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
Xxx, 0000, having its Corporate office at 000-00 X.X. Xxxx, Xxxxxxxxxx
(X), Xxxxxx 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 000 Xxxxxxxxxx Xxxxx, Xxxxxx, Xxxxxxxxxx,
XXX 00000, 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
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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,
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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, xxxxx 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 xxxx, 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 xxxx, 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
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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
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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
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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.
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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.
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(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
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 or to which FDC has access or rights, in order to
allow SPECTRUM to assess the Product or Products and prepare an ANDA
(Abbreviated New Drug Application).
d) After the ANDA has been filed and before the ANDA is approved by the
FDA, FDC and SPECTRUM will agree on a price at which FDC will sell
the said Product to SPECTRUM, on terms reasonably acceptable to both
parties, which terms shall be intended to allow each party to obtain
a usual and customary profit margin from the distribution and sale
of the Products. Depending upon the competitive landscape and
pricing by other generic manufacturers flexibility in pricing will
be essential which will have to be reviewed by both companies
periodically depending upon the changes in prices for the said drug
in the market.
4. OBLIGATIONS OF SPECTRUM
4.1. SPECTRUM hereby agrees at its own cost:
a) To comply with all statutory rules, regulations, drug laws and all
other government regulations affecting the importation and sale of
the said Products in United States of America.
b) To sell/market the said products bought from FDC in accordance with
marketing rules and regulations applicable in United States of
America and for this purpose to adopt high marketing standards and
observe and comply with such reasonable marketing practices as are
common to marketing such products in United States of America by
entities of similar size to SPECTRUM. Without prejudice the
generality of the aforesaid, SPECTRUM shall in its sole
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discretion carry out the sales promotion activities and such other
activities as are necessary to distribute and market the said
products in the United States of America.
c) To collect and store all market information and data on the sales of
the said products, including the regions and areas in which the
sales are higher/lower, the prices at which the sales are being made
and also to collect such other market data as may be reasonably
required by FDC from time to time. To provide all such market data
to FDC on a monthly basis or on such other earlier frequency as may
be mutually agreed.
d) To store the said products in accordance with the product storage
specifications.
5. PRODUCT WARRANTIES AND PRODUCT LIABILITY
5.1. FDC hereby represents that the products supplied by them shall be in
compliance with the USA CGMP regulations, as defined in Title 21 CFR
parts 210 and 211. FDC represents and warrants that the products,
their packaging and labeling will not, on the date of delivery into
the U.S. be adulterated or misbranded, and will otherwise meet all
applicable specifications established by FDC, confirming to
B.P./U.S.P. Pharmaceutical specifications.
5.2. SPECTRUM may, but will not have an obligation to, carry out such
tasks or activities as it may desire to test or verify whether the
said products delivered comply with the specifications. In the
event of SPECTRUM or its agent being of the view that the products
do not so comply with the FDA, USA requirements for any reason, then
in such an event SPECTRUM shall ensure that the products found to be
non-compliant are not sold or to the customers and FDC is
immediately notified of
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the same. Such inspection and notification shall be completed within
a reasonable time not exceeding 60 days from the date of receipt of
the said products in USA. However all such notices of
non-compliance shall be subject to verification of the same by the
representatives of FDC. FDC shall not be required to take back any
such goods, unless the same has been confirmed by an independent
laboratory mutually identified to be non-compliant. The decision of
the independent laboratory in this regard shall be final and
binding. For the purpose of making any such inspection and
examination, the representatives of SPECTRUM shall provide full and
complete co-operation to the designated representative of FDC. ALL
THE EXPENSES IN CONNECTION WITH LABORATORY TEST TO BE DONE BY THE
INDEPENDENT LABORATORY WOULD BE BORNE BY THE LOOSING PARTY. SPECTRUM
shall not be liable to make any payments to FDC with respect to
products found to be non-compliant at the time of receipt of the
goods and shall, at FDC's direction, either destroy such products or
return such products to FDC at FDC's expense.
6. TRADEMARKS, PATENTS AND OTHER INTELLECTUAL PROPERTY
6.1 FDC hereby represents and warrants that it is the owner of all
Intellectual Property Rights in respect of the said products.
6.2 In the event that any Patents, Trade Marks, Copyrights, Intellectual
Property Rights related to the said products being challenged or if
any infringement proceedings being initiated in the USA either
against SPECTRUM or FDC in respect of any of the said products, the
same shall be defended by SPECTRUM at FDC's expense. SPECTRUM shall
co-operate and provide FDC with all necessary information as may be
within SPECTRUM'S control and necessary to defend any/all such
proceedings.
