Claim of a NovaDel
Patent covering the Licensed Product exists in a country in the Territory and
(b) no regulatory exclusivity with respect to such Licensed Product exists
in
such country (whether as a result of expiration of the exclusivity period or
otherwise), the royalty payment set forth in Section 6.3 with respect to the
Licensed Product in such country shall be reduced by [***]
percent
([***]%).
In
addition, if at any time during the Term the royalties owed by HANA to NovaDel
pursuant to the NovaDel-Hana License are reduced, then (i) HANA shall promptly
provide PAR with written notice of such reduction and (ii) HANA and PAR shall
amend this Article 6 to reduce the royalties owed by PAR to HANA in the
identical manner.
6.8 Accounting.
The
Parties acknowledge that any expenses or costs deducted from Net Sales under
this Agreement may be based upon accruals, which accruals will be compliant
with
Generally Accepted Accounting Principles (“GAAP”),
consistently applied; provided that when the actual results become known
relative to any accrued amount, any difference between the actual results and
the accrual is reported and accounted for in the next payment due hereunder.
To
the extent that the difference between such accruals and the actual results
has
led to an underpayment, PAR shall pay HANA the amount of such underpayment
on
the next date payment is due to HANA hereunder. To the extent that the
difference between such accruals and the actual results has led to an
overpayment to HANA, PAR may set-off such overpayments against subsequent
payments to be made to HANA; additionally, if any overpayments remain upon
the
expiration or termination of this Agreement, HANA shall refund such overpayments
to PAR within thirty (30) days of receiving an invoice for such overpayment
together with applicable supporting documentation.
ARTICLE
7
INTELLECTUAL
PROPERTY RIGHTS AND LICENSES
7.1 Ownership
of Intellectual Property.
Subject
to Sections 3.1 and 7.2, PAR hereby acknowledges and agrees that NovaDel owns
and shall continue at all times to own all right, title and interest in and
to:
(a) the NovaDel Patent Rights and NovaDel Know-How, including all intellectual
property rights appurtenant thereto; (b) the Licensed Technology and
Improvements; and (c) other Information and Inventions that are conceived,
discovered, developed or otherwise made by or on behalf of any Party (or its
Affiliates or its sublicensees), whether or not patented or patentable, and
any
and all Patent Rights and other intellectual property rights with respect
thereto.
17
7.2 Ownership
of the Licensed Process.
Subject
to the license grants to PAR under Article 3, NovaDel shall own and retain
all
right, title and interest in and to the Licensed Process, including any and
all
Information and Inventions with respect to the Licensed Process (including
any
Improvements thereto) that are conceived, discovered, developed or otherwise
made, by or on behalf of PAR or its Affiliates, whether or not patented or
patentable, and any and all Patent Rights and other intellectual property rights
with respect thereto. PAR acknowledges and agrees that (a) the licenses granted
to it pursuant to Section 3.1 permit PAR to use the Licensed Process solely
for
the Exploitation of Licensed Product as provided in this Agreement, (b) PAR
has
no right to use the Licensed Process or to discover, develop or otherwise make
Improvements with respect to the Licensed Process under such grants outside
the
scope of this Agreement, and (c) neither it, nor any of its Affiliates will
engage, directly or indirectly, in activities designed to, or otherwise
undertake or attempt, either on behalf of itself or another, to discover,
develop or make any Information and Inventions that relate to the Licensed
Process.
7.3 Disclosure
and Assignment.
PAR
shall promptly disclose to NovaDel in writing, the conception or reduction
to
practice, or the discovery, development or making of all intellectual property
rights identified in Sections 7.1 and 7.2, and shall, and does hereby, assign,
and shall cause its Affiliates to so assign, to NovaDel, without additional
compensation, all of their respective rights, titles and interests in and to
any
such intellectual property rights. To the extent necessary to assign any such
intellectual property rights, PAR shall enter into and execute all reasonable
and appropriate assignments, transfers and other agreements, and enter into
all
agreements with its employees, contractors, and Affiliates, that are necessary
or appropriate to ensure the assignment of such intellectual property rights
to
NovaDel. For the avoidance of doubt, all such intellectual property rights
shall
be included in the Licensed Technology, and PAR shall be entitled to use such
intellectual property rights in accordance with the licenses granted pursuant
to
Article 3.
7.4 Non-Use
of Trademarks.
Except
as set forth explicitly in this Agreement, no Party shall have the right to
use
the trademarks, trade names or logos of any other Parties, nor any adaptation
thereof, nor the names of any employees or consultants of any other Party,
without the prior written consent of such other Party in each instance, except
that any Party may use any other Party’s name in its general list of
collaborators and any Party may use any other Party’s name to the extent
required by Applicable Law, including pursuant to the Securities Act of 1933,
as
amended, and the rules and regulations thereunder.
7.5 United
States Law.
The
determination of whether Information and Inventions are conceived, discovered,
developed or otherwise made by a Party for the purpose of allocating proprietary
rights (including Patent Right, copyright or other intellectual property rights)
therein, shall, for purposes of this Agreement, be made in accordance with
applicable United States law.
ARTICLE
8
REPORTS
AND RECORDS
8.1 Record
Retention.
PAR
shall maintain (and shall ensure that its Affiliates shall maintain) complete
and accurate books, records and accounts that fairly reflect their respective
Net Sales, other income and any milestones payable with respect to Licensed
Product in sufficient detail to confirm the accuracy of any payments required
hereunder and in accordance with GAAP, which books, records and accounts shall
be retained by PAR until the later of (a) three (3) years after the end of
the
period to which such books, records and accounts pertain, and (b) the expiration
of the applicable tax statute of limitations (or any extensions thereof), or
for
such longer period as may be required by Applicable Law.
18
8.2 Audit.
HANA
shall have the right, on behalf of itself and NovaDel, to have an independent
certified public accounting firm of nationally recognized standing, reasonably
acceptable to PAR, to have access during normal business hours, and upon
reasonable prior written notice, to such of the records of PAR (and its
Affiliates) as may be reasonably necessary to verify the accuracy of all sales
and payments due to HANA for any calendar quarter ending not more than
thirty-six (36) months prior to the date of such request; provided, however,
that neither HANA shall not have the right to conduct more than one such audit
in any twelve (12)-month period. The accounting firm shall disclose to each
Party only whether such sales or payments are correct or incorrect and the
specific details concerning any discrepancies. HANA shall bear the cost of
such
audit unless the audit reveals an under-reporting or underpayment in excess
of
the greater of one hundred thousand dollars ($100,000) or two percent (2%)
of
royalties or milestone payments payable for such period, in which case PAR
shall
bear the cost of the audit, rectify such underpayment and pay HANA applicable
interest as required by Section 8.5. Any overpayment shall be promptly repaid
by
HANA. All payments required under this Section 8.2 shall be due within thirty
(30) days of the date that notice of the payment due. The results of such
accounting firm shall be final, absent manifest error. PAR acknowledges that
the
results of any such audit may be shared by HANA with NovaDel and such results
shall be treated as “Confidential Information” subject to the terms of Article
9.
8.3 Reports.
Within
forty-five (45) days of the end of each quarter of each calendar year, PAR
shall
deliver to HANA and NovaDel complete and accurate reports, giving such
particulars of the business conducted by PAR during the preceding quarter under
this Agreement as shall be pertinent to an accounting for royalties, milestone
payments and other amounts due hereunder. These shall include at least the
following:
8.3.1 All
Licensed Product used, leased or sold, by or for PAR or its
Affiliates.
8.3.2 Total
amounts invoiced for Licensed Product used, leased or sold, by or for PAR or
its
Affiliates.
8.3.3 Total
milestone payments due based on achievement of milestones.
8.3.4 Total
Net
Sales and the royalties due by or for PAR and its Affiliates.
8.3.5 Names
and
addresses of all Affiliates of PAR.
8.4 Interest.
Amounts
which are not paid when due and which are not the subject of a bona fide dispute
shall accrue interest from the due date until paid, at an annual rate equal
to
the then prevailing prime rate of Citibank, N.A., plus six percent (6%), but
in
no event exceeding the amount permitted by applicable law.
