Manufacture and Supply Agreement - Seragen Inc. and Cambrex Bio Science Hopkinton Inc.
MANUFACTURE AND SUPPLY AGREEMENT
This Manufacture and Supply Agreement (hereinafter called "Agreement") is made
and entered into as of the date of last signature below and is effective as of
the 1st day of January, 2004 (the "Effective Date"), by and among
SERAGEN, INC., a corporation organized and existing under the laws of Delaware
and having its principal place of business at 10275 Science Center Drive, San
Diego, California 92121 (hereinafter called "SERAGEN") and
CAMBREX BIO SCIENCE HOPKINTON, INC., a corporation organized and existing under
the laws of Delaware and having a principal place of business at 97 South
Street, Hopkinton, MA 01748 (hereinafter called "CBSH").
WHEREAS, SERAGEN has developed a biological entity designated as DAB389IL-2,
prepared as a purified drug substance; and
WHEREAS, SERAGEN desires to have CBSH (a) manufacture, store, test and supply
Fermentation Pellets, First Gen PDS and Second Gen PDS (each as defined below),
(b) test First Gen FDP and Second Gen FDP (each as defined below), and (c)
perform stability testing on Fermentation Pellets, First Gen PDS, Second Gen
PDS, First Gen FDP and Second Gen FDP, and (d) perform any and all services as
described in Article II of this Agreement, all in accordance with cGMP; and
WHEREAS, SERAGEN may, from time to time, desire to purchase from CBSH additional
services such as, but not limited to, cell line stock storage, supplemental
Fermentation Pellets, First Gen PDS and Second Gen PDS storage and
regulatory/CMC consulting, all in accordance with cGMP; and
WHEREAS, CBSH is willing to (a) undertake the manufacture, storage, testing and
supply of Fermentation Pellets, First Gen PDS and Second Gen PDS, (b) test First
Gen FDP and Second Gen FDP, (c) perform stability testing on Fermentation
Pellets, First Gen PDS, Second Gen PDS, First Gen FDP and Second Gen FDP, and
(d) perform services as described above according to the terms, conditions and
covenants hereinafter set forth.
NOW, THEREFORE, the parties hereto, in consideration of the promises and the
mutual covenants and agreements contained herein, the sufficiency of which are
hereby acknowledged, agree as follows:
ARTICLE I
DEFINITIONS
1.0 DEFINED TERMS. In addition to terms otherwise defined in this Agreement, the
following terms have the specified meanings for purposes of this Agreement:
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1.01 "Affiliate" shall mean any corporation, firm, partnership, individual or
other form of business organization which is now or hereafter owned or
controlled by a Party or, any corporation in which a Party owns at least fifty
percent (50%) of the stock entitled to vote for directors or otherwise controls
the election of directors, and any corporation, firm, partnership, individual or
other form of business organization in which a Party has the maximum ownership
interest it is permitted to have in the country where such business organization
exists.
1.02 "Batch" shall mean:
For First Gen PDS: the total amount of PDS from the purification of a
single Fermentation Pellet resulting in not less than *** of DAB389IL-2; and
For Second Gen PDS: the total amount of PDS from the purification of ***
Fermentation Pellets resulting in not less than the minimum validated yield for
DAB389IL-2 as shall be set forth on two (2) schedules to be proposed by SERAGEN
and mutually agreed upon by the Parties and thereafter attached to this
Agreement (and made a part thereof); a separate schedule shall be proposed,
agreed and attached for each of (i) clinical and commercial Batches of Second
Gen PDS and (ii) development and validation Batches of Second Gen PDS; and
For Fermentation Pellets: A minimum of *** pellets resulting in not less
than *** grams of total protein per pellet according to validated procedures
then in effect.
1.03 "Batch Acceptance Date" shall mean the later of (a) the date set forth on
the applicable purchase order or (b) thirty (30) days after SERAGEN's receipt of
all MRR Documentation, subject to the acceptance and rejection procedures set
forth in Sections 2.14(a) and 2.14(c).
1.04 "Certificate of Analysis" means the form listing: the name and CBSH part
number of the applicable Product, SERAGEN's name, all tests performed on such
Product as specified in the current Specifications for such Product, each test
method, each test specification and the reported assay result for each test.
1.05 "cGMP" shall mean as of the Effective Date of this Agreement, the current
good manufacturing practices standards required by the FDA, as set forth in
Title 21 C.F.R., Parts 210, 211 and 600 as applicable, in the United States Food
and Drug Act, as amended, the good manufacturing practices required by the EMEA,
as set forth in the European Rules and Guidances for Pharmaceutical
Manufacturers and Distributors and/or the European Good Manufacturing Guidances,
Rules and Directives, or the applicable FDA and EMEA regulations, policies or
guidelines in effect, at the time of manufacture, for the manufacture and
testing of pharmaceutical materials as applied to bulk pharmaceuticals and/or
biologics.
1.06 "DAB389IL-2" shall mean a fusion protein developed by SERAGEN and sold in
the United States under the trademark ONTAK(R) comprising the first 389 amino
acids of the A and B fragments of the diphtheria toxin combined with
interleukin-2.
1.07 "EMEA" shall mean the European Agency for the Evaluation of Medicinal
Products.
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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1.08 "Facility" shall mean the testing and manufacturing facility at 97 South
Street, Hopkinton, Massachusetts 01748 and the warehouse facility located at 99
South Street, Hopkinton, Massachusetts 01748.
1.09 "FDA" shall mean the United States Food and Drug Administration.
1.10 "Fermentation Pellet" shall mean the inclusion body preparation of
unpurified DAB389IL-2 protein produced from the growth and induction of the
DAB389IL-2 working cell bank.
1.11 "First Gen FDP" shall mean the final drug product processed and/or packaged
in its final dosage form resulting from formulation and fill of First Gen PDS
and whose samples are received by CBSH under CBSH part #90-204-02.
1.12 "First Gen PDS" shall mean DAB389IL-2 prepared as a purified drug substance
and ready for fill/finish by SERAGEN, manufactured by CBSH pursuant to the
applicable Manufacturing and Release Requirements set forth in the Production
Record and in CBSH part #60-104.
1.13 "Food and Drug Act" shall mean the Food, Drug and Cosmetic Act, as set
forth in 21 U.S.C. 301-391.
1.14 "Intellectual Property" shall mean all know-how, copyrights, designs,
databases, mask works, patents, trademarks, trade names and other proprietary
data and rights, and all registrations and applications therefor.
1.15 "Lot" shall mean, as applicable, (i) the total number of vials of First Gen
FDP and Second Gen FDP resulting from a single fill and finishing process or
(ii) the total number of vials qualified as part of a reference standard
qualification or re-qualification.
1.16 "Manufacturing and Release Requirements" shall mean any and all
Specifications and release requirements mutually agreed on between the Parties
for Fermentation Pellets, First Gen PDS, or Second Gen PDS as the case may be,
and as to each, its manufacture, including, without limitation, all raw
materials, solvents, reagents, processing, storage, shipping and packaging
specifications and necessary test protocols, release specifications,
Certificates of Analysis and other documentation required to describe, control
and assure the quality manufacture and testing of each in compliance with the
applicable Regulatory Requirements, all as contained in the Production Record or
the MRR Documentation and any SOPs which govern the manufacture, storage,
handling and testing of each.
1.17 "MRR Documentation" means all production and release documentation as
described in Exhibit "A".
1.18 "Party" or "party" shall mean either SERAGEN or CBSH, and the terms
"Parties" or "parties" shall, as appropriate, mean SERAGEN and CBSH.
1.19 "Process Improvements" shall mean any improvement made to the method of
manufacture of Fermentation Pellets, First Gen PDS and/or Second Gen PDS.
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1.20 "Product" shall mean Fermentation Pellets, First Gen PDS, Second Gen PDS,
First Gen FDP and/or Second Gen FDP.
1.21 "Product Intellectual Property" shall mean all Intellectual Property which
is specifically related to the Product and its method of manufacture, including
Process Improvements which are specifically related to the Product. Product
Intellectual Property shall not include Intellectual Property (including Process
Improvements) that relates generally to the development and manufacture of
biopharmaceuticals and that has application to and or value for developing and
manufacturing biopharmaceuticals other than the Product.
1.22 "Production Record" means the documentation that contains a detailed
description of the manufacturing process for Fermentation Pellets, First Gen PDS
or Second Gen PDS, as the case may be, and any other instructions to be followed
by CBSH in the production of Fermentation Pellets, First Gen PDS and/or Second
Gen PDS.
1.23 "Regulatory Agency" shall mean, as of the Effective Date of this Agreement,
the regulatory agencies with authority over the manufacture, testing and/or
shipment of Product, and as further defined or supplemented pursuant to Exhibit
"D".
1.24 "Regulatory Requirements" means the cGMP in effect at the particular time,
issued or required by the Regulatory Agency for the methods to be used in, and
the facilities and controls to be used for, the manufacture, processing,
packaging and storage of the manufactured Product.
1.25 "Second Gen FDP" shall mean the final drug product processed and/or
packaged in its final dosage form resulting from formulation and fill of Second
Gen PDS and whose samples are received by CBSH under CBSH part #90-304-02.
1.26 "Second Gen PDS" shall mean DAB389IL-2 prepared as a purified drug
substance and ready for formulation, fill and finish by SERAGEN, manufactured by
CBSH pursuant to the applicable Manufacturing and Release Requirements set forth
in the Production Record and in CBSH part #60-304.
1.27 "SERAGEN Authorized Personnel" shall mean SERAGEN or Ligand Pharmaceuticals
Incorporated personnel set forth on attached Exhibit "F."
1.28 "Shipment Date" shall mean the date designated by SERAGEN in writing upon
which Fermentation Pellets, First Gen PDS and/or Second Gen PDS will be
delivered by CBSH to SERAGEN's designated carrier.
1.29 "SOPs" shall mean standard operating procedures related to the Product and
the process of manufacturing the Product, as approved by both SERAGEN and CBSH.
1.30 "Specifications" shall mean any and all specifications mutually agreed on
between the Parties for the manufacture of Fermentation Pellets, First Gen PDS
and/or Second Gen PDS, including, without limitation, all raw materials,
solvents, reagents and processing specifications contained within the MRR
Documentation and part of the Manufacturing and Release Requirements.
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1.31 "Summary of Testing" shall mean the form that is used to report the results
of testing for which there are no corresponding Specifications or for First Gen
FDP and/or Second Gen FDP which is not released by CBSH; the responsibility for
release of such First Gen FDP and/or Second Gen FDP rests with SERAGEN.
ARTICLE II
MANUFACTURE AND SUPPLY
OF FERMENTATION PELLETS, FIRST GEN PDS, AND
SECOND GEN PDS AND RELATED SERVICES
2.01 MANUFACTURE AND SUPPLY OF FERMENTATION PELLETS, FIRST GEN PDS AND/OR SECOND
GEN PDS. CBSH shall, from time to time, as requested by SERAGEN, manufacture and
supply to SERAGEN Fermentation Pellets, First Gen PDS and/or Second Gen PDS
produced, tested and packaged according to the Manufacturing and Release
Requirements under the terms and conditions of this Agreement, and in accordance
with all Regulatory Requirements.
2.02 VALIDATION REQUIREMENTS.
(a) SECOND GENERATION VALIDATION. CBSH shall provide validation for all
equipment, manufacturing processes and procedures, cleaning processes
and procedures, and analytical test methodologies (together "Equipment
and Procedures") which are used in the manufacture and testing of
Second Gen PDS and testing of Second Gen FDP, in accordance with a
mutually agreed-upon validation plan according to the rates set forth
in Exhibit "C".
(b) MAINTENANCE OF CURRENT & FUTURE VALIDATIONS. CBSH shall use
commercially reasonable efforts to maintain the current and all future
validations for all Equipment and Procedures which are used in the
manufacture and testing of Fermentation Pellets, First Gen PDS and/or
Second Gen PDS and testing of First Gen FDP and/or Second Gen FDP.
CBSH shall use commercially reasonable efforts to maintain such
validations in accordance with cGMP.