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6.3 In the event of SPECTRUM perceiving any threat to any of the
Patents, Trade Marks, Copyrights or Intellectual Property Rights of
FDC or being aware of any third party infringing any of the rights
of FDC under the Patents held by FDC in respect of the
said-products, SPECTRUM shall bring the same immediately to the
attention of FDC. Thereafter, if so reasonably required by FDC,
SPECTRUM shall initiate such proceedings as may be required by FDC
to arrest any such infringements. All such proceedings shall be at
the costs of FDC. In the event that FDC is desirous of taking any
action against such infringement, then SPECTRUM shall provide all
commercially reasonable cooperation as may be required by FDC to
enable FDC to file such proceedings and obtain appropriate reliefs.
6.4. SPECTRUM recognizes that, as between SPECTRUM and FDC, the
Trademarks and/or Copyrights, Intellectual Property Rights in the
said products as mentioned in the Appendix 'A' are the exclusive
property of FDC and/or its affiliates. SPECTRUM shall use
commercially reasonable efforts not do or cause to be done anything
whereby the rights or reputation of FDC in respect of the said
Trademarks and/or copyrights of the said products are likely to be
adversely affected.
6.5. Without prejudice to the generality of clause 6.3 above, SPECTRUM
shall not be entitled to use the said Trademarks, copyrights or any
Intellectual Property rights, if any, in any manner whatsoever
without FDC's express permission. SPECTRUM shall also use
commercially reasonable efforts to ensure that the said Trademarks
and Copyrights on the packaging of the products imported from FDC
are not modified, obliterated or altered in any manner whatsoever.
All marketing, sale and distribution of the said products by
SPECTRUM shall be deemed to be "use" of the said Trademarks by FDC
for the purpose of applicable trademark legislation.
13
6.6. Nothing herein contained shall at any time during the term of this
Agreement or upon expiry or earlier termination thereof be deemed to
give SPECTRUM any right, claim, interest in the said Trademarks,
copyright or patent or any Intellectual Property Rights arising in
terms of this Agreement, in respect to the said products. SPECTRUM
shall not be entitled to any benefit or right in the said
Trademarks, copyright or patent as a consequence of any marketing,
sale or distribution of the said products. It is hereby expressly
agreed by and between the parties hereto that SPECTRUM shall have no
right to acquire the said Trademarks, copyright or patent from FDC
under any circumstances whatsoever by virtue of this Agreement.
6.7. SPECTRUM shall render all commercially reasonable assistance to FDC
as may be required to ensure that the said Trademarks are duly
registered in the USA in the name of FDC.
6.8. SPECTRUM hereby recognizes that although certain of the Trademarks
related to the said products are unregistered in the USA, as between
SPECTRUM and FDC, FDC is the owner of the said Trademarks,
copyrights or patents. In the event of SPECTRUM being aware of any
infringement of any of the trademarks, copyright or patent or any
passing off, SPECTRUM shall forthwith intimate the same to FDC.
Thereafter, if so reasonably required by FDC, SPECTRUM shall
initiate such proceedings as may be required by FDC to arrest any
such infringements or to prevent any passing off, including such
injunctive actions as may be required. All such proceedings shall be
at the costs of FDC. In the event that FDC is desirous of taking any
action against such infringement or passing off, then SPECTRUM shall
provide all commercially reasonable cooperation as may be required
by FDC to enable FDC to file appropriate proceedings and obtain
reliefs.
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7. PLACEMENT OF ORDERS
7.1. SPECTRUM shall place written orders with FDC for supply of the
required said products from time to time, and FDC shall deliver the
ordered said products at the times and places, and in the amounts,
specified in such written orders. FDC will require a reasonable time
of a minimum of 60 days prior estimates of the quantities sought to
be ordered to enable FDC to supply the same to SPECTRUM.
8. PRICES
8.1. Generic business is an extremely price sensitive business. Also the
prices of generic drugs can change rapidly due to many factors that
are beyond the control of either FDC or SPECTRUM. It is understood
that FDC will price their drugs in good faith in consultation with
SPECTRUM and in a manner that the drugs can be sold in the United
States at a reasonable profit to both the companies. Prices for the
said products to be supplied will be agreed to after the ANDA has
been filed and before the ANDA is approved by the FDA, the prices
will be at a supply price to be mutually decided between the
parties. Prior to obtaining regulatory approval of each specific
product in the USA, FDC shall supply to SPECTRUM at no cost such
quantities of such specific product as SPECTRUM shall reasonably
require in order to obtain regulatory approval of such specific
product in the USA.
