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. AMENDED AND RESTATED LICENSE AND DEVELOPMENT AGREEMENT
Exhibit
10.2
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION.
AMENDED
AND RESTATED
THIS
AMENDED AND RESTATED LICENSE AND DEVELOPMENT AGREEMENT
(this
“Agreement”),
dated
as of July 31, 2007 (the “Execution
Date”),
is
entered into by and between NovaDel
Pharma, Inc.,
a
Delaware corporation (“NovaDel”),
and
Hana
Biosciences, Inc.,
a
Delaware corporation (the “Licensee”).
NovaDel and Licensee each may be referred to herein individually as a
“Party,”
or
collectively as the “Parties.”
WHEREAS,
NovaDel
has certain proprietary rights and intellectual property (including to certain
patents) with respect to lingual sprays for the metered delivery of
pharmaceutical products to humans (the “Technology”);
and
WHEREAS,
pursuant to that certain License and Development Agreement by and between
NovaDel and Licensee, effective as of October 26, 2004 (the “Effective
Date”),
as
amended by that certain Amendment No. 1 To License and Development Agreement
dated August 3, 2005, as amended by that certain Amendment No. 2 To License
and
Development Agreement dated May 15, 2006, and as amended by that certain
Amendment No. 3 To License and Development Agreement dated December 22, 2006,
(collectively, the “Initial
Agreement”),
Licensee obtained from NovaDel, and NovaDel granted to Licensee, an exclusive,
restricted, sublicensable license to develop and
commercialize a pharmaceutical product containing ondansetron as an active
ingredient that will be administered only to humans using the Technology;
and
WHEREAS,
the
Parties desire to amend and restate the Initial Agreement in its entirety upon
the terms and conditions as set forth herein in connection with the PAR
Sublicense Agreement.
NOW,
THEREFORE, in
consideration of the foregoing premises, the mutual promises and covenants
of
the Parties contained herein, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereto,
intending to be legally bound, do hereby agree as follows:
ARTICLE
1
DEFINITIONS
For
the
purposes of this Agreement, the following words and phrases shall have the
following meanings, unless otherwise specifically provided herein:
1.1 “AAA”
shall
have the meaning set forth in Section 9.1.
1.2 “Affiliate”
shall
mean, with respect to any Entity, any other Entity that directly or indirectly
through one or more intermediaries, controls, is controlled by or is under
common control with such Entity. For purposes of this Section 1.2 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 Entity, 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 an Entity.
Page
1 of
40
1.3 “Agreement”
shall
have the meaning set forth in the preamble.
1.4 “Agreement-Related
Assets”
shall
have the meaning set forth in Section 8.7.2.
1.5 “Anticipated
Filing Date”
shall
have the meaning set forth in Section 3.2.2.
1.6 “Applicable
Law”
shall
mean the applicable laws, rules, regulations, guidelines and requirements of
the
Regulatory Authorities, in the Territory.
1.7 “Claims”
shall
have the meaning set forth in Section 3.10.6.
1.8 “CMC”
shall
have the meaning set forth in Section 3.4.1.
1.9 “Commercially
Reasonable Efforts”
shall
mean, with respect to the development or commercialization of a 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 “Confidential
Information”
shall
have the meaning set forth in Article 15.
1.11 “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.
1.12 “Control”
shall
mean, with respect to any item of Information and Inventions, Patents 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 “Designated
Compound”
shall
mean ondansetron.
1.14 “Development
Activities”
shall
mean the activities performed by the Parties under the Development Plan pursuant
to Article 3.
1.15 “Development
Budget”
shall
have the meaning set forth in Section 3.2.2.
1.16 “Development
Committee”
shall
have the meaning set forth in Section 3.3.1.
Page
2 of
40
1.17 “Development
Plan”
shall
have the meaning set forth in Section 3.2.1.
1.18 “Effective
Date”
shall
have the meaning set forth in the preamble.
1.19 “Execution
Date”
shall
have the meaning set forth in the preamble.
1.20 “Entity”
shall
mean any individual, sole proprietorship, corporation, limited liability
company, association, joint venture, partnership, limited partnership, limited
liability partnership, trust, university, business, government or political
subdivision thereof, including an agency, or any other organization that
possesses independent legal standing.
1.21 “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.
1.22 “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.
1.23 “Extraterritorial
Licensees”
shall
mean NovaDel’s Affiliates and licensees outside of the Territory.
1.24 “FDA”
shall
mean the United States Food and Drug Administration, or any successor agency
responsible for the evaluation and approval of pharmaceutical
products.
1.25 “GAAP”
shall
mean Generally Accepted Accounting Principles as consistently
applied.
1.26 “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.
1.27 “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.
1.28 “Indemnification
Claim Notice”
shall
have the meaning set forth in Section 10.3.1.
Page
3 of
40
1.29 “Indemnified
Party”
shall
have the meaning set forth in Section 10.3.1.
1.30 “Initial
Commercial Sale”
shall
mean the first sale for use or consumption by the general public of the Licensed
Product by Licensee or its Affiliates or Sublicensee 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 “Initial
Agreement”
shall
have the meaning set forth in the preamble.
1.32 “Infringement
Suit”
shall
have the meaning set forth in Section 6.8.2.
1.33 “Information
and Inventions”
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.
1.34 “Knowledge”
shall
mean the good faith understanding of the vice presidents, senior vice
presidents, executive vice presidents, president or chief executive officer
of
the respective Party of the facts and information then in their possession
without any duty to conduct any investigation with respect to such facts and
information.
1.35 “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 and any Improvements thereto that are conceived and reduced to practice
by
NovaDel in the course of performing the Development Activities.
1.36 “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 ingredient, the
Designated Compound delivered by means of the Licensed Process.
1.37 “Licensed
Technology”
shall
mean the NovaDel Patents, the NovaDel Know-How and the Drug Master File,
collectively, but only with respect to the Exploitation of the Licensed
Product.
1.38 “Licensee”
shall
have the meaning set forth in the preamble.
1.39 “Licensee
Shares”
shall
have the meaning set forth in Section 4.4.
Page
4 of
40
1.40 “Losses”
shall
have the meaning set forth in Section 10.1.
1.41 “NDA”
shall
mean a New Drug Application filed pursuant to the requirements of the FDA,
as
more fully defined in 21 C.F.R. § 314.5 et
seq.,
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.
1.42 “Net
Sales”
shall
mean [***]
Page
5 of
40
1.43 “NovaDel”
shall
have the meaning set forth in the preamble.
1.44 “NovaDel Know-How”
shall
mean all Information and Inventions Controlled by NovaDel or an Affiliate of
NovaDel as of the Effective Date 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 Licensed Process, and (b) are not generally
known, but excluding any Information and Inventions to the extent claimed by
any
NovaDel Patents.
1.45 “NovaDel
Patents”
shall
mean the Patents that NovaDel Controls (a) as of the Effective Date that are
listed on Exhibit A hereto and (b) from time to time during the Term that claim
(i) the Licensed Process, (b) the Licensed Product, (c) NovaDel Know-How, or
(d)
any Improvements that are conceived and/or reduced to practice in the course
of
Exploiting the Licensed Product or Licensed Process.
1.46 “PAR”
shall
have the meaning set forth in Section 3.2.1.
1.47 “PAR
Sublicense Agreement”
shall
have the meaning set forth in Section 3.2.1.
1.48 “Parties”
shall
have the meaning set forth in the preamble.
1.49 “Party”
shall
have the meaning set forth in the preamble.
1.50 “Patents”
shall
mean 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.
1.51 “Regulatory
Approval”
shall
mean 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.
Page
6 of
40
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 any
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 “Sublicensee”
shall
mean any Third Party to which Licensee grants a sublicense pursuant to Section
2.4 under the licenses granted to Licensee by NovaDel under Section
2.1.
1.55 “Technology”
shall
have the meaning set forth in the preamble.
1.56 “Term”
shall
have the meaning set forth in Section 7.1.
1.57 “Territory”
shall
mean the United States of America and Canada.
1.58 “Third
Party”
shall
mean any Entity other than NovaDel, Licensee and their respective
Affiliates.
1.59 “Third
Party Claim”
shall
have the meaning set forth in Section 10.3.2.
1.60 “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.
