<PAGE>
Exhibit 10.44
Confidential treatment has been requested
for portions of this exhibit. The copy
filed herewith omits the information
subject to the confidentiality request.
Omissions are designated as [Intentionally
Redacted]. A complete version of the
exhibit has been filed separately with the
Securities and Exchange Commission.
GENERIC DRUG MARKETING AND SUPPLY AGREEMENT
THIS
AGREEMENT is made and entered into on the 20th day of November
2003,
BY AND
BETWEEN
FDC
LIMITED, a company incorporated under the provisions of the
Companies
Act, 1956,
having its Corporate office at 142-48 S.V. Road, Jogeshwari
(W),
Mumbai 400 102, India, hereinafter referred to as "FDC", (which
term
shall
include its successors and permitted assigns) of the One Part;
AND
SPECTRUM
PHARMACEUTICALS, INC. a corporation organized in accordance
with
the laws
of the State of Delaware within the United States of America,
having its
principal office at 157 Technology Drive, Irvine, California,
USA 92618,
hereinafter referred to as "SPECTRUM" (which term shall include
its
successors and permitted assigns) of the Other Part;
A.
WHEREAS,
FDC is currently involved in or intends to be involved in
the manufacture in India of the drugs mentioned in Appendix 'A',
The
products detailed in the said Appendix 'A' are hereinafter
collectively referred to as "THE SAID PRODUCTS". As new
products
become available, Appendix 'A' may be amended to incorporate
such
new products as mutually decided by the parties.
B.
WHEREAS,
Spectrum is a pharmaceutical company organized in the
United States of America ("USA") for the purposes of
<PAGE>
2
gaining regulatory approval, marketing and distributing
products.
The drugs detailed in the said specific product appendix A are
hereinafter collectively referred to as "THE SAID PRODUCTS".
c)
WHEREAS,
FDC desires to engage Spectrum to obtain regulatory
approval from the United States Food and Drug Administration
("FDA")
to market the said products in the USA, and to market and
distribute
the said products in United States of America; (hereinafter
referred
to as the "Territory").
Now
THEREFORE, for and in consideration of the foregoing premises, and
the
mutual
covenants, stipulations, terms and conditions herein contained
the
parties
agree as follows:
1.
APPOINTMENT AND TERRITORIAL LIMITS
1.1
Subject to the
terms and conditions of this Agreement, FDC hereby
appoints SPECTRUM as its exclusive agent/ distributor for
registration and the sale of the said-products in United States
of
America and SPECTRUM agrees to exclusively register and market
and
distribute the said products in United States of America in
accordance with the terms and conditions of this Agreement. FDC
hereby grants to SPECTRUM an exclusive license to use the
Intellectual Property Rights associated with the said products
to
the extent necessary for the limited purposes of obtaining
regulatory approval of the said products in United States of
America
and marketing, distributing and selling the said products in
United
States of America. For the purposes of this Agreement,
"Intellectual
Property Rights" means, collectively, worldwide Patents,
Copyrights,
Trademarks, mask work rights, trade names and all other
intellectual
property rights and proprietary rights, whether arising under
the
laws of the United States or any other state,
<PAGE>
3
country or jurisdiction, including all rights or causes of
action
for infringement or misappropriation of any of the foregoing.
For
purposes of this Agreement: (a) "Patents" means all patent
rights
and all right, title and interest in all letters patent or
equivalent rights and applications, including provisional
applications, for letters patent or rights, industrial and
utility
models, industrial designs, petty patents, patents of
importation,
patents of addition, certificates of invention and other
government
issued or granted indicia of invention ownership, including any
reissue, extension, division, continuation or
continuation-in-part
applications throughout the world; (b) "Trade Secrets" means
all
right, title and interest in all trade secrets and trade secret
rights arising under common law, state law, federal law or laws
of
foreign countries; (c) "Copyrights" shall mean all copyrights,
and
all
other literary property and authorship rights, and all right,
title, and interest in all copyrights, copyright registrations,
certificates of copyright and copyrighted interests throughout
the
world; and (d) "Trademarks" means all right, title and interest
in
all trademark, service mark, trade name and trade dress rights
arising under the common law, state law, federal laws and laws
of
foreign countries, and all right, title, and interest in all
trademark, service mark, trade name and trade dress applications
and
registrations interests throughout the world. The exclusive
rights
granted to Spectrum to market the said products in United States
of
America will be subject to the Non-performance Clause given in
Clause 12.3 with respect to any of the said products.