8.2. All prices as agreed to between the Parties shall be CIF (Cost,
Insurance and Freight Prices). The risk in the said goods shall
stand transferred to SPECTRUM forthwith on delivery of the goods to
the port of entry into the USA, whether landed, by sea or by air.
In the event of any loss of goods in transit, SPECTRUM shall not be
liable for payment and if such event occurs, FDC
15
shall make every reasonable effort to replace the lost goods. In the
event of any loss of goods in transit subsequent to arrival at the
USA port of entry, Spectrum shall bear all costs of loss, including
the liability to pay FDC for the goods subsequent to the port of
entry into the USA.
9. PAYMENTS
9.1. Payments for the orders shall be made through irrevocable letters of
credit to be opened by SPECTRUM through a bank of International
repute, the branch of which bank is also operating in India, which
bank is acceptable to FDC. The letters of credit shall be opened in
favour of FDC prior to the scheduled date of shipment authorizing
payments to FDC upon presentation of the relevant documents to the
negotiating bank. The letters of credit shall be opened in favour of
FDC Limited, 000-00, X.X. Xxxx, Xxxxxxxxxx(Xxxx), Xxxxxx- 400 102
The letters of credit shall be governed by the terms of UCP 500.
10. FORCE MAJEURE
10.1 Neither Party shall be under any liability whatsoever to the other
for failure or delay in the performance of any of its obligations
hereunder where such performance becomes impractical by reason of
any event of Force Majeure (as hereinafter defined).
10.2. For purposes of this Article, the expression "Force Majeure" shall
mean war, acts of aggression, civil strife and terrorism, labour
disputes, including strikes and lockouts, accidents, acts of God,
shortages of materials, and other inputs, acts of Government,
failure of networking, viruses, or any other bugs in systems or any
matter (whether or not of the same nature as
16
the foregoing) which are beyond the control of the Party affected by
such event.
10.3. In the event a Force Majeure event hinders the performance of this
Agreement by a Party, the other Party shall be entitled to suspend
the operation of this Agreement by giving written notice to the
party who is affected by the event of Force Majeure, if the
continuance of this Agreement becomes impractical by reason of such
event of Force Majeure. In the event the event of Force Majeure
does not subside for a period of sixty days after the notice for
suspension as aforesaid, the affected party may in its discretion
choose to forthwith terminate this Agreement by providing notice of
such termination in writing,
11. ASSIGNMENT
11.1 Neither party shall without the other's prior written consent,
assign any of its rights or duties hereunder. It is however
clarified that nothing in this Agreement shall prevent any of the
parties from performing, sub-contracting any of its obligations
herein to any of its subsidiaries or group companies, provided that
the principal responsibility of performance of the terms and
conditions of this agreement remains and continues to remain on any
of the parties and all such delegation or sub-contracting is in
accordance with the other terms and conditions of this Agreement.
11.2. This Agreement shall be binding on the successors and permitted
assigns of the parties hereto.
12. DURATION AND TERMINATION
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12.1 This Agreement shall remain in effect unless terminated by mutual
agreement of the Parties; provided, however, that each specific
product addendum may provide that this Agreement shall terminate
earlier with respect to the specific product subject to such
addendum. On termination of this Agreement each parties to the
Agreement, shall perform their obligations to the orders
12.2 This Agreement may be terminated by either party if the other party
commits a breach of any material obligation or any other material
clause or material requirement of the Agreement, and such breach is
not rectified within 30 days by the breaching party.
12.3 This Agreement may be terminated by either party on account of
non-performance by either of the other parties. Non-performance
shall be defined as:
12.3.1. United States Food and Drug Administration (USFDA) approval
not being received within two (2) years of the filing of an
application.
12.3.2. FDC not completing studies necessary and/or not providing
data necessary to file Abbreviated New Drug Applications (ANDAs) for
said products within one year of the signing of this agreement.
12.3.3. Spectrum not filing an ANDA for any said product within six
(6) months of receiving information described in section 12.3.2.
12.3.4. Revenue not being generated from the sale of any said
product within six months of the latter of the approval of the ANDA
by the USFDA for said product or the expiration of the
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patent and/or any exclusivity period for generic marketing of said
product.
12.3.5. If both the Parties mutually are unable to arrive/reach at a
supply price with respect to the said Product. If the Agreement is
terminated under this sub-section, then FDC will be prohibited from
selling the said Product within the Territory, either directly or
indirectly, for a price below the price last offered by FDC to
SPECTRUM hereunder.
13. APPLICABLE LAW AND DISPUTE RESOLUTION
13.1 In the event of any disagreement, dispute or conflict between the
Parties relating to or arising out of the provisions of this
Agreement that cannot otherwise be resolved promptly by the
management of SPECTRUM and FDC within a period of thirty days from
such date of the dispute, disagreement or conflict, the same shall
be resolved by arbitration.