8.5 Confidentiality.
Each
report received by HANA and NovaDel shall be treated by HANA and NovaDel as
if
it were “Confidential Information” subject to the terms of Article
9.
19
ARTICLE
9
CONFIDENTIALITY
9.1 Definition.
“Confidential Information” of a Party shall mean all information and know-how
and any tangible embodiments thereof provided by or on behalf of such Party
to
another Party either in connection with the discussions and negotiations
pertaining to, or in the course of performing, this Agreement, including the
terms of this Agreement; the Designated Compound; data; knowledge; practices;
processes; ideas; research plans; engineering designs and drawings; research
data; manufacturing processes and techniques; scientific, manufacturing,
marketing and business plans; and financial and personnel matters relating
to
the disclosing Party or to its present or future products, sales, suppliers,
customers, employees, investors or business. For purposes of this Agreement,
notwithstanding the Party that disclosed such information or know-how, all
NovaDel Know-How and all Information and Inventions with respect to the Licensed
Process shall be Confidential Information of NovaDel.
9.2 Exclusions.
Notwithstanding the foregoing, information or know-how of a Party shall not
be
deemed Confidential Information with respect to a receiving Party for purposes
of this Agreement if such receiving Party can affirmatively demonstrate through
the production of written documentation that such information or
know-how:
9.2.1 was
already known to the receiving Party or its Affiliates, other than under an
obligation of confidentiality or non-use, at the time of disclosure to such
receiving Party;
9.2.2 was
generally available or known to parties reasonably skilled in the field to
which
such information or know-how pertains, or was otherwise part of the public
domain, at the time of its disclosure to such receiving Party;
9.2.3 became
generally available or known to parties reasonably skilled in the field to
which
such information or know-how pertains, or otherwise became part of the public
domain, after its disclosure to such receiving Party through no fault of a
Party
other than the Party that Controls such information and know-how;
9.2.4 was
disclosed to such receiving Party or its Affiliates, other than under an
obligation of confidentiality or non-use, by a Third Party who had no obligation
to the Party that Controls such information and know-how not to disclose such
information or know-how to others; or
9.2.5 was
independently discovered or developed by such receiving Party or its Affiliates,
as evidenced by their written records, without the use of Confidential
Information belonging to the Party that Controls such information and know-how,
except with respect to the NovaDel Know-How with respect to the Licensed
Process, which shall be and remain Confidential Information of
NovaDel.
9.3 Disclosure
and Use Restriction. Except as expressly provided herein, the Parties agree
that during the Term of this Agreement, and for five (5) years thereafter,
each
Party and its Affiliates shall keep completely confidential and shall not
publish or otherwise disclose and shall not use for any purpose except for
the
purposes contemplated by this Agreement any Confidential Information of another
Party or its Affiliates.
20
9.4 Authorized
Disclosure.
Each
Party may disclose Confidential Information of another Party to the extent
that
such disclosure is:
9.4.1 Required
by Governmental Order.
Made in
response to a valid order of a court of competent jurisdiction or other
supra-national, federal, national, regional, state, provincial or local
governmental or regulatory body of competent jurisdiction; provided, however,
that such Party shall first have given notice to the owning Party and given
the
owning Party a reasonable opportunity to quash such order and to obtain a
protective order requiring that the Confidential Information and documents
that
are the subject of such order be held in confidence by such court or agency
or,
if disclosed, be used only for the purposes for which the order was issued;
and
provided further that if a disclosure order is not quashed or a protective
order
is not obtained, the Confidential Information disclosed in response to such
court or governmental order shall be limited to that information which is
legally required to be disclosed in response to such court or governmental
order;
9.4.2 Required
by Law.
Otherwise required by law; provided, however, that the disclosing Party shall
(a) provide the owning Party with reasonable advance notice of and an
opportunity to comment on any such required disclosure, (b) if requested by
the
owning Party, seek confidential treatment with respect to any such disclosure
to
the extent available, and (c) use good faith efforts to incorporate the comments
of the owning Party in any such disclosure or request for confidential
treatment;
9.4.3 Required
by Regulatory Authority.
Made by
such Party to the Regulatory Authorities as required in connection with any
filing, application or request for Regulatory Approval; provided, however,
that
reasonable measures shall be taken to assure confidential treatment of such
information; or
9.4.4 Required
by Agreement.
Made by
such Party, in connection with the performance of this Agreement, to Affiliates,
research parties, employees, consultants, representatives or agents, each of
whom prior to disclosure must be bound by obligations of confidentiality and
non-use at least equivalent in scope to those set forth in this Article
9.
9.5 Injunctive
Relief.
The
Parties acknowledge that any breach of this Article 9 will constitute
irreparable harm, and that the non-breaching Party shall be entitled to specific
performance or injunctive relief to enforce this Article 9 in addition to
whatever remedies such Party may otherwise be entitled to at law or in
equity.
ARTICLE
10
PATENT
PROSECUTION AND INFRINGEMENT
10.1 Prosecution
of NovaDel Patent Rights.
10.1.1 NovaDel
shall have the sole right, at its cost and expense, to obtain, prosecute and
maintain throughout the world the NovaDel Patent Rights. PAR shall, and shall
cause its Affiliates to, cooperate fully with NovaDel in the preparation,
filing, prosecution, enforcement and maintenance of the NovaDel Patents. Such
cooperation includes (a) promptly executing all papers and instruments and
requiring employees to execute such papers and instruments as reasonable and
appropriate so as to enable NovaDel to file, prosecute, enforce and maintain
the
NovaDel Patents in any country; (b) promptly informing NovaDel in reasonable
detail of any Improvements by PAR or any of its Affiliates or agents; and (c)
promptly informing NovaDel of any matters of which PAR may be aware that may
affect the preparation, filing, prosecution or maintenance of any such NovaDel
Patent.
21
10.1.2 NovaDel
shall provide PAR with drafts of all patent applications and other material
submissions to and correspondence with any patent authorities in the Territory
to the extent such applications or submissions relate to the Licensed Technology
(other than the Licensed Process), in sufficient time, but in any event not
less
than thirty (30) days prior to the date a reply is required by the relevant
patent authorities in the Territory, to allow for review and comment by PAR.
In
addition, NovaDel shall provide PAR with an opportunity to consult with NovaDel
regarding the filing and contents of any such application, submission or
correspondence in the Territory. If PAR provides to NovaDel comments with
respect to any such application, submission or correspondence, to the extent
such comments relate to any Licensed Technology (other than the Licensed
Process) in the Territory, NovaDel agrees to reasonably consider such comments,
it being understood that NovaDel retains the right to determine whether to
comply with or incorporate such comments, if at all. If (x) NovaDel elects
not
to pursue the filing, prosecution or maintenance of a NovaDel Patent in a
particular country, in the Territory or to take any other action with respect
to
a NovaDel Patent in a particular country in the Territory that is necessary
or
useful to establish or preserve rights with respect to the Licensed Product,
and
(y) such NovaDel Patent does not claim or cover the Licensed Process, then
NovaDel shall so notify PAR promptly in writing and in good time to enable
PAR
to meet any deadlines by which an action must be taken to establish or preserve
any such rights in such NovaDel Patent in such country in the Territory. Upon
receipt of any such notice by NovaDel or if, at any time, NovaDel fails to
initiate any such action within thirty (30) days after a request by PAR that
it
do so (and thereafter diligently pursue such action), PAR shall have the right,
but not the obligation, to pursue the filing or registration, or support the
continued prosecution or maintenance, of such NovaDel Patent at its expense
in
such country in the Territory. If PAR elects to pursue such filing or
registration, as the case may be, or continue such support, then PAR shall
notify NovaDel of such election and NovaDel shall, and shall cause its
Affiliates to, (x) reasonably cooperate with PAR in this regard, and (y)
promptly grant to PAR, without additional consideration, an exclusive,
perpetual, irrevocable, royalty-free license in such country in the Territory
under such NovaDel Patent in order to Exploit the Licensed Product in accordance
with the terms of this Agreement.
10.2 Infringement
of NovaDel Patent Rights.
