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Exhibit 10-3
Confidential Treatment has been requested for
portions of this exhibit. The copy filed herewith omits the
information subject to the confidentiality request. Omissions are
designated as “***”. A complete version of this exhibit
has been filed separately with the Securities and Exchange
Commission.
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:
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1.1
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AAA has the meaning set
forth in Section 15.2.1.
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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
***Portion for which confidential treatment
requested.
ownership, directly or indirectly, of at least fifty
percent (50%) of the voting securities or other ownership interest
of a Person
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1.3
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Agreement has the
meaning set forth in the preamble.
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1.4
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Agreement Related Assets has the meaning set forth in Section 11.3.2.
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1.5
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Anticipated Filing Date has the meaning set forth in Section 4.2.2.
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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.
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1.11
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Confidential Information has the meaning set forth in Section 9.1.
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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.
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1.13
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Development Committee has the meaning set forth in Section 4.1.2.
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1.14
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Designated Compound means ondansetron.
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2
***Portion for which confidential treatment
requested.
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1.15
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Development Plan has
the meaning set forth in Section 4.1.1.
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1.16
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Effective Date has the
meaning set forth in the preamble.
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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.
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1.20
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GAAP shall have the
meaning set forth in Section 6.8.
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1.21
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HANA has the meaning
set forth in the preamble.
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1.22
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HANA Indemnified Parties has meaning set forth in Section 12.1.
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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.
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1.26
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Indemnification Claim Notice
shall have the meaning set forth in
Section 12.4.1.
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1.27
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Indemnified Party has
meaning set forth in Section 12.4.1.
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***Portion for which confidential treatment
requested.
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.
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1.29
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Infringement Suit has
meaning set forth in Section 10.3.
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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.
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1.35
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Lock-Up Period has
meaning set forth in Section 6.1.
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1.36
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Losses has the meaning
set forth in Section 12.1.
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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.
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***Portion for which confidential treatment
requested.
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1.38
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Net Sales means
[***] .
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1.39
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NovaDel has the meaning
set forth in the preamble.
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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.
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1.41
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NovaDel Indemnified Parties
has meaning set forth in Section 12.1.
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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.
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1.44
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Par has the meaning set
forth in the preamble.
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1.45
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PAR Indemnified Parties has meaning set forth in Section 12.2.
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1.46
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Party or Parties means
HANA, NovaDel and/or PAR, as applicable.
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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.
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***Portion for which confidential treatment
requested.
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.
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1.50
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Product Trademarks has
meaning set forth in Section 5.4.
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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.
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1.54
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Subscription Agreement has the meaning set forth in Section 6.1.
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1.55
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Term has the meaning
set forth in Section 11.1.
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1.56
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Territory means the
United States of America and Canada.
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1.57
Third Party means any
Person other than PAR, NovaDel, HANA and their respective
Affiliates.
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1.58
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Third Party Claim shall
have the meaning set forth in Section 12.5.2.
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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
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***Portion for which confidential treatment
requested.
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.
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
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***Portion for which confidential treatment
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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.
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 5.4, 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
4.1 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
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***Portion for which confidential treatment
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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.
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3.4
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Additional Covenants and Agreements.
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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.
3.5.1 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.
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***Portion for which confidential treatment
requested.
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.
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
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4.1
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Development Plan; Responsibility and
Control
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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
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***Portion for which confidential treatment
requested.
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.
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.
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4.2
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Clinical and Regulatory Approval
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.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 2.2 or this Section 4.2.2, PAR shall file the NDA with the
FDA on or before the last day of the thirty-
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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.
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
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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.
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 2.2 or this Section
5.3, 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.
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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.
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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:
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 www.oanda.com. 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
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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.
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 s
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