13.2 Arbitration will in London as per ICC rules and will be conducted in
English Language.
14. INDEMNIFICATION
14.1 FDC hereby indemnifies and agrees to defend, save and hold harmless
SPECTRUM and each of its officers, directors and employees, from and
against any and all Liabilities, which may be imposed upon or
incurred by SPECTRUM by reason of:
(i) FDC's negligence or willful misconduct in connection with
their activities under this Agreement;
(ii) FDC's breach of any of the covenants, agreements, warranties
and representations made to Spectrum under this Agreement;
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(iii) FDC's said Products not meeting the required specifications
established by FDC, confirming to B.P./U.S.P. Pharmaceutical
specifications or the requirements of any applicable law or
regulation in the territory
14.2 Spectrum hereby indemnifies and agrees to defend, save and hold
harmless FDC and each of its officers, directors and employees, from
and against any and all Liabilities which may be imposed upon or
incurred by FDC by reason of:
(i) Spectrum's negligence or willful misconduct in connection
with their activities under this Agreement;
(ii) Spectrum's breach of any of the covenants, agreements,
warranties and representations made to FDC under this
Agreement;
(iii) SPECTRUM'S importation, handling, storage, use, distribution,
marketing and selling the said Product in the United States of
America in violation of this Agreement or the requirements of
any applicable laws or regulations of the Territory.
14.3 For purposes of this Article 14 Liabilities means any and all
claims, actions, suits, losses, liabilities, penalties, costs,
charges and expenses (including, without limitation, attorney's
fees, expert witness fees and other costs of suit).
15 MODIFICATION
This Agreement shall not be subject to modification, except by
modification in writing, signed by the parties, or their legal
agents or representatives. This Agreement may not be varied except
by written agreement duly executed by all parties hereto.
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16. This Agreement is on a principal to principal basis. Except to the
extent herein expressly provided, neither party is an agent of the
other. The relationship created between FDC and Spectrum under this
Agreement shall be that of seller and purchaser. Except to the
extent Spectrum may act as agent for FDC in connection with the
filing and processing of one or more ANDAs as herein contemplated,
Spectrum and its Affiliates shall under no circumstances be deemed
to be agents, representatives, partners or employees of FDC.
17. NOTICES
All notices, letters and communications between the Parties shall be
in writing. Any notices, letters or communications to be given
pursuant to this Agreement shall be given only if transmitted by
Telefax or electronic delivery subject to acknowledgement of
electronic delivery by the recipient. The notice shall be deemed to
be received only on the date of acknowledgement of electronic
delivery, on the date of transmission by Telefax if such
transmission is confirmed as having been successfully received ,or
on the date of actual delivery by an internationally known courier
service. Addresses for notice are as follows:
FOR: Spectrum Pharmaceuticals, Inc.
000 Xxxxxxxxxx Xxxxx
Xxxxxx, XX
00000
X.X.X.
Attention: Xx. X. Xxxxxxxxx Chairman and CEO
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Telephone: (000) 000-0000
Telefax: (000) 000-0000
Email: xxxxxxxxxx@xxxxxxxxxxxxx.xxx
FOR: FDC Limited
000-00, X.X. Xxxx
Xxxxxxxxxx(Xxxx)
Xxxxxx- 400 102
India
Attention: Xx. Xxxxxx X. Xxxxxxxxxxxx
Director
Telephone: (009122) 00000000
Fax.: (009122) 26788123
Email: xxxxxx_x@xxxx.xxx
xxxxxx@xxx0.xxxx.xxx.xx
The parties may from time-to-time change their designated addresses,
telephone numbers and person/s to whom notice should be sent, by
sending to the other party a notice in accordance with the above
sub-paragraph.
[Signature Page Follows]
22
Appendix A
[Intentionally Redacted]
[Intentionally Redacted]
[Intentionally Redacted]
[Intentionally Redacted] Certain information on this page has been omitted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
23
IN WITNESS WHEREOF, the parties hereto have signed this Agreement on the date
set forth below.
For and on behalf of FDC
By: /s/ M.A. Xxxxxxxxxxxx
------------------------------------
M.A. Xxxxxxxxxxxx, Managing Director
Date: November 20th, 2003
Place: Mumbai, India
For and on behalf of Spectrum Pharmaceuticals, Inc
By: /s/ Xxxxxx Xxxxxxxxx
------------------------------------
Xxxxxx Xxxxxxxxx, Chief Executive Officer
Date: November 20th, 2003
Place: Irvine, California, U.S.A
