PRODUCT DEVELOPMENT AND COMMERCIALIZATION SUBLICENSE AGREEMENTDevelopment Agreement |
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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
COMMERCIALIZATION
SUBLICENSE AGREEMENT
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 mark, 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 regar