10.2.1 PAR
and
HANA shall inform each other and NovaDel promptly in writing of any alleged
or
suspected infringement by a Third Party of any Licensed Technology, and of
any
available evidence thereof. Each Party shall provide reasonable assistance
to
other Parties, including providing access to relevant records, papers,
information, samples, specimens and other evidence, making its employees
available at reasonable business hours, and joining the action to the extent
necessary to maintain the action.
22
10.2.2 In
respect of any alleged or suspected actual or constructive infringement by
a
Third Party of any NovaDel Patent, NovaDel Know-How or Improvements, in each
case related solely to the Licensed Process and Licensed Product, most
particularly where a Third Party files an ANDA or a 505(b)(2) application
containing a Paragraph IV certification with the FDA targeting or referencing
the Licensed Product, as the NDA holder, PAR shall have the right to institute
a
suit and control the prosecution, settlement negotiation, settlement or
compromise thereof or defend against any suit alleging the invalidity or
noninfringement or unenforceability of the Patent Rights of a Party or its
Affiliates to the extent related solely to the Licensed Product; provided that
PAR shall not enter into any settlement or compromise with respect to any
NovaDel Patent, NovaDel Know-How or Improvement without NovaDel’s prior written
consent, such consent not to be unreasonably withheld, unless such settlement
or
compromise does not include any statements as to or otherwise affect the
validity or enforceability of the NovaDel Patents, NovaDel Know-How or
Improvements and the only form of consideration paid by the Third Party is
monetary that has not been reduced or offset by any consideration by PAR.
PAR shall bear all the costs of such a suit. At PAR’s request,
NovaDel shall be named as a party in such litigation, and NovaDel shall execute
all papers and perform such acts as may be reasonably required, in respect
thereof; provided, however, that NovaDel’s joining of such action shall not
affect PAR’s control thereof. NovaDel and HANA shall, at the request and
sole expense of PAR, provide reasonable cooperation and, to the extent possible,
each of NovaDel and HANA shall have its employees testify when requested and
make available relevant records, papers, information, samples, specimens and
the
like regardless of whether NovaDel has joined such suit. NovaDel shall
have the right to select, at NovaDel’s expense, separate counsel to participate
in such suits on NovaDel’s behalf. In the event that PAR fails within
ninety (90) days following notice of such infringement, or earlier notifies
NovaDel in writing of its intent not to take commercially appropriate steps
to
remove any infringement of any NovaDel Patent, NovaDel Know-How or Improvement,
NovaDel shall have the right, but not the obligation, to do so at its own
expense; provided, however, that if PAR has commenced negotiations with an
alleged infringer for discontinuance of such infringement within such ninety
(90) day period, PAR shall have an additional ninety (90) days to conclude
its
negotiations before NovaDel may bring suit for such infringement. Each of
PAR, HANA, and NovaDel shall provide reasonable assistance to the Person
controlling such litigation, including providing access to relevant documents
and other evidence, making its employees available at reasonable business hours,
and joining the action to the extent necessary to allow the enforcing Party
to
maintain the action, with all reasonable expenses incurred by HANA in providing
such assistance to such Person to be paid in full by PAR. Any amounts,
royalties, payments, damages, expenses, fees or other awards received by or
recovered by NovaDel or PAR, as applicable, pursuant to this Section 10.2.2,
whether by settlement or by judgment, shall be used to reimburse such Person
for
their reasonable costs and expenses in making such recovery, with any remainder
to be shared [***]
percent
([***]%)
to
NovaDel and [***]
percent
([***]%)
to
PAR. For all other NovaDel Patents, NovaDel Know-How or Improvements,
NovaDel shall have the sole right to institute a suit and control prosecution,
settlement negotiation, settlement or compromise thereof and defend against;
provided that NovaDel shall consult with PAR and NovaDel shall use reasonable
business judgment to determine whether to consent to instituting a suit, such
reasonable business judgment to include consideration of any other existing
or
contemplated products covered by the NovaDel Patents, NovaDel Know-How or
Improvements.
23
10.3 Third
Party Litigation.
In the
event that a Third Party institutes a patent or other infringement suit against
any of NovaDel, PAR or HANA or any of its respective Affiliates during the
Term,
alleging manufacture, use or sale of a Licensed Product in the Territory,
infringes one or more patent or other intellectual property rights held by
such
Third Party (an “Infringement
Suit”),
the
Parties shall cooperate with one another in defending such suit. PAR, as
the NDA holder, shall have the first right to direct and control, at its
expense, any Infringement Suit (including settlement negotiations, settlement
or
compromise thereof) to the extent that it relates to the manufacture, use or
sale of a Licensed Product but does not implicate the Licensed Technology or
Licensed Process. In the event that the Infringement Suit relates to the
use of the Licensed Technology or Licensed Process, NovaDel shall have the
first
right to direct and control, at its expense, any such Infringement Suit
(including settlement negotiations, settlement or compromise thereof). To
the extent that any amounts become payable to any Third Party as a result of
such action, whether through judgment or settlement, then PAR shall, unless
HANA
is jointly promoting and commercializing the Licensed Product pursuant to
Section 2.4 and subject to Section 12.2, bear [***]
percent
([***]%)
of
such amounts with respect to the Exploitation of the Licensed Product; provided,
however, that PAR shall have the right to credit [***]
percent
([***]%)
of any
amounts paid by PAR through judgment or settlement with respect to such country
against the royalty payments to be paid by PAR to HANA with respect to the
sale
of the Licensed Product under Section 6.3; provided further, however, that
no
royalty payment when due, regardless of the amount or number of credits
available to PAR shall be reduced by more than [***]
percent
([***]%)
of the
amounts otherwise owed pursuant to Section 6.3 in any calendar quarter.
Credits not exhausted in any calendar quarter may be carried into future
calendar quarters. Notwithstanding the foregoing, in the event that no payments
are due or owing, or contemplated to be due or owing, by PAR to HANA under
Article 6 with respect to the sale of the Licensed Product, then NovaDel shall
pay to PAR such amount owed to a Third Party up to a cap of [***]%
of such
amount owed to such Third Party, less any amount already credited to PAR under
this Section 10.3. Notwithstanding the foregoing, NovaDel shall have no
obligation under this Section 10.3 for any costs, expenses or damages that
are
paid or payable to a Third Party as a result of an actual or alleged
infringement by PAR or HANA to the extent such costs, expenses or damages result
from the use of a Product Trademark.
10.4 Retained
Rights.
Nothing
in this Section 10 shall prevent PAR, at its own expense, from obtaining any
license or other rights from Third Parties it deems appropriate in order to
permit the full and unhindered exercise of its rights under this
Agreement.
ARTICLE
11
TERMINATION
11.1 Term.
Unless
otherwise terminated pursuant to this Article 11, this Agreement shall enter
into effect on the Effective Date and shall remain in full force and effect
on a
country-by-country basis until the later of (a) expiration date of the last
to
expire of any issued NovaDel patent that includes at least one Valid Claim
and
(b) the twentieth (20th) anniversary of the Effective Date (the “Term”).
11.2 Termination
Events.
This
Agreement may be terminated prior to expiration of the Term as
follows:
24
11.2.1 Termination
Upon Insolvency.
11.2.1.1 If
HANA
shall become bankrupt, or shall file a petition in bankruptcy or insolvency
or
for reorganization or for an arrangement or for the appointment of a receiver
or
trustee or of its assets, or if an involuntary petition for any of the foregoing
shall be filed with respect to HANA and not dismissed within sixty (60) days,
or
if the business of HANA shall be placed in the hands of a receiver, assignee
or
trustee for the benefit of creditors, whether by the voluntary act of HANA
or
otherwise, PAR or NovaDel (subject to Section 11.6.3) shall have the right
to
terminate this Agreement.
11.2.1.2 If
PAR
shall become bankrupt, or shall file a petition in bankruptcy or insolvency
or
for reorganization or for an arrangement or for the appointment of a receiver
or
trustee or of its assets, or if an involuntary petition for any of the foregoing
shall be filed with respect to PAR and not dismissed within sixty (60) days,
or
if the business of PAR shall be placed in the hands of a receiver, assignee
or
trustee for the benefit of creditors, whether by the voluntary act of PAR or
otherwise, HANA or NovaDel shall have the right to terminate this
Agreement.