1.61 “Valid
Claim”
shall
mean, with respect to a particular country, a claim of a Patent 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
GRANT OF RIGHTS
GRANT OF RIGHTS
2.1 License
Grants to Licensee. Subject
to Section 2.3 and the other terms and conditions of this Agreement, NovaDel
hereby grants to Licensee and Licensee accepts, a non-transferable (except
as
provided in Article 12), sublicenseable (only as provided in Section 2.4),
royalty-bearing, exclusive right and license 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.
Page
7 of
40
2.2 License
Grant to NovaDel.
Licensee
hereby grants to NovaDel a limited, royalty-free, non-exclusive right and
license in the Territory in and to the Licensed Technology to the extent
necessary to perform its Development Activities under Article 3.
2.3 Retained
Rights.
NovaDel
retains all right, title and interest, including the right to grant licenses
to
Third Parties, in and to the Licensed Technology. Licensee shall have no rights,
express or implied, with respect to the Licensed Technology, except as expressly
set forth in Section 2.1, and Licensee covenants to NovaDel that none of
Licensee, its Affiliates or Sublicensees 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, NovaDel
does hereby retain, without any duty of accounting or otherwise to Licensee
or a
Sublicensee, as applicable,:
2.3.1 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
2.3.2 The
right
to independently Exploit products containing compounds other than the Designated
Compound and to use the Licensed Process in connection therewith;
and
2.3.3 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
2.3.4 The
rights for all other territories other than the Territory and non-human uses
of
the Designated Compound.
2.4 Sublicenses.
Licensee
shall have the right to grant sublicenses under the grants in Section 2.1 to
Third Parties pursuant to a separate written agreement, subject to the following
requirements and conditions:
2.4.1 Licensee
must obtain NovaDel’s prior written consent in respect of each such sublicense,
such consent not to be unreasonably withheld but in no case will exceed thirty
(30) days. Except to the extent the Parties otherwise agree pursuant to the
terms of a particular sublicense granted under this Section 2.4, any sublicense
agreement must be fully consistent with the terms and conditions of this
Agreement, and provide that Sublicensee will indemnify NovaDel and its
Affiliates to the extent provided in Article 10.
2.4.2 Within
five (5) days after execution or receipt thereof, as applicable, Licensee shall
provide NovaDel with a full and complete copy of each sublicense agreement
granted hereunder and shall deliver copies of all reports (including relating
to
royalties and other payments) received by Licensee from such Sublicensees.
Page
8 of
40
2.4.3 Termination
of this Agreement by NovaDel pursuant to Section 8.3 with respect to Licensee
shall not terminate any sublicense granted by Licensee pursuant to this Section
2.4 with respect to a Sublicensee, provided that (a) such Sublicensee is not
in
breach of any provision of this Agreement or the applicable sublicense
agreement, (b) such Sublicensee shall perform all obligations of Licensee under
this Agreement, (c) NovaDel shall have all rights with respect to any and all
Sublicensees as it had hereunder with respect to Licensee prior to termination
of this Agreement with respect to Licensee, and (d) Licensee shall include
in
any sublicense a provision in which said Sublicensee acknowledges its
obligations to NovaDel hereunder and the rights of NovaDel to terminate such
sublicense agreement for a breach of such sublicense agreement by such
Sublicensee. The failure of Licensee to include in a sublicense the provisions
referenced in clause (d) shall render the affected sublicense void.
ARTICLE
3
DEVELOPMENT
AND COMMERCIALIZATION ACTIVITIES
3.1 Development
and Commercialization.
Licensee or its Sublicensee shall have the sole right and obligation to develop
and commercialize the Licensed Product in the Territory. NovaDel shall perform
or cause to be performed, on behalf of Licensee, certain Development Activities
in accordance with this Article 3. Except as set forth herein or in an
applicable sublicense, Licensee shall be solely responsible for all costs and
expenses in connection with all development and commercialization activities,
including the Development Activities performed by NovaDel on behalf of Licensee.
3.2 Development
Activities. Except
as
the Parties otherwise agree pursuant to the terms of a sublicense agreement:
3.2.1 Election
Upon Termination of Par Sublicense.
If that
certain Product Development and Commercialization Sublicense Agreement by and
between Licensee, NovaDel and PAR Pharmaceutical, Inc. (“PAR”),
dated
as of the Execution Date (the “PAR
Sublicense Agreement”)
is
terminated, Licensee shall notify NovaDel within sixty (60) days following
such
termination of Licensee’s election to undertake further development of Licensed
Product. Within sixty (60) days following delivery of such notice to NovaDel,
Licensee will adopt and provide to NovaDel a development plan describing its
strategy and principal activities in seeking Regulatory Approval and
commercializing the Licensed Product in accordance with the terms of this
Agreement (the “Development
Plan”).
If
Licensee fails to notify NovaDel within the sixty (60) day period of its
election to undertake further development, fails to provide NovaDel within
the
sixty (60) day period a Development Plan, or elects not to continue development
of Licensed Product, this Agreement shall terminate in accordance with the
provisions of Section 8.4
3.2.2 General.
Under
the direction and supervision of the Development Committee, NovaDel and Licensee
each shall perform, or cause to be performed, its respective Development
Activities in accordance with the Development Plan and corresponding development
budget (the “Development
Budget”).
Notwithstanding the foregoing, the Parties acknowledge and agree that there
can
be no assurances that the objectives of the Development Activities can be
achieved, or that they can be achieved in the manner or in the time set forth
in
the Development Plan. Although outcomes cannot be guaranteed, each Party shall
use Commercially Reasonable Efforts to perform or cause to be performed its
respective Development Activities in good scientific manner, and in material
compliance with Applicable Law. In addition, and without limiting Licensee’s
obligations under this Section 3.2.2, Licensee or its Sublicensee shall file
the
NDA with the FDA on or before the last day of the thirty-second (32nd) month
after the Execution Date (the “Anticipated
Filing Date”);
provided, however, that Licensee or its Sublicensee may extend the Anticipated
Filing Date by four (4) months by delivering, at any time after the second
(2nd)
anniversary of the Execution Date, written notice of such extension to NovaDel.
The Anticipated Filing Date, as extended, may thereafter be extended only upon
the mutual agreement of Licensee or its Sublicensee and NovaDel.
Page
9 of
40
3.2.3 Reports.
Within
thirty (30) days after the end of each calendar quarter in which Development
Activities are performed, each Party shall provide to the Development Committee
a written progress report, which shall describe the Development Activities
it
has performed, or cause to be performed, during such calendar quarter, evaluate
the work performed in relation to the goals of the Development Plan and in
relation to the Development Budget, and provide such other information as may
be
required by the Development Plan or reasonably requested by the Development
Committee with respect to the Development Activities. Minutes from periodic
project team meetings or other meetings between the Parties can serve as a
substitute for the required progress reports outlined in this Section
3.2.3.
3.2.4 Development
Plan and Budget. The
Development Committee shall review the Development Plans and the Development
Budgets at least quarterly and shall have the right to make such modifications
or updates to the Development Plans or Development Budgets that it deems
appropriate. The Parties acknowledge and agree that the amounts set forth in
the
Development Budgets are estimates and, given the unpredictability of the
Development Activities, there can be no assurances that the Development
Activities can be completed within the Development Budgets, provided, however,
that the Parties agree to use their Commercially Reasonable Efforts to adhere
to
the Development Budgets not to exceed the amounts set forth in such Development
Budgets without written approval of the Development Committee.
3.3 Development
Committee.
Except
as the Parties otherwise agree pursuant to the terms of a sublicense
agreement:
3.3.1 Formation
and Authority of Development Committee. NovaDel
and Licensee shall establish a development committee (the “Development
Committee”),
which
shall oversee the Development Activities performed by the Parties, review and
approve the Development Budget and approve any changes to the Development Plan
and Development Budget. Each Party shall appoint an equal number of
representatives with the requisite experience and seniority to enable them
to
make decisions on behalf of the Parties with respect to the Development
Activities. From time to time, each Party may substitute its representatives
on
written notice to the other Party.
3.3.2 Procedural
Rules of Development Committee. The
Development Committee shall meet monthly, or as otherwise agreed to by the
Parties. The Development Committee shall adopt such standing rules as shall
be
necessary for its work. A quorum of the Development Committee shall exist
whenever there is present at a meeting at least one representative appointed
by
each Party. Members of the Development Committee may attend a meeting either
in
person or by telephone, video conference or similar means in which each
participant can hear what is said by the other participants. Representation
by
proxy shall not be allowed. The Development Committee shall take action by
unanimous consent of NovaDel and Licensee, with each such Party having a single
vote, irrespective of the number of representatives actually in attendance
at a
meeting, or by a written resolution signed by the designated representatives
of
each of NovaDel and Licensee.
