Exhibit
10.40
AMENDMENT TO NO. 3
TO
LICENSE AND DEVELOPMENT
AGREEMENT
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
Ext