11.2.2 Termination
for Payment Default.
Should
PAR fail to make payment to HANA of royalties or other amounts due in accordance
with the terms of this Agreement, HANA or NovaDel shall have the right to
terminate this Agreement within ten (10) days after giving said notice of
termination unless PAR shall pay to HANA, within the 10-day period, all such
amounts due and payable. Upon the expiration of the 10-day period, if PAR shall
not have paid all such amounts due and payable, the rights, privileges and
licenses granted hereunder shall, at the option of HANA or NovaDel, immediately
terminate. In the event a payment is the subject of a bona fide dispute between
HANA and PAR that is being pursued by a Party pursuant to the dispute resolution
mechanism in Article 15, then PAR shall make such payment, but shall provide
HANA with written notice that such payment is being made subject to the outcome
of such pending dispute resolution procedure and in the event such dispute
is
finally and conclusively resolved in favor of PAR, HANA shall refund such
payment to PAR with interest calculated pursuant to Section 8.5 from the date
of
such payment.
11.2.3 Termination
for Material Breach.
11.2.3.1 Upon
any
material breach or default of this Agreement by either HANA or PAR, other than
as set forth in Section 11.2.2, NovaDel shall, subject to Section 11.6.3, have
the right to terminate this Agreement and the rights, privileges and licenses
granted hereunder upon giving thirty (30) days notice to HANA and PAR. Such
termination shall become effective upon the expiration of such thirty (30)-day
period unless the breaching Party shall have cured any such breach or default
prior to the expiration of such thirty (30) day period.
11.2.3.2 Upon
any
material breach or default of this Agreement by HANA, other than as set forth
in
Section 11.2.2, PAR shall have the right to terminate this Agreement and the
rights, privileges and licenses granted hereunder upon giving thirty (30) days
notice to the HANA and NovaDel. Such termination shall become effective upon
the
expiration of such thirty (30)-day period unless HANA shall have cured any
such
breach or default prior to the expiration of such thirty (30) day
period.
11.2.3.3 Upon
any
material breach or default of this Agreement by PAR, other than as set forth
in
Section 11.2.2, HANA shall have the right to terminate this Agreement and the
rights, privileges and licenses granted hereunder upon giving thirty (30) days
notice to the PAR and NovaDel. Such termination shall become effective upon
the
expiration of such thirty (30)-day period unless PAR shall have cured any such
breach or default prior to the expiration of such thirty (30) day
period.
25
11.2.4 Termination
By PAR.
PAR
shall have the right at any time to terminate this Agreement in whole or as
to
any Licensed Product by giving ninety (90) days notice thereof in writing to
HANA and NovaDel.
11.3 Return
of Information; Assignment and License.
11.3.1 Upon
termination of this Agreement as a result of PAR’s material breach hereof
pursuant to Section 11.2.2, 11.2.3.1 or 11.2.3.3, or as a result of PAR’s
insolvency pursuant to Section 11.2.1.2 or by PAR pursuant to Section 11.2.4,
PAR shall, and shall cause its Affiliates to return to HANA and NovaDel any
and
all data, files, records and other materials in its possession or control that
relate to the Licensed Technology or contain or comprise Information and
Inventions or other Confidential Information (except one copy of each that
may
be retained for archival purposes).
11.3.2 Upon
termination of this Agreement as a result of PAR’s material breach hereof
pursuant to Section 11.2.2, 11.2.3.1 or 11.2.3.3, or as a result of PAR’s
insolvency pursuant to Section 11.2.1.2, or by PAR pursuant to Section 11.2.4,
PAR: (a) shall, and shall cause its Affiliates to, promptly disclose to HANA
and
NovaDel, in whatever form HANA may request, all Regulatory Documentation and
all
other Information and Inventions in the possession or Control of PAR or its
Affiliates that relate to the Exploitation of such Licensed Product, (b) shall,
and does hereby, assign, and shall cause its Affiliates to assign, to HANA,
without additional compensation, all of their respective rights, titles and
interests in and to any and all (i) patent, trademark, copyright or other
intellectual property rights and (ii) Regulatory Documentation and all data
included or referenced therein (the “Agreement-Related
Assets”)
and
are permitted to be assigned, (c) to the extent that the Agreement-Related
Assets may not be assigned, shall, and does hereby, grant, and shall cause
its
Affiliates to grant, to HANA, without additional compensation, a perpetual,
irrevocable, royalty-free, exclusive, sublicenseable through multiple tiers
of
sublicenses, right and license to Exploit such Licensed Product in the Territory
and (d) shall, and does hereby, assign, and shall cause its Affiliates to
assign, to NovaDel, without additional compensation, all of their respective
rights, titles and interests in and to any and all other Information and
Inventions in the possession or Control of PAR or its Affiliates in each case
that relate to the Exploitation of such Licensed Product to the extent not
already assigned to NovaDel pursuant to Section 7.1 or Section 7.2.
11.4 Cumulative
Remedies.
The
rights and remedies set forth in this Article 11 are cumulative and in addition
to any other rights that may be available to the Parties.
11.5 Non-Refundability
of Payments.
Any and
all license fees, royalties and milestone payments made to HANA by PAR under
Article 6 of this Agreement shall be non-refundable, notwithstanding the
termination of this Agreement under any provision of this
Agreement.
26
11.6 Effect
of Termination.
11.6.1 The
termination or expiration of this Agreement for any reason shall be without
prejudice to any rights which shall have accrued to the benefit of any Party
prior to such termination or expiration. Such termination or expiration shall
not relieve any Party from obligations which are expressly indicated to survive
termination or expiration of this Agreement.
11.6.2 Upon
the
termination of the Agreement pursuant to Section 11.2.1.2 or by HANA in
accordance with Section 11.2.2 or 11.2.3.3 or by NovaDel pursuant to Section
11.2.2 or 11.2.3.1, all rights and licenses granted to PAR pursuant to this
Agreement shall automatically and immediately terminate and PAR immediately
shall discontinue Commercialization of the Licensed Product.
11.6.3 Upon
the
termination of the Agreement pursuant to Section 11.2.1.1 or by PAR or NovaDel
as a result of HANA’s material breach pursuant to Section 11.2.2 or 11.2.3.2,
then, in such event, HANA shall, contemporaneously with the termination of
this
Agreement and in exchange for the good and valuable consideration set forth
herein (the sufficiency of which is hereby acknowledged by HANA), assign all
of
its rights and interests in, under and to, the NovaDel-Hana License (without
regard to any termination thereunder) and PAR shall assume the obligations
of
HANA thereunder (and NovaDel hereby consents to such assignment and assumption);
provided, however, that NovaDel acknowledges that in no event shall PAR have
any
greater obligations (economically or otherwise) to NovaDel than it has to HANA
under the terms of this Agreement; provided further, that if there are any
operational obligations of HANA that are not covered by the terms of this
Agreement, then NovaDel and PAR shall, at the time of such assignment, in good
faith negotiate commercially reasonable terms in respect of such operational
obligations.
11.7 Disposition
of Product.
Upon
any termination of this Agreement pursuant to other than for which Section
11.6.2 would be applicable, PAR shall within thirty (30) days after the
effective date of such termination notify HANA in writing of the amount of
each
Licensed Product which PAR and its Affiliates then have completed on hand,
the
sale of which would, but for the termination, be subject to royalty. At HANA’s
sole election, evidenced by written consent, HANA may grant PAR and/or its
Affiliates written permission during the one (1) year following such termination
to sell that amount of Licensed Product, provided that PAR shall pay royalties
owing thereon in accordance with the provisions of this Agreement.
11.8 Survival.
In
addition to all rights that have accrued as of the date of termination, the
following provisions shall survive the termination of this Agreement for
whatever reason: Articles 7, 8, 9, 12, 14 and 15, and Sections 4.5, 10.3, 11.3,
11.4, 11.5, 11.6. 11.7, 11.8, 13.6, 16.4, 16.7, 16.9, 16.10, 16.11, 16.12,
16.13, 16.14 and 16.15. In addition, any other provision required to interpret
and enforce the Parties’ rights and obligations under this Agreement shall also
survive, but only to the extent required for the observation and performance
of
the aforementioned surviving rights or portions of this Agreement.