Page
10
of 40
3.3.3 Dispute
Resolution. If
the
Development Committee cannot, or does not, reach agreement on an issue, then
either Party shall have the right to refer such issue to the Chief Executive
Officers of the Parties who shall confer on the resolution of the issue. Any
final decision mutually agreed to by the Chief Executive Officers of the Parties
shall be in writing and shall be conclusive and binding on the Parties. If
such
officers are not able to agree on the resolution of an issue within twenty
(20)
days after such issue was first referred to them, either Party shall have the
right to refer such dispute to arbitration pursuant to Article 9.
3.3.4 Limitations
on Authority of Development Committee. Each
Party to this Agreement shall retain the rights, powers, and discretion granted
to it under this Agreement, and no such rights, powers, or discretion shall
be
delegated to or vested in the Development Committee unless such delegation
or
vesting of rights is expressly provided for in this Agreement or the Parties
expressly so agree in writing. The Development Committee shall not have the
power to amend or modify this Agreement, which may only be amended or modified
as provided in Section 16.4.
3.4 Regulatory
Approvals.
Except
as the Parties otherwise agree pursuant to the terms of a sublicense, all INDs,
NDAs and other filings, applications or requests pursuant to or in connection
with the Regulatory Approvals required under the Development Plan shall be
made
in the name of Licensee; provided, however, that Licensee shall consult with
NovaDel with respect to the preparation and submission of any such filings,
applications or requests in connection with Regulatory Approvals.
3.4.1 Licensee
will be the primary contact for Chemistry, Manufacturing and Control
(“CMC”)
matters in all relevant regulatory applications except to regulatory bodies
outside the United States and Canada. Licensee will keep NovaDel reasonably
informed of all such communications, if any, between Licensee and the Regulatory
Authorities in the United States and Canada.
3.4.2 NovaDel
and NovaDel’s Extraterritorial Licensees shall have a perpetual, royalty-free,
irrevocable, worldwide right to use and reference the Regulatory Documentation
with respect to the Licensed Product and any data included or referenced therein
for all purposes. Licensee 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 Licensee’s outside of the
Territory. Licensee shall keep NovaDel reasonably informed as to the
communications, if any, between Licensee and the Regulatory
Authorities.
3.4.3 Licensee
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 15.
Page
11
of 40
3.5 Regulatory
Records. NovaDel
and Licensee each shall maintain, or cause to be maintained, records of its
respective 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 respective Development Activities, and which
shall be retained by such Party for at least five (5) years after the
termination of this Agreement, or for such longer period as may be required
by
Applicable Law. Each Party shall have the right, during normal business hours
and upon reasonable notice, to inspect and copy any such records; provided,
however, that neither Party shall have the right to conduct more than one such
inspection in any twelve (12)-month period.
3.6 Development
Expenses. Except
as
the Parties otherwise agree pursuant to the terms of a sublicense:
3.6.1 Licensee’s
Obligation. In
consideration of NovaDel’s performance of its Development Activities, Licensee
shall reimburse NovaDel for the reasonable and documented costs and expenses
incurred by NovaDel in performing such activities in accordance with the
Development Budget (as may be amended in accordance with Section 3.2.4).
Licensee shall bear all costs and expenses incurred by or on behalf of Licensee
in connection with the performance of its Development Activities.
3.6.2 Invoices
and Payments. Within
thirty (30) days after the end of each month in which Development Activities
are
performed, NovaDel shall invoice Licensee for any costs and expenses incurred
by
NovaDel or its Affiliates in such month. Each invoice shall be payable to
NovaDel within thirty (30) days after invoice date.
3.6.3 Books
and Records.
Each
Party shall
maintain complete and accurate books, records and accounts that, in reasonable
detail, fairly reflect any reimbursable costs and expenses incurred by it or
its
Affiliates in performance of the Development Activities in conformity with
GAAP.
Each Party shall
retain such books, records and accounts 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. Each Party shall have the right to have its certified public accountant,
who shall be reasonably acceptable to NovaDel and Licensee, as applicable,
audit
the books and financial records of the other Party and their respective
Affiliates relating to its Development Activities during one or more calendar
quarters; provided, however, that Licensee shall not have the right to audit
a
calendar quarter more than two (2) years after the end of such quarter, to
conduct more than one such audit in any twelve-month period, or to audit any
calendar quarter more than once; and provided further that each Party shall
bear
the cost of such audit unless the audit reveals a variance of more than five
percent (5%) from the reported results, in which case audited Party shall bear
the cost of the audit. The results of such accounting firm shall be final,
absent manifest error.
3.7 Cooperation.
Each
Party shall cooperate with any and all reasonable requests for assistance from
the other Party with respect to the Development Activities, including by making
its employees, consultants and other scientific staff available upon reasonable
notice during normal business hours at their respective places of employment
to
consult with such other Party on issues arising in connection with the
performance of such Development Activities.
Page
12
of 40
3.8 Development
and Use of Trademarks. Licensee
shall have the sole right to determine the Trademarks to be used with respect
to
the Exploitation of the Licensed Product in the Territory, provided that the
product labeling and promotional materials disclose that the Licensed Product
are delivered using the Licensed Process.
3.9 Diligence
Obligations. Following
receipt of Regulatory Approval of the Licensed Product by the FDA, Licensee
(or
its Sublicensees) shall use Commercially Reasonable Efforts to Exploit the
Licensed Product in the United States. Licensee shall have the right, but not
the obligation, to Exploit the Licensed Product in Canada. In addition, Licensee
directly or through a Sublicensee will 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. Licensee (or its Sublicensee if there
is
a sublicense agreement) 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. Licensee (or its Sublicensee if a there
is
a sublicense agreement) shall, at all times during the Term of this Agreement,
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 after receipt of Regulatory Approval for those formulations and
indications for which Licensee (or its Sublicensee if a there is a sublicense
agreement) is commercializing the Licensed Product. Should Licensee (or its
Sublicensee if a there is a sublicense agreement) fail to meet the above
'standard', the Parties will discuss Licensee’s (or its Sublicensee’s if a there
is a sublicense agreement) continued commitment to commercialize the Licensed
Product and the termination of this Agreement or sublicense agreement, if
applicable.
3.10 Manufacturing.
Except
as the Parties otherwise agree pursuant to the terms of an applicable
sublicense:
3.10.1 Subject
to the other provisions of this Section 3.10.1, Licensee 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 Licensee may contract with a Third Party to perform
such
manufacturing services. Licensee 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. Any disputes
between NovaDel and Licensee relating to the manufacture of the Licensed Product
shall be resolved in the manner set forth in Section 3.3.3 hereof. NovaDel
and
its Extraterritorial Licensees retain the right to purchase product from said
Third Party, if applicable, at the same costs as Licensee with the exception
of
an increase of cost due to a modification to the packaging/labeling by NovaDel
or any Extraterritorial Licensee.
3.10.2 Licensee
agrees that, at all times during the performance of the Development Activities,
it, or its designee, will act in accordance with all Applicable
Laws.
Page
13
of 40
3.10.3 To
the
extent Licensee 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 15 of this Agreement.
3.10.4 NovaDel
and its Extraterritorial Licensees may purchase Licensed Product under Section
3.10.1 in the identical packaging and labeling as Licensee 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
Licensee.
3.10.5 Licensee
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 Licensee for obtaining such licenses or
permissions within thirty (30) days of an Extraterritorial Licensee’s receipt of
an invoice from Licensee itemizing such expenses.
3.10.6 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 Licensee 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
Licensee; provided, however, that in no event shall the scope of the
indemnification to Licensee be any less than the scope of the Extraterritorial
Licensee’s indemnification obligations to NovaDel.
ARTICLE
4
ROYALTIES
AND OTHER CONSIDERATION
4.1 Royalties.
As
consideration for the rights, privileges and licenses granted hereunder and
the
Development Activities performed by NovaDel pursuant to Article 3, Licensee
shall make the following payments to NovaDel:
4.1.1 Licensee
shall pay to NovaDel royalties as follows: (i) [***]
percent
([***]%)
of up
to the first $[***]
of
Net
Sales by Licensee or any Affiliate or Sublicensee of Licensee of the Licensed
Product during each calendar year in the Territory plus (ii) [***]
percent
([***]%)
of Net
Sales greater than $[***]
and up
to $[***]
by
Licensee or any Affiliate or Sublicensee of Licensee of the Licensed Product
during each calendar year in the Territory plus (iii) [***]
percent
([***]%)
of Net
Sales greater than $[***]
by
Licensee or any Affiliate or Sublicensee of Licensee of the Licensed Product
during each calendar year in the Territory (see Exhibit B for schedule of
royalty calculation).
