1
EXHIBIT 10.11
Portions of this Exhibit
have been omitted pursuant to
a request for confidential
treatment. The omitted
portions are marked ***** and
have been filed separately
with the Commission.
SUPPLY AGREEMENT
This Agreement is made the 21st day of January, 1997 between CELL THERAPEUTICS,
INC., whose registered office is at 000 Xxxxxxx Xxxxxx Xxxx, Xxxxx 000, Xxxxxxx,
Xxxxxxxxxx, 00000, XXX ("Company"), and CHIREX, LTD., of Dudley, Xxxxxxxxxxx,
Xxxxxxxxxxxxxx, XX00 0XX, XXXXXXX ("Supplier").
RECITALS
WHEREAS, Company has developed a proprietary therapeutic agent, lisofylline, and
will require certain quantities of the Compound and other intermediates used in
manufacturing the Compound;
Company has developed a proprietary, commercial synthetic process for preparing
the Compound and other intermediates;
Supplier has certain technical expertise in and physical facilities for
commercial manufacturing of organic compounds;
Company desires that Supplier manufacture for Company, on an exclusive basis
during the initial term of the contract, the Compound (and corresponding
intermediates) in sufficient quantities to meet at least Company's needs for
pilot and validation lots, and commercial product launch and market supplies for
production years subsequent to New Drug Application ("NDA") approval; and
Supplier is willing to provide manufacturing services to Company for the
Compound and intermediates.
AGREEMENTS
NOW THEREFORE, in consideration of the premises and mutual promises
hereinafter set forth, the parties agree as follows:
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
1. Definitions
-----------
COMPOUND is Company's proprietary compound, lisofylline, having a
chemical name, *****
CCA is the key intermediate *****, having a chemical name, *****.
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cGMP are current Good Manufacturing Practices, specifically as defined in United
States Code of Federal Regulations, Title 21, (S) 210 and 211, related FDA
guidelines, and as interpreted by Company.
EFFECTIVE TERMINATION DATE is the date written notice of termination is provided
to the other party.
EXPIRATION DATE is December 31, 2001, unless earlier terminated in accordance
with the terms and conditions as set forth in Xxxxxxxxx 0, Xxxx and Termination.
INTELLECTUAL PROPERTY (IP) includes, but is not limited to, patentable
inventions, trade secrets and know how.
OFFICIAL COPY is an exact duplicate, having an appropriate certifying xxxx (and
signature), of original documents that are generated and held in Supplier's
permanent files.
PROJECT PLAN FOR PILOT LOTS (PROJECT PLAN) will be independently agreed to by
the parties. The Project Plan defines the detailed scope of work and is a
comprehensive compilation of the technical specifications and compliance
requirements that govern the manufacturing, testing, packaging and labeling of
pilot lots of Compound and/or intermediates prepared by Supplier for Company.
VALIDATION LOT PLAN will be independently agreed to by the parties. The
Validation Lot Plan defines the detailed scope of work and is a comprehensive
compilation of the technical specifications and compliance requirements that
govern the manufacturing, testing, packaging and labeling of validation lots of
Compound and/or intermediates prepared by Supplier for Company.
COMMERCIAL OPERATION PLAN will be independently agreed to by the parties. The
Commercial Operation Plan defines the detailed scope of work and is a
comprehensive compilation of the technical specifications and compliance
requirements that govern the manufacturing, testing, packaging and labeling of
commercial lots of Compound and or intermediates prepared by Supplier for
Company.
WORK-IN-PROGRESS is work commenced by Supplier for Company that Supplier has not
yet completed, and may comprise, without limitation, engineering costs, raw
materials, intermediate products, or manufacturing services for preparing
Compound and/or intermediates.
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2. Agreement Scope
---------------
a. Generally, Supplier will manufacture for Company and Company agrees to
purchase the following quantities of the Compound and a key
intermediate, CCA:
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
i. At least ***** (Project Plan);
ii. At least *****, using CCA prepared by Supplier (Project Plan);
and
iii. At least *****, using CCA produced by Supplier. The parties
forecast that a target quantity of 5 manufacturing-scale lots is
required to ensure production of 3 consecutively validated lots
(Validation Lot Plan).