27
ARTICLE
12
INDEMNIFICATION
12.1 Indemnification
By PAR.
PAR
shall at all times during the term of this Agreement and thereafter, indemnify,
defend and hold HANA and its Affiliates and their respective officers,
directors, employees and agents, and the successors and assigns of the foregoing
(“Hana
Indemnified Parties”)
and
NovaDel and its Affiliates and their respective officers, directors, employees
and agents, and the successors and assigns of the foregoing (“NovaDel
Indemnified Parties”),
harmless from and against all liability, demands, damages, including expenses
or
loses including death, personal injury, illness or property damage of any kind
whatsoever, including legal expenses and reasonable attorneys’ fees
(collectively, “Losses”)
arising directly or indirectly out of (a) any breach of this Agreement by PAR
or
its Affiliates or permitted Third Party manufacturers, including the failure
of
PAR or its Affiliates or permitted Third Party manufacturers to manufacture,
test or release Licensed Product in accordance with Applicable Law, agreed-to
specifications or CGMP, (b) the negligence or willful misconduct or willful
omissions by PAR or its Affiliates or permitted Third Party manufacturers,
(c)
actual or asserted violations of Applicable Law by PAR or its Affiliates or
permitted Third Party manufacturers, (d) the Exploitation of the Licensed
Product in the Territory (subject to Section 12.4 and intellectual property
infringement claims, which shall be governed by Article 10), and (e) the use
of
the Product Trademark, except to the extent of those Losses for which, as
applicable, HANA has an obligation to indemnify the PAR Indemnified Parties
pursuant to Section 12.2 or to the extent caused by a breach of this Agreement
by NovaDel or the negligence or willful misconduct or willful omissions of
NovaDel.
12.2 Indemnification
By HANA.
HANA
shall defend, indemnify and hold PAR and its Affiliates and their respective
officers, directors, employees and agents (“PAR
Indemnified Parties”)
and
the NovaDel Indemnified Parties harmless from and against all Losses arising
directly or indirectly out of (a) any breach of this Agreement or the
NovaDel-Hana License by HANA or Affiliates, (b) the negligence or willful
misconduct or willful omissions by HANA or its Affiliates, and (c) actual or
asserted violations of Applicable Law by HANA or its Affiliates, except to
the
extent of those Losses for which PAR has an obligation to indemnify the HANA
Indemnified Parties pursuant to Section 12.1.
12.3 Indemnification
By NovaDel.
NovaDel
shall defend, indemnify and hold the Indemnified Parties harmless from and
against all Losses arising directly or indirectly out of (a) any breach of
this
Agreement or the NovaDel-Hana License by NovaDel or Affiliates, (b) the
negligence or willful misconduct or willful omissions by NovaDel or its
Affiliates and (c) actual or asserted violations of Applicable Law by NovaDel
or
its Affiliates, except to the extent of those Losses for which PAR has an
obligation to indemnify the NovaDel Indemnified Parties pursuant to Section
12.1.
28
12.4 Product
Liability Claims.
If any
Party becomes aware of a Product Liability Claim solely with respect to Licensed
Product sold by PAR or its Affiliates during the Term that is not otherwise
subject to indemnification by a Party under Section 12.1, 12.2 or 12.3, it
shall promptly notify the other Parties in writing of any such Product Liability
Claim. PAR shall have the first option to control the defense of such Product
Liability Claim with counsel of its choice and PAR will fund the litigation
expenses with respect to such Product Liability Claim; provided that NovaDel
shall reimburse PAR for [***]%
of such
expenses within forty-five (45) days of receiving an invoice setting forth
such expenses and NovaDel’s share of the same. NovaDel will have the option of
joining in any action related to such Product Liability Claim, and upon so
joining, if NovaDel shall be represented in such action by its own counsel,
such
representation shall be at its own expense. In the event that PAR does not
so
elect to defend against such Product Liability Claim within ninety (90)
days of becoming aware of the same, NovaDel shall be free to proceed and solely
control such defense and NovaDel shall fund the litigation expenses with respect
to such Product Liability Claim; provided that PAR shall reimburse NovaDel
for
[***]%
of such
expenses within forty-five (45) days of receiving an invoice setting forth
such expenses and PAR’s share of the same. Each Party, and its employees and
agents, shall provide to the other Party and its legal representatives
reasonable assistance and cooperation with respect to such Product Liability
Claim, including entering into any joint defense and/or joint privilege
agreement that may be reasonably requested by such Party, to the extent
possible, having its employees testify when requested and making available
relevant records, papers, information, samples, specimens and the like. To
the
extent either Party incurs any Losses arising from or in connection with any
such Product Liability Claim with respect to the Licensed Product that is not
otherwise subject to indemnification by a Party under Section 12.1, 12.2 or
12.3 of this Agreement, such Losses shall be shared [***]%
by
NovaDel and [***]%
by
PAR.
12.5 Indemnification
Procedure.
12.5.1 Notice
of Claim.
The
indemnified Party shall give the indemnifying Party prompt written notice (an
“Indemnification
Claim Notice”)
of any
Losses or discovery of fact upon which such indemnified Party intends to base
a
request for indemnification, but in no event shall the indemnifying Party be
liable for any Losses that result from any delay in providing such notice.
Each
Indemnification Claim Notice must contain a description of the claim and the
nature and amount of such Loss (to the extent that the nature and amount of
such
Loss is known at such time). The indemnified Party shall furnish promptly to
the
indemnifying Party copies of all papers and official documents received in
respect of any Losses. All indemnification claims in respect of a Party, its
Affiliates or their respective directors, officers, employees and agents shall
be made solely by such Party to this Agreement (the “Indemnified
Party”).
12.5.2 Third
Party Claims.
The
obligations of an indemnifying Party under this Article 12 with respect to
Losses arising from claims of any Third Party that are subject to
indemnification as provided for in Section 12.1, 12.2 or 12.3 (a “Third
Party Claim”)
shall
be governed by and be contingent upon the following additional terms and
conditions:
29
12.5.2.1 Control
of Defense.
At its
option, the indemnifying Party may assume the defense of any Third Party Claim
by giving written notice to the Indemnified Party within thirty (30) days after
the indemnifying Party’s receipt of an Indemnification Claim Notice. The
assumption of the defense of a Third Party Claim by the indemnifying Party
shall
not be construed as an acknowledgment that the indemnifying Party is liable
to
indemnify any indemnified Party in respect of the Third Party Claim, nor shall
it constitute a waiver by the indemnifying Party of any defenses it may assert
against any indemnified Party’s claim for indemnification. Upon assuming the
defense of a Third Party Claim, the indemnifying Party may appoint as lead
counsel in the defense of the Third Party Claim any legal counsel selected
by
the indemnifying Party. In the event the indemnifying Party assumes the defense
of a Third Party Claim, the Indemnified Party shall immediately deliver to
the
indemnifying Party all original notices and documents (including court papers)
received by any indemnified Party in connection with the Third Party Claim.
Should the indemnifying Party assume the defense of a Third Party Claim, the
indemnifying Party shall not be liable to the Indemnified Party or any other
indemnified Party for any legal expenses subsequently incurred by such
indemnified Party in connection with the analysis, defense or settlement of
the
Third Party Claim. In the event that it is ultimately determined that the
indemnifying Party is not obligated to indemnify, defend or hold harmless an
Indemnified Party from and against the Third Party Claim, the Indemnified Party
shall reimburse the indemnifying Party for any and all costs and expenses
(including attorneys’ fees and costs of suit) and any Losses incurred by the
indemnifying Party in its defense of the Third Party Claim with respect to
such
Indemnified Party.
12.5.2.2 Right
to Participate in Defense.
Without
limiting Section 12.5.2.1, any Indemnified Party shall be entitled to
participate in, but not control, the defense of such Third Party Claim and
to
employ counsel of its choice for such purpose; provided, however, that such
employment shall be at the Indemnified Party’s own expense unless (i) the
employment thereof has been specifically authorized by the indemnifying Party
in
writing or (ii) the indemnifying Party has failed to assume the defense and
employ counsel in accordance with Section 12.5.2.1 (in which case the
Indemnified Party shall control the defense).