1.2
It is however
agreed and clarified between the Parties hereto that
the rights of SPECTRUM to act as the agent/distributor of FDC
<PAGE>
4
shall be initially confined to the territorial limits of United
States of America and may thereafter extend to other
neighboring
countries with
the prior written consent of, and at the sole
discretion of FDC.
1.3
It is also
agreed and clarified that FDC is free to assign its
trademark(s) to any person or party outside of United States of
America, as long
as that person or party does not market or intend
to market the said product(s) carrying such trademark(s) in
United
States of America.
2.
CONFIDENTIALITY
2.1
Neither Party
shall disclose to any third party any Confidential
Information which was obtained from the other Party in
connection
with this Agreement. This obligation of secrecy of the
Confidential
Information shall not apply to information which is required to
be
disclosed to governmental agencies for product registration
purposes
or as may be required by applicable law or Governmental
authority
having competent jurisdiction over the receiving Party. In
addition,
the secrecy obligation shall expire for Confidential
Information
which:
a) is or
ceases to be Confidential Information as a consequence
of authorized disclosures;
b) was
already in the possession of a Party at the time of
receipt from the disclosing Party, as shown by documentary
evidence;
c) after
the date of this Agreement is received from a third
party whose direct or indirect source is not the disclosing
party.
For the purpose of this Article, the term "CONFIDENTIAL
INFORMATION"
shall mean any information or data (including
<PAGE>
5
but not limited to any technical or non-technical data, and any
formula, patents, methods, processes, patterns, compilation,
programs, device or technique) that derive economic value, actual
or
potential, from not being generally known to other persons.
Confidential Information would also include all information
exchanged by and between the Parties in relation to this
Agreement
or otherwise marked as confidential by any Party to this
Agreement.
2.2.
The Parties agree: (a)
to exercise the same degree of care and
protection (but no less than a reasonable degree of care and
protection) with respect to each other's Confidential Information
as
a Party
would exercise with respect to its own confidential
information; and (b) except as expressly authorized by this
Agreement, or as necessary to the performance of the
obligations
hereunder, not to directly or indirectly disclose, copy,
transfer,
or allow access to the Confidential Information. Without
limitation
to the generality of the foregoing, all persons with access to
the
Confidential Information will be subject to the same
restrictions
and limitations as that of the Parties to this Agreement. The
Parties shall ensure that appropriate non-disclosure
undertakings
are obtained in this regard. Provided that obtaining of such
non-disclosure undertakings shall not absolve any of the
Parties
hereto from any breach that may be committed by reason of a
breach
by any of the persons to whom the Confidential Information has
been
disclosed pursuant to this Agreement.
2.3.
The obligations
contained in this Article shall survive the duration
of this Agreement and thereafter for a period of five(5) years
or
until the expiration of all Patents for the said products
(including
any extended term), whichever is later.
2.4.
Without prejudice to
any other provision of this Agreement, the
Parties acknowledge and agree that any violation of this Article
2
<PAGE>
6
by a Party would cause the other Party irreparable injury for
which
such other would have no adequate remedy at law, and that such
other Party shall be entitled to preliminary and other
injunctive
relief against the defaulting Party for any such violation.
Such
injunctive relief will be in addition to, and in no way a
limitation
of, any and all other remedies or rights that such other Party
shall
have at law or in equity.
3.
OBLIGATIONS OF FDC
3.1.