More specifically, the Project and Validation Lot Plans set forth
technical detail regarding: the synthetic process for manufacturing
and isolating Compound, CCA and other relevant intermediates;
operational requirements for pilot lots and validation lots; and
Supplier's and Company's activities and responsibilities in connection
with Supplier's manufacture of pilot and validated lots of Compound
and CCA. Both parties shall independently agree to and execute the
Project and Validation Lot Plans.
b. In addition to preparing the above pilot and validation lots of
Compound and CCA, Supplier will manufacture and supply commercial
quantities of Compound and CCA. The Commercial Operation Plan sets
forth technical detail regarding: the synthetic process for
manufacturing and isolating Compound, CCA and other relevant
intermediates in commercial scale lots; operational requirements for
manufacturing commercial material; and Supplier's and Company's
activities and responsibilities in connection with Supplier's
manufacture of commercial quantities of Compound and CCA for Company.
c. At present, Supplier and Company have not established specific,
commercial production quantities, but the following table provides
current estimated commercial quantities through the 2001 production
year (1998-2001), subject to modification in accordance with the
procedures set forth in Paragraph 11, Commercial Forecasting.
Paragraph 11 also specifically establishes a mechanism by which
Company and Supplier will prepare and revise annual forecasts for
commercial supplies of Compound. Subject to the provisions
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herein, Company and Supplier agree that Supplier will manufacture the
Compound (and corresponding intermediates) for Company on an exclusive
basis through the 2000 production year.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
YEAR 1998 1999 2000 2001
---------------------------------------------------------------
ESTIMATED QUANTITY ***** ***** ***** *****
---------------------------------------------------------------
3. Term and Termination
--------------------
This Agreement shall commence upon complete execution by both parties, and
unless terminated sooner in accordance with the terms and conditions set
forth below, shall remain in full force and effect until the Expiration
date. Thereafter, Company may renew this Agreement for successive one (1)
year periods. Company shall provide written notice to Supplier of Company's
intent to renew no more than twelve (12) months and no less than six (6)
months prior to the Expiration date. Within thirty (30) days of Company's
written notice to Supplier, Supplier will provide written notice to Company
that it agrees to Company's renewal period.
Either party may terminate this Agreement, upon twelve (12) months written
notice to the other party; provided however that Supplier may not terminate
this Agreement prior to supplying Company's commercial requirements for
Compound through December 31, 2000.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Upon termination, where practical and without compromising the integrity or
quality of the Work-in-Progress, Supplier will not create additional Work-
in-Progress and will use its best efforts to minimize expense to Company in
bringing the Work-in-Progress to a logical conclusion, as mutually agreed
upon by Supplier and Company. Company agrees to purchase and Supplier
agrees to sell, *****, available quantities of Compound and/or
intermediates held in storage by Supplier on the Effective Termination
Date.
Company will remain liable for costs of services rendered through the
Effective Termination Date and costs for services required to complete
Work-in-Progress.
4. Manufacturing Standards
-----------------------
Supplier will perform all work hereunder for Company in accordance with
strict application of current laboratory research and manufacturing
standards, as reflected by standards contained in the Project, Validation
Lot and Commercial Operation Plans. Supplier will strictly comply with all
current United States governmental regulatory requirements and policies
concerning cGMP (as
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interpreted by Company) for all phases of production (pilot, validation and
commercial lots).
5. Material Warranty
-----------------
Supplier warrants that it will exercise extreme care and high standards to
achieve the desired results in accordance with standards and procedures
agreeable to and accepted by the parties. In the event the material is
non-conforming and the Material Review Board determines that the Supplier
is responsible for the non-conformance in accordance with the provisions of
Paragraph 6.d, Material Non-Conformance, Supplier and Company shall
mutually agree to one (or a combination of) the following remedies: a)
Supplier replacing non-conforming material with conforming material at no
additional cost to Company; b) Supplier remediating unacceptable
performance at no additional expense to Company; or c) Supplier refunding
or crediting to Company any fees paid or payable by Company in connection
with Supplier's unacceptable performance.
In the event material is non-conforming and the Material Review Board
determines that the Company is responsible for the non-conformance in
accordance with the provisions of Xxxxxxxxx 0x, Xxxxxxxx Xxx-Xxxxxxxxxxx,
the Company shall make payment to the Supplier of all fees due to the
Supplier under this Agreement in respect of such non-conforming material.
Should United States regulatory requirements change during the course of
Supplier's performance of manufacturing services hereunder, Supplier will
make every reasonable effort to meet the new requirements. In the event
that modified regulatory requirements necessitate revisions in the
manufacturing process, Supplier will submit to Company a revised technical
proposal and cost estimate, for which, if necessary, the parties will
further negotiate and to which the parties will mutually agree.
6. Documentation, Specifications, Release and Delivery
---------------------------------------------------
a. Manufacturing Documentation
---------------------------
Prior to or in conjunction with delivery of any material manufactured
for Company, Supplier will provide Official Copies of at least the
following documentation to Company:
i. A complete copy of all relevant and completed Batch Production
Records for each manufacturing run of Compound, and all
intermediates;
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which is set forth in documentation establishing the analytical
methods contained in the Project, Validation Lot or Commercial
Operation Plans (by inclusion or reference therein).