12.5.2.3 Settlement.
With
respect to any Losses relating solely to the payment of money damages in
connection with a Third Party Claim and that will not result in the Indemnified
Party’s becoming subject to injunctive or other relief or otherwise adversely
affect the business of the Indemnified Party in any manner, and as to which
the
indemnifying Party shall have acknowledged in writing the obligation to
indemnify the Indemnified Party hereunder, the indemnifying Party shall have
the
sole right to consent to the entry of any judgment, enter into any settlement
or
otherwise dispose of such Loss, on such terms as the indemnifying Party, in
its
sole discretion, shall deem appropriate. With respect to all other Losses in
connection with Third Party Claims, where the indemnifying Party has assumed
the
defense of the Third Party Claim in accordance with Section 12.5.2.1, the
indemnifying Party shall have authority to consent to the entry of any judgment,
enter into any settlement or otherwise dispose of such Loss provided it obtains
the prior written consent of the Indemnified Party (which consent shall not
be
unreasonably withheld or delayed). The indemnifying Party shall not be liable
for any settlement or other disposition of a Loss by an indemnified Party that
is reached without the written consent of the indemnifying Party. Regardless
of
whether the indemnifying Party chooses to defend or prosecute any Third Party
Claim, no indemnified Party shall admit any liability with respect to, or
settle, compromise or discharge, any Third Party Claim without the prior written
consent of the indemnifying Party.
12.5.2.4 Cooperation.
Regardless of whether the indemnifying Party chooses to defend or prosecute
any
Third Party Claim, the Indemnified Party shall, and shall cause each other
indemnified Party to, cooperate in the defense or prosecution thereof and shall
furnish such records, information and testimony, provide such witnesses and
attend such conferences, discovery proceedings, hearings, trials and appeals
as
may be reasonably requested in connection therewith. Such cooperation shall
include access during normal business hours afforded to indemnifying Party
to,
and reasonable retention by the Indemnified Party of, records and information
that are reasonably relevant to such Third Party Claim, and making indemnified
Parties and other employees and agents available on a mutually convenient basis
to provide additional information and explanation of any material provided
hereunder, and the indemnifying Party shall reimburse the Indemnified Party
for
all its reasonable out-of-pocket expenses in connection therewith.
30
12.5.2.5 Expenses.
Except
as provided above, the costs and expenses, including fees and disbursements
of
counsel, incurred by the Indemnified Party in connection with any claim shall
be
reimbursed on a calendar quarter basis by the indemnifying Party, without
prejudice to the indemnifying Party’s right to contest the Indemnified Party’s
right to indemnification and subject to refund in the event the indemnifying
Party is ultimately held not to be obligated to indemnify the Indemnified
Party.
12.6 Insurance.
12.6.1 At
all
times from and after the Effective Date, PAR shall have and maintain such type
and amounts of liability insurance covering the manufacture, supply, use and
sale of the Licensed Product as is normal and customary in the pharmaceutical
industry generally for parties similarly situated, and shall upon request
provide NovaDel and HANA with a copy of its policies of insurance in that
regard, along with any amendments and revisions thereto.
12.6.2 PAR
shall, starting 6 months prior to anticipated receipt of NDA approval of the
Licensed Product and extending through the remaining term of this Agreement
and
for a period of not less than 36 months following the termination of this
Agreement, carry liability insurance (including blanket contractual liability)
in an amount of not less than $[***]
combined
single limit, which insurance will be written on a “claims-made” policy basis
with an insurance carrier reasonably acceptable to NovaDel and HANA. PAR shall
provide NovaDel and HANA with evidence of coverage contemplated hereby, in
the
form of certificates of insurance, as reasonably requested. Such certificates
shall be provided by written notice to each of NovaDel and HANA thirty (30)
days
prior to any material change, cancellation or non-renewal of the policy. The
said amount can vary if mutually agreed by both parties.
12.7 Indemnification
for Infringement Claims.
The
provisions of this Article 12 shall supplement the terms of Section 10.3 with
respect to Third Party patent infringement claims. In the event of a conflict
between this Article 12 and Section 10.3, the terms of Section 10.3 shall
control (except as expressly made subject to Section 12.2 therein).
ARTICLE
13
REPRESENTATIONS
AND WARRANTIES
13.1 Legal
Authority.
Each of
HANA and PAR represents and warrants as follows: (a) such Party is a corporation
duly organized, validly existing and in good standing under the laws of the
state in which it is incorporated, and has full corporate power and authority
and the legal right to own and operate its property and assets and to carry
on
its business as it is now being conducted and as is contemplated to be conducted
by this Agreement; (b) such Party has the legal power, authority and right
to
enter into this Agreement and to perform its respective obligations set forth
herein; and (c) this Agreement has been duly executed and delivered by such
Party and constitutes the valid and binding obligation of such Party,
enforceable against such Party in accordance with its terms, except as
enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency,
reorganization, moratorium and other laws relating to or affecting creditors’
rights generally and by general equitable principles.
31
13.2 No
Conflicts.
Each of
HANA and PAR represents or warrants that as of the date of this Agreement it
is
not a party to any agreement or arrangement with any Third Party or under any
obligation or restriction, including pursuant to its corporate charter, bylaws
or comparable governing documents, which in any way limits or conflicts with
its
entering into this Agreement or its ability to fulfill any of its obligations
under this Agreement.
13.3 Litigation.
Each of
HANA and PAR represents or warrants that it is not aware of any pending or
threatened litigation (and has not received any communication) that alleges
that
such Party’s activities related to this Agreement have violated, or that by
conducting the activities as contemplated herein such Party would violate,
any
of the intellectual property rights of any other Person.
13.4 Additional
Covenants of PAR.
PAR on
behalf of itself and its Affiliates, agrees and covenants to the extent
permitted by Applicable Law, never, in any country, region or jurisdiction
in
the Territory, to institute or prosecute any claim, action or suit at law or
in
equity seeking to have any claim in a NovaDel Patent Right declared invalid
or
unenforceable; provided, however, that nothing contained herein shall prohibit
PAR and its Affiliates from either (a) asserting any and all defenses available
to it, including assertions relating to the validity or enforceability of the
NovaDel Patent Rights, in any suit or proceeding brought against them alleging
the infringement of any of the NovaDel Patent Rights, or (b) asserting any
and
all defenses, evidence and arguments, including lack of patentability of the
subject matter of a count or claim and lack of support for a count or claim,
in
any interference involving a patent or patent application owned by PAR or its
Affiliates and a patent or patent application included within the definition
of
the NovaDel Patent Rights. PAR and its Affiliates will take all reasonable
action (including signing required documents) and offer full cooperation to
allow NovaDel to exercise the march-in rights provided herein, to the extent
permitted by law; provided, however, that such rights shall be subject to PAR’s
right to notice and cure and shall be subject to the dispute resolutions
provided herein.
13.5 Additional
Representations and Warranties of HANA.
HANA
hereby represents, warrants and covenants to PAR as follows:
(i) Neither
HANA nor any of its Affiliates has received any written notice from any Person,
or has knowledge, of any actual or threatened claim or assertion that the
development of the Licensed Product infringes (or would infringe) or
misappropriates any intellectual property rights of any Third Party;
(ii) There
is
no action or proceeding pending or, to HANA’s knowledge, threatened that
questions the validity of this Agreement or any action taken by HANA in
connection with the effectiveness of this Agreement;
32
(iii) HANA
has
no knowledge of any pending patent application, which if issued, would similarly
be infringed by the use of the Licensed Technology as contemplated by this
Agreement;
(iv) HANA
has
not violated the trade secrets or misappropriated the confidential information
or intellectual property of any Third Party in connection with the development
of the Licensed Technology;
(v) HANA
has
the right to grant the sublicense granted to PAR herein;
(vi) To
HANA’s
knowledge, as of the Effective Date, there is no unauthorized use, infringement
or misappropriation of any of the Licensed Technology by any Third Party,
including any current or former employee or consultant of HANA and its
Affiliates; and
(vii) HANA
has
made available to or provided PAR with copies of all information in HANA’s
Control regarding the Licensed Technology, which could reasonably be expected
to
be material to assessing the commercial potential for the Licensed Product,
or
the ability to timely gain Regulatory Approval of the Licensed
Product.