(c) ADDITIONAL VALIDATIONS. Additional validations that may be requested
by SERAGEN (i) in connection with the manufacture and testing of
Fermentation Pellets, First Gen PDS, Second Gen PDS, First Gen FDP
and/or Second Gen FDP or (ii) to comply with the Regulatory
Requirements of a Regulatory Agency, will be executed as described in
the terms and conditions of this Agreement. All such additional
validations will be performed in accordance with the Additional
Services rates set forth in Exhibit "B". Any other additional
validations not covered by this Section 2.02(c) shall be at CBSH's
cost and expense.
2.03 REGULATORY INSPECTIONS. CBSH shall prepare for, submit to and endeavor to
pass all inspections deemed necessary by the Regulatory Agencies, and both
Parties shall cooperate to allow CBSH to promptly correct all deficiencies, and
both Parties shall cooperate, such that CBSH is able to timely manufacture and
supply Fermentation Pellets, First Gen PDS and/or Second Gen PDS for SERAGEN.
Cost for such preparations, inspections and corrective actions
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for Fermentation Pellets, First Gen PDS, and/or Second Gen PDS-related
inspections will be in accordance with the Additional Services rates set forth
in Exhibit "B".
2.04 DEVIATIONS & INVESTIGATIONS. SERAGEN shall be notified in writing of all
process deviations, manufacturing failures, errors/accidents and
out-of-specification results, which are significant in each case, within one (1)
working day of CBSH's knowledge of such. For purposes of this Section 2.04, all
such notifications must be made by facsimile transmission to the current
"Director, Quality Assurance & Compliance" for Ligand Pharmaceuticals
Incorporated ("LIGAND") and LIGAND quality assurance (quality assurance
hereinafter referred to as "QA"), which shall be deemed received upon
confirmation of facsimile transmission, and those notice provisions set forth in
Section 10.01 shall not be applicable. SERAGEN and CBSH shall agree on the scope
and timing of resulting investigations as well as process changes for any
subsequent Batches, all as consistent with cGMP and/or Regulatory Requirements.
2.05 RELEASE TESTING. CBSH shall, from time to time as requested by SERAGEN,
perform analytical release testing using validated procedures for First Gen FDP
and Second Gen FDP according to SOPs. CBSH shall perform the work detailed in
all SOPs under cGMP conditions, and shall perform the work as detailed in the
SOPs within the time defined in the SOP, including laboratory testing, QA review
of data and final report. In the event that SERAGEN requests a repeat of a test,
and the request is in accordance with CBSH's retest policy, CBSH shall begin the
work within one (1) week of the request, and complete the work within the time
specified in the SOPs. In the event that analytical results fail to meet
Specifications or acceptance criteria as defined in the SOPs or Manufacturing
and Release Requirements, CBSH will undertake any resulting investigations and
other action required as per cGMP and CBSH internal standard operating
procedures or protocols. Any investigations other than those required by cGMP
and/or CBSH internal standard operating procedures or protocols and if requested
by SERAGEN will be performed in accordance with the Additional Services rates
set forth in "Exhibit B." Although CBSH will be performing First Gen FDP and
Second Gen FDP release testing, SERAGEN is, and at all times will remain,
responsible for final release of the First Gen FDP and Second Gen FDP for sale
and/or use. CBSH assumes no responsibility or liability whatsoever related to
final release of First Gen FDP and Second Gen FDP for sale and/or use.
2.06 STABILITY TESTING. CBSH shall, from time to time, as requested by SERAGEN,
perform stability testing using validated procedures for First Gen FDP, Second
Gen FDP, Fermentation Pellets, First Gen PDS and/or Second Gen PDS, according to
SOPs. CBSH shall perform the work detailed in all SOPs or protocols under cGMP
conditions, and shall perform the work as detailed in the SOPs or protocols
within the time defined in the SOP or protocol, including laboratory testing, QA
review of data and final report. In the event that SERAGEN requests a repeat of
a test/SOP or protocol, CBSH shall begin the work within one (1) week of the
request, and complete the work within the time specified in the SOPs or
protocols. In the event that stability test results fail to meet Specifications
or acceptance criteria as defined in the SOPs, protocols, or Manufacturing and
Release Requirements, CBSH will undertake any resulting investigations and other
action required as per cGMP and CBSH internal standard operating procedures or
protocols. Any stability testing or investigations other than those required by
cGMP and/or CBSH internal standard operating procedures or protocols and if
requested by
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SERAGEN will be performed in accordance with the Additional Services rates set
forth in "Exhibit B."
2.07 FORECASTS. SERAGEN will provide CBSH with an initial preliminary
non-binding forecast for production of Fermentation Pellets, First Gen PDS
and/or Second Gen PDS, covering the calendar year 2004, no later than ten (10)
business days following the date of last signature below. Thereafter, on or
before each December 31st (as to July through December of the following calendar
year) and June 30th (as to January through June of the following calendar year)
during the Term of the Agreement, SERAGEN will provide CBSH with a twelve (12)
month preliminary non-binding forecast for production of Fermentation Pellets,
First Gen PDS and/or Second Gen PDS. CBSH shall notify SERAGEN within ten (10)
business days of receipt of each forecast if it anticipates that it will be
unable to meet any or all of the last six (6) months of the forecasted
requirements, provided however, that failure to make such notification will not
obligate CBSH to supply amounts of Fermentation Pellets, First Gen PDS and/or
Second Gen PDS beyond the limitations set forth below in Section 2.08.
2.08 PURCHASE ORDERS. SERAGEN will provide CBSH with the initial binding
purchase order for production of Fermentation Pellets, First Gen PDS and/or
Second Gen PDS requirements, covering the first six (6) months of calendar year
2004 and providing CBSH with no less than six (6) months lead time on the first
proposed Batch Acceptance Date, no later than ten (10) business days following
the date of last signature below. Thereafter, on or before each December 31st
(as to July through December of the following calendar year) and June 30th (as
to January through June of the following calendar year) during the Term of the
Agreement, SERAGEN will provide CBSH with a six (6)-month binding purchase order
for production of Fermentation Pellets, First Gen PDS and/or Second Gen PDS
requirements. All binding purchase orders submitted by SERAGEN for manufacture
of Fermentation Pellets, First Gen PDS and/or Second Gen PDS must contain Batch
Acceptance Date(s) for such Fermentation Pellets, First Gen PDS and/or Second
Gen PDS within the relevant time period covered by such purchase order. If CBSH
is unable to meet a Batch Acceptance Date, CBSH shall notify SERAGEN within ten
(10) business days of receipt of a purchase order and CBSH and SERAGEN shall
work together, in good faith, to set an amended Batch Acceptance Date which is
acceptable to both Parties. SERAGEN shall provide CBSH with a binding purchase
order for First Gen FDP and/or Second Gen FDP release/stability testing and/or
Fermentation Pellets, First Gen PDS and/or Second Gen PDS stability testing at
least one (1) month prior to the scheduled initiation of the testing.
If SERAGEN requires additional manufacture of Fermentation Pellets, First Gen
PDS and/or Second Gen PDS before or during any period that is over and above the
quantity specified in the binding purchase order for such period, SERAGEN shall
submit additional purchase order(s) for such additional Fermentation Pellets,
First Gen PDS and/or Second Gen PDS. Such additional purchase orders shall be
submitted to CBSH as soon as SERAGEN becomes aware of such additional quantity
needs, but no later than ninety (90) days prior to the Batch Acceptance Date set
forth in a binding purchase order for that additional quantity. CBSH will use
commercially reasonable efforts to fulfill such additional purchase orders, but,
subject to the foregoing, CBSH is under no obligation to accept and/or to
fulfill any additional purchase order(s) for Fermentation Pellets, First Gen PDS
and/or Second Gen PDS to the extent such purchase order(s), (i) when aggregated
with previously received purchase orders for such period, exceeds
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by more than *** the amounts set forth in the binding portion of the forecast
related to such period and submitted in accordance with Section 2.07, or (ii)
cannot be filled due to circumstances arising under Section 10.10. CBSH shall
notify Seragen in writing within ten (10) business days of receipt of any such
additional purchase order(s) which CBSH rejects and/or will be unable to
fulfill. If such notice is not received by SERAGEN within ten (10) business days
of CBSH's receipt of such additional purchase order(s), the additional purchase
order(s) shall be deemed accepted by CBSH.
CBSH shall notify SERAGEN, within ten (10) business days of receipt of a
purchase order, of the scheduled commencement date for manufacture of
Fermentation Pellets, First Gen PDS and/or Second Gen PDS.
Purchase orders shall be submitted by LIGAND on behalf of SERAGEN in
substantially the form shown on Exhibit "E" hereto. In the event of a conflict
between the terms and conditions listed on the reverse side of the purchase
order and this Agreement, this Agreement shall govern. Unless otherwise noted on
the face of such form, the Batch Acceptance Date shall appear under the title
"Delivery Date".
2.09 SUPPLY AND STORAGE OF MATERIALS. CBSH shall be responsible for planning,
ordering and maintaining an adequate supply of components, supplies, raw
materials and reagents meeting the Specifications that are necessary to
manufacture Fermentation Pellets, First Gen PDS and/or Second Gen PDS and to
provide the services as described in this Agreement. Reference standard and
controls qualification, maintenance and storage will be provided by CBSH in
accordance with cGMP and all other Regulatory Requirements. Reference standard
and controls qualifications shall be provided in accordance the applicable rates
set forth in Exhibit "B." Further, CBSH shall provide facilities to adequately
store and maintain all raw materials, reagents, and intermediates in accordance
with Specifications. CBSH shall ensure that appropriate diligence, caution and
management are taken in CBSH's storage and control of key cell lines and other
reagents owned by SERAGEN which are directly related to the testing of First Gen
FDP and/or Second Gen FDP and Fermentation Pellets, First Gen PDS and/or Second
Gen PDS, such as, but not limited to, applicable cell lines and antibodies.
2.10 STORAGE OF FERMENTATION PELLETS, FIRST GEN PDS AND/OR SECOND GEN PDS. CBSH
will store Fermentation Pellets if manufactured by CBSH under a purchase order
in accordance with Section 2.08 and up to an amount necessary to manufacture a
twelve (12)-months' supply of First Gen PDS and Second Gen PDS, as determined by
the forecast submitted for such period, plus a *** safety stock. In addition,
CBSH will store First Gen PDS and Second Gen PDS for up to twelve (12) months
following the applicable Batch Acceptance Date. CBSH may store quantities of
Fermentation Pellets, First Gen PDS or Second Gen PDS in excess of those set
forth above and/or may store such for periods of time in excess of those set
forth above at the storage rates set forth in Exhibit "B."
2.11 MANUFACTURING PROCESS CHANGES. Manufacturing and Release Requirements
cannot be changed unless agreed to in a dated, written document signed by the
Parties and incorporated into the Production Record. In addition, if any
Regulatory Agency having jurisdiction in any country where SERAGEN is selling
First Gen FDP and/or Second Gen FDP requires any changes to the Fermentation
Pellets, First Gen PDS and/or Second Gen PDS Specifications,
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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CBSH shall make reasonable efforts to make the required changes per section
3.02, so long as such changes do not conflict with cGMP. In the event amendments
or supplements are required to the Specifications for the purpose of complying
with current Regulatory Requirements, the Parties shall mutually agree on
appropriate amendments or supplements and shall incorporate or include such
amendment or supplement in or as part of the Production Record. Such activities
shall be additional services if they are requested by SERAGEN (i) in connection
with the manufacture and testing of Fermentation Pellets, First Gen PDS, Second
Gen PDS, First Gen FDP and/or Second Gen FDP or (ii) to comply with the
Regulatory Requirements of a Regulatory Agency, and will be performed in
accordance with the Additional Services rates set forth in Exhibit "B".
2.12 PROCESS IMPROVEMENTS. Each of CBSH and SERAGEN shall have the right to
request changes to implement Process Improvements or to reduce the cost of
manufacturing at the Facility, by written notice delivered to the other party.