Page
14
of 40
4.1.2 The
conversion rate for payments under Section 4.1.1, 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 Section 4.1.1 will apply.
4.1.3 Notwithstanding
anything to the contrary contained herein, any and all royalties to be received
by Licensee pursuant to the PAR Sublicense Agreement shall be paid to a lock-box
account. Accordingly, the Parties agree that, within thirty (30) days after
the
Execution Date, the Parties and the Sublicensee 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 Licensee’s right, title and interest under the Par Sublicense Agreement
(including without limitation its right to receive payments of the sublicense
fees and other amounts payable by Par thereunder) and in and to any lockbox
account(s) to which royalty 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 this Agreement and (iii)
irrevocably instruct PAR to make all royalty payments under the PAR Sublicense
Agreement directly to such lockbox account(s).
4.2 Royalty
Term.
Except
as the Parties otherwise agree pursuant to the terms of an applicable
sublicense, Licensee’s royalty obligations under Section 4.1.1 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 Execution 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 Execution Date
and
(ii) and 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 4.1.1 in such country
shall be reduced in accordance with the terms of Section 4.6.
4.3 Royalty
Payments. Royalties
under Section 4.1.1 shall be payable to NovaDel on a calendar quarterly basis,
within forty-five (45) days after the end of each calendar quarter. Licensee
will submit to NovaDel documentation to support the total amount of funds spent
by the Licensee on pharmaceutical development and clinical studies for the
Licensed Product. Licensee will submit along with payment to NovaDel, a
quarterly royalty statement in a format mutually agreed by both Parties. Along
with the statement will be all supporting documentation comprising of a
statement of net sales for the period and copies of actual paid invoices
covering clinical supplies, consultants, clinical studies, investigator fees,
document preparation, regulatory fees and other direct fees related to
development of the Licensed Product,
Page
15
of 40
4.4 Licensee
Fee & Equity. Simultaneously
with the execution of the Initial Agreement, Licensee issued and sold to NovaDel
73,121 shares of its common stock (the “Licensee
Shares”)
totaling a value of $500,000. Upon execution of this Agreement, NovaDel will
transfer and assign to Licensee all of its right, title and interest in and
to
the Licensee Shares and Licensee will redeem the Licensee Shares. Such transfer
and assignment by NovaDel will be evidenced by a duly executed stock power
or
other form of assignment and shall be accompanied by the original certificate
representing the Licensee Shares.
4.5 Milestone
Payments.
4.5.1 Licensee
has paid, and NovaDel hereby acknowledges receipt of, the Milestone Payments
in
the total sum of $[***],
as
described in Sections 4.5.1, 4.5.2 and 4.5.3 of the Initial
Agreement.
4.5.2 Licensee
shall pay to NovaDel the additional sum of $[***]
within
ten (10) Business Days from the date on which the NDA for the Licensed Product
is approved by the FDA.
4.6 Reduction
of Payments.
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 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 payments set forth in Section 4.1.1 with respect to the Licensed Product
in such country shall be reduced by [***]
percent
([***]%).
4.7 Mode
of Payment.
All
payments to NovaDel under this Agreement shall be paid in United States Dollars
to a bank account in the United States as NovaDel may reasonably designate.
4.8 Non-Refundable,
Non-Creditable. Subject
to Sections 4.9 and 5.2, the amounts paid or payable under this Article 4 shall
be non-refundable and non-creditable against any other amounts due NovaDel
under
this Agreement.
4.9 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
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, Licensee shall pay NovaDel the amount of such
underpayment on the next date payment is due to NovaDel hereunder. To the extent
that the difference between such accruals and the actual results has led to
an
overpayment to NovaDel, Licensee may set-off such overpayments against
subsequent payments to be made to NovaDel; additionally, if any overpayments
remain upon the expiration or termination of this Agreement, NovaDel shall
refund such overpayments to Licensee within thirty (30) days of receiving an
invoice for such overpayment together with applicable supporting documentation.
Page
16
of 40
ARTICLE
5
REPORTS
AND RECORDS
5.1 Record
Retention. Licensee
shall maintain (and shall ensure that its Affiliates and any Sublicensee and
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 Licensee 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.
5.2 Audit.
NovaDel
shall have the right to have an independent certified public accounting firm
of
nationally recognized standing, reasonably acceptable to Licensee, to have
access during normal business hours, and upon reasonable prior written notice,
to such of the records of Licensee and its Affiliates as may be reasonably
necessary to verify the accuracy of such Net Sales, Milestone Payments for
any
calendar quarter ending not more than thirty-six (36) months prior to the date
of such request, and NovaDel may, at its expense, request Licensee to have
such
an audit conducted of its Sublicensee and its Affiliates, as applicable;
provided, however, that in each case NovaDel 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 whether such Net Sales, Other Income or milestone
payments are correct or incorrect and the specific details concerning any
discrepancies. NovaDel shall bear the cost of such audit unless the audit
reveals an under-reporting or underpayment in excess of the greater of
[***]
dollars
($[***])
or
[***]
percent
([***]%)
of
royalties, Milestone Payments or Sublicense Income payable for such period,
in
which case Licensee shall bear the cost of the audit, rectify such underpayment
and pay NovaDel applicable interest as required by Section 5.5. All payments
required under this Section 5.2 shall be due within thirty (30) days of the
date
NovaDel provides Licensee notice of the payment due. The results of such
accounting firm shall be final, absent manifest error.
5.3 Reports.
Within
forty-five (45) days of the end of each quarter of each calendar year, Licensee
shall deliver to NovaDel complete and accurate reports, giving such particulars
of the business conducted by Licensee during the preceding quarter under this
Agreement as shall be pertinent to an accounting for royalties, milestone
payments and Other Income hereunder. These shall include at least the
following:
5.3.1 All
Licensed Product used, leased or sold, by or for Licensee or its
Affiliates.
5.3.2 Total
amounts invoiced for Licensed Product used, leased or sold, by or for Licensee
or its Affiliates.
5.3.3 Deductions
applicable in computed “Net Sales” as defined in Section 1.42.
5.3.4 Total
milestone payments due based on achievement of milestones.
5.3.5 Total
Net
Sales and the royalties due by or for Licensee or its Affiliates or its
Sublicensees, including any adjustments pursuant to Section 4.1.
Page
17
of 40
5.3.6 Names
and
addresses of all Sublicensees and their respective Affiliates and Affiliates
of
Licensee.
5.4 Financial
Statements. Within
one hundred twenty (120) days of the end of each fiscal year of Licensee,
Licensee shall provide NovaDel with a copy of Licensee’s audited financial
statements for such year to NovaDel.
5.5 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 a rate equal to the
then
prevailing prime rate of Citibank, N.A., plus [***]
percent
([***]%),
but
in no event exceeding the amount permitted by Applicable Law.
5.6 Confidentiality.
Each
report received by NovaDel shall be treated by NovaDel as if it were
“Confidential Information” subject to the terms of Article 15.
ARTICLE
6
PATENT
PROSECUTION AND MAINTENANCE
6.1 Ownership
of Information and Inventions. Subject
to Section 6.2 and the license grants under Article 2, as between the Parties,
NovaDel shall own and retain all right, title and interest in and to any and
all: (a) Information and Inventions that are conceived, discovered, developed
or
otherwise made by or on behalf of either Party (or its Affiliates or its
Sublicensees), whether or not patented or patentable, and any and all Patent
and
other intellectual property rights with respect thereto; and (b) other
Information and Inventions, and Patent and other intellectual property rights
with respect thereto that are Controlled (other than pursuant to the license
grants set forth in Article 2) by either Party, its Affiliates or Sublicensees.
Subject to the license grants to Licensee under Article 2, as between the
Parties, NovaDel shall own and retain all right, title and interest in and
to
all Licensed Technology.