13.6 DISCLAIMER
OF WARRANTY.
EXCEPT
FOR THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 13.1, 13.2, 13.3 AND 13.5,
NEITHER HANA, PAR NOR NOVADEL MAKES ANY REPRESENTATIONS OR GRANTS ANY
WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY
STATUTE OR OTHERWISE, UNDER THIS AGREEMENT, AND HANA AND NOVADEL EACH
SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS
OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR
A
PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENT
RIGHTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES UNDER THIS AGREEMENT.
ARTICLE
14
LIMITATION
OF LIABILITY
14.1 LIMITATION
OF LIABILITY.
EXCEPT
FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS IN RESPECT OF THIRD PARTY CLAIMS
UNDER THIS AGREEMENT, NONE OF HANA, PAR, NOVADEL OR ANY OF THEIR RESPECTIVE
AFFILIATES SHALL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL
DAMAGES (INCLUDING FOR LOST PROFITS), WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE,
TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (A) THE USE OF THE LICENSED
TECHNOLOGY OR LICENSED TRADEMARKS OR (B) ANY BREACH OF OR FAILURE TO PERFORM
ANY
OF THE PROVISIONS OF THIS AGREEMENT.
33
ARTICLE
15
DISPUTE
RESOLUTION
15.1 Good
Faith Negotiations.
In the
event of any dispute or disagreement among the Parties as to the interpretation
of any provision of this Agreement or the performance of obligations hereunder,
the matter, upon written request of any Party, shall first be referred to the
chief executive officers of the Parties for decision. Such chief executive
officers shall promptly meet in a good faith effort to resolve the
dispute.
15.2 Arbitration.
15.2.1 Procedures.
Any
dispute arising from or relating to this Agreement that is not resolved by
the
Parties chief executive officers pursuant to Section 0
shall be
determined before a tribunal of three arbitrators in New York, New York in
accordance with the Commercial Arbitration Rules of the American Arbitration
Association (the “AAA”).
One
arbitrator shall be selected by NovaDel, one arbitrator shall be selected by
PAR
and the third arbitrator shall be selected by mutual agreement of the first
two
arbitrators or by the AAA, if the arbitrators appointed by the Parties are
unable to select a third arbitrator within thirty (30) days.
15.2.2 Patent
Disputes.
Any
claim, dispute, or controversy concerning the validity, enforceability, or
infringement of any patent contained in the NovaDel Patents licensed hereunder
shall be resolved in any court having jurisdiction thereof. In the event that,
in any arbitration proceeding, any issue shall arise concerning the validity,
enforceability, or infringement of any patent contained in the NovaDel Patents
licensed hereunder, the arbitrators shall, to the extent possible, resolve
all
issues other than validity, enforceability, and infringement; in any event,
the
arbitrators shall not delay the arbitration proceeding for the purpose of
obtaining or permitting ether Party to obtain judicial resolution of such
issues, unless an order staying the arbitration proceeding shall be entered
by a
court of competent jurisdiction. No Party hereto shall raise any issue
concerning the validity, enforceability, or infringement of any patent contained
in the NovaDel Patents licensed hereunder, in any proceeding to enforce any
arbitration award hereunder, or in any proceeding otherwise arising out of
any
such arbitration award.
15.2.3 Costs.
The
costs of such arbitration shall be borne proportionate to the finding of fault
as determined by the arbitration panel. Judgment on the arbitration award may
be
entered by any court of competent jurisdiction.
ARTICLE
16
MISCELLANEOUS
16.1 Publicity.
No
Party hereto shall originate any publicity, news release or other public
announcement, written or oral, relating to this Agreement or the existence
of a
collaboration among the Parties, without the prior written approval of the
other
Parties except as otherwise permitted by this Agreement or required, in the
reasonable judgment of the disclosing Party’s attorneys, by Applicable Law,
including the Securities Act of 1933, as amended, and the rules and regulations
thereunder or as promulgated by an applicable securities exchange governing
body.
34
16.2 Publications.
In the
event that any Party desires to publish or disclose, by written, oral or other
presentation, Licensed Technology or any material information relating thereto,
then such Party shall notify the other in writing of its intention at least
sixty (60) days prior to any speech, lecture or other oral presentation and
at
least sixty (60) days before any written or other publication or disclosure,
and
shall include with such notice a description of any proposed oral presentation
or, with respect to any proposed written or other disclosure, a current draft
of
such proposed disclosure or abstract. NovaDel may request that PAR, no later
than thirty (30) days following the receipt of such notice, delay such
presentation, publication or disclosure in order to enable NovaDel to file,
or
have filed on its behalf or jointly, as applicable, a patent application,
copyright or other appropriate form of intellectual property protection related
to the information to be disclosed or request that PAR do so. Upon receipt
of
such request to delay such presentation, publication or disclosure, PAR shall
arrange for a delay of such presentation, publication or disclosure until such
time as PAR or NovaDel has filed, or had filed on its behalf, such patent
application, copyright or other appropriate form of intellectual property
protection in form and in substance reasonably satisfactory to NovaDel. If
PAR
does not receive any such request from NovaDel to delay such presentation,
publication or disclosure, PAR may submit such material for presentation,
publication or other form of disclosure. Notwithstanding the foregoing, in
no
event shall PAR have any right to publish or disclose the Licensed Process
or
any information or data related thereto without the prior written consent of
NovaDel, which consent NovaDel may withhold in its sole discretion.
16.3 Assignment.
During
the Term, neither this Agreement nor any of the rights or obligations hereunder
may be assigned by without the prior written consent of the other Parties
hereto, which consent shall not be unreasonably withheld.
16.4 Governing
Law.
This
Agreement shall be governed by and construed in accordance with the laws of
the
State of New Jersey, excluding any conflicts or choice of law rule or principle
that might otherwise refer construction or interpretation of this Agreement
to
the substantive law of another jurisdiction.
16.5 Registration.
If this
Agreement or any associated transaction is required by the law of any nation
to
be either approved or registered with any governmental agency, PAR shall assume
all legal obligations to do so and the costs in connection
therewith.
16.6 Trade
Regulations.
PAR
shall observe all applicable United States and foreign laws with respect to
the
transfer of Licensed Product and related technical data to foreign countries,
including the International Traffic in Arms Regulations (ITAR) and the Export
Administration Regulations.
16.7 Equitable
Relief.
Each
Party acknowledges and agrees that the restrictions set forth in Article 9
of
this Agreement are reasonable and necessary to protect the legitimate interest
of the other Parties and that such other Parties would not have entered into
this Agreement in the absence of such restrictions, and that any violations
or
threatened violation of any provision of Article 9 may result in irreparable
injury to such other Parties. Each Party also acknowledges and agrees that
in
the event of a violation or threatened violation of any provision of Article
9,
the affected Party shall be entitled to seek preliminary and permanent
injunctive relief, without the necessity of having to post a bond, as well
as to
an equitable accounting of all earnings, profits and other benefits arising
from
any such violation. The rights provided in the immediately preceding sentence
shall be cumulative and in addition to any other rights or remedies that may
be
available to such other Party. Nothing in this Section 16.7 is intended, or
should be construed, to limit such other Party’s right to preliminary and
permanent injunctive relief or any other remedy for breach of any other
provision of this Agreement.
35
16.8 Force
Majeure.
In the
event that any Party fails to perform any of its obligations under this
Agreement (other than an obligation to pay money) due to any act of God, fire,
casualty, flood, war, strike, lockout, failure of public utilities, injunction,
act of a governmental authority (including enactment of any governmental law,
order or regulation permanently or temporarily prohibiting or reducing the
level
of research, development or production work hereunder or the manufacture, use
or
sale of the Licensed Product), epidemic, destruction of production facilities,
riot, insurrection, inability to procure or use materials, labor, equipment,
transportation or energy in quantities sufficient to meet experimentation or
manufacturing needs, or any other cause beyond the reasonable control of the
Party invoking this Section 16.8; provided, in each case, that such Party shall
have used Commercially Reasonable Efforts to avoid such failure, then such
Party
shall promptly give written notice of such occurrence to the other Party, 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.