CBSH and SERAGEN shall meet as soon as possible after such notification to
discuss such changes, the cost impact of such changes and the continued
provision of Fermentation Pellets, First Gen PDS and/or Second Gen PDS under
this Agreement. No change shall be implemented by CBSH or SERAGEN, whether
requested by either of the parties or requested or required by a Regulatory
Agency and/or a governmental agency, until the Parties have agreed in writing to
such change. Under no circumstances shall this section be construed to require
either Party to agree to changes that do not comply with cGMP. Such activities
shall be additional services if they are requested by SERAGEN (i) in connection
with the manufacture and testing of Fermentation Pellets, First Gen PDS, Second
Gen PDS, First Gen FDP and/or Second Gen FDP or (ii) to comply with the
Regulatory Requirements of a Regulatory Agency, and will be performed in
accordance with the Additional Services rates set forth in Exhibit "B".
2.13 QUALITY CONTROL AND QUALITY ASSURANCE. CBSH shall conduct quality control
testing and release of Fermentation Pellets, First Gen PDS and/or Second Gen PDS
(hereafter referred to as "CBSH QA Release") to SERAGEN or SERAGEN's designated
carrier for further processing by SERAGEN in accordance with (a) the methods and
procedures described in the Manufacturing and Release Requirements, and (b)
current Regulatory Requirements. Shipment by SERAGEN's designated carrier of
Fermentation Pellets, First Gen PDS and/or Second Gen PDS shall not occur unless
and until (i) CBSH QA Release of the Fermentation Pellets, First Gen PDS and/or
Second Gen PDS has occurred, (ii) Batch acceptance of such Fermentation Pellets,
First Gen PDS and/or Second Gen PDS has occurred in accordance with Section
2.14(a) and (iii) the occurrence of the designated Shipment Date. Batch
acceptance by SERAGEN will be based solely upon SERAGEN's review of the complete
MRR Documentation supplied by CBSH and SERAGEN's internal standard operating
procedures related to the manufacture of Fermentation Pellets, First Gen PDS
and/or Second Gen PDS or otherwise in accordance with Section 2.14(a). CBSH
shall retain all records pertaining to testing as required by cGMP.
2.14 NON-CONFORMING MANUFACTURED PRODUCT.
(a) REJECTION BY SERAGEN. CBSH shall provide SERAGEN's QA and Compliance
department with copies of completed MRR Documentation listed in
Exhibit "A", and shall endeavor to do so within ten (10) business days
of CBSH QA Release of Fermentation Pellets, First Gen PDS and/or
Second Gen PDS.
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Within thirty (30) days after SERAGEN's receipt of all MRR
Documentation, SERAGEN shall determine by review of the MRR
Documentation whether or not, in SERAGEN's sole opinion, the given
Batch of Fermentation Pellets, First Gen PDS and/or Second Gen PDS
conforms to the Manufacturing and Release Requirements, and was
manufactured in accordance with cGMP; provided that CBSH provides
timely answers to information requests and resolution of issues
arising from SERAGEN's review of MRR Documentation. If within the
thirty (30) day period, SERAGEN QA makes a determination that SERAGEN
believes the Batch to be nonconforming, SERAGEN shall have the right
to reject the Batch in its entirety and shall notify CBSH in writing
within the thirty (30) day period. If SERAGEN does not submit written
notice of rejection within such thirty (30) day period, the Batch will
be deemed accepted by SERAGEN. In the event that SERAGEN desires to
accept the Batch prior to the end of the thirty (30) day period,
SERAGEN will fax a signed Batch acceptance form specifying the new
Batch Acceptance Date(s) to CBSH's Director of QA. Any dispute between
CBSH and SERAGEN as to whether or not a Batch that has been rejected
by SERAGEN is nonconforming will be resolved in accordance with the
procedures set forth in Section 2.14(c). Replacement of a
non-conforming Batch shall be in accordance with Section 2.14(d).
(b) REJECTION BY CBSH. CBSH shall notify SERAGEN promptly of rejection of
a Batch by CBSH QA or any delay or irregularity encountered during
manufacture which could lead to a rejection per SOPs. Any dispute
between CBSH and SERAGEN as to whether or not a Batch that been
rejected by CBSH is nonconforming will be resolved in accordance with
the procedures set forth in Section 2.14(c). Replacement of a
non-conforming Batch shall be in accordance with Section 2.14(d).
(c) RESOLUTION OF DISPUTES. In the event of a dispute between the Parties
over the validity of a Batch rejection for non-conformance of
Fermentation Pellets, First Gen PDS and/or Second Gen PDS pursuant to
Section 2.14(a), the Parties agree to submit a representative sample
of the rejected Batch to a qualified independent cGMP test facility to
be agreed upon by the Parties, and to accept the results of the
testing performed by that facility as binding with regard to that
Batch. The testing procedures utilized must be formally transferred
and qualified and/or validated at the independent test facility prior
to the independent testing facilities commencement of the testing. In
the event that the independent test facility confirms that a Batch was
improperly rejected, all expenses related to such testing shall be
borne by SERAGEN. In the event that the independent testing facility
confirms that a Batch was properly rejected, all expenses related to
such testing shall be borne by the Party deemed responsible for such
non-conformance per Section 2.14(d). The Parties agree to make good
faith efforts to resolve disputes regarding non-conformance of
Fermentation Pellets, First Gen PDS and/or Second Gen PDS, including
disputes regarding the source of or cause of any non-conformance,
within sixty (60) days of initiation of the dispute.
In the event that the Parties cannot resolve a dispute regarding
(i) the cause of a
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Batch's non-conformance with Fermentation Pellet, First Gen PDS
and/or Second Gen PDS Specifications and/or failure to meet the
Manufacturing and Release Requirements, (ii) conformance of a Batch
with cGMP, or (iii) conformance of a Batch with the required MRR
Documentation, the Parties shall submit the issue to a mutually agreed
upon arbitrator. Such arbitrator, employing the Commercial Arbitration
rules of the American Arbitration Association, will determine whether
the Batch was produced in conformity with cGMP and/or whether CBSH
personnel followed and executed the Production Record and required MRR
Documentation as written and approved by both Parties. The findings of
the arbitrator shall be binding on the Parties. CBSH shall bear such
expenses of the arbitration proceeding if and only if the findings of
the arbitrator confirm the Fermentation Pellets' First Gen PDS's
and/or Second Gen PDS's nonconformity with cGMP and/or a failure of
CBSH personnel to follow and execute the Production Record and
required MRR Documentation as written and approved by both Parties,
and SERAGEN shall bear such expenses if the findings of the arbitrator
confirm that the Fermentation Pellets, First Gen PDS and/or Second Gen
PDS were manufactured in accordance with cGMP and/or that CBSH
personnel followed and executed the Production Record and required MRR
Documentation as written and approved by both Parties.
(d) REPLACEMENT OF NONCONFORMING PRODUCT. Fermentation Pellets, First Gen
PDS and/or Second Gen PDS. In the event that SERAGEN and CBSH mutually
agree or an arbitrator determines, pursuant to Section 2.14(c), that a
Batch of Fermentation Pellets, First Gen PDS and/or Second Gen PDS is
non-conforming due to (i) the failure of CBSH personnel or
subcontractors to follow cGMP, (ii) the failure of CBSH personnel or
subcontractors to follow and execute the Production Record and
required MRR documentation as written and approved by both Parties,
(iii) the failure of the Facility equipment or utilities, (iv) the
failure or non-conformance of the raw materials with SOPs or
Specifications, (v) the breach of CBSH's obligations, representations
or warranties hereunder or (vi) the acts or omissions of CBSH's
subcontractors, CBSH shall replace all such Batches at its expense,
reimburse SERAGEN for the cost of the Fermentation Pellets used in the
manufacture of the nonconforming First Gen PDS and/or Second Gen PDS
at the cost paid by SERAGEN for such pellets, and shall reimburse
SERAGEN for any reasonable charges incurred by SERAGEN for shipping or
storage, if applicable, of the nonconforming Batch. SERAGEN and CBSH
shall promptly and mutually agree upon new dates for the initiation
and completion, by CBSH, of the manufacture of a replacement Batch of
Fermentation Pellets, First Gen PDS and/or Second Gen PDS, if required
to meet any outstanding purchase order(s). Notwithstanding the
foregoing, CBSH shall have no obligation to manufacture a replacement
Batch, and shall have no liability to SERAGEN whatsoever, unless it is
determined in accordance with the procedures set forth in Section
2.14(c) that any one of any combination of events set forth in
subsections (i) through (vi) of this Section 2.14(d) have resulted in
the Batch of Fermentation Pellets, First Gen PDS and/or Second PDS
being non-conforming. SERAGEN acknowledges and agrees that, except for
the indemnifications provided in Article VII hereunder, its sole
remedy with respect to nonconforming Fermentation Pellets, First Gen
PDS
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and/or Second Gen PDS is as set forth in this Section 2.14, and
in furtherance thereof, SERAGEN hereby waives all other remedies at
law or in equity regarding the foregoing claims.
In the event that a replacement Batch is commenced prior to a
final determination, in accordance with Section 2.14(c), as to the
cause of a non-conforming Batch, and the Parties subsequently
determine that the replacement Batch is not required, SERAGEN will
bear the costs associated with the manufacture of the replacement, up
to the time of such determination. SERAGEN and CBSH will negotiate in
good faith, terms for the continuance or discontinuation of the
manufacture of any such replacement Batch.
(e) DESTRUCTION OF NONCONFORMING PRODUCT. Fermentation Pellets, First Gen
PDS and/or Second Gen PDS. CBSH shall destroy, after thorough
investigation and upon determination that no further action can be
taken, all Fermentation Pellets, First Gen PDS and/or Second Gen PDS
in CBSH's possession, which is deemed to be nonconforming in
accordance with Section 2.14(c) and upon written authorization from
SERAGEN Destruction shall be in accordance with all applicable laws
and regulations (including without limitation, environmental laws and
regulations) and in a manner to which SERAGEN has given its prior
written approval. Such Fermentation Pellets, First Gen PDS and/or
Second Gen PDS shall not be sold, reprocessed, salvaged, reclaimed or
otherwise reused in any manner by CBSH. SERAGEN, or its designees,
shall return all non-conforming Batches to CBSH, whose non-conformance
is attributable to CBSH in accordance with Sections 2.14 (c & d), for
destruction at CBSH's expense. The cost and expense of the destruction
of Batches determined to be nonconforming in accordance with Sections
2.14 (c & d), whose nonconformance is not attributable to CBSH, shall
be the sole responsibility of SERAGEN. Representatives of SERAGEN
shall be permitted to witness the destruction of nonconforming
Fermentation Pellets, First Gen PDS and/or Second Gen PDS under this
section, and shall receive from CBSH proof of such destruction, upon
written request.
2.15 ADDITIONAL SERVICES; PROJECT SCOPE CHANGE ORDER PROCESS. Services in
addition to those described elsewhere in Article II (such as but not limited to:
cell line stock storage and regulatory/CMC consulting) may be requested of CBSH
from time to time by SERAGEN. All additional services requested by SERAGEN in
accordance with this Agreement will be provided by CBSH in accordance with cGMP
and all other Regulatory Requirements as applicable. Requests for such
additional services must be submitted in writing by SERAGEN to CBSH, and,
specifications, procedures, processes and other related activities must be
mutually agreed upon by both Parties prior to commencement of those services by
CBSH. Pricing for such services shall be billed at the applicable rates set
forth in Exhibit "B". In addition, any project scope change orders or requests
for additional services shall be mutually agreed to by the Parties, and
implemented pursuant to a Manufacturing Services Agreement: Additional Services
Quotation attached to this Agreement as Exhibit "H". In addition, if the project
scope change or additional services will cause additional costs to CBSH, LIGAND,
on behalf of SERAGEN, will submit a purchase order for such in the form attached
to this Agreement as Exhibit "E".