6.2 Ownership
of the Licensed Process. Subject
to the license grants to Licensee under Article 2, as between the Parties,
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 Licensee, its
Affiliates or Sublicensees (other than NovaDel and its Affiliates), whether
or
not patented or patentable, and any and all Patent and other intellectual
property rights with respect thereto. Licensee acknowledges and agrees that
(a)
the licenses granted to it pursuant to Section 2.1 permit Licensee to use the
Licensed Process solely for the Exploitation of Licensed Product as provided
in
this Agreement, (b) Licensee 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, and (c) neither it, nor any of its Affiliates or
Sublicensees, 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. Accordingly, Licensee shall promptly disclose to NovaDel
in
writing, the conception or reduction to practice, or the discovery, development
or making of any such Information and Inventions that relate to the Licensed
Process and shall, and does hereby, assign, and shall cause its Affiliates
and
Sublicensees to so assign, to NovaDel, without additional compensation, all
of
their respective rights, titles and interests in and to any such Information
and
Inventions.
Page
18
of 40
6.3 Disclosure
and Assignment.
Licensee
or its Sublicensee, as applicable, 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 6.1 and
6.2, and shall, and does hereby, assign, and shall cause its respective
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, Licensee or its Sublicensee, as applicable, 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
Licensee or its Sublicensee, as applicable, shall be entitled to use such
intellectual property rights in accordance with the licenses granted pursuant
to
Article 2.
6.4 Non-Use
of Trademarks.
Except
as set forth explicitly in this Agreement, neither Licensee or any of its
Sublicensees or Affiliates nor NovaDel shall have the right to use the
trademarks, trade names or logos of the other parties, nor any adaptation
thereof, nor the names of any employees or consultants of any of the other
parties, 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
and
the Securities Exchange Act of 1934, each as amended, and the rules and
regulations thereunder.
6.5 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, copyright or other intellectual property rights)
therein, shall, for purposes of this Agreement, be made in accordance with
applicable United States law.
6.6 Prosecution
of Patents. Except
as
the Parties otherwise agree pursuant to the terms of an applicable
sublicense:
6.6.1 Prosecution
of NovaDel Patents. As
between the Parties, NovaDel shall have the sole right, at its cost and expense,
to obtain, prosecute and maintain throughout the world the NovaDel Patents;
provided, however, that Licensee shall reimburse NovaDel for [***]
percent
([***]%)
of the
reasonable out-of-pocket costs incurred by NovaDel, as of the Effective Date,
for filing, prosecuting and maintaining such NovaDel Patents to the extent
that
they claim or cover solely the Exploitation of the Licensed Product in the
Territory.
Licensee
shall, and shall cause its Affiliates and Sublicensees, as applicable, to,
cooperate fully with NovaDel in the preparation, filing, prosecution, and
maintenance of NovaDel’s 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, and maintain its Patents in any country; and (b) promptly
informing NovaDel of matters that may affect the preparation, filing,
prosecution, or maintenance of any such Patents.
NovaDel
shall provide Licensee with drafts of all patent applications and other material
submissions to and correspondence with any patent authorities 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, to allow for review and comment by Licensee. In addition, NovaDel
shall provide Licensee with an opportunity to consult with NovaDel regarding
the
filing and contents of any such application, submission or correspondence.
If
Licensee 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), 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, or to take any other action with respect to
a
NovaDel Patent in a particular country that is necessary or useful to establish
or preserve rights with respect to the Licensed Product, and (y) such Patent
does not claim or cover the Licensed Process, then NovaDel shall so notify
Licensee promptly in writing and in good time to enable Licensee 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. 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 Licensee that it do so (and thereafter
diligently pursue such action), Licensee 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. If Licensee elects to pursue such filing or registration, as the case
may be, or continue such support, then Licensee shall notify NovaDel of such
election and NovaDel shall, and shall cause its Affiliates to, (x) reasonably
cooperate with Licensee in this regard, and (y) promptly grant to Licensee,
without additional consideration, an exclusive, perpetual, irrevocable,
royalty-free license in such country under such NovaDel Patent.
Page
19
of 40
6.7 Enforcement
of NovaDel Patents. Except
as
the Parties otherwise agree pursuant to the terms of an applicable
sublicense:
6.7.1 Technology
of NovaDel. If
either
Party determines that any Technology or NovaDel or any joint Technology is
being
infringed by a Third Party’s activities and that such infringement could affect
the exercise by the Parties of their respective rights and obligations under
this
Agreement, it shall promptly notify such other Party in writing and provide
such
other Party with any evidence of such infringement that is reasonably
available.
Promptly
after the receipt of such written notice, the Parties shall meet and discuss
in
good faith the removal of such infringement. NovaDel shall consider in good
faith any comments from Licensee and shall keep Licensee reasonably informed
of
any steps taken to remove such infringement. NovaDel shall have the first right,
but not the obligation, to remove such infringement at its sole cost and
expense; provided, however, that Licensee shall reimburse NovaDel for one
hundred percent (100%) of the reasonable out-of-pocket costs incurred by NovaDel
with respect to the removal of any such infringement to the extent that such
infringement adversely affects the Exploitation of the Licensed Product in
the
Territory. In
the
event that NovaDel fails within ninety (90) days following notice of such
infringement, or earlier notifies Licensee in writing of its intent not, to
take
commercially appropriate steps to remove any infringement of any NovaDel Patent
that is likely to have a material adverse effect on the sale of a Licensed
Product, Licensee shall have the right to do so at Licensee’s expense; provided,
however, that if NovaDel has commenced negotiations with an alleged infringer
for discontinuance of such infringement within such ninety (90) day period,
NovaDel shall have an additional ninety (90) days to conclude its negotiations
before Licensee may bring suit for such infringement, and provided further
that
Licensee shall not enter into any settlement or compromise with respect to
any
NovaDel Patent without NovaDel’s prior consent, which consent shall not be
unreasonably withheld. Each Party shall provide reasonable assistance to the
other Party, 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. Any
amounts recovered by a Party pursuant to this Section, whether by settlement
or
judgment, shall be used to reimburse the Parties for their reasonable costs
and
expenses in making such recovery (which amounts shall be allocated pro rata
if
insufficient to cover the totality of such expenses), with any remainder being
retained by the Party that brought the enforcement action; provided,
however,
that to
the extent that any award is attributable to the loss of sales of Licensed
Product, such amount shall be paid to Licensee and shall be treated as Net
Sales
on which royalties shall be due under Article 4.
Page
20
of 40
6.8 Potential
Third Party Rights.
Except
as the Parties otherwise agree pursuant to the terms of an applicable
sublicense:
6.8.1 Third-Party
Licenses. If
(a) in
the opinion of outside patent counsel to Licensee, Licensee, or any of its
Affiliates or Sublicensees, cannot Exploit a Licensed Product in a country
in
the Territory without infringing one or more Patents that have issued to a
Third
Party in such country, or (b) as a result of any claim made against a Party,
or
any of its Affiliates or Sublicensees, alleging that the Exploitation of a
Licensed Product infringes or misappropriates any Patent or any other
intellectual property right of a Third Party in a country in the Territory,
a
judgment is entered by a court
of
competent jurisdiction from which no appeal is taken within the time permitted
for appeal, such that Licensee cannot Exploit such Licensed Product in such
country without infringing the Patent or other proprietary rights of such Third
Party, then, in either case, Licensee shall have the first right, but not the
obligation to negotiate and to obtain a license from such Third Party as
necessary for the Exploitation of any Licensed Product hereunder in such
country; provided, however, that NovaDel shall have the sole right to seek
any
such license with respect to the Licensed Process and shall use commercially
reasonable efforts to obtain such a license in its own name from such Third
Party in such country, under which NovaDel shall, to the extent permissible
under such license, grant a sublicense to Licensee as necessary for Licensee,
and any of its Affiliates and Sublicensees, to Exploit the Licensed Product
as
provided hereunder in such country. Licensee shall be solely responsible for
[***]
percent
([***]%)
of all
royalty and other obligations with respect to the Exploitation of the Licensed
Product; provided, however, that Licensee shall have the right to credit
[***]
percent
([***]%)
any
royalties paid by Licensee, its Affiliates or Sublicensees under such license
with respect to such country against the royalty payments to be paid by Licensee
to NovaDel with respect to the sale of the Licensed Product under Section 4.1;
provided, however, that no royalty payment when due, regardless of the amount
or
number of credits available to Licensee in accordance with this Agreement,
shall
be reduced by more than [***]
percent
([***]%)
of the
amounts otherwise owed pursuant to Section 4.1 in any calendar quarter. Credits
not exhausted in any calendar quarter may be carried into future calendar
quarters.