If Supplier intends to utilize a third party to conduct a portion or
all of the analytical testing, Company shall have an opportunity to
evaluate and approve the third party prior to the third party
commencing work in support of Supplier's performance hereunder. In any
event, Company reserves the right to repeat a portion of or all tests
conducted by Supplier prior to Company's release of material to
confirm that the material meets established specifications.
d. Material non-conformance
------------------------
In the event that Company cannot release the material in accordance
with the foregoing procedures or if the material is released and
Company, Supplier or a third party later discovers that the material
is not in compliance with material specifications, the material shall
be non-conforming.
Company and Supplier will establish a Material Review Board (MRB)
composed of members of Company's Compliance and Manufacturing
Operations Units, and Supplier's Quality Assurance and Manufacturing
Departments to investigate and assess the circumstances of the
non-conformance. Based on the MRB's evaluation and assessment, the MRB
will establish a cause for the non-conformance. Company and Supplier
will ascertain responsibility for the cause of the non-conformance,
and the responsible party(ies) shall bear the financial obligation for
the non-conformance, and Company and Supplier have rights and
obligations as set forth in Xxxxxxxxx 0, Xxxxxxxx Xxxxxxxx.
In the event that the MRB is unable to resolve discrepancies among
test results relied upon by Company for release of material
manufactured by Supplier, Company and Supplier agree to submit the
material to a mutually-agreed third party to verify disputed test
results of Company or Supplier, using validated analytical methods
previously utilized by both Company and Supplier. Company and Supplier
agree to share equally in the cost of obtaining such verified results.
Based on an analysis of these results, Company will either purchase
material or have the option of enforcing its rights as defined in
Xxxxxxxxx 0 Xxxxxxxx Xxxxxxxx.
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e. Shipping
--------
Company will notify Supplier of intended shipments for material
released by Company. Except as provided herein with respect to
non-conforming product, title and risk of loss as to all materials
shipped shall pass upon transfer by Supplier to such carrier at the
manufacturing facility. Company will establish all shipment,
packaging, labeling and storage requirements, with which Supplier will
comply. The Project, Validation Lot or Commercial Plans will include
these specific requirements. Supplier will ship Compound, CCA or other
intermediates or material to a location specified in writing by
Company. Company shall be responsible for paying all shipping costs,
tariffs and duties assessed and due. Supplier will provide storage for
packaged material, without charge, until Company provides shipping
instructions to Supplier. Company will provide shipping instructions
to Supplier for finished lots of Compound not more than ninety (90)
days from the date Company releases finished lots of Compound.
Supplier will maintain adequate business insurance to cover material
replacement in the event of material loss during Supplier's
manufacture or material storage up to a maximum of $750,000.
7. Independent Contractor and Third Party Subcontractors
-----------------------------------------------------
Supplier is an independent contractor, not an employee or agent of Company,
and will be solely responsible for maintaining its labor force and
operations. Company and Supplier do not intend to create any partnership,
joint venture, employment or agency relationship pursuant to this
Agreement. Except upon the prior written consent of Company, Supplier shall
have no right to bind Company by contract, or otherwise to transact any
business in Company's name or on Company's behalf, in any manner or form,
or to make any promises or representations on its behalf. Supplier will not
represent to anyone that it is an agent of Company or otherwise authorized
to bind or commit Company in any way.
Supplier shall remain directly responsible for Supplier's performance
hereunder, even though Supplier may utilize third party contractors that it
deems have the requisite expertise and skill to meet Supplier's performance
obligations under this Agreement. Should Supplier utilize third party
personnel other than those to whom Company has agreed, Supplier will
provide Company with an opportunity to review and confirm Supplier's
selection. Should Company object to Supplier's candidate, Company and
Supplier will negotiate to identify other, more suitable personnel.
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8. Document Retention, Facility Access and Notice to Company
---------------------------------------------------------
a. Document Retention
------------------
Supplier agrees to assist Company in its submission and maintenance
post approval of the New Drug Application (NDA) for Compound and will
compile, organize and retain all information necessary to support
Company's regulatory requirements for Compound, and will provide
Official Copies of relevant documentation within a mutually agreed
period. Supplier will maintain a current Type I Facility Drug Master
File and will provide to Company a Letter of Authorization to cross-
reference the Drug Master File. All cGMP-related documentation and
data (relating to Compound, CCA and other intermediates, including,
without limitation, material samples, slides, records, and other
documents and/or materials generated by Supplier on Company's behalf)
shall be retained by Supplier unless otherwise indicated by the
Company. Company shall notify Supplier in writing as to the
disposition of any such documentation, data and information retained
by Supplier prior to such action. All documentation or material
furnished to Supplier by Company and used in connection with
Supplier's performance under this Agreement, will be returned to
Company upon the first to occur of: 1) completion of any specific
project; or 2) termination of this Agreement, except for one (1)
archival copy and required material samples which must be retained at
least 5 years past approval of the NDA.
b. Facility Access
---------------
Upon giving prior written notice to Supplier, Company or its
authorized designees shall have the right to inspect Supplier's
facilities and documentation at normal business hours to ensure
compliance with this Agreement, including applicable regulatory
requirements. Company may review or request copies of regulatory or
cGMP data at any time.