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ARTICLE III
PROVISION OF MANUFACTURING SERVICES
3.01 FACILITIES, STAFFING, MATERIALS, EQUIPMENT. CBSH shall perform all
manufacturing, storage, handling, packaging and testing of First Gen FDP, Second
Gen FDP Fermentation Pellets , First Gen PDS and /or Second Gen PDS at the
Facility or other testing facility as agreed to by the Parties. CBSH shall use
commercially reasonable efforts to maintain at all times such staffing,
supplies, equipment, facilities and expertise as are sufficient to ensure it has
the ability to supply Fermentation Pellets, First Gen PDS and/or Second Gen PDS
and to perform services in accordance with the terms of this Agreement.
3.02 PRODUCT CHANGE ORDER PROCEDURE. Both parties shall provide one another with
thirty (30) days prior written notice, and receive SERAGEN's prior written
consent before making any changes in the raw materials, process, procedures,
suppliers, facilities, equipment, testing, packaging and labeling Specifications
or other significant changes. If the Parties agree that such changes do not have
a Regulatory Requirement impact, they may thereafter be implemented. If,
however, such changes have a Regulatory Requirement impact, not only must both
Parties agree to the proposed change prior to implementation, in addition, all
necessary approvals of applicable Regulatory Agencies must be received prior to
implementation.
3.03 MAINTENANCE OF SUPPLIER QUALIFICATION. At CBSH's cost and expense, CBSH
shall maintain current supplier qualification of raw materials, reagents,
solvents, and packaging components used in the manufacture of Fermentation
Pellets, First Gen PDS and/or Second Gen PDS according to CBSH's written
procedures consistent with cGMPs. A list of current critical suppliers, as of
the Effective Date, has been attached to this Agreement as Exhibit "G1". CBSH
shall receive SERAGEN's written consent prior to using any new critical supplier
of raw materials, reagents, solvents, or packaging components used in the
manufacture of Fermentation Pellets, First Gen PDS and/or Second Gen PDS.
Pursuant to cGMPs, only suppliers qualified according to CBSH's supplier
qualification program shall be used in the manufacture of Fermentation Pellets,
First Gen PDS and/or Second Gen PDS.
3.04 SUBCONTRACTING. CBSH shall receive SERAGEN's written consent prior to
entering into any new subcontract with any third party for the provision of
services under this Agreement, including the manufacture, storage, handling,
packaging and testing of Fermentation Pellets, First Gen PDS , Second Gen PDS ,
First Gen FDP and Second Gen FDP. A list of subcontractors, as of the Effective
Date, has been attached to this Agreement as Exhibit "G2". Any third party or
contract laboratory used for the testing of Fermentation Pellets, First Gen PDS,
Second Gen PDS, First Gen FDP and/or Second Gen FDP or intermediates must (i) be
approved by SERAGEN in advance, (ii) have signed a confidentiality agreement
with CBSH, substantially in the form previously approved in writing by SERAGEN,
(iii) have completed a successful qualification/validation by CBSH or SERAGEN,
or a SERAGEN designated contractor, which qualification/validation by SERAGEN or
a SERAGEN designated contractor shall be at SERAGEN's cost and (iv) have agreed
to provide access to CBSH such that SERAGEN shall have access to the records of
such subcontractor to permit SERAGEN to conduct routine annual cGMP audits. A
copy of the qualification/validation and procedures and
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results must be submitted by CBSH to SERAGEN for SERAGEN's approval prior to
CBSH's use of the contractor for the designated purposes.
3.05 AUDITS, INVESTIGATIONS, ACCESS.
(a) SERAGEN shall be allowed to conduct Audits of CBSH facilities. SERAGEN
shall send a request to schedule an Audit with CBSH at least sixty
(60) days prior to the proposed Audit date. SERAGEN shall be permitted
to conduct one (1) Audit per calendar year at no expense to SERAGEN;
any additional Audits shall be in accordance with the Additional
Services rates set forth in Exhibit "B." For purposes of this Section
3.05 "Audits" shall mean cGMP audits involving the audit and
inspection of all elements and systems of the Product manufacturing
processes, starting with material receipt, inspection and CBSH QA
Release through and including First Gen PDS and/or Second Gen PDS, as
applicable.
(b) In addition, with at least five (5) days advance notice, SERAGEN shall
be permitted to investigate/audit CBSH facilities and records in the
event of any failure of any Batch to meet Specifications, any major
deviation from Specifications, Batch failure(s) or any regulatory
actions, violations or complaints relevant to this Agreement.
(c) With at least five (5) days advance notice, SERAGEN's authorized
representative(s) shall be allowed during regular business hours to
monitor activities and procedures related to the manufacture of
Fermentation Pellets, First Gen PDS and/or Second Gen PDS under this
Agreement. SERAGEN's authorized representatives shall be allowed,
during regular business hours, to examine and inspect that portion of
the Facility required for the manufacture of Fermentation Pellets,
First Gen PDS and/or Second Gen PDS under this Agreement, including
inspections relating to the manufacture, testing, handling, storage,
packaging and labeling of Fermentation Pellets, First Gen PDS and/or
Second Gen PDS, and to inspect and request copies of all MRR
Documentation following CBSH QA audit of such MRR Documentation
related to Fermentation Pellets, First Gen PDS and/or Second Gen PDS,
including, but not limited to: Batch records, validation
documentation, analytical results on raw materials, components,
intermediates and final products, deviation reports, in process
testing and reports, trend analysis reports, inspection reports
generated by Regulatory Agencies and responses to reports and
inspections by Regulatory Agencies (both edited to maintain client
confidentiality).
(d) CBSH shall provide reasonable cooperation to SERAGEN in connection
with Audits, investigations, other audits or access pursuant to this
Section 3.05.
3.06 ADDITIONAL SOURCE ASSISTANCE AND COOPERATION. Upon request by SERAGEN, CBSH
shall use commercially reasonable efforts to provide all reasonable assistance
and cooperation to SERAGEN in qualifying additional source(s) of manufacture of
Fermentation Pellets, First Gen PDS and/or Second Gen PDS. Such assistance shall
be provided in accordance with the Additional Services rates set forth in
Exhibit "B", and shall include assistance and cooperation in
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the transfer of manufacturing methods and processes which constitute Product
Intellectual Property, including but not limited to the Production Records,
solution preparation documents, pertinent QC assay and manufacturing SOPs,
equipment specifications, QC assay validation protocols, process validation
protocols and such other technology and know-how owned by or licensed to
SERAGEN.
3.07 INFORMATION. CBSH shall provide SERAGEN copies of all MRR Documentation
relating to the services provided and Fermentation Pellets, First Gen PDS and/or
Second Gen PDS supplied under this Agreement. All such MRR Documentation shall
be provided within 10 business days of CBSH QA Release.
3.08 TAXES. Subject to the provisions of this Section 3.08, SERAGEN shall
reimburse CBSH for any applicable sales tax that may be paid by CBSH with
respect to the sales of the Fermentation Pellets, First Gen PDS and/or Second
Gen PDS to SERAGEN pursuant to this Agreement. Notwithstanding the foregoing,
SERAGEN shall have no reimbursement obligations under this Section 3.08 to the
extent that (i) such taxes are based on CBSH's net income, or (ii) such taxes
are recoverable or offset by CBSH.
ARTICLE IV
STANDARDS OF CARE AND COMPLIANCE WITH LAW
4.01 GENERAL. CBSH shall manufacture and supply Fermentation Pellets, First Gen
PDS and/or Second Gen PDS and services in accordance with current regulatory
standards prevailing in the pharmaceutical industry. Without limiting the
foregoing, CBSH shall exercise all due and reasonable care with regard to any
biological raw materials, work-in-process, clinical products or finished
products in its custody relating to the Fermentation Pellets, First Gen PDS
and/or Second Gen PDS and their respective manufacture.
4.02 COMPLIANCE WITH APPLICABLE LAW. CBSH shall comply with all applicable laws,
requirements, rules, regulations and standards prescribed by public authorities
(including the Food and Drug Act) in supplying Fermentation Pellets, First Gen
PDS and/or Second Gen PDS and services and shall maintain all necessary records
to comply with these applicable laws, requirements, rules, regulations and
standards. Without limiting the foregoing, CBSH shall comply with current
Regulatory Requirements.
4.03 DOCUMENTS AND REPORT RETENTION. CBSH shall use commercially reasonable
efforts to ensure that documents required to be retained according to cGMP are
stored in a confidential manner to maintain their integrity and protection from
fire and other hazards, for the required length of storage.
4.04 REGULATORY/CMC CONSULTING AND/OR ASSISTANCE. CBSH shall participate and
provide information and data, excluding confidential business and proprietary
information of CBSH, as are reasonably requested by SERAGEN to support
regulatory submissions. These activities may include but are not limited to drug
product complaint investigations, annual product reviews, and biologics product
deviation reporting. CBSH shall cooperate fully with SERAGEN in promptly filing
all documents and reports required or reasonably requested by any Regulatory
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Agency in a form reasonably acceptable to SERAGEN, and shall provide SERAGEN
with such information and assistance as SERAGEN may require with regard to those
filings, including all reports, authorizations, certificates, methodologies,
specifications and other documentation in the possession of or under the control
of CBSH, and shall ensure that the content of all submissions is suitable for
regulatory filings. SERAGEN shall reimburse CBSH for all such consulting and/or
assistance at the Additional Services rates set forth in Exhibit "B".
4.05 DEBARMENT. CBSH represents and warrants to SERAGEN that it has neither been
debarred nor is subject to debarment and that it will make commercially
reasonable efforts to not use in any capacity, in connection with Fermentation
Pellets, First Gen PDS and/or Second Gen PDS or services to be supplied under
this Agreement, any person who has been debarred pursuant to subsections 306(a)
or 306(b) of the Food and Drug Act or who is the subject of a conviction
described in such Food and Drug Act. CBSH agrees to inform SERAGEN immediately
in writing if it is, or becomes aware, that any person who is performing
services hereunder on behalf of CBSH is debarred or is the subject of a
conviction described in subsections 306(a) or 306(b) of the Food and Drug Act or
if any action, suit, claim, investigation, or proceeding is pending or, to the
knowledge of CBSH threatened, relating to the debarment of CBSH or any person
performing services on behalf of CBSH hereunder.
4.06 COMPLAINTS, ANNUAL PRODUCT REVIEWS, ACCIDENT REPORTING; ADVERSE EVENTS;
BIOLOGICS PRODUCT DEVIATION REPORTING. CBSH shall participate and provide
information and data, excluding confidential business and proprietary
information of CBSH, as are reasonably requested by SERAGEN to support First Gen
FDP and Second Gen FDP complaint investigations, annual product reviews, and
biologics product deviation reporting. In the event that CBSH receives any
complaint or report of adverse drug event(s) as defined by 21 CFR 600.80 (an
"Adverse Event") regarding the Product, then CBSH shall notify SERAGEN in
writing by facsimile on or before the fifth (5th) calendar day following the
receipt thereof; provided that CBSH shall notify SERAGEN in writing by facsimile
and by telephone within twenty four (24) hours following the receipt thereof, of
any fatal or life-threatening Adverse Event. SERAGEN shall have primary
responsibility for fielding, investigating and responding to all Product
complaints and Adverse Events. CBSH shall ensure that its manufacturing, QA and
quality control personnel cooperate fully with SERAGEN, as appropriate and
needed, to investigate any Product complaints or Adverse Events and to provide
such information or assistance as is reasonably requested by SERAGEN in order to
support SERAGEN's compliance with Adverse Events, field alert and other
reporting requirements imposed by any Regulatory Agency. SERAGEN, as the product
licensee for Regulatory Agency purposes, shall have the right to exercise full
functional control over the resolution of complaints and Adverse Events as
required by all applicable regulations. The Parties shall each report to the
other on the resolution of complaints and Adverse Events. CBSH will undertake
any investigations related to complaints, annual product reviews, accident
reporting, adverse events, and biologics product deviation report and other
action required as per cGMP and CBSH internal standard operating procedures or
protocols. Any such investigations shall be additional services if they are
requested by SERAGEN (i) in connection with the manufacture and testing of
Fermentation Pellets, First Gen PDS, Second Gen PDS, First Gen FDP and/or Second
Gen FDP or (ii) to comply with the Regulatory Requirements of a Regulatory
Agency, and will be performed in accordance with the Additional Services rates
set forth in Exhibit "B".