Page
21
of 40
6.8.2 Third
Party Litigation. In
the
event that a Third Party institutes a patent or other infringement suit
(including any suit alleging the invalidity or unenforceability of the Patents
of a Party or its Affiliates) against either Party or its respective Affiliates,
licensees or Sublicensees during the Term, alleging use of the Licensed
Technology or any other activities hereunder, 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. NovaDel shall
have the first right to direct and control any Infringement Suit to the extent
that it relates to the use of the Licensed Technology or the Licensed Process;
provided
that
Licensee shall bear [***]
percent
([***]%)
of the
costs and expenses associated with any such Infringement Suit to the extent
that
it relates to the Exploitation of the Licensed Product.
6.8.3 Retained
Rights. Nothing
in this Section 6.8 shall prevent Licensee or its Sublicensee, as applicable,
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
7
TERM
OF THE AGREEMENT
7.1 Term.
Unless
otherwise terminated pursuant to Article 8, 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) 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 Execution Date (the “Term”).
ARTICLE
8
TERMINATION
8.1 Termination
Upon Insolvency. If
Licensee 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 Licensee and not dismissed within
sixty (60) days, or if the business of Licensee shall be placed in the hands
of
a receiver, assignee or trustee for the benefit of creditors, whether by the
voluntary act of Licensee or otherwise, this Agreement shall automatically
terminate.
8.2 Termination
for Payment Default. Should
Licensee fail to make payment to NovaDel of royalties or other amounts due
in
accordance with the terms of this Agreement, NovaDel shall have the right to
terminate this Agreement within ten (10) days after giving said notice of
termination unless Licensee shall pay to NovaDel, within the 10-day period,
all
such amounts due and payable. Upon the expiration of the 10-day period, if
Licensee shall not have paid all such amounts due and payable, the rights,
privileges and licenses granted hereunder shall, at the option of NovaDel,
immediately terminate. In the event a payment is the subject of a bona fide
dispute between NovaDel and Licensee that is being pursued by a Party pursuant
to the dispute resolution mechanism in Article 9, then Licensee shall make
such
payment, but shall provide NovaDel 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
Licensee, NovaDel shall refund such payment to Licensee with interest calculated
pursuant to Section 5.5 from the date of such payment.
Page
22
of 40
8.3 Termination
for Material Breach. Upon
any
material breach or default of this Agreement by either Party, other than as
set
forth in Section 8.2, and subject to Section 2.4.3, the other Party shall have
the right to terminate this Agreement and the rights, privileges and licenses
granted hereunder upon giving thirty (30) days notice to the breaching Party.
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.
8.4 Termination
By The Licensee. Licensee
shall have the right at any time to terminate this Agreement in whole or as
to
any Licensed Product (i) by giving 90 days notice thereof in writing to NovaDel
or (ii) if Licensee elects not to effect the Milestone Payment which is due
and
payable as provided in Section 4.5.2.
8.5 Survival.
Any
expiration or termination of this Agreement shall not affect the rights and
obligations of the Parties accrued prior to such expiration or termination.
Without limiting the foregoing, Articles 4, 5, 6, 9, 10, 11, 14, 15 and 16
and
Sections 8.6, 8.7, 16.1, 16.7 and this Section 8.5 shall survive the termination
or expiration of this Agreement for any reason.
8.6 Work-in-Progress.
Licensee
and/or any Sublicensee thereof may, however, after the effective date of such
termination and continuing for a period not to exceed six (6) months thereafter,
sell all completed Licensed Product, and any Licensed Product in the process
of
manufacture at the time of such termination, and sell the same, provided that
Licensee shall pay or cause to be paid to NovaDel the royalties thereon as
required by Article 4 of this Agreement and shall submit the reports required
by
Article 5 hereof on the sales of Licensed Product.
8.7 Return
of Information; Assignment and License.
8.7.1 Upon
termination of this Agreement, Licensee shall, and shall cause its Affiliates
and Sublicensees, as applicable, to return to 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 NovaDel’s Information and Inventions
or other Confidential Information (except one copy of each that may be retained
for archival purposes).
8.7.2 Upon
the
termination of this Agreement, Licensee (a) shall, and shall cause its
Affiliates and, subject to Section 8.7.3, Sublicensees to, promptly disclose
to
NovaDel, in whatever form NovaDel may request, all Regulatory Documentation
and
all other Information and Inventions in the possession or Control of Licensee,
its Affiliates or Sublicensees that relate to the Exploitation of such Licensed
Product, (b) shall, and does hereby, assign, and shall cause its Affiliates
and,
subject to Section 8.7.3, Sublicensees to assign, to NovaDel, 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 and, subject to Section 8.7.3, Sublicensees to grant, to NovaDel,
without additional compensation, a perpetual, irrevocable, royalty-free,
exclusive, sublicenseable through multiple tiers of sublicensees, right and
license to Exploit such Licensed Product in the Territory, and (d) shall, and
does hereby, and shall cause its Affiliates and, subject to Section 8.7.3,
Sublicensees 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 Licensee and its
Affiliates or any Sublicensee and its Affiliates in each case that relate to
the
Exploitation of such Licensed Product to the extent not already assigned to
NovaDel pursuant to Sections 6.1 or 6.2.
Page
23
of 40
8.7.3 Notwithstanding
anything contained in Sections 8.7.1 and 8.7.2, in the event that any sublicense
granted by Licensee survives pursuant to Section 2.4.3, the Sublicensee may
retain (a) the information and materials identified in Section 8.7.1 that are
rightfully in its possession and (b) Agreement-Related Assets, in each case
until the termination of such sublicense, whereupon such Sublicensee shall
return such materials to NovaDel.
8.8 Cumulative
Remedies. The
rights and remedies set forth in this Article 8 are cumulative and in addition
to any other rights that may be available to the Parties.
8.9 Non-Refundability
of Milestones and Development Costs.
Any and
all Milestone Payments made to NovaDel by Licensee under Article 4 of this
Agreement shall be non-refundable in the event of termination of this Agreement
by either Party under any of the provisions of Article 8.
ARTICLE
9
ARBITRATION
9.1 Procedures.
Any
dispute arising from or relating to this Agreement 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
Licensee 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.
9.2 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 either Party to obtain judicial resolution of such
issues, unless an order staying the arbitration proceeding shall be entered
by a
court of competent jurisdiction. Neither Party 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.
Page
24
of 40
9.3 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
10
INDEMNIFICATION
AND INSURANCE
10.1 Indemnification
of NovaDel. Subject
to any Sublicensee’s first obligations to directly indemnify, defend and hold
NovaDel harmless under an applicable sublicense agreement, Licensee shall
defend, indemnify and hold NovaDel, its Affiliates, and their respective
directors, officers, employees and agents harmless from and against all
liability, demands, damages, including expenses or losses including death,
personal injury, illness or property damage (collectively, “Losses”)
arising directly or indirectly out of any: (a) breach of this Agreement by
Licensee, its Affiliates, Sublicensees or permitted assigns or transferees;
(b)
actual or asserted violations of Applicable Law by Licensee, its Affiliates,
Sublicensees or permitted assignees or transferees; (c) use by Licensee, its
Affiliates, Sublicensees or permitted assignees or transferees of the Licensed
Technology or (d) Exploitation of the Licensed Product by Licensee, its
Affiliates, Sublicensees or permitted assignees or transferees, except for
those
Losses for which NovaDel has an obligation to indemnify Licensee and its
Affiliates pursuant to Section 10.2, as to which Losses each Party shall
indemnify the other to the extent of their respective liability for the Losses
and other than as a result of NovaDel’s gross negligence, recklessness or
willful misconduct.
10.2 Indemnification
of Licensee.
Subject
to any Sublicensee’s first obligations to directly indemnify, defend and hold
Licensee harmless under an applicable sublicense agreement, NovaDel shall
defend, indemnify and hold Licensee, its Affiliates, and their respective
directors, officers, employees and agents harmless from and against all Losses
arising directly or indirectly out of any: (a) breach of this Agreement by
NovaDel or its Affiliates; or (b) actual or asserted violations of Applicable
Law by NovaDel or its Affiliates, except for those Losses for which Licensee
has
an obligation to indemnify NovaDel and its Affiliates pursuant to Section 10.1,
as to which Losses each Party shall indemnify the other to the extent of their
respective liability for the Losses.
10.3 Indemnification
Procedure.
10.3.1 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 under Section 10.1 or Section 10.2, 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 (the “Indemnified
Party”).
Page
25
of 40
10.3.2 Third
Party Claims.
