AMENDMENT TO NO. 3 TO LICENSE AND DEVELOPMENT AGREEMENT
Exhibit
10.40
AMENDMENT
TO NO. 3 TO
THIS
AMENDMENT NO. 3 TO LICENSE AND DEVELOPMENT AGREEMENT
(this
“Amendment”),
dated
as of December 22, 2006, 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,
the
Parties entered into that certain License and Development Agreement dated
October 26, 2004 (the “Agreement”),
as
amended on August 8, 2005 and again on May 15, 2006, pursuant to which Licensee
licensed from NovaDel certain exclusive rights to develop and commercialize
a
pharmaceutical product containing ondansetron as an active ingredient that
will
be administered to humans using the Technology on the terms and conditions
set
forth in the Agreement; and
WHEREAS,
the
Agreement as amended on August 8, 2005 provided that NovaDel would have certain
rights to use and reference the Regulatory Documentation with respect to the
Licensed Product, and to purchase the product from Licensee or its third party
manufacturer; and
WHEREAS,
the
Parties desire to amend the Agreement to clarify the Parties’ intentions with
regard to the rights of NovaDel’s Extraterritorial Licensees (as defined in this
Amendment) to use and reference the Regulatory Documentation with respect to
the
Licensed Product, and to purchase such product from Licensee or its third party
manufacturer.
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:
1. Definition
of Extraterritorial Licensee.
A new
Section 1.54 shall be added to the Agreement, as follows:
“1.54 “Extraterritorial
Licensee”
shall
mean NovaDel’s Affiliates and licensees outside the Territory.”
2. Regulatory
Approvals.
Section
3.5 of the Agreement shall be amended and restated in its entirety to provide
as
follows:
“3.5
Regulatory
Approvals.
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 the responsibility of Licensee and 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.
3.5(a)
Licensee
will be the primary contact for Chemistry, Manufacturing and Control (“CMC”)
matters in all relevant regulatory applications except to regulatory bodies
outside the US and Canada. Licensee will keep NovaDel reasonably informed of
all
such communications, if any, between Licensee and the Regulatory Authorities
in
the US and Canada.
3.5(b)
NovaDel
and
NovaDel’s Extraterritorial Licensees
shall
have a perpetual, 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.
3.5(c)
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
(“FOIA”) strictly confidential and will obtain prior written consent from
NovaDel prior to sharing with any third party.”
2. Manufacturing
Section
3.11 of the Agreement shall be amended and restated in its entirety to provide
as follows:
“3.11 Manufacturing
3.11.1
Subject
to the other provisions of this Section 3.11.1, Licensee shall be solely
responsible for the manufacture of 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 3.4.3 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.
2
3.11.2
Licensee
agrees that, at all times during the performance of the Development Activities,
it, or its designee, will act in accordance with GMP and all applicable laws,
rules and regulations.
3.11.3
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.
3.11.4
NovaDel
and its Extraterritorial Licensees may purchase Licensed Product under section
3.11.1 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.
3.11.5
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 Products from the United States. NovaDel shall reimburse all
reasonable expenses incurred by Licensee for obtaining such licenses or
permissions within 30 days of a the Extraterritorial Licensee receipt of an
invoice from Licensee itemizing such expenses.
3.11.6
NovaDel
warrants, covenants and agrees that any license agreement that NovaDel enters
into with an Extraterritorial Licensee regarding Licensed Products 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 Products 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.”
3. Confirmation
of Agreement.
Except
as otherwise amended or modified hereby, all terms of the Agreement shall remain
in full force and effect.
4.
Capitalized
Terms.
Capitalized terms used but not defined in this Amendment shall have the meanings
ascribed to them in the Agreement.
3
5. Counterparts.
This
Amendment may be executed in one or more counterparts, each of which shall
be
deemed an original but all of which taken together shall constitute one and
the
same instrument.
IN
WITNESSE WHEREOF,
the
duly authorized officers of the Parties have executed this Agreement as of
the
dates set forth below their respective signatures.
|
NOVALDEL
PHARMA INC.
|
HANA
BIOSCIENCES, INC.
|
|
By:
/s/
Xxx Xxxxxxx
|
By:
/s/
Xxxx X. Xxxxxx
|
|
Name:
Xxx
Xxxxxxx
|
Name:
Xxxx
X. Xxxxxx
|
|
Title:
President
& CEO
|
Title:
VP
& CBO
|
|
Date:
1/2/07
|
Date:
12/22/06
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