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4.07 NOTIFICATION OF POTENTIAL LIABILITY. Each Party shall notify the other in
writing as soon as is reasonably possible following any event, including receipt
of any notice, warning, citation, finding, report or service of process or the
occurrence of any release, spill, upset or discharge of hazardous wastes or
substances, related to the Fermentation Pellets, First Gen PDS, Second Gen PDS
and/or First Gen FDP and Second Gen FDP, or to testing or services provided
under this Agreement that could reasonably be expected to give rise to liability
on the part of the other Party under any law, rule or regulation prescribed by a
public authority or otherwise.
4.08 GOVERNMENTAL COMMUNICATIONS AND INSPECTIONS. The Parties will notify each
other within twenty-four (24) hours of their receipt of notice of any
inspections of the Facility relating to Fermentation Pellets, First Gen PDS
and/or Second Gen PDS, whether prescheduled or unannounced, by a Regulatory
Agency and if possible shall give the other Party the opportunity to be present
and observe such an inspection. The findings of these inspections shall be
provided to the other Party in a manner which protects the confidential
information of third parties, to the extent they relate to or impact the
manufacture, testing, packaging, storage, or handling of Fermentation Pellets,
First Gen PDS and/or Second Gen PDS for SERAGEN or the provision of services to
SERAGEN. Both parties shall notify each other within twenty-four (24) hours of
receipt of any communications from a Regulatory Agency relating to the Facility
or the Product manufactured in the Facility, including any communication or
directive from a Regulatory Agency commencing or threatening seizure of any
Fermentation Pellets, First Gen PDS and/or Second Gen PDS or other removal of
any Fermentation Pellets, First Gen PDS and/or Second Gen PDS. If such
communication is a written communication, the notifying Party shall attach a
copy of the communication. Otherwise, the notifying Party shall provide a
reasonable description to the other Party of the communication. The Parties
shall have the right to review in advance any response to the communication or
investigation submitted by the other party related to the Product. The Parties
shall cooperate fully with each other in providing the information needed for
any such communication. The wording and final submission of a response to a
communication or investigation shall be the final responsibility of the
addressee, provided SERAGEN retains the right to approve in advance the wording
and final submission.
4.09 NOTIFICATION AND INVESTIGATION OF ALLEGED DEFECTS. In the event that either
Party is notified that Fermentation Pellets, First Gen PDS and/or Second Gen PDS
is alleged or proven not to meet Specifications, the Party receiving notice of
the failure shall notify the other Party immediately, and both Parties shall
cooperate fully regarding the investigation and disposition of the matter.
4.10 ALLOCATION OF BURDEN OF PRODUCT RECALL. In the event (a) any government
authority issues a request, directive or order that First Gen FDP and Second Gen
FDP prepared from Fermentation Pellets, First Gen PDS and/or Second Gen PDS
manufactured by CBSH for SERAGEN be recalled, or (b) a court of competent
jurisdiction orders such a recall, or (c) SERAGEN shall reasonably determine
that the Product should be recalled, the Parties shall take all appropriate
actions to effectuate the recall as determined by SERAGEN and/or by the
applicable Regulatory Agency, and shall cooperate in the investigations
surrounding the recall. For clarity, as between the Parties, SERAGEN shall have
responsibility for and exclusive control of all recall activities. In the event
that such recall results from (i) the failure of CBSH personnel or
subcontractors to follow cGMP, (ii) the failure of CBSH personnel or
subcontractors to follow and execute the Production Record and required MRR
documentation as written and approved
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by both Parties, (iii) the failure of the Facility equipment or utilities, (iv)
the failure or non-conformance of the raw materials with SOPs or Specifications,
(v) the breach of CBSH's obligations, representations or warranties hereunder or
(vi) the acts or omissions of CBSH's subcontractors, CBSH shall (A) promptly
replace such Fermentation Pellets, First Gen PDS and/or Second Gen PDS necessary
for SERAGEN to replace the recalled Batches of First Gen FDP and Second Gen FDP,
at no additional cost to SERAGEN, consistent with directions received from the
appropriate Regulatory Agency and (B) promptly reimburse SERAGEN for its
reasonable direct costs and third-party expenses documented and actually
incurred in recalling the affected Product and replacing such Product at the
wholesaler level. In all other cases, SERAGEN shall be responsible for the costs
and expenses of recall, including the cost of replacement material for the
Product. For the purposes of this Agreement, the expenses of recall shall
include, without limitation, the expenses of notification and destruction or
return of the recalled Fermentation Pellets, First Gen PDS and/or Second Gen PDS
and all other costs incurred in connection with such recall, but shall not
include lost profits of either Party.
4.11 MATERIAL SAFETY. During the Term of this Agreement and for one year
thereafter, each Party shall promptly provide the other Party with all new
information, excluding confidential business and proprietary information of the
disclosing Party, within its possession or control or otherwise available to the
disclosing Party from time to time regarding handling precautions, toxicity and
hazards associated with the manufactured Fermentation Pellets, First Gen PDS
and/or Second Gen PDS.
4.12 WASTE DISPOSAL. CBSH will conduct the manufacture, storage, packaging, and
testing of Fermentation Pellets, First Gen PDS and/or Second Gen PDS for SERAGEN
and the provision of additional services, including the disposal of all wastes
generated thereby, in conformance with CBSH's waste handling procedures and
appropriate local, provincial or national environmental laws or regulations.
SERAGEN shall provide CBSH with any information required for environmental
assessments, such as disposal requirements, etc. CBSH will provide SERAGEN, upon
SERAGEN's written request, with information, documents, and permits reasonably
requested by SERAGEN for SERAGEN to perform an environmental assessment to be
made available to the Regulatory Agencies through SERAGEN's marketing approval
from the relevant Regulatory Agency, including any supplements and/or license,
and as required by other appropriate regulatory authorities. Such regulatory
assistance shall be performed in accordance with the Additional Services rates
set forth in Exhibit "B".
ARTICLE V
PRICING, PAYMENT AND DELIVERY
5.01 PRICING. Pricing for manufacture of Fermentation Pellets, First Gen FDP and
Second Gen FDP release and stability testing, Fermentation Pellets, First Gen
PDS and/or Second Gen PDS stability testing, and any other additional services
agreed upon by the Parties shall be as specified in Exhibits "B" and "C"
attached hereto.
Pricing for First Gen PDS Batches will be as specified in Exhibit "B"; pricing
for Second Gen PDS Batches shall be as set forth in Exhibit "C", and in each
case such pricing shall be effective through the first anniversary of the
Effective Date and may only be adjusted once as of January
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1st of each subsequent calendar year. Pricing for stability testing and
additional services will be as specified in Exhibit "B" and such pricing shall
be effective through the first anniversary of the Effective Date and may only be
adjusted once as of January 1st of each subsequent calendar year. Price
adjustments shall include, but are not limited to, changes in: the Consumer
Price Index ("CPI"); the cost of reagents, supplies and equipment; or the cost
of direct and indirect labor and shall not exceed the lesser of (a) CPI for the
prior calendar year or (b) ***. CBSH shall provide SERAGEN written notice of any
such price adjustment as promptly as practicable following January 1,which price
adjustment shall take effect for purchase orders with Batch Acceptance Dates
from and after such January 1.
5.02 PAYMENT TERM. CBSH will aggregate charges and will submit monthly invoices
to SERAGEN except as otherwise set forth below,
(a) terms of payment for Fermentation Pellets, First Gen PDS and/or Second
Gen PDS shall be payment due net thirty (30) days from the delivery of
MRR Documentation, but not due earlier than the Batch Acceptance Date
in effect for such Batch of Fermentation Pellets, First Gen PDS and/or
Second Gen PDS, provided all other conditions specified on the face of
such purchase order have been met, unless a Batch is determined to be
non-conforming pursuant to Section 2.14. In such an event, payment
shall be net thirty (30) days following resolution of a dispute over
nonconforming Fermentation Pellets, First Gen PDS and/or Second Gen
PDS in accordance with the dispute resolution procedure in Section
2.14(c). Payment for Fermentation Pellets, First Gen PDS and/or Second
Gen PDS, however, does not in any way impact SERAGEN's rights under
this Agreement.
(b) terms of payment for First Gen FDP and Second Gen FDP release testing
shall be net thirty (30) days from receipt by SERAGEN of a complete
Summary of Testing and an invoice submitted by CBSH.
(c) terms of payment for stability testing shall be net thirty (30) days
from receipt by SERAGEN of stability data and an invoice submitted by
CBSH for scheduled work performed during the preceding month.
(d) terms of payment for Additional Services provided under this Agreement
shall be net thirty (30) days from receipt by SERAGEN of an invoice
submitted by CBSH for scheduled work performed during the preceding
month.
5.03 MATTERS AFFECTING PRICING OR TESTING. The pricing of Fermentation Pellets,
First Gen PDS, Second Gen PDS and/or First Gen FDP and Second Gen FDP as set
forth in Exhibits "B" or "C", as applicable, is based upon current Manufacturing
and Release Requirements, the current release and stability testing procedures
for First Gen FDP and Second Gen FDP, stability testing procedures for
Fermentation Pellets, First Gen PDS and/or Second Gen PDS, as well as current
Regulatory Requirements. In the event that any Regulatory Requirements change,
or the manner of performing release and stability testing for First Gen FDP and
Second Gen FDP or stability testing of Fermentation Pellets, First Gen PDS
and/or Second Gen PDS changes in such a way to increase or decrease the cost or
burden on CBSH to manufacture Fermentation Pellets,
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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First Gen PDS and/or Second Gen PDS, or perform such release and stability
testing, the Parties agree to negotiate an appropriate price adjustment.
5.04 DELIVERY AND SHIPMENT OF FERMENTATION PELLETS, FIRST GEN PDS AND/OR SECOND
GEN PDS. Shipment of Fermentation Pellets, First Gen PDS and/or Second Gen PDS
shall be FOB the Facility. Fermentation Pellets, First Gen PDS, and/or Second
Gen PDS shall be made available to SERAGEN as of the Batch Acceptance Date and
will be physically delivered to SERAGEN's designated carrier on the Shipment
Date. Fermentation Pellets, First Gen PDS, and/or Second Gen PDS shall not be
physically delivered to SERAGEN's designated carrier before the Shipment Date
specified by SERAGEN without SERAGEN's prior written consent. Transfer of title
and risk of loss of Fermentation Pellets, First Gen PDS and/or Second Gen PDS
shall pass to SERAGEN or its designee on the Batch Acceptance Date. The Shipment
Date has no bearing on transfer of title or risk of loss as between CBSH and
SERAGEN. SERAGEN shall, at its cost, ensure that adequate insurance coverage,
for full replacement cost, exists on Fermentation Pellets, First Gen PDS and/or
Second Gen PDS in transit to SERAGEN or its designee, in the event that such
Fermentation Pellets, First Gen PDS and/or Second Gen PDS is damaged, destroyed
or lost, and shall bear all costs of such insurance.
ARTICLE VI
CONFIDENTIALITY AND INTELLECTUAL PROPERTY
6.01 CONFIDENTIALITY. The Parties recognize that all non-public information
including, where appropriate and without limitation, any information, know-how,
patent disclosures, patent applications, structures, models, techniques,
processes, compositions, compounds, apparatus and other confidential or
proprietary data and information relating to one Party disclosed to the other
Party pursuant to this Agreement is of proprietary value and is to be considered
highly confidential ("Proprietary Information"). The Parties agree not to use
(except in accordance with this Agreement), and not to disclose to any third
party, any Proprietary Information except with the prior written consent of the
other Party. The foregoing obligations shall survive the expiration or
termination of the Agreement for a period of ten (10) years. For purposes of
this Article VI, all confidential information specifically relating to the
Product and its manufacture acquired or generated by CBSH on behalf of SERAGEN
as a result of this Agreement shall be considered to be Proprietary Information
disclosed by SERAGEN to CBSH, provided, however, that this shall not impact
CBSH's rights to file patent applications and prosecute, maintain, enforce and
defend such applications and subsequently issued patents pursuant to the terms
of Section 6.05 of this Agreement covering such Proprietary Information.