The
obligations of an indemnifying Party under this Article 10 with respect to
Losses arising from claims of any Third Party that are subject to
indemnification as provided for in Sections 10.1 or 10.2 (a “Third
Party Claim”)
shall
be governed by and be contingent upon the following additional terms and
conditions:
(a) 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.
(b) Right
to Participate in Defense.
Without
limiting Section 10.3.2(a), 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 10.3.2(a) (in which case the
Indemnified Party shall control the defense).
(c) 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 10.3.2(a), 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.
Page
26
of 40
(d) 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.
(e) 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.
10.4 Insurance.
10.4.1 At
all
times from and after the Effective Date, Licensee or its Sublicensee
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 with a copy of its policies
of
insurance in that regard, along with any amendments and revisions
thereto.
10.4.2 At
all
times from and after the Effective Date, NovaDel 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 the Licensee with a copy of its
policies of insurance in that regard, along with any amendments and revisions
thereto.
10.4.3
Each of
Licensee and NovaDel shall, starting 6 months prior to anticipated receipt
of
NDA approval of 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 the other Party. Each Party
shall provide the other Party 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 the other Party 15 days
prior to any material change, cancellation or non-renewal of the policy. The
said amount can vary if mutually agreed by both Parties.
Page
27
of 40
ARTICLE
11
REPRESENTATIONS
AND WARRANTIES;
LIMITATION
OF LIABILITY
11.1 Representations,
Warranties and Covenants. Each
Party hereby represents and warrants to the other Party as of the Effective
Date
as follows:
11.1.1
Duly Organized. 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.
11.1.2 Corporate
Authority. Such
Party (a) has the power and authority and the legal right to enter into this
Agreement and perform its obligations hereunder, and (b) has taken all necessary
action on its part required to authorize the execution and delivery of this
Agreement and the performance of its obligations hereunder. The Agreement has
been duly executed and delivered on behalf of such Party and is enforceable
against it in accordance with its terms, subject to the effects of bankruptcy,
insolvency or other laws of general application affecting the enforcement of
creditor rights and judicial principles affecting the availability of specific
performance and general principles of equity, whether enforceability is
considered in a proceeding at law or in equity.
11.1.3 Litigation.
Such
Party 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 Entity.
11.1.4 Consents,
Approvals, etc. All
necessary consents, approvals and authorizations of all regulatory and
governmental authorities and other Entities required to be obtained by such
Party in connection with the execution and delivery of this Agreement and the
performance of its obligations hereunder have been obtained.
11.1.5 Conflicts.
The
execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder (a) do not conflict with or violate any requirement of
Applicable Law or regulation or any provision of the articles of incorporation,
bylaws, or any similar constitutive document of such Party, as applicable,
in
any material way, and (b) do not conflict with, violate, or breach or constitute
a default or require any consent under, any contractual obligation or court
or
administrative order by which such Party is bound.
Page
28
of 40
11.2 Additional
Representations, Warranties and Covenants of NovaDel. NovaDel
hereby represents and warrants and, on behalf of its Affiliates, agrees and
covenants as follows:
11.2.1 NovaDel
represents and warrants to Licensee that, to its Knowledge, as of the Effective
Date, NovaDel is the owner or (sub)licensee (with the right to grant sublicenses
to Licensee as contemplated under this Agreement) of the NovaDel Patents, and
has
all
right, title, and interest in and to the NovaDel Patents, including exclusive,
absolute, irrevocable right, title and interest thereto, free and clear of
all
liens, charges, encumbrances or other restrictions or limitations of any kind
whatsoever and to the NovaDel’s knowledge and belief there are no licenses,
options, restrictions, liens, rights of Third Parties, disputes, royalty
obligations, proceedings or claims relating to, affecting, or limiting its
rights or the rights of the Licensee under this Agreement with respect to,
or
which may lead to a claim of infringement or invalidity regarding, any part
or
all of the Licensed Technology and their use as contemplated in the underlying
patent applications as presently drafted. The
NovaDel Patents have not, as of the Effective Date, been held by a court of
competent jurisdiction to be invalid or unenforceable, in whole or in
part;
11.2.2 To
NovaDel’s knowledge and belief there is no claim, pending or threatened, of
infringement, interference or invalidity regarding, any part or all of the
Licensed Technology and their use as contemplated in the underlying patent
applications as presently drafted;
11.3 Additional
Representations, Warranties and Covenants of Licensee. Licensee
hereby represents and warrants and,
on
behalf of itself and its Affiliates, agrees and covenants as
follows:
11.3.1 To
the
extent permitted by Applicable Law, in
any
country, region or jurisdiction in the Territory, Licensee, on behalf of its
Affiliates, agrees and covenants never to institute or prosecute any claim,
action or suit at law or in equity seeking to have any claim in a NovaDel Patent
declared invalid or unenforceable; provided,
however,
that
nothing contained herein shall prohibit Licensee and its Affiliates and
Sublicensees from either (a) asserting any and all defenses available to it,
including assertions relating to the validity or enforceability of the NovaDel
Patents, in any suit or proceeding brought against them alleging the
infringement of any of the NovaDel Patents, 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 Licensee or
its
Affiliates or Sublicensees and a patent or patent application included within
the definition of the NovaDel Patents.
11.3.2 Except
as
the Parties otherwise agree pursuant to the terms of an applicable sublicense,
Licensee shall include covenants in its agreements with each of its Sublicensees
materially identical to those Licensee is making in Sections 11.3.1 and 11.3.2
on the part of the Sublicensee, and shall provide that NovaDel shall have
march-in right to seek termination of such agreement in the event the
Sublicensee breaches the covenant. NovaDel’s right to seek termination of such
agreement with the Sublicensee shall be subject to notice, cure and dispute
resolutions provisions materially identical to the provisions set forth in
Article 9. Licensee 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.
Page
29
of 40
11.4 DISCLAIMER
OF WARRANTY. EXCEPT
FOR THE EXPRESS WARRANTIES SET FORTH IN SECTIONS 11.1, 11.2 AND 11.3, NEITHER
NOVADEL NOR LICENSEE MAKE ANY REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS
OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE,
UNDER THIS AGREEMENT, AND EACH PARTY 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 PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY
RIGHTS OF THIRD PARTIES UNDER THIS AGREEMENT.
11.5 LIMITATION
OF LIABILITY. EXCEPT FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS IN RESPECT OF
THIRD PARTY CLAIMS UNDER THIS AGREEMENT, NONE OF NOVADEL OR ANY OF ITS
AFFILIATES OR LICENSEE OR ANY OF ITS AFFILIATES OR ANY SUBLICENSEE OR ANY OF
ITS
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 (B) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS
OF
THIS AGREEMENT.
ARTICLE
12
ASSIGNMENT
This
Agreement and the rights and duties appertaining hereto may not be assigned
by
either Party without first obtaining the written consent of the other which
consent shall not be unreasonably withheld. Any such purported assignment,
without the written consent of the other Party, shall be null and of no effect.
Notwithstanding the foregoing, Licensee may assign this Agreement (i) to a
purchaser, merging or consolidating corporation, or acquiror of substantially
all of Licensee’s assets or business and/or pursuant to any reorganization
qualifying under section 368 of the Internal Revenue Code of 1986, as amended,
and as may be in effect at such time, or (ii) to an Affiliate of Licensee
subject to the consent of NovaDel which consent shall not be reasonably
withheld.
ARTICLE
13
USE
OF NAMES AND PUBLICATION
13.1 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 and the Securities Exchange Act of 1934, each as amended,
and the rules and regulations thereunder or as promulgated by an applicable
securities exchange governing body.
Page
30
of 40
13.2 Relationship
of the Parties. Nothing
herein shall be deemed to establish a relationship of principal and agent
between NovaDel and Licensee, nor any of their agents or employees for any
purpose whatsoever. This Agreement shall not be construed as creating a
partnership between NovaDel and Licensee, or as creating any other form of
legal
association or arrangement which would impose liability upon one Party for
the
act or failure to act of the other Party.
13.3 Publications.
In
the
event that either Party desires to publish or disclose, by written, oral or
other presentation, Licensed Technology or any material information related
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 Licensee or its Sublicensee, 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 Licensee or its Sublicensee do so. Upon receipt of such request
to
delay such presentation, publication or disclosure, Licensee or its Sublicensee
shall arrange for a delay of such presentation, publication or disclosure until
such time as Licensee or its Sublicensee 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 Licensee or its Sublicensee does not receive any
such request from NovaDel to delay such presentation, publication or disclosure,
Licensee or its Sublicensee may submit such material for presentation,
publication or other form of disclosure. Notwithstanding the foregoing, in
no
event shall Licensee or its Sublicensee 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.
