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EXHIBIT 10.11
AMENDMENT NO. 1 TO SERVICE AGREEMENT
This Amendment No. 1 to Service Agreement (the "Amendment") is
made between Seragen, Inc., a Delaware corporation having a usual place of
business at 97 South Street, Hopkinton, Massachusetts ("Seragen"), and Marathon
Biopharmaceuticals, LLC, a Massachusetts limited liability company having a
usual place of business at 97 South Street, Hopkinton, Massachusetts (the
"Service Provider"), as successor by assignment of Trustees of Boston University
("BU"), as of May 11, 1998, for the purpose of amending that certain Service
Agreement, dated as of February 14, 1997 (the "Service Agreement"), between
Seragen and BU.
This Amendment is made with reference to the following facts:
A. Seragen entered into the Service Agreement to purchase certain
services relating to product research, development, manufacturing, clinical
trial, quality control, and quality assurance.
B. Service Provider is the successor by assignment to BU, one of
the original parties to the Service Agreement.
C. Seragen has made certain business decisions that will result
in a reduction of the amount of product research, development, manufacturing,
clinical trial, quality control, and quality assurance services that will be
required in the second Contract Year (as defined in the Service Agreement).
D. Seragen is willing, on the terms set forth in this Amendment,
to perform for itself certain clinical trial services originally subject to the
Service Agreement and Service Provider desires to make available to Seragen the
assets necessary for Seragen to perform those services.
E. Section 2.01 of the Service Agreement provides that, in the
event that Seragen's research and development requirements change, the parties
to the Service Agreement shall negotiate amendments (including appropriate price
reductions) to the services required to be performed under the Service
Agreement. Section 4.01 of the Service Agreement provides that, in such an
event, the parties shall agree on appropriate adjustments to the Technology
Service Fees (as defined in the Service Agreement) payable under the Service
Agreement; provided, however, that in no event shall the Technology Service Fees
payable with respect to any Contract Year be reduced to less than $4,300,000.
NOW, THEREFORE, in consideration of the mutual covenants and
agreements contained in this Amendment, the parties to this Amendment, intending
to be legally bound, agree as follows:
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1. In lieu of the services required to be provided pursuant to
Schedule 1 to the Service Agreement by Service Provider in the second Contract
Year, Service Provider shall provide the services specified in Schedule 1
attached to this Amendment.
2. In light of the reduced services to be provided to Seragen in
the second Contract Year, the Technology Service Fees for the second Contract
Year shall be $4,300,000.
3. Service Provider shall make available without any additional
compensation to Seragen all assets necessary for Seragen to perform such
clinical trial services at the facility located at 99 South Street, Hopkinton,
Massachusetts, as Seragen may from time to time reasonably specify, which
services are not required to be performed by Service Provider under this
Amendment.
4. Capitalized terms used in this Amendment and not otherwise
defined shall have the meaning given those terms in the Service Agreement.
5. Except as expressly modified by this Amendment, the Service
Agreement shall remain in full force and effect.
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Seragen and Service Provider have executed this Amendment
effective as of the date first set forth above.
SERAGEN, INC.
/s/ Reed R. Prior
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By: Reed R. Prior
Chairman, Chief Executive
Officer & Treasurer
MARATHON BIOPHARMACEUTICALS, LLC
Service Provider
/s/ Kenneth G. Condon
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By: Kenneth G. Condon
Manager
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SCHEDULE 1- SERVICE AGREEMENT
SERVICES TO BE PERFORMED BY SERVICE PROVIDER FOR SERAGEN IN 1998:
MANUFACTURING OF BATCHES - 1998:
ORIGINAL
ESTIMATED
COMPLETION
SERVICE SPECIFICATIONS DATE CURRENT PLANS FOR 1998 COMMENTS
Fermentation cost of 6 batches of Master Batch Record 22-004, Q4 98 Q2 98 Fermentation plans from
DAB389IL-2 30-004 1997 to be conducted in
Q1/Q2 1998 for PAI will
provide sufficient
inventory
Purification cost of 10 batches of Master Batch Record 31-304, Q2 98 Eliminated Sufficient inventories
2nd Generation - DAB389IL-2 32-304, 34-304, 60-304 for clinicals permit
shift to 1999
Purification cost of 13 batches of Master Batch Record 31-004, Q3 98 Q2 98 Purification plans from
1st Generation - DAB389IL-2 32-004, 60-104 1997 to be conducted in
Q1/Q2 1998 for PAI will
provide sufficient
inventory to cover
product launch
Fermentation cost of 5 batches of Master Batch Record 22-007, Q3 98
DAB389EGF* 24-007
Purification cost of 10 batches of Master Batch Record 31-007, Q4 98
DAB389EGF* 34-007, 44-007, 47-007,
65-007, 66-007 and 70-007
Manufacture of formulation buffer* Q1 98 For Lilly PAI
Includes raw materials, labor and utilities
Schedule 1 - Page 1
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SCHEDULE 1- SERVICE AGREEMENT
SERVICES TO BE PERFORMED BY SERVICE PROVIDER FOR SERAGEN IN 1998:
MANUFACTURING FILL OF BATCHES - 1998:
ORIGINAL
ESTIMATED
SERVICE SPECIFICATIONS COMPLETION DATE CURRENT PLANS FOR 1998 COMMENTS
Fill of DAB389EGF Performed at fill-finish Q4 98 Eliminated Shift to Q2 99
site following their
Master Batch Record(s).