The obligations of non-use and nondisclosure shall not apply to Proprietary
Information that:
(a) is known by the receiving Party at the time of its receipt, and not
through a prior disclosure by the disclosing Party, as documented by
written records or as proven in a court of law by the receiving Party;
(b) is at the time of disclosure or thereafter becomes published or
otherwise part of the public domain without breach hereof by the
receiving Party;
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(c) is subsequently disclosed to the receiving Party by a third party who
has no confidentiality obligation to the disclosing Party with respect
to the information disclosed;
(d) is developed by the receiving Party independently of Proprietary
Information or other information received from the disclosing Party
and such independent development can be properly demonstrated by the
receiving Party;
(e) is disclosed to governmental or other regulatory authorities in order
to obtain patents or to gain approval to conduct clinical trials or to
market the Product, but such disclosure may be only to the extent
reasonably necessary to obtain such patents or authorizations;
(f) is necessary to be disclosed to sublicensees, agents, consultants,
Affiliates, or other third parties for the research and development,
manufacturing, or marketing of the Product (or for such parties to
determine their interest in performing such activities) in accordance
with this Agreement on the condition that such third parties agree to
be bound by the confidentiality obligations and use restrictions
contained in this Agreement and that the term of such obligations and
restrictions for such third parties shall be no less restrictive than
the terms of such obligations and restrictions hereunder, but such
disclosure may be only to the extent reasonably necessary for such
purposes; or
(g) is required to be disclosed by law or court order, provided that
notice is promptly delivered to the other Party in order to provide it
with an opportunity to seek a protective order or other similar order
with respect to such Proprietary Information, but such disclosure may
be only to the extent reasonably necessary to comply with the required
disclosure, whether or not a protective order or other similar order
is obtained by the other Party.
6.02 CBSH LICENSE. SERAGEN represents and warrants to CBSH that SERAGEN owns all
necessary rights to manufacture, market, sell and distribute the Product, to
allow CBSH to perform the services as described in this Agreement, and to allow
CBSH and SERAGEN to perform their obligations under this Agreement. During the
Term of this Agreement, SERAGEN hereby grants to CBSH a paid-up, royalty-free,
non-exclusive license, without the right to sublicense or transfer, to all
rights held by SERAGEN necessary to manufacture Fermentation Pellets, First Gen
PDS and/or Second Gen PDS and to perform services for SERAGEN under this
Agreement, but only for such purposes and only to the extent necessary for CBSH
to perform its obligations under this Agreement. The parties agree that the
grant contained in this section is personal to CBSH only and CBSH agrees to make
use of SERAGEN's Proprietary Information only in accordance with this license
and only by CBSH.
6.03 INTELLECTUAL PROPERTY.
(a) All Intellectual Property worldwide related to ideas, innovations or
inventions (whether or not patentable) developed solely by CBSH and
its employees during the course of fulfilling its obligations under
this Agreement, including any
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Process Improvements for manufacture of Fermentation Pellets,
First Gen PDS, or Second Gen PDS, shall be solely owned by CBSH.
(b) Intellectual Property worldwide related to ideas, innovations or
inventions (whether or not patentable) developed solely by SERAGEN and
its employees while this Agreement is in force, including any Process
Improvements, shall be solely owned by SERAGEN.
(c) Intellectual Property worldwide related to ideas innovations or
inventions (whether or not patentable) developed jointly by CBSH and
SERAGEN and their respective employees, while this Agreement is in
force, including any Process Improvements, shall be jointly owned by
the Parties.
CBSH agrees to promptly disclose to SERAGEN as they occur any Intellectual
Property developed by CBSH employees or agents during the course of fulfilling
its obligations under this Agreement. CBSH represents and warrants that all of
its employees and such agents as provide services as permitted hereunder are
obligated by written agreement to assign to CBSH any of their inventions that
arise as a result of the provision of services under this Agreement.
6.04 SERAGEN LICENSE. CBSH hereby grants to SERAGEN (i) an irrevocable,
worldwide, royalty free, fully paid-up exclusive license, with the right to
sublicense, under Product Intellectual Property, owned in whole or in part by
CBSH, and (ii) an irrevocable, worldwide, royalty free, fully paid-up
non-exclusive license, with the right to sublicense, under other Intellectual
Property, owned in whole or in part by CBSH, and which is necessary or actually
used in the manufacture of Product. Such licenses shall be only for SERAGEN or
its sublicensee(s) to make, have made, use and sell the Product, and to offer
the Product for sale. The Parties agree that this license does not apply to the
use of Intellectual Property for purposes other than to make, have made, use and
sell the Product or to offer the Product for sale and CBSH retains all other
rights to the Intellectual Property, including the right to license such other
rights. Upon request by SERAGEN, CBSH agrees to execute any documents necessary
for SERAGEN to exercise its rights under the licenses granted under this
provision.
6.05 PATENTS. With respect to Intellectual Property owned solely by SERAGEN or
jointly by SERAGEN and CBSH under this Agreement, SERAGEN shall decide, at its
sole discretion, whether, when and where to file a patent application and if
SERAGEN decides to file a patent application, it shall be solely responsible for
filing, prosecuting, maintaining, enforcing and defending such application or
subsequently issued patent. Upon request by SERAGEN, CBSH shall provide SERAGEN
with reasonable assistance in obtaining any copyright, patent or other
Intellectual Property protection covering any Intellectual Property created or
developed under this Agreement and owned solely or jointly by SERAGEN, provided
that CBSH's costs are paid for by SERAGEN.
With respect to Intellectual Property owned solely by CBSH, CBSH shall first
decide whether, when or where to file a patent application. If CBSH decides to
file a patent application to protect Intellectual Property, it shall be solely
responsible for filing, prosecuting, maintaining, enforcing and defending such
application or subsequently issued patent. If CBSH decides not to file a patent
application to protect Product Intellectual Property, or decides to abandon an
existing
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patent or patent application covering Product Intellectual Property, it shall
promptly notify SERAGEN of its decision and SERAGEN shall have the right to file
a patent application to protect Product Intellectual Property, or to maintain
the existing patent or patent application. If SERAGEN exercises its rights to
assume responsibility for Product Intellectual Property abandoned by CBSH under
this provision, CBSH shall assign its rights to the Product Intellectual
Property to SERAGEN and shall provide SERAGEN with reasonable assistance in
obtaining patent protection, provided that CBSH's costs are paid for by SERAGEN.
6.06 NO PUBLICITY. No Party shall disclose the terms of this Agreement without
the prior written consent of the other Party. Nothing in the foregoing, however,
shall prohibit a Party from making such disclosures to the extent deemed
necessary under applicable federal or state securities laws or any rule or
regulation of any nationally recognized securities exchange; in such event,
however, the disclosing Party shall use good faith efforts to consult with the
other Party prior to such disclosure and where applicable, shall request
confidential treatment to the extent available. In addition, CBSH may disclose
the identity of SERAGEN as a customer of CBSH to other customers and potential
customers.
6.07 TRADEMARKS AND TRADE NAMES. The Parties hereby acknowledge and agree that
neither Party has acquired, nor shall it acquire by virtue of the Agreement or
the activities contemplated hereby, any interest in any of the other Party's
trademarks or trade names.
6.08 INJUNCTIVE RELIEF. The Parties hereto understand and agree that remedies at
law may be inadequate to protect against any breach of any of the provisions of
this Article VI by any Party or their employees agents, officers or directors or
any other person acting in concert with it or on its behalf. Accordingly, each
Party shall be entitled to the granting of injunctive relief by a court of
competent jurisdiction against any action that constitutes any breach of this
Article VI.
6.09 NO OTHER RIGHTS. Except as otherwise expressly set forth in this Agreement,
it is understood and agreed by the Parties that this Agreement does not grant
any license or other right under any Intellectual Property of the Parties.
ARTICLE VII
INDEMNIFICATION
7.01 INDEMNIFICATION BY SERAGEN. SERAGEN shall indemnify and hold harmless CBSH
and its Affiliates, and their respective directors, officers, shareholders,
employees, consultants and agents from and against all suits, claims, losses,
demands, liabilities, damages, costs and expenses (including court costs,
reasonable attorney's fees and reasonable investigative costs) (together
"Liabilities") in connection with any suit, demand or action by any third party
(a "Third Party Action") arising out of, resulting from or relating to: (a) the
further processing, formulation, storage, labeling, promotion, marketing, use or
sale of the Product by SERAGEN, as long as (i) the Fermentation Pellets, First
Gen PDS and/or Second Gen PDS were manufactured in accordance with cGMP and (ii)
CBSH followed and executed the Production Record and the MRR Documentation as
written and approved by both Parties, (b) storage, labeling, promotion,
marketing, use or sale of the Product by SERAGEN, (c) breach of any
representation, warranty, covenant or agreement contained in this Agreement by
SERAGEN,
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(d) SERAGEN's negligence, recklessness or willful misconduct or the negligence,
recklessness or willful misconduct of any employee or agent of SERAGEN, (e) any
representation or warranty made by SERAGEN to its customers or users with
respect to the Product, other than a representation that the Product conformed
to cGMP and the Manufacturing and Release Requirements at the time of CBSH's
release to SERAGEN, (f) any Third Party Action alleging that the Product or
provision of the services pursuant to the Agreement infringes any patent or
other proprietary rights except to the extent such Third Party Action relates to
the use of CBSH's patents or other proprietary rights which are not deemed
Proprietary Information of SERAGEN, or (g) actions taken based on authorizations
in writing from SERAGEN Authorized Personnel; except in each case to the extent
that any of the foregoing arises out of or results from (i) the breach by CBSH
of the terms of this Agreement or failure of CBSH to follow and execute or to
manufacture, handle, test, or store the Product in accordance with the
Production Record and the MRR Documentation as written and approved by both
Parties and the Manufacturing and Release Requirements if caused by the action
or inaction of CBSH or its subcontractors, or (ii) the negligence, recklessness
or willful misconduct of CBSH, its employees, subcontractors or agents.
7.02 INDEMNIFICATION BY CBSH. CBSH shall indemnify and hold harmless SERAGEN and
its Affiliates, and their respective directors, officers, shareholders,
employees, consultants and agents from any and all Liabilities to third parties
to the extent that such Liability arises from: (a) CBSH's failure to follow and
execute or to manufacture, handle, test, or store the Product in accordance with
the Production Record and MRR Documentation as written and approved by both
Parties if caused by the action or inaction of CBSH or its subcontractors, (b)
the negligence, recklessness or willful misconduct of CBSH, its employees,
subcontractors or agents, (c) CBSH's failure to manufacture Fermentation
Pellets, First Gen PDS, Second Gen PDS, First Gen FDP, or Second Gen FDP in
accordance with cGMPs, (d) CBSH's failure to reasonably comply with all laws,
regulatory filings, rules or regulations applicable to its performance under
this Agreement, or (e) breach of any representation, warranty, covenant or
agreement contained in the Agreement by CBSH.
7.03 INDEMNIFICATION PROCEDURES. As a condition of the indemnification rights
provided in this Article VII, the indemnified Party shall promptly notify the
indemnifying party in writing of any claim, action or suit (the "Asserted
Liability") potentially giving rise to the indemnification obligation hereunder.
The indemnifying party may elect to compromise or defend, and control the
defense of, at its own expense and by counsel reasonably satisfactory to the
indemnified party, any such Asserted Liability, provided that the indemnified
party shall have no liability under any compromise or settlement agreed to by
the indemnifying party which it has not approved in writing. The indemnified
party shall cooperate upon the request and at the expense of the indemnifying
party, in the compromise of, or defense against, such Asserted Liability. If the
indemnifying party elects not to compromise or defend the Asserted Liability, or
fails to notify the indemnified party of its election to compromise or defend
within a reasonable time after receipt of the required notice, the indemnified
party may pay, compromise or defend such Asserted Liability and receive full
indemnification for its losses as provided in Sections 7.01 or 7.02 hereof,
including all costs of defending such suit. In any event, the indemnified party
and the indemnifying party may participate, at their own expense, in the defense
of such Asserted Liability. If the indemnifying party chooses to defend any
claim, the indemnified party shall make available to the indemnifying party any
books, records or other documents within its
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control that are reasonably requested for such defense and shall otherwise
cooperate with the indemnifying party, in which event the indemnified party
shall be reimbursed for its out-of-pocket expense.