ARTICLE
14
PAYMENTS,
NOTICES AND OTHER COMMUNICATIONS
All
notices or other communications that are required or permitted hereunder shall
be in writing and delivered personally, sent by telecopier (and promptly
confirmed by personal delivery, registered or certified mail or overnight
courier as provided herein), sent by nationally-recognized overnight courier
or
sent by registered or certified mail, postage prepaid, return receipt requested,
addressed as follows:
If
to
NovaDel to:
NovaDel
Pharma Inc.
00
Xxxxxxxxxxxx Xxxx
Page
31
of 40
Xxxxxxxxxx,
XX 00000
Attention:
President
000.000.0000
(fax)
with
a
copy (not constituting notice) to:
Xxxxxx,
Xxxxx & Xxxxxxx LLP
000
Xxxxxxxx Xxxxxx
Xxxxxxxxx,
XX 00000
Attention:
Xxxxxxx X. Xxxxxxx, Esq.
Fax:
(000) 000-0000
If
to
Licensee 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
3300
Xxxxx Fargo Center
00
Xxxxx
Xxxxxxx Xxxxxx
Xxxxxxxxxxx,
Xxxxxxxxx 00000
Attention:
Xxxxxxxxxxx X. Xxxxxx, 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 Article 14 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.
ARTICLE
15
CONFIDENTIALITY
15.1 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 the other 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.
Page
32
of 40
15.2 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:
15.2.1 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;
15.2.2 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;
15.2.3 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;
15.2.4 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
15.2.5 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.
Specific
aspects or details of Confidential Information shall not be deemed to be within
the public domain or in the possession of a Party merely because the
Confidential Information is embraced by more general information in the public
domain or in the possession of such Party. Further, any combination of
Confidential Information shall not be considered in the public domain or in
the
possession of a Party merely because individual elements of such Confidential
Information are in the public domain or in the possession of such Party unless
the combination and its principles are in the public domain or in the possession
of such Party.
15.3 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
and sublicensees 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 the other Party, its Affiliates or
Sublicensees.
Page
33
of 40
15.4 Authorized
Disclosure.
Each
Party may disclose Confidential Information of the other Party to the extent
that such disclosure is:
15.4.1 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 such other Party and given
such
other 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;
15.4.2 Required
by Law. Otherwise
required by law; provided,
however,
that
the disclosing Party shall (a) provide the other Party with reasonable advance
notice of and an opportunity to comment on any such required disclosure, (b)
if
requested by such other 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 such other Party in any such disclosure or request
for confidential treatment;
15.4.3 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
15.4.4 Required
by Agreement.
Made by
such Party, in connection with the performance of this Agreement, to Affiliates,
Sublicensees, 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 15.
15.5 Press
Releases.
Press
releases or other similar public communication by either Party relating to
this
Agreement, shall be approved in advance by the other Party, which approval
shall
not be unreasonably withheld or delayed, except for those communications
required by Applicable Law (which shall be provided to the other Party as soon
as practicable after the release or communication thereof), disclosures of
information for which consent has previously been obtained, and information
of a
similar nature to that which has been previously disclosed publicly with respect
to this Agreement, each of which shall not require advance
approval.
ARTICLE
16
MISCELLANEOUS
PROVISIONS
16.1 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.
Page
34
of 40
16.2 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, Licensee or
its
Sublicensee, as applicable, shall assume all legal obligations to do so and
the
costs in connection therewith.
16.3 Trade
Regulations. Licensee
or its Sublicensee and its Affiliates 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.
16.4 Entire
Agreement. The
Parties hereto acknowledge that this Agreement, including the Appendices and
documents incorporated by reference, sets forth the entire agreement and
understanding of the Parties hereto as to the subject matter hereof, and shall
not be subject to any change of modification except by the execution of a
written instrument subscribed to by the Parties hereto. This Agreement shall
supersede all previous communications, representations or understandings, either
oral or written, between the Parties relating to the subject matter hereof,
including the Initial Agreement.
16.5 Severability.
If
any
provision of this Agreement is held to be illegal, invalid or unenforceable
under any present or future law, and if the rights or obligations of either
Party under this Agreement will not be materially and adversely affected
thereby, (a) such provision shall be fully severable, (b) this Agreement shall
be construed and enforced as if such illegal, invalid or unenforceable provision
had never comprised a part hereof, (c) the remaining provisions of this
Agreement shall remain in full force and effect and shall not be affected by
the
illegal, invalid or unenforceable provision or by its severance herefrom, and
(d) in lieu of such illegal, invalid or unenforceable provision, there shall
be
added automatically as a part of this Agreement a legal, valid and enforceable
provision as similar in terms to such illegal, invalid or unenforceable
provision as may be possible and reasonably acceptable to the Parties herein.
To
the
fullest extent permitted by Applicable Law, each Party hereby waives any
provision of law that would render any provision prohibited or unenforceable
in
any respect.
16.6 Waiver.
The
waiver by a Party of a breach or a default of any provision of this Agreement
by
the other 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
a 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.
16.7 Equitable
Relief. Each
Party acknowledges and agrees that the restrictions set forth in Articles 6
and
16 of this Agreement are reasonable and necessary to protect the legitimate
interests of the other Party and that such other Party would not have entered
into this Agreement in the absence of such restrictions, and that any violation
or threatened violation of any provision of Article 6 and 16 may result in
irreparable injury to such other Party. Each Party also acknowledges and agrees
that in the event of a violation or threatened violation of any provision of
Article 6 and 16, the other 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.
Page
35
of 40
16.8 Force
Majeure. In
the
event that a 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 Construction.
Except
where the context otherwise requires, wherever used, the singular shall include
the plural, the plural the singular, the use of any gender shall be applicable
to all genders and the word “or” is used in the inclusive sense (and/or). The
captions of this Agreement are for convenience of reference only and in no
way
define, describe, extend or limit the scope or intent of this Agreement or
the
intent of any provision contained in this Agreement. The term “including” as
used herein shall mean including, without limiting the generality of any
description preceding such term. The language of this Agreement shall be deemed
to be the language mutually chosen by the Parties and no rule of strict
construction shall be applied against either Party hereto.
16.10 Further
Assurance.
Each
Party shall duly execute and deliver, or cause to be duly executed and
delivered, such further instruments and do and cause to be done such further
acts and things, including the filing of such assignments, agreements, documents
and instruments, as may be necessary or as the other Party may reasonably
request in connection with this Agreement or to carry out more effectively
the
provisions and purposes, or to better assure and confirm unto such other Party
its rights and remedies under this Agreement.
16.11 Expenses.
Each of
Licensee and NovaDel shall be responsible for their own expenses relating to
the
negotiation, execution and performance of this Agreement.
16.12 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
NovaDel or Licensee or any Sublicensee and its Affiliates 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.
Page
36
of 40
16.13 Counterparts.
This
Agreement may be executed in two or more counterparts, each of which shall
be
deemed an original, but all of which together shall constitute one and the
same
instrument.
16.14 Binding.
This
Agreement shall not be binding upon the Parties until it has been signed below
on behalf of each Party.
[Signature
Page Follows]
Page
37
of 40
IN
WITNESS WHEREOF,
the duly
authorized officers of the Parties have executed this Agreement as of the dates
set forth below their respective signatures.
| NOVADEL PHARMA INC. | HANA BIOSCIENCES, INC. | |||
|
By:
|
/s/ Xxxxxx Xxxxxx |
By:
|
/s/ Xxxx X. Xxx | |
|
Name:
|
Xxxxxx Xxxxxx |
Name:
|
Xxxx X. Xxx | |
|
Title:
|
Chairman, President and CEO |
Title:
|
President & CEO |
|
Date:
|
July 31, 2007 |
Date:
|
July 31, 2007 |
Page
38
of 40
EXHIBIT
A
PATENTS
1. United
States Patent No. 6,676,931 B2
Page
39
of 40
EXHIBIT
B
Royalty
Rate Structure
|
Net
Sales (U.S. Sales and Canadian Sales Converted to U.S.
Dollars)
|
Royalty
Rate
|
|
|
$[***]
to $[***]
|
[***]%
|
|
|
Plus
|
||
|
$[***]
to
$[***]
|
[***]%
|
|
|
Plus
|
||
|
$[***]
and
above
|
[***]%
|
Page
40
of 40