Prior to fill,
formulation performed at
Service Provider
following Master Batch
Record 65-007, 66-007,
70-007.
Fill of DAB389IL-2 Performed at fill-finish Q4 98 1 - 4 fills between Fills planned for 1997 to
1st Generation site following their Q2 - Q4 98 be conducted in Q3/Q4
Master Batch Records(s) 1998 will provide
sufficient inventory to
cover product launch
Fill of DAB389IL-2 Performed at fill-finish Q4 98 Eliminated Shift to Q2 99
2nd Generation site following their
Master Batch Record(s).
Prior to fill
formulation performed at
Service Provider
following Master Batch Record
70-304, 70-404.
Fill of formulation
buffer for PAI* Q2 98
Schedule 1 - Page 2
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SCHEDULE 1- SERVICE AGREEMENT
Shipment of bulk to fill
sites. Storage of fermentation
pellets, purified drug
substance, in process samples
and final drug product
(clinical trial material
only). Shipment of clinical
trial material to clinical
sites (also return,
accountability). Shipment of
material to sites for
non-clinical use. Label
control for clinical and
non-clinical materials (i.e.
not market product)*
SERVICES TO BE PERFORMED BY SERVICE PROVIDER FOR SERAGEN IN 1998:
QUALITY CONTROL AND RELEASE TESTING OF BATCHES - 1998:
ORIGINAL
ESTIMATED
COMPLETION
SERVICE SPECIFICATIONS DATE CURRENT PLANS FOR 1998 COMMENTS
QC testing of 6 fermentation batches Product spec. 30-004 Q4 98 - ongoing Q2 98 - ongoing
of DAB389IL-2
QC testing of 13 purification batches Product spec. 60-304 Q4 98 - ongoing Q2 98 - ongoing
of 1st Generation DAB389IL-2
QC testing of 5 fermentation batches Q3 98
of DAB389EGF*
QC testing of 10 purification batches Product spec. 60-007 Q4 98 - ongoing Q4 98 - ongoing
of DAB389EGF
QC testing of Fills, DAB389IL-2 Product spec. 90-204-02 Q4 98 - ongoing Q2 98 - ongoing
1st Generation
QC testing of Fills, DAB389IL-2 Product spec. 70-304 and Q4 98 - ongoing Eliminated Shift to 1999
2nd Generation 91-304-01; 5 mg/ml
QC testing of Fills, DAB389IL-2 Product spec. 70-404 and Q4 98 - ongoing Eliminated Shift to 1999
2nd Generation 91-404-02; 150 ug/ml
QC testing of Fills, DAB389EGF Product spec. 70-007 and Q4 98 - ongoing Eliminated Shift to 1999
91-007
Schedule 1 - Page 3
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SCHEDULE 1- SERVICE AGREEMENT
Stability testing of Q4 98 - ongoing Q1 98 - on-going
DAB389IL-2 and DAB389EGF
products held by service
provider for Seragen
Includes raw materials, labor
and overhead
SERVICES TO BE PERFORMED BY SERVICE PROVIDER FOR SERAGEN IN 1998:
QUALITY ASSURANCE - 1998:
ORIGINAL
ESTIMATED
COMPLETION
SERVICE SPECIFICATIONS DATE CURRENT PLANS FOR 1998 COMMENTS
Documentation and auditing Q4 98 Q1 98 - on-going
(audit report) specific to the
products in Manufacturing and
Product Development. Review
and approval of all Master
Batch Records, SOPs and
reports as listed in services
agreement.