7.04 SURVIVAL OF REMEDIES. All limitations on either Party's remedies and
liabilities under this Article VII shall survive the expiration, termination or
cancellation of this Agreement.
7.05 LIMITATION OF LIABILITY.
(a) NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOST PROFITS ARISING OUT OF THE
PERFORMANCE OF THIS AGREEMENT.
(b) THE MAXIMUM AGGREGATE LIABILITY OF CBSH FOR ALL CAUSES OF ACTION
ARISING OUT OF OR RELATED TO THIS AGREEMENT, EXCLUDING LIABILITY
ARISING UNDER SECTION 7.02 (INDEMNIFICATION), BUT INCLUDING LIABILITY
ARISING FROM A BREACH OF THIS AGREEMENT OR NONPERFORMANCE UNDER THIS
AGREEMENT (INCLUDING LIABILITY ASSOCIATED WITH OR ARISING OUT OF
SERAGEN'S ATTEMPT TO FIND ALTERNATE SOURCES OF SUPPLY IN THE EVENT OF
CBSH'S NONPERFORMANCE OR BREACH) AND LIABILITY ARISING OUT OF OR
RELATED TO THE MANUFACTURE AND/OR STORAGE OF FERMENTATION PELLETS,
FIRST GEN PDS, SECOND GEN PDS OR TESTING OF FERMENTATION PELLETS,
FIRST GEN PDS, SECOND GEN PDS, OR FIRST GEN FDP AND SECOND GEN FDP,
AND THE PROVISION OF ADDITIONAL SERVICES PROVIDED BY CBSH PURSUANT TO
THIS AGREEMENT, SHALL NOT EXCEED THE LESSER OF (I) *** TIMES THE
AGGREGATE AMOUNTS INVOICED TO SERAGEN BY CBSH DURING THE PRIOR
CALENDAR YEAR OR (II) ***. TO THE EXTENT THAT THIS CLAUSE CONFLICTS
WITH ANY OTHER CLAUSE, THIS CLAUSE SHALL TAKE PRECEDENCE OVER SUCH
CONFLICTING CLAUSE. IF APPLICABLE LAW PREVENTS ENFORCEMENT OF THIS
CLAUSE, THEN THIS CLAUSE SHALL BE DEEMED MODIFIED TO PROVIDE THE
MAXIMUM PROTECTION FOR THE LIABLE PARTY AS IS ALLOWABLE UNDER
APPLICABLE LAW.
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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<PAGE>
7.06 INSURANCE.
(a) Throughout the Term, SERAGEN shall obtain and maintain comprehensive
general liability insurance (including broad form general liability,
completed operations and products liability, personal injury
liability, blanket contractual liability and broad form property
damage liability) with limits of not less than *** combined single
limit for bodily injury and property damage liability per occurrence
and annual aggregate. Without limiting the foregoing, SERAGEN shall
obtain and maintain, at its sole expense, product liability insurance
relating to the Product that is comparable in type and amount to the
insurance it maintains with respect to its most similar other
products. With respect to all insurance coverage required under this
clause (a): (i) SERAGEN shall, promptly upon CBSH's request, furnish
CBSH with certificates of insurance evidencing such insurance; (ii)
SERAGEN shall provide a Certificate of Insurance to CBSH showing that
the general liability insurance policy has been endorsed to designate
CBSH as an additional named insured and (iii) all policies shall
include provisions for at least thirty (30) days' prior written notice
of any material change or cancellation (whether for non-payment or
otherwise). SERAGEN shall use its commercially reasonable efforts to
obtain and maintain five (5) year tail coverage for the
above-mentioned insurance.
(b) Throughout the Term, CBSH shall obtain and maintain comprehensive
general liability insurance (including broad form general liability,
completed operations and products liability, blanket contractual
liability and broad form property damage liability) with limits of not
less than *** combined single limit for bodily injury and property
damage liability per occurrence and annual aggregate. During the Term,
CBSH shall obtain and maintain worker's compensation insurance as
required under Massachusetts law and employer's liability insurance
with a limit of not less than ***. With respect to all insurance
coverage required under this clause (b): (i) CBSH shall, promptly upon
SERAGEN's request, furnish SERAGEN with certificates of insurance
evidencing such insurance; and (ii) all policies shall include
provisions for at least thirty (30) days' prior written notice of any
material change or cancellation (whether for non-payment or
otherwise). CBSH shall use its commercially reasonable efforts to
obtain and maintain *** year tail coverage for the above mentioned
insurance.
ARTICLE VIII
WARRANTIES AND REPRESENTATIONS
8.01 REPRESENTATIONS AND WARRANTIES OF EACH PARTY. Each Party represents and
warrants to the other that (a) it is a corporation, duly organized and validly
existing under the laws of the State of Delaware; (b) it has all requisite
corporate power and authority to own its properties, conduct its business as
presently conducted and enter into and perform its obligations under this
Agreement; (c) it has taken all necessary corporate action to authorize this
Agreement; (d) it has duly executed and delivered this Agreement and this
Agreement constitutes its legal and valid
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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<PAGE>
obligation, enforceable against it in accordance with its terms; (e) the
execution and delivery of this Agreement and the performance of its obligations
hereunder do not and will not (i) violate any other agreement or instrument of
any nature to which it is a party or by which it is bound, (ii) violate any law,
rule or regulation to which it is subject or by which it is bound, or (iii)
require any filing approval, authorization, permit or license from or with any
governmental authority which has not been made or obtained.
8.02 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF SERAGEN. SERAGEN represents
and warrants (i) that it is providing CBSH with a validated process for
Fermentation Pellets and First Gen PDS, that it is not aware of any asserted or
threatened claim or demand that it believes may be enforced against its patents
and other proprietary rights relating to Fermentation Pellets and First Gen PDS,
(ii) in entering into this Agreement, to its knowledge it will not infringe on
any patent or other proprietary rights of any third party, (iii) that SERAGEN is
a wholly owned subsidiary of LIGAND, (iv) that CBSH is authorized to take all
direction necessary to perform its obligations under this Agreement from SERAGEN
Authorized Personnel and (v) that it is the owner of all right, title and
interest in and to, or has a license, sublicense or other permission to make,
have made, use or sell, the Product.
8.03 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF CBSH. CBSH represents and
warrants that, at the time of CBSH's QA release of the Fermentation Pellets and
First Gen PDS and shipment to SERAGEN, the Fermentation Pellets and First Gen
PDS (a) will have been manufactured, stored and shipped in accordance with
current Regulatory Requirements and cGMPs, (b) was manufactured, stored, handled
and tested in accordance with the Production Record and MRR Documentation as
written and approved by both Parties and (c) meets or exceeds the Manufacturing
and Release Requirements, and (d) not be adulterated or misbranded under the
Food and Drug Act or any other applicable law, rule or regulation.
8.04 REMEDIES. In the event that any Fermentation Pellets, First Gen PDS and/or
Second Gen PDS provided by CBSH was not manufactured in accordance with cGMPs or
the warranties provided herein, as determined in accordance with Section 2.14,
SERAGEN's sole remedies (excluding indemnities) with respect to a non-conforming
Batch shall be at SERAGEN's option (i) rejection of the Batch without cost to
SERAGEN or (ii) re-supply, at CBSH's cost, of said non-conforming Batch of
Fermentation Pellets, First Gen PDS and/or Second Gen PDS in conformance with
the Manufacturing and Release Requirements and in accordance with Section
2.14(d).
8.05 DISCLAIMER OF WARRANTIES. THE PARTIES ACKNOWLEDGE AND AGREE THAT ALL
SERVICES PROVIDED UNDER THIS AGREEMENT WILL BE PERFORMED BY CBSH AT THE
DIRECTION OF SERAGEN. CBSH DISCLAIMS ANY AND ALL WARRANTIES EXPRESSED OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, ANY WARRANTIES ARISING FROM COURSE OF DEALING
OR USAGE OF TRADE OR ANY WARRANTIES OF PATENT VALIDITY OR FREEDOM OF OR FROM
PATENT INFRINGEMENT, WITH RESPECT TO ANY PRODUCT OR SERVICES DELIVERED UNDER
THIS AGREEMENT (OTHER THAN THOSE WARRANTIES EXPRESSLY SET FORTH IN THIS
AGREEMENT).
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ARTICLE IX
TERM AND TERMINATION
9.01 TERM. The term (the "Term") of this Agreement shall be for five (5) years,
commencing on January 1, 2004. Upon expiration of the Term of this Agreement,
the Parties shall have the option to renew this Agreement, for a period of time
mutually agreed upon by the Parties.
9.02 TERMINATION FOR BREACH OR DEFAULT. Upon any material breach or default by
either Party hereto in the performance of any obligation to be performed by such
a Party under this Agreement, the non-breaching Party or Party not in default,
shall give notice in writing to the breaching Party or Party in default,
specifying the breach or matter in default. Unless such breach or default is
cured within sixty (60) days following the giving of such notice, (or if such
cure cannot be completed within such sixty (60) day period, if the cure has not
been undertaken promptly upon receipt of such notice, and diligently pursued
thereafter) the Party giving such notice may give further written notice to
breaching Party or Party in default, terminating this Agreement; in such event,
this Agreement shall terminate on the date specified in such further notice,
which date shall be no earlier than sixty (60) days from the date of such
further written notice.
9.03 TERMINATION FOR FORCE MAJEURE. If an event under Section 10.10 causes the
failure of performance of a Party for a period of ninety (90) days or more, any
Party to this Agreement, including the Party whose performance has failed
pursuant to Section 10.10, shall have the right to terminate this Agreement upon
written notice to the other Party or Parties.
9.04 BANKRUPTCY. Either Party shall have the right to terminate this Agreement
effective immediately in the event the other Party files a voluntary petition in
bankruptcy, is adjudicated as bankrupt, makes a general assignment for the
benefit of creditors, admits in writing that it is insolvent or fails to
discharge within fifteen (15) days an involuntary petition in bankruptcy filed
against it. CBSH shall have the right to terminate this Agreement effective
immediately in the event SERAGEN or LIGAND files a voluntary petition in
bankruptcy, is adjudicated as bankrupt, makes a general assignment for the
benefit of creditors, admits in writing that it is insolvent or fails to
discharge within fifteen (15) days an involuntary petition in bankruptcy filed
against it.
9.05 TERMINATION OF ADDITIONAL SERVICES. With respect only to additional
services provided under Section 2.15, either Party may terminate the provision
of such additional services upon six (6) months advance written notice to the
other Party. Provided, however, termination of such additional services under
this Section 9.05 shall not affect the commercial manufacture and supply and
related services provided under Article II or any other provisions of this
Agreement, nor shall it relieve either Party of any obligations under this
Agreement that have accrued prior to termination of such additional services.
9.06 CONSEQUENCES OF TERMINATION.
(a) In the event of termination of this Agreement by CBSH pursuant to
Sections 9.02 or 9.04, CBSH shall complete all work covered by an
unfilled binding purchase
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order from SERAGEN at the time of termination. In the event of
termination of this Agreement by SERAGEN pursuant to Sections 9.02 or
9.04, SERAGEN shall have the option, exercisable in its sole
discretion at the time of such termination, to elect to have CBSH
complete all work covered by an unfilled binding purchase order from
SERAGEN at the time of termination.