16.9 Waiver.
The
waiver by any Party of a breach or a default of any provision of this Agreement
by another Party shall not be construed as a waiver of any succeeding breach
of
the same or any other provision, nor shall any delay or omission on the part
of
any Party to exercise or avail itself of any right, power or privilege that
it
has or may have hereunder operate as a waiver of any right, power or privilege
by such Party.
16.10 Notices.
Any and
all notices or other communications made or given pursuant to this Agreement
shall be in writing and shall be delivered (i) by express overnight or two-day
international courier service, (ii) by certified or registered mail, return
receipt requested, or (iii) by confirmed facsimile or other electronic
transmission (with confirming copy to follow by express overnight courier
service):
If
to HANA to:
|
Hana
Biosciences, Inc.
0000
Xxxxxxxxx Xxxxx, Xxxxx 000
Xxxxx
Xxx Xxxxxxxxx, Xxxxxxxxxx 00000
Attention:
President
Fax:
(000) 000-0000
|
|
With
a copy (not constituting notice) to:
|
Xxxxxx
Xxxxxxx Xxxxxx & Brand, LLP
Attention:
Xxxxxxxxxxx X. Xxxxxx Esq.
3300
Xxxxx Fargo Center
00
Xxxxx Xxxxxxx Xxxxxx
Xxxxxxxxxxx,
Xxxxxxxxx 00000
|
36
In
the case of PAR:
|
Par
Pharmaceutical, Inc.
000
Xxxx Xxxxxxxxx
Xxxxxxxxx
Xxxx, XX 00000
Attn:
Xxxx XxxXxxx, President, Branded Division and
General
Counsel’s Office
Fax:
(000) 000-0000
|
|
with
a copy (not constituting notice) to:
|
Xxxxxx,
Xxxxxxxxxx & Xxxxxxxxx LLP
000
Xxxxx Xxxxxx
Xxx
Xxxx, XX 00000-0000
Attn:
X. Xxxx Milling, Jr., Esq.
Fax:
(000) 000-0000
|
|
In
the case of NovaDel
|
NovaDel
Pharma, Inc.
00
Xxxxxxxxxxxx Xxxx
Xxxxxxxxxx,
XX 00000
Attn:
President
Fax:
(000) 000-0000
|
|
with
a copy (not constituting notice) to:
|
Xxxxxx,
Xxxxx & Xxxxxxx LLP
000
Xxxxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000
Attn:
Xxxxxxx X. Xxxxxxx, Esq.
Fax:
(000) 000-0000
|
or
to
such other address as the Party to whom notice is to be given may have furnished
to the other Party in writing in accordance herewith. Any such communication
shall be deemed to have been given (a) when delivered, if personally delivered
or sent by telecopier on a business day, (b) on the business day after dispatch,
if sent by nationally-recognized overnight courier, and (c) on the third
business day following the date of mailing, if sent by mail. It is understood
and agreed that this Section 16.10 is not intended to govern the day-to-day
business communications necessary between the Parties in performing their
duties, in due course, under the terms of this Agreement. Notices provided
in
accordance with this Section 16.10 shall be deemed delivered upon receipt of
the
notice by the Party being sent the notice.
16.11 No
Agency.
Nothing
herein shall be deemed to constitute any Party as the agent or representative
of
any other Party, or the Parties hereto as joint venturers or partners for any
purpose. HANA shall be an independent contractor, not an employee or partner
of
PAR or NovaDel, and the manner in which HANA performs its obligations under
this
Agreement shall be within HANA’s sole discretion. PAR shall be an independent
contractor, not an employee or partner of HANA or NovaDel, and the manner in
which PAR performs its obligations under this Agreement shall be within PAR’s
sole discretion (subject to PAR’s compliance with its obligations under this
Agreement). No Party hereto shall be responsible for the acts or omissions
of
any other Party, and no Party shall have authority to speak for, represent
or
bind any other Party in any way without prior written authority from such other
Party.
37
16.12 Entire
Agreement.
This
Agreement and the Exhibits and Schedules attached hereto (which Exhibits and
Schedules are deemed to be a part of this Agreement for all purposes) contain
the full understanding of the Parties with respect to the subject matter hereof
and supersede all prior understandings and writings relating thereto. No waiver,
alteration or modification of any of the provisions hereof shall be binding
unless made in writing and signed on behalf of the Parties by their respective
officers thereunto duly authorized.
16.13 Headings;
Interpretation.
The
section headings contained in this Agreement are for convenience of reference
only, do not form a part of this Agreement and shall not affect in any way
the
meaning or interpretation of this Agreement. Whenever the context may require,
any pronoun shall include the corresponding masculine, feminine and neuter
forms. The words “include,” “includes” and “including” shall be deemed to be
followed by the phrase “but not limited to.” All references herein to Articles,
Sections and Exhibits shall be deemed references to Articles and Sections of,
and Exhibits to, this Agreement unless the context shall otherwise require.
All
Exhibits and Schedules attached to this Agreement shall be deemed incorporated
herein by reference as if fully set forth herein. Words such as “herein,”
“hereof,” “hereto,” “hereby” and “hereunder” refer to this Agreement and to the
Exhibits, taken as a whole. Except as otherwise expressly provided herein:
(a)
any reference in this Agreement to any agreement shall mean such agreement
as
amended, restated, supplemented or otherwise modified from time to time; and
(b)
any reference in this Agreement to any law shall include corresponding
provisions of any successor law and any regulations and rules promulgated
pursuant to such law or such successor law.
16.14 Severability.
In the
event that any provision of this Agreement is held by a court of competent
jurisdiction to be unenforceable because it is invalid or in conflict with
any
law of any relevant jurisdiction, the validity of the remaining provisions
shall
not be affected, and the rights and obligations of the Parties shall be
construed and enforced as if the Agreement did not contain the particular
provisions held to be unenforceable.
16.15 Successors
and Assigns.
This
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their permitted successors and assigns.
16.16 Counterparts.
This
Agreement may be executed in any number of counterparts (including signature
by
facsimile), each of which shall be deemed an original but all of which together
shall constitute one and the same instrument.
16.17 Export
Controls.
Each
Party acknowledges that it is subject to United States laws and regulations
controlling the export of technical data, computer software, laboratory
prototypes and other commodities (including the Arms Export Control Act, as
amended and the United States Department of Commerce Export Administrations
Regulations). The transfer of such items may require a license from the
cognizant agency of the United States Government and/or written assurances
by
PAR or HANA that it shall not export data or commodities to certain foreign
countries without prior approval of such agency. No Party makes any
representation as to whether any such license will be required or, if required,
whether it will be issued.
38
16.18 Further
Assurances.
Each
Party hereby agrees, without further consideration, to execute and deliver
such
documents and take such other actions as the other Party may reasonably request
to carry out the provisions hereof and further the intent of this
Agreement.
16.19 Consent
to Sublicense.
NovaDel
hereby consents to the terms of this Agreement and the sublicense granted
hereunder.
[Signature
Page Follows]
39
IN
WITNESS WHEREOF, the Parties hereto have caused this Development and
Commercialization Sublicense Agreement to be executed as a sealed instrument
in
their names by their properly and duly authorized officers or representatives
as
of the date first above written.
HANA BIOSCIENCES, INC. | PAR PHARMACEUTICAL, INC. | |||
By:
|
/s/ Xxxx X. Xxx
|
By:
|
/s/ Xxxx XxxXxxx
|
|
Name: Xxxx X. Xxx
|
Name: Xxxx XxxXxxx
|
|||
Title: President and CEO
|
Title: President, Branded Division
|
NOVADEL PHARMA, INC.
/s/ Xxxxxx Xxxxxx
|
||
Title: Chairman, President and CEO
|
40
EXHIBIT
A
NOVADEL
PATENTS
1.
United
States Patent No.
6,676,931 B2
41