XXXXXXXX XXXX
DATED 18th MARCH 2003
(1) SKYEPHARMA INC
and
(2) ASTRALIS LIMITED
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AMENDMENT 1 TO AGREEMENT FOR SERVICES
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00 Xxxxxxx Xxxxxx Xxxxxx X0X 0XX
Tel: 000 0000 0000 Fax: 000 0000 0000
(1) THIS amendment #1 to the Service Agreement dated December 10, 2001, by and
between Astralis Ltd. ("Astralis"), a Delaware corporation, and
SkyePharma, Inc. ("SkyePharma") is made and entered into this 18th day of
March 2003 by and between Astralis and SkyePharma and is effective as of
January 1, 2003. Capitalized terms used in this Amendment shall have the
meanings set forth in the Service Agreement unless otherwise indicated.
Recitals
(A) The parties determined, during the first quarter of 2003, that the project
definition and timelines set forth in the Service Agreement for the
conduct of Services have changed materially
(B) The Service Agreement terminated on December 31, 2002 and the parties wish
to enter into an Amendment to extend the application of the Service
Agreement for certain of the Services to December 31, 2004.
The parties hereby agree to amend the Service Agreement as follows:
1 Sections 11.3 and 11.4 of the Agreement are hereby amended in their
entirety to read as follows:
"11.3 Fees paid to the Contractor in equal installments of $US 665,000
during each month of 2002, shall be considered to be allocated to services
provided as follows for the revised agreed services schedule: (i) for the
year ended December 31, 2002, $US2,100,000 (ii) for the year ending
December 31, 2003, $US1,600,000 and (iii) for the year ending December 31,
2004, $US1,600,000.
11.4 The fees payable to the Contractor for services not covered by the
revised schedule shall be the subject of good faith negotiations to be
conducted between the parties. During the fourth calendar quarter of 2004,
the parties shall meet to discuss the development of the project
contemplated herein to date and negotiate in good faith the continuation
of this Agreement on mutually suitable financial terms, which shall be
based upon, among other things, Contractor's usual financial terms for
providing like services."
2 In further recognition of this Amendment, the parties agree that the
following services have been completed as at December 31, 2002 and that of
the $US11,000,000 paid to the Contractor during the years ended December
31, 2001 and December 31, 2002, the total value
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of services actually provided was $US1,700,000 in the year ending December
31, 2001 and $US3,100,000 million ($US2,100,000 pursuant to services
described in Sections 2.1 and 2.2 hereunder and $US1,000,000 pursuant to
the achievement of the milestone described in 3 (i) hereunder) during the
year ended December 31, 2002,
2.1 Regulatory Services in respect of the IND under Section 5.1 of the
Service Agreement
2.2 Development Services under Section 6.1.2 of the Service Agreement.
3 In further recognition of this Amendment, and in respect of payments
already received by SkyePharma in 2001 and 2002, the parties agree that
the following sums shall be deemed to have been paid by Astralis to
SkyePharma upon the occurrence of the relevant milestone event:
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Amount Milestone
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One million US dollars (US$1,000,000) (i) Establishment of cell line.
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One million US dollars (US$1,000,000) (ii) Submission of IND.
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Five hundred thousand US dollars (US$500,000) (iii) Completion of Phase I.
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Five hundred thousand US dollars (US$500,000) (iv) Initiation of Phase II.
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One million US dollars (US$1,000,000) (v) Completion of Phase II.
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It is agreed that milestone (i) has been achieved and that all future
milestones will be deemed to have occurred upon completion of the relevant
event, whether or not the activity is successful. Notwithstanding the
above, it is expressly understood that all amounts payable above have been
previously advanced by Astralis during 2001 and 2002 and it is agreed that
Astralis will make no further payments to Contractor unless otherwise
agreed upon in writing by the parties. Additionally it is agreed that all
amounts advanced by Astralis during 2001 and 2002 are non-refundable.
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4 In further recognition of this Amendment the parties agree that Investor
Relations services under Section 8 of the Agreement have been completed
and shall no longer be included within the service fees.
5 In further recognition of this Amendment, Clauses 4.1.1 to 4.1.12 of the
Agreement are hereby replaced with:
"4.1.1 General Strategic Support and Consulting: Responsible for general
strategic support and consulting. Estimated time commitment is for 30
hours / week with trips and expenses that include one monthly trip to
Astralis in New Jersey. Consulting will include technical, manufacturing,
R&D and clinical support.
4.1.2 Clinical Management and Monitoring for Phase II Venezuelan Clinical
Trials: Responsible for the management, and monitoring of the on-going AS
200 Phase II Venezuelan Clinical Trial. This includes providing that the
trial is compliant.
4.1.3 U.S Phase I and Phase II Protocol and CRF Revisions: Responsible for
the complete revision of the United States based Phase I and Phase II
Trial Protocols and corresponding CRFs.
4.1.4 Toxicology Program Management: Responsible for the management of the
AS 210 Toxicology Programs, including the on-going TOX 1 study with MPI
Research Inc and finishing the protocol and managing the second toxicology
study, TOX 2 and development of any additional toxicology studies required
for filing the NDA.
4.1.5 Clinical Research Associate (CRA): Responsible for the managing &
directing the activities of CROs or monitors chosen to monitor the conduct
of the U.S. Phase I and Phase II Trials. Estimated time commitment is 30
hours / week.
4.1.6 Regulatory and Clinical Development Management: Responsible for
guidance and preparation for the IND and NDA (including the preparation of
the manufacturing and CMC section of an IND) guidance for an NDA
submission; coordination of the regulatory requirements; updating the IND
for any formulation changes which may occur to the AS 210 covered by the
IND as required and agreed by the Board of Astralis."
In all other respects the Service Agreement and all provisions thereof shall
remain unchanged and in effect through December 31, 2004 unless otherwise
terminated in accordance therewith.
4
AS WITNESS the hands of the parties or their duly authorised representatives the
day and the year first above written
Signed by:
/s/
--------------------------------
duly authorised for and on behalf of
SKYEPHARMA INC
Title: Finance
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Date: 18 March, 2003
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Signed by:
/s/ Xxxx Xxxxxxx
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duly authorised for and on behalf of
ASTRALIS LIMITED
Title: Chief Financial Officer
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Date: 18 March 2003
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