(b) Nothing in this Agreement shall be construed to release either Party
from any obligation that matured (including, without limitation, the
obligation to make payment for Fermentation Pellets, First Gen PDS
and/or Second Gen PDS manufactured or other services rendered prior to
such termination, or thereafter, if rendered in accordance with this
Section 9.06) or any breach of this Agreement that occurred before the
effective date of termination; provided, however, that upon any
termination of this Agreement CBSH shall, except as set forth in (a)
above and (c) below, cease any further provision of services under
this Agreement. Upon termination of the Agreement, in addition to
payment for the Fermentation Pellets, First Gen PDS and/or Second Gen
PDS and other services rendered prior to such termination, SERAGEN
shall be responsible for paying to CBSH the amounts of any outstanding
commitments to which CBSH has obligated itself in connection with
CBSH's performance under this Agreement and which CBSH is unable,
using reasonable commercial efforts, to terminate.
(c) In the event of termination of this Agreement for material breach or
default by CBSH (or a failure of supply due to matters covered in
Section 10.10 of this Agreement), CBSH shall, if CBSH is able and
SERAGEN elects for CBSH to do so, (i) manufacture any Fermentation
Pellets , First Gen PDS and/or Second Gen PDS and SERAGEN shall take
possession of such Fermentation Pellets First Gen PDS and/or Second
Gen PDS and shall purchase any raw materials, and components covered
by a binding purchase order(s) from SERAGEN at the time of
termination, provided that such Fermentation Pellets, First Gen PDS
and/or Second Gen PDS are not determined to be non-conforming for
reasons attributable to CBSH in accordance with the procedure set
forth in Section 2.14 and provided that such Fermentation Pellets,
First Gen PDS and/or Second Gen PDS have been manufactured in
accordance with cGMPs (to the extent work continues pursuant to this
section following the termination date, the terms of this Agreement
shall continue to apply to such work) and (ii) transfer all raw
materials used in the manufacture of Fermentation Pellets, First Gen
PDS and/or Second Gen PDS which have been paid for by SERAGEN and are
in CBSH's possession to an alternate supplier of Fermentation Pellets,
First Gen PDS and/or Second Gen PDS designated by SERAGEN, and (iii)
have CBSH technical personnel available (at the Additional Services
rate listed in Exhibit "B") for reasonable assistance in effecting
such transfer of manufacture of Fermentation Pellets, First Gen PDS
and/or Second Gen PDS for a period of six (6) months from the
effective date of termination. Upon purchase by SERAGEN in accordance
with this Agreement, the materials and components specified in (i) of
the preceding sentence shall become the exclusive property of SERAGEN.
The obligations under Sections 3.08, Taxes, Section 4.10,
Allocation of Burden of
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Product Recall, Article VI, Confidentiality and Intellectual
Property, Article VII, Indemnification, Article VIII, Warranties and
Representations, and this Article IX shall survive expiration or
termination of this Agreement or any extensions thereof. With respect
to confidential information exchanged under Article VI, upon
termination of the Agreement the receiving Party shall return all
confidential information to the disclosing Party, except the receiving
Party shall be entitled to retain one (1) copy of all confidential
information for legal purposes
ARTICLE X
MISCELLANEOUS
10.01 NOTICES. All notices or other communications that are required or
permitted under this Agreement shall be in writing and shall be deemed to have
been duly given when delivered by registered or certified mail, return receipt
requested, postage prepaid, by facsimile transmission, by reputable overnight
courier service of national reputation, or by hand, addressed as follows:
If to CBSH:
CAMBREX BIO SCIENCE HOPKINTON, INC.
97 South Street
Hopkinton, Massachusetts 01748
Facsimile: (508) 497-0777
Attention: General Manager
With a copy to:
CAMBREX CORPORATION
5901 E. Lombard St.
Baltimore, MD 21224
Facsimile: (410) 563-9206
Attention: Shelly Upton, Corporate Counsel
If to SERAGEN:
SERAGEN, INC.
10275 Science Center Drive
San Diego, CA 92121
Facsimile: (858) 550-1801
Attention: Manufacturing and Supply Operations
Page 30 of 42
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With a copy to LIGAND:
LIGAND PHARMACEUTICALS INCORPORATED
10275 Science Center Drive
San Diego, CA 92121
Facsimile: (858) 550-1825
Attention: General Counsel
or to such other address as either Party may be notice to the other Party have
directed.
10.02 FURTHER ASSURANCES. Each Party to this Agreement covenants and agrees that
it will promptly, during the Term of the Agreement and on the request of the
other Party, execute, acknowledge and deliver or otherwise properly
authenticate, as may be required by law, all documents, instruments,
applications, assignments, registration, or other legal papers necessary to
effectuate the provisions of this Agreement.
10.03 ASSIGNMENT. CBSH and/or SERAGEN shall not assign this Agreement without
the prior written consent of the other Party, which consent shall not
unreasonably withheld, however, CBSH and/or SERAGEN may, without such written
consent, assign this Agreement, and its rights and objections hereunder, in
connection with the transfer or sale of all or substantially all of its
business, or in the event of its merger or consolidation or change in control or
similar transaction. In the event of any assignment, performance shall be
guaranteed by the assignor in a form satisfactory to the other Party.
10.04 EFFECTS. This Agreement is binding on, and shall redound to the benefit
of, the Parties to this Agreement and their respective successors and permitted
assigns. Except as otherwise expressly provided in this Agreement, this
Agreement does not create or confer, and is not to be construed as creating or
conferring, any right, remedy, claim or benefit on any third party, other than
the respective successors and permitted assigns of the Parties to this
Agreement.
10.05 WAIVERS AND AMENDMENTS. Any amendment or supplementation of this Agreement
or any waiver of any term or condition of this Agreement shall be effective only
if in writing and signed by all Parties. A waiver of any breach of any of the
terms or conditions of this Agreement is not in any way to be construed as a
waiver of any subsequent breach.
10.06 SEVERABILITY. In the event that any one or more of the provisions of this
Agreement is determined to be invalid, illegal or unenforceable in any respect
for any reason, the validity, legality and enforceability of any such provision
in any other respect and the remaining provisions of this Agreement shall not,
at the election of the Party for whom the benefit of the provision exists, be in
any way impaired.
10.07 COUNTERPARTS. This Agreement may be executed in one or more counterparts,
all of which together constitute one and the same instrument.
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10.08 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the Commonwealth of Massachusetts, without regard to
the conflict-of-laws rules of Massachusetts law.
10.09 ENTIRE AGREEMENT. This Agreement (including all Exhibits) contains the
entire agreement among the parties with respect to the manufacture and/or
testing of the Product for the Term of the Agreement and supersedes all prior
agreements, written or oral, with respect thereto.
10.10 FORCE MAJEURE. Any delays in or failure by either Party in performance of
any obligations hereunder shall be excused if and to the extent caused by such
occurrences beyond such Party's reasonable control, including, but not limited
to, acts of God, strikes, or other labor disturbances, war, whether declared or
not, sabotage, product shortages, terrorist acts, acts or omissions of
governmental authorities, and other causes, whether similar or dissimilar to
those specified, which cannot reasonably be controlled by the Party who failed
to perform.
10.11 INDEPENDENT CONTRACTORS. The status of the Parties under this Agreement is
that of independent contractors. Neither Party shall have the right to enter
into any agreements on behalf of the other Party, nor may either Party represent
to any person that it has any such right or authority. Nothing in this Agreement
is to be construed as establishing a partnership or joint venture relationship
between the Parties.
10.12 HEADINGS. Headings are used in this Agreement for convenience only and
shall not affect any construction or interpretation of this Agreement.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date
first above written.
SERAGEN, INC. CAMBREX BIO SCIENCE HOPKINTON, INC.
By: /S/ GIAN ALIPRANDI By: /S/ DOMINIC MICALE
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Title: VICE PRESIDENT, OPERATIONS Title: CONTROLLER
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Date: 11 OCTOBER 2003 Date: OCTOBER 10, 2003
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| LIGAND |
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| /S/WRB |
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| LEGAL |
| |
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EXHIBIT "A"
MRR DOCUMENTATION
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EXHIBIT "B"
FERMENTATION PELLET, FIRST GEN PDS, SECOND GEN PDS, SECOND GEN FDP
AND OTHER SERVICES PRICING
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EXHIBIT "C"
SECOND GEN PDS AND SECOND GEN FDP PRICING
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EXHIBIT "D"
REGULATORY AGENCIES
The Regulatory Agencies with authority over the manufacture, testing and/or
shipment of the Product covered by this Agreement are as follows:
The United States FDA (or any successor agency)
The EMEA (or any successor agency), but only following filing for regulatory
approvals required to market the Product in the EMEA's jurisdiction.
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EXHIBIT "E"
SAMPLE PURCHASE ORDER
________________________________________________________________________________
------------------------------------
| Purchase Order |
|----------------------------------|
|PURCHASE ORDER NO. REVISION PAGE|
| 994523 0 1 |
[LOGO] |----------------------------------|
LIGAND PHARMACEUTICALS | THIS PURCHASE ORDER NUMBER MUST |
10275 Science Center Drive | APPEAR ON ALL INVOICES, PACKING |
San Diego, CA 92121-1117 |LISTS, CARTONS AND CORRESPONDENCE |
858/550-7500 | RELATED TO THIS ORDER. |
|----------------------------------|
|SHIP TO: |
| NOT APPLICABLE |
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| |
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CAMBREX BIO SCIENCE HOPKINTON, INC. | |
VENDOR: ATTN: DOTTIE RUMBEL |----------------------------------|
97 SHOUTH STREET |BILL TO: |
HOPKINTON, MA 01748 | LIGAND PHARMACEUTICALS INC. |
United States | 10275 SCIENCE CENTER DRIVE |
| SAN DIEGO ,CA 92121 |
| United States |
| |
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Order Confirmation #:
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|CUSTOMER ACCT NO. VENDOR NO. DATE OF ORDER/BUYER REVISED DATE/BUYER |
| 5203 11-SEP-03 DEAMICIS, S |
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|PAYMENT TERMS SHIP VIA F.O.B. |
|N30 SHIPPING POINT |
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|FREIGHT TERMS REQUESTOR/DELIVER TO CONFIRM TO/TELEPHONE|
|PREPAY & ADD |
|------------------------------------------------------------------------------|
ITEM|PART NUMBER/DESCRIPTION|DELIVERY DATE|QUANTITY|UNIT|UNIT PRICE|EXTENSION|T|
| | | | | | | |A|
| | | | | | | |X|
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| |AUTHORIZED SIGNATURE |
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EXHIBIT "F"
SERAGEN AUTHORIZED PERSONNEL
LIGAND TITLE*
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*or such other personnel as may be designated in writing by LIGAND or SERAGEN
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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EXHIBIT "G1"
SUPPLIERS AS OF EFFECTIVE DATE
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RAW MATERIAL CBSH PART NO. SUPPLIER/CAT. NO.
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***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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EXHIBIT "G2"
SUBCONTRACTORS AS OF EFFECTIVE DATE
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SUBCONTRACTOR NAME SUBCONTRACTOR ADDRESS SUBCONTRACTED ASSAYS
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* denotes alternate or proposed laboratory.
***Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
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EXHIBIT "H"
SAMPLE
MANUFACTURING SERVICES AGREEMENT:
ADDITIONAL SERVICES QUOTATION
MANUFACTURE AND SUPPLY AGREEMENT:
ADDITIONAL SERVICES QUOTATION
This document (the "Quote"), effective as of the date of last signature (the
"Effective Date"), shall constitute a binding agreement for additional services
to the Manufacture and Supply Agreement (the "Agreement"), dated _____________
by and between SERAGEN Inc. ("SERAGEN") and Cambrex Bio Science Hopkinton, Inc.
("CBSH") This quotation shall be governed by and construed in accordance with
the terms and conditions of the Agreement, except as the terms and conditions of
the Agreement are modified by this Quote.
1.0 SERVICES: CBSH shall perform the following additional services ("Services")
for SERAGEN:
2.0 COST ESTIMATE: CBSH will invoice SERAGEN against purchase orders that will
be issued by SERAGEN individually for the Services and associated cost
listed below:
3.0 ASSUMPTIONS:
CAMBREX BIO SCIENCE HOPKINTON, INC. SERAGEN INC.-APPROVED
-APPROVED
By: By:
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(signature of (signature of
authorized representative) authorized representative)
Name: Name:
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Title: Title:
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Date: Date:
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