Supplier will not unreasonably withhold access by Company to data,
documentation, material, laboratories or facilities, wherever located,
if such access is required for verification of Supplier's performance
hereunder or in connection with government regulatory agency requests.
c. Notice to Company
-----------------
Supplier will immediately notify Company's Director of a duly
authorized regulatory agency's (federal, state or municipal)
communication, visit, investigation or inquiry of Supplier's process
or facilities and relating to Company's Compound (Event), and
Supplier's written confirmation thereof
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shall not be later than twenty-four (24) hours from Supplier's first
knowledge of the Event. Supplier's notice shall provide Company's
Director of Compliance with the following information:
i. The agency;
ii. Purpose of communication, visit, investigation or inquiry;
iii. Name(s) of inspector(s) and credential number; and
iv. A copy of form(s) issued by inspector, if any.
Communications to Supplier by the FDA regarding Supplier's Type I
DMF will require notification of the Company's Director of
Regulatory Affairs, both orally and in writing, within 24 hours
of receipt of such communication.
In addition, Supplier will handle Confidential and Proprietary
Information in accordance with the provisions of Paragraph 13,
Confidentiality. Supplier shall obtain Company's approval prior
to Supplier providing to any third party copies of documentation
which contain information related to Company.
Company will assist Supplier in responding to the communication,
visit, investigation or inquiry relating to Company's Compound.
In addition to the foregoing, Supplier will notify Company's
Director of Manufacturing Operations orally and in writing of any
interruption in Supplier's manufacturing activities that relates
to or affects Supplier's performance under this Agreement and
could likely affect delivery schedules. Supplier's notice shall
not be later than twenty- four (24) hours from Supplier's first
knowledge of the manufacturing interruption.
9. Licensing and Permitting
------------------------
Supplier shall be responsible for applying for and obtaining all federal
and local licenses and permits required in connection with its manufacture
of Compound, CCA and other intermediates. In this regard, Company shall
provide all reasonable assistance to Supplier. In addition, Supplier shall
bear the cost of all license and permit fees.
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10. Production Results
------------------
Each month, Supplier will provide to Company, particularly in connection
with Supplier's manufacture of commercial quantities of Compound,
Supplier's status and quantities of inventories of raw materials,
intermediates and Compound. In addition, at the conclusion of production
runs, as defined in the Project, Validation Lot and Commercial Operation
Plans. Supplier will provide a final Campaign Report for the production
runs, as requested by Company.
11. Commercial Forecasting
----------------------
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Commencing in June 1997 and continuing ***** thereafter through the end of
the Agreement term, Company and Supplier will meet to prepare commercial
production and delivery forecasts. The parties intend that the *****
meetings will provide timely notice of potential conflicts in Company's
needs for Compound and Supplier's scheduling and production vacancies or
restrictions. Based on these discussions, Company and Supplier will agree
to a "rolling" production and delivery schedule for each successive
12-month period.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
In June 1997, Company and Supplier will agree to an initial ***** forecast,
which will commit both parties to production, delivery and payment
obligations for the *****. Thereafter, at each quarterly meeting, Company
and Supplier will commit to production, delivery and payment obligations
for the ***** and establish a forecast for the *****. The commercial
forecasting procedures discussed herein are subject to any provisions of
Xxxxxxxxx 0, Xxxx and Termination.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Following each ***** meeting with Supplier, Company will issue a Purchase
Order for Supplier's committed production and delivery, reflecting
Supplier's and Company's current commitment. Product deliveries made
thereafter will be applied against outstanding Purchase Orders, as
specified by Company.
12. Costs and Payments
------------------
Generally, Company and Supplier agree to a fixed price for Supplier's
manufacture of pilot plant and validation lots for both the Compound and
the CCA intermediate. Commercial Compound prices will be based on a
per-kilo, volume-adjusted manufacturing price, which take into account
specific inflation, currency and yield adjustments (resulting from gained
process efficiencies or technical advances in manufacturing). Supplier is
liable for paying all necessary taxes, licensing fees and other assessments
in connection with manufacturing material hereunder. All invoices will be
billed in US dollars (USD $).