FDC hereby agrees:
a)
That it
will take all reasonable care to hold and keep in force all
manufacturing licenses and permission in respect of the said
products and comply with requirements of all laws applicable to
the
said products.
b)
To provide
SPECTRUM, with all necessary documents required to enable
the regulatory approval of the said products by the FDA and
SPECTRUM
shall render all assistance to FDC for registration of the said
products in the name of FDC. All data, information, notes,
documents, dossiers, knowledge, formulae, Intellectual Property
Rights, etc provided by FDC to Spectrum in terms of this
Agreement
shall for at all times and forever remain the exclusive property
of
FDC.
c)
It is
clarified between the parties that all the product
registrations and the ANDA'S for the said Products in the
Territory
shall be obtained by Spectrum in the name of FDC and the
product
registrations for the said Products, shall for all times and
forever
shall remain the sole and exclusive property of FDC, and
Spectrum
shall not have any claim, right, title or interest of whatsoever
in
the same.
<PAGE>
7
d)
It is
hereby clarified and agreed to by and between the Parties that
the costs of such regulatory approval, incurred in the United
States, for the said products, shall be borne solely and
exclusively
by SPECTRUM.
e)
To provide
all technical information and documents in respect of the
said products as may be required to facilitate regulatory
approval,
distribution and marketing of the said products by SPECTRUM in
United States of America. FDC will also provide to Spectrum a
protocol or method of assay of all ingredients. The stability
or
shelf-life of finished products will be for a minimum of 2 years.
It
is hereby clarified and agreed to by and between the Parties
that
the costs of producing and providing such technical information
for
the said products shall be borne solely and exclusively by FDC.
f)
To
manufacture the said Products from time to time, either
directly
or indirectly through any of its subsidiaries or group companies
or
any
other third parties in such quantities as may be required to
enable the fulfillment of the orders placed by SPECTRUM from time
to
time.
g)
To
maintain high standards in manufacturing the said products, and
to
produce quality products as per quality specifications
established by FDC, confirming to B.P./U.S.P. Pharmaceutical
specifications.
h)
To comply
with the applicable US regulations contained in 21 CFR -
Sections 210 and 211, to the extent the same is not contrary to
provisions of Indian law.
<PAGE>
8
(i)
To procure the
raw material for the manufacture of the said products
from the suppliers whose manufacturing plants have been approved
by
the FDA, as applicable.
j)
FDC will
carryout all manufacturing/packaging activities in the
manufacturing facilities duly approved by the FDA, whether such
facilities be of FDC
or any subsidiary, group concern or any other
person in India.
k)
Any
deficiencies noted during an FDA audit, of the
manufacturing/packaging plant in India will be remedied
immediately
by FDC and the total cost of such remediation shall be borne by
FDC.
3.2
RECORDS AND
REPORTS
a)
FDC shall
ensure that all Records that may reasonably be expected to
relate to any regulatory process in the United States that may
be
applicable to the said Product from time to time, or that have
been
or may reasonably be expected to be used to support any
regulatory
submission made by SPECTRUM in the United States or elsewhere
related to the said Product, are maintained as statutorily
required,
and in any event for a period of not less than 7 years following
the
completion of the applicable regulatory process, unless the
parties
hereto unanimously agree otherwise.
b)
FDC agrees
to provide SPECTRUM with copies of such Records required
to be maintained under Section 3.2(a) as SPECTRUM may
reasonably
request from time to time. All such copies shall be delivered
to
SPECTRUM
within twenty-one (21) days of receipt of a request for
copies.
c)
FDC and
SPECTRUM will jointly identify the drugs/products for the
US market, depending upon the manufacturing/development
<PAGE>
9
capabilities of FDC and regulatory approval and sales potential
in
the US. Once the decision has been made the regulatory process
for
filing ANDA will begin by both the companies. FDC will provide
to
SPECTRUM all data and information related to such Product or
Products as SPECTRUM shall reasonably request that is in the
possession of FDC o