Certificate of Analysis and Appropriate SOP's and Q4 98 On-going
release notification for release documents
batches and lots listed in
services agreement
Provide copies of all
manufacturing records,
laboratory records, deviation
reports and other records and
documents to Seragen for
review*
Schedule 1 - Page 4
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SCHEDULE 1- SERVICE AGREEMENT
Provide reports, data and other
information needed for Seragen to assess
compliance with regulatory requirements*
Preparation for PAI - implement audit -
specified and other changes to GMP
systems, procedures and documents as
necessary to prepare for FDA inspection.
Provide periodic progress reports to
Seragen. Notify Seragen of any
significant issues impacting on ability
to correct deficiencies and prepare for
inspections*
Includes raw materials, labor and overhead
SERVICES TO BE PERFORMED BY SERVICE PROVIDER FOR SERAGEN IN 1998:
PRODUCT DEVELOPMENT - 1998:
ORIGINAL
ESTIMATED
COMPLETION
SERVICE SPECIFICATIONS DATE CURRENT PLANS FOR 1998 COMMENTS
2nd Generation; improve lyophilization - Q2 98 Eliminated
and characterization of new DMF
EGF process development continue responses - Q4 98 Eliminated
for BLA
Development of topical formulations and - Q4 98 Eliminated
new molecules
Includes labor and direct materials
Schedule 1 - Page 5
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SCHEDULE 1- SERVICE AGREEMENT
SERVICES TO BE PERFORMED BY SERVICE PROVIDER FOR SERAGEN IN 1998:
CLINICAL / PRE-CLINICAL / REGULATORY STUDIES - 1998:
ORIGINAL
ESTIMATED
COMPLETION
SERVICE SPECIFICATIONS DATE CURRENT PLANS FOR 1998 COMMENTS
Phase I/II Psoriasis* Protocol 96-04-21 Trial on-going Trial on-going - estimated
completion Q4 98
Phase I/II Psoriasis Protocol 96-04-19 Q2 97 Trial on-going Trial on-going - estimated
completion Q4 98
Phase I (SC) Psoriasis Protocol 98-08-01 Q3 98 Q3 98 Estimated start - Q3 98 with
completion Q3 99
Schedule 1 - Page 6
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SCHEDULE 1- SERVICE AGREEMENT
Phase I/II EGF Protocol 96-02-03 Q3 97 Trial on-going Trial on-going - estimated
completion Q4 98
Limited use - Rheumatoid Protocol 95-04-18 Trial on-going Trial on-going
Arthritis*
Phase I 2nd Generation - Q1 98 Eliminated
Psoriasis
Phase II/III NHL - Q4 98 Eliminated
Phase I (SC) Derm - Q4 98 Eliminated
Phase I/II (IV) Other - Q4 98 Eliminated
Includes clinical trail site fees, labs, pathology fees, supplies and
overhead, clinical assays
SERVICES TO BE PERFORMED BY SERVICE PROVIDER FOR SERAGEN IN 1998:
CLINICAL / PRE-CLINICAL / REGULATORY STUDIES AND OTHER- 1998:
ORIGINAL
ESTIMATED
COMPLETION
SERVICE SPECIFICATIONS DATE CURRENT PLANS FOR 1998 COMMENTS
CTCL trials: service provider -Protocols for studies 93-04-11, Q4 98 On-going Estimated completion
labor and outside contract 93-04-14 date Q2
labor CTCL 00
Non-Besselaar contracts
Pre-Clinical studies: new Q4 98 Eliminated
refold 2nd generation and
EGF studies - includes labor,
supplies and overhead
Schedule 1 - Page 7
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SCHEDULE 1- SERVICE AGREEMENT
* Services were included in original Schedule 1 to Service Agreement but are
being specifically mentioned in this amendment for clarity.
PRICE FOR SERVICES RENDERED IN 1997 - $6,605,651(Original estimate)
PRICE FOR SERVICES RENDERED IN 1997 - $4,300,000 (Revised estimate)
Initials:
- --------------- ---------------- ---------------
Pat Bacha Elizabeth Chen Jean Nichols
- --------------- ----------------
John O'Loughlin Tony Rotunno
Schedule 1 - Page 8