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(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Specifically, Company will be liable to Supplier for the *****
PILOT LOTS OF CCA
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
*****
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(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
*****
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(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Company and Supplier agree that ***** of the total payment--less ***** as
discussed below--will be due to Supplier net ***** upon receipt of
Supplier's invoice to Company. Supplier will invoice Company (in USD $) for
the CCA intermediate and Compound produced during pilot plant or validation
lot operations upon providing documentation to the Company as set forth in
Paragraph 6a, Manufacturing Documentation. However, Company will reimburse
Supplier for all ***** set forth above as they are incurred by Supplier.
Reimbursement for ***** will be due net ***** upon receipt of Supplier's
invoice.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Within ***** of Company's receipt of all completed production records (as
specified in Paragraph 6.a, Manufacturing Documentation) Company will issue
a Certificate of Analysis and product release document, provided that the
corresponding documentation conforms with agreed specifications and
standards as set forth in the Project Plan and Validation Lot Plan.
Supplier will then invoice the Company for the remaining ***** balance
which will be due net ***** upon receipt of Supplier's invoice. Company's
payment of any outstanding dues will not serve to waive any rights it may
have in law or as specifically stated herein, should delivered material not
meet established standards.
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Price for manufacturing commercial Compound lots and payment schedules will
be discussed upon commencement of the June 1997 forecasting meeting as
discussed in Paragraph 11, Commercial Forecasting. Supplier and Company
will agree to manufacturing rates by the end of the ***** for the upcoming
calendar year and will revise manufacturing rates accordingly. Factors that
affect manufacturing rates will include:
(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
*****
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(The information below marked by ***** has been omitted by a request for
confidential treatment. The omitted portion has been separately filed with the
Commission.)
Company may increase Supplier's production of Compound intermediates above
levels required to meet Company's forecasted needs for Compound. If so
requested, Supplier will manufacture designated intermediates and will
store this material without charge for future conversion to Compound. In
this event, Supplier may invoice Company, at a mutually agreed price, for
manufacturing the additional requested inventory of intermediates. Unless
otherwise stated, all invoices from Supplier will be due net ***** from
Company's receipt of the invoice.
The cost for any capital improvements that Supplier and Company deem
necessary for the manufacture of material under the Commercial Operation
Plan shall be an itemized cost in the cost structure for manufacturing
during the initial term of Supplier's commercial production for the
Company.
The parties agree that in the event a dispute arises regarding the accuracy
of Supplier's costs, Company may appoint an independent financial auditor,
at Company's sole expense, to review Supplier's records at reasonable and
convenient times to verify Supplier's calculations. Said independent
financial auditor shall be permitted to verify and report to Company on the
accuracy of Supplier's price. Based on the findings of this independent
auditor, Company and Supplier will negotiate and agree to commercial
manufacturing price adjustments.
13. Confidentiality
---------------
Supplier shall remain bound by the terms and conditions of the Confidential
Disclosure Agreement between Company and Supplier, dated March 22, 1994,
and amended April 25, 1996 (collectively, CDA), which is incorporated by
reference in its entirety and attached hereto as Exhibit A. Company and
Supplier agree that the Confidentiality Period set forth in the CDA shall
be extended to run ten (10) years from the date of termination of this
Agreement.
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14. Intellectual Property
---------------------
IP created during performance under and specifically in connection with
this Agreement which is conceived:
i. Solely by Company's personnel shall be owned by the Company (Company
IP);
ii. Solely by Supplier's personnel shall be owned by Supplier (Supplier
IP); and
iii. Jointly by Company's and Supplier's personnel shall be jointly owned
by Company and Supplier (Joint IP).
Inventorship in IP that is created and developed during performance under
this Agreement shall be determined by Company, in consultation with
Supplier, according to United States patent law and the Washington State
Uniform Trade Secrets Act.
Patents covering Supplier IP shall be prepared, filed and prosecuted solely
by counsel selected by Supplier and reviewed and approved by Company (which
approval shall not be unreasonably withheld), but at Company's sole cost
and expense. Supplier shall provide Company with copies of all such patent
applications and relevant communications therefor, including, but not
limited to, patent office correspondence. Prior to filing a patent
application or filing or responding to any outstanding communication in the
Supplier IP patent application, Supplier will make all reasonable effort to
provide Company with thirty (30) days notice to review and provide comment.
Patents for Company and Joint IP shall be prepared, filed and prosecuted
solely by counsel selected by Company and at Company's sole cost and
expense. In the case of Company IP, Company will timely notify Supplier
that Company has filed a patent application covering Company IP.
In the case of Joint IP, Company shall provide Supplier with copies of all
such Joint IP patent applications and relevant communications, including,
but not limited to, correspondence from or to counsel or a patent office.
Prior to filing a patent application or filing or responding to any
outstanding communication from counsel or a patent office in connection
with a Joint IP patent application, Company will provide Supplier with
thirty (30) days notice to review and provide comment.
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15. Intellectual Property Rights
----------------------------
If during the course of performing work under this Agreement, Supplier or
Joint IP is created and developed which is pertinent to the synthesis of
Compound or an intermediate, Supplier will assign all its rights in
Supplier or Joint IP to Company, but shall retain a non-exclusive,
royalty-free license to use Supplier or Joint IP in applications which do
not compete with the synthesis of Company's Compound or intermediates.
The parties acknowledge that Supplier owns or may own (or may have license
rights in) manufacturing technology (Supplier Technology) that may offer
certain manufacturing advantages if utilized in Supplier's performance
under this Agreement. In the event that Supplier and Company agree that
incorporating such Supplier Technology into Company's process for
manufacturing Compound, CCA and/or intermediates is prudent and warranted,
Supplier will use reasonable efforts to obtain Company's ability to utilize
Supplier Technology, on reasonable terms to be negotiated.
Furthermore, should Company integrate Supplier Technology into Company's
process for manufacturing Compound, CCA and/or intermediates and Company
subsequently requires the manufacturing services of a third party, Company
will obtain Supplier's authorization for a third party's use of the
Supplier Technology, on reasonable terms to be negotiated.
16. Publication and Promotion
-------------------------
Supplier may only publish details of the synthesis or manufacture of
Compound, CCA or intermediates upon obtaining prior written permission of
Company.
The text of any press release or other communication to be published in the
media concerning the subject matter of this Agreement, Compound or the
parties' relationship shall require the approval of both Company and
Supplier. Company shall have the right to request removal of confidential
information and may require that publication be delayed up to a maximum of
three (3) months from first notification of such publication to enable
Company to protect its Intellectual Property rights.
Supplier agrees not to use or imply Company's name for advertising,
self-promotion purposes, raising capital, recommending investments, which,
inter alia, implies endorsement by Company, and will only reference
Company's name after obtaining Company's prior written permission.
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17. Indemnification
---------------
a. Supplier to Company
-------------------
Supplier shall indemnify, defend and hold harmless Company, its
officers, directors, employees, and agents against any liability,
obligation, loss, damage, penalty, action, judgment, suit, expenses
(including reasonable attorney's fees) or disbursements of any kind
and nature whatsoever arising out of: (i) any breach by Supplier of
its obligations under this Agreement; (ii) a patent infringement claim
relating to manufacturing technology provided by Supplier; or (iii)
personal injury resulting from an adverse reaction of the Compound,
which is due to Supplier's breach of Material Warranty, determined in
accordance with the provisions of paragraph 6(d), provided that
Company gives reasonable notice to Supplier of such claim, suit or
action and such liability, obligation, loss, damage, penalty, action
or judgment is not the result of Company's negligent act or omission
or willful misconduct.
Provided Supplier properly protects the interests of Company and
Supplier and Company do not have conflicting defenses, Supplier shall
have exclusive control of the defense of any such action and
settlement or compromise negotiations, except that prior to accepting
any settlement or compromise, Supplier will inform Company in writing
of the terms of the anticipated settlement or compromise. Company will
provide Supplier, at Supplier's expense with reasonable assistance in
defending any claim, suit or action. Such assistance shall not be
deemed a waiver of Company's indemnification rights hereunder.
b. Company to Supplier
-------------------
Company shall indemnify, defend and hold harmless Supplier, its
officers, directors, employees, and agents against any liability,
obligation, loss, damage, penalty, action, judgment, suit, expenses
(including reasonable attorney's fees) or disbursements of any kind
and nature whatsoever arising out of: (i) any breach by Company of its
obligations under this Agreement; (ii) a patent infringement claim
relating to the Compound, intermediates and/or manufacturing
technology provided by Company; or (iii) personal injury resulting
from an adverse reaction of the Compound, which is not caused by
Supplier's breach of Material Warranty, determined in accordance with
the provisions of paragraph 6(d), provided that Supplier gives
reasonable notice to Company of such claim, suit or action and such
liability, obligation, loss, damage, penalty, action or judgment is
not the result of Supplier's negligent act or omission or willful
misconduct.
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Provided Company properly protects the interests of Supplier and
Company and Supplier do not have conflicting defenses, Company shall
have exclusive control of the defense of any such action and
settlement or compromise negotiations, except that prior to accepting
any settlement or compromise, Company will inform Supplier in writing
of the terms of the anticipated settlement or compromise. Supplier
will provide Company, at Company's expense with reasonable assistance
in defending any claim, suit or action. Such assistance shall not be
deemed a waiver of Supplier's indemnification rights hereunder.
18. Notices
-------
All notices required or permitted to be given under this Agreement shall be
in writing and shall be delivered personally, sent by secure facsimile or
mailed prepaid to the persons named and addresses set forth below.
If to Company: Director of Manufacturing Operations
Cell Therapeutics, Inc.
000 Xxxxxxx Xxxxxx Xxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxxxx 00000
Telephone No.: (000) 000-0000
Facsimile No.: (000) 000-0000
If to Supplier: Chairman and CEO
ChiRex Ltd.
Xxxxxx, Xxxxxxxxxxx
Xxxxxxxxxxxxxx, XX00 0XX
XXXXXXX
Telephone No.: 0000 000 0000
Facsimile No.: 0191 250 1154
19. Applicable Law and Jurisdiction
-------------------------------
This Agreement shall be construed in accordance with, and its performance
shall be governed by, the laws of the State of Washington, exclusive of
choice of law provisions.
20. Force Majeure
-------------
If Supplier cannot perform its obligations hereunder by reason of
impediment such as Acts of God, war, rebellion, tumult, riot, civil
commotion, insurrection, political disturbance, strike, lock-out, fire,
flood, interruption of transportation, embargo, shortage of raw materials,
instruction of the authorities or any other
Page 19 of 21
19
cause or event of similar nature affecting Supplier and over which Supplier
has no control, Supplier shall have the right to postpone performance of
such obligation for the duration of such impediment. Supplier shall
immediately notify Company (no later than twenty-four (24) hours from
Supplier's first knowledge of the impediment) and provide an anticipated
duration of the impediment. In addition, Supplier shall subsequently notify
Company as quickly as possible of its cessation.
In the case of Force Majeure affecting Supplier, should Supplier not be
able to resume performance hereunder within two (2) weeks of the occurrence
of the impediment, Company shall be entitled to obtain Compound or other
materials from an alternative supplier. Materials obtained from another
source will accordingly reduce commercial forecasts. Company will remain
liable to Supplier only for fees and expenses of material manufactured by
Supplier satisfying all requirements of this Agreement and shipped to
Company in accordance with the provision of Paragraph 6.e, Shipping through
the occurrence of the impediment. Supplier shall cooperate and make all
effort to assist Company in transferring technology for manufacturing of
Compound to the other source for material.
21. Amendments
----------
Any amendments, changes, or revisions to this Agreement must be proposed in
writing by either party, and accepted in writing by the other party before
they shall become effective and binding.
22. Assignment
----------
This Agreement being for specialized manufacturing services, Supplier shall
not assign, transfer or convey this Agreement or any moneys due or to
become due hereunder without the prior written consent of Company; however,
this Agreement shall enure to benefit Company, its assigns, subsidiaries or
successors in business.
23. Entire Agreement
----------------
This Agreement (all Exhibits and documents attached hereto and referenced
herein) represents the entire understanding and agreement between Company
and Supplier. In the event that a conflict arises between this Agreement
and printed terms and conditions on any subsequently prepared document
concerning performance of the parties under this Agreement, the terms and
conditions provided in this Agreement shall prevail, unless the document
satisfies the requirements herein for amendments to this Agreement.
Page 20 of 21
20
IN WITNESS WHEREOF, the parties by their authorized representatives have
set their hands on the day first above written.
CELL THERAPEUTICS, INC. CHIREX LTD.
By: /s/ Xxxxxxx X. Xxxxxxx By: /s/ Xxxx X. Xxxxx
--------------------------------- ---------------------------------
Xxxxxxx X. Xxxxxxx Xxxx X. Xxxxx
Title: EVP, Product Development Title: Chairman CEO
-------------------------- ------------------------------
Address: 000 Xxxxxxx Xxxxxx Xxxx Address: Dudley, Cramlington
-------------------------- ---------------------------
Xxxxxxx, Xxxxxxxxxx 00000 Xxxxxxxxxxxxxx, XX000XX
-------------------------- ---------------------------
USA ENGLAND
-------------------------- ---------------------------
The remaining portion of this page left intentionally blank.
Page 21 of 21
21
Exhibit A
SANOFI WINTHROP LIMITED
AND
CELL THERAPEUTICS INC
AND
STERLING ORGANICS
---------------------------------
CONFIDENTIAL DISCLOSURE AGREEMENT
---------------------------------
Sanofi Winthrop Limited
One Xxxxxx Xxxxxx
Xxxxxxxxx
Xxxxxx XX0 0XX
Telephone :0000 000000
Reference :AWS/ERIB.SOA11054
Date :11th May 1994
22
2
THIS AGREEMENT is made the 22 day of March 1994 BETWEEN SANOFI WINTHROP LIMITED
whose principal office is situate at One Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxx XX0
0XX (hereinafter called "Sanofi Winthrop") of the one part and CELL THERAPEUTICS
INC of 000 Xxxxxxx Xxxxxx Xxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxxxx 00000, XXX
(hereinafter called "Cell") of the other part and STERLING ORGANICS, a division
of Sterling Winthrop of 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxxx, Xxx Xxxx 00000, XXX
(hereinafter called "Sterling Organics").
WHEREAS:
Sanofi Winthrop, Cell and Sterling Organics wish to exchange information
concerning various processing options for Compound CT-1501R (hereinafter called
"the Options") enabling Cell to evaluate their interest in pursing the options
(hereinafter called "the Evaluation")
Much of the information disclosed by Sanofi Winthrop, Cell and Sterling Organics
will be of a confidential nature and by entering into this agreement the parties
wish to ensure that such confidentiality is preserved.
NOW THEREFORE IT IS AGREED as follows:
1. Confidential Information
In this Agreement "Confidential Information" means any scientific,
statistical, commercial or technical information, know-how or data
relevant to the Options which may be disclosed or communicated hereunder
by one party hereto to another either directly or indirectly and whether
in writing, by drawings, samples or by any other means for the purpose of
the Evaluation.
2. Disclosure
Promptly after the execution of this Agreement, Sanofi Winthrop, Cell and
Sterling Organics shall disclose all such Confidential Information which
the disclosure is free to disclose for the purpose only of enabling the
Evaluation to take place.
3. Undertaking
In consideration of the disclosure of Confidential Information by each
party to the other, Sanofi Winthrop, Cell and Sterling Organics hereby
undertakes to keep secret and strictly confidential all such Confidential
Information of the other party which shall not be disclosed to any third
party nor used for purposes other than the said Evaluation without the
disclosing party's express written consent to such disclosure or use.
23
3
4. Limitation of Confidentiality
The obligations of confidence and non-use herein and any implied by law
shall continue for a period of ten (10) years from the date hereof
notwithstanding the completion of the Evaluation but shall not apply to
any part of the Confidential Information which:
(a) it can be proved by evidence in writing was known to the recipient
before its receipt from the discloser;
(b) was available to the public before that date or was in the public
domain;
(c) becomes available to the public or to the public domain after that
date otherwise than as a result of an act or default of the
recipient;
(d) is received by the recipient from a third party not bound to the
disclosing party by any obligation of secrecy; or
(e) is independently developed by the recipient after that date without
using the Confidential Information.
5. Employee's Obligations
All parties shall ensure that any of their employees who receive the
Confidential Information are both advised of the confidentiality and use
terms of this Agreement and have, as part of their terms and conditions of
employment, undertaken obligations of confidentiality to their employer
concerning information received in the course of their employment.
6. Return of Information
Whether on termination of the Discussions for any reason whatsoever or at
any time upon the request of any party, the other shall return forthwith
to the party making the request all written or other documentary
Confidential Information, by whomsoever prepared, together with all
samples, models and the like in its possession embodying Confidential
Information of the other.
7. Governing Law
This Agreement shall be governed in all respects by the laws of the State
of Washington, USA.
24
4
IN WITNESS whereof the parties have caused this Agreement to be signed by their
duly authorized representatives the day and year first above written.
SIGNED BY ) /s/ J. Xxxxxx Xxxxxx
for and on behalf of ) March 22, 1994
SANOFI WINTHROP LIMITED )
SIGNED BY ) /s/ Xxxxxxx X. Xxxxx
for and on behalf of ) March 22, 1994
CELL THERAPEUTICS INC )
SIGNED BY ) /s/ Xxxx X. Xxxxxxx
for and on behalf of ) March 22, 1994
STERLING ORGANICS )
25
[CHIREX LTD. LETTERHEAD]
JGT/ljc secrecy/c94008 20th March 1996
Cell Therapeutics Inc.
000 Xxxxxxx Xxxxxx Xxxx
Xxxxxxx
Xxxxxxxxxx 00000
XXX
Notification of Name Change and Transfer of Responsibilities
Dear Sirs,
I refer to the agreement dated March 22nd, 1994 made between Sterling Organics
Limited and Cell Therapeutics Inc. concerning various processing options for
Compound CT-1501R ("the Agreement").
I am writing to advise you that Sterling Organics Ltd. has merged with
SepraChem Inc. to form a new Public Company called ChiRex Inc.
The manufacturing and research and development facilities of the new company
are based at Xxxxxx and are encompassed by the new U.K. legal entity ChiRex
Ltd. Accordingly the above agreement is transferred to ChiRex Ltd. who will
continue to fulfill the terms and obligations of the agreement.
Yours faithfully,
/s/ X.X. Xxxxxx
X.X. XXXXXX
-----------
Business Development Director
Accepted and Acknowledged by Xxxxxx Xxxxxxx (Name)
----------------------
/s/ Xxxxxx Xxxxxxx (Signature)
----------------------
April 25, 1996 (Date)
----------------------
