Exhibit 10.10
[LOGO] XXXXXXXX XXXX
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DATED December 10, 2001
(1) SKYEPHARMA INC
and
(3) ASTRALIS LIMITED
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AGREEMENT FOR
SERVICES
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00 Xxxxxxx Xxxxxx Xxxxxx X0X 0XX
Tel: 000 0000 0000 Fax: 000 0000 0000
INDEX
Page Xx
0 Xxxxxxxxxxxxxx 0
0 Xxxxxxxxxxx 0
0 Xxxxx Project Team 6
4 Clinical Services 8
5 Regulatory Services 9
6 Development Services 10
7 Changes to the Services 10
8 Investor Relations 11
9 Confidentiality 11
10 Ownership of Materials and Inventions 13
11 Fees and Budgets 14
12 Relationship of Parties 15
13 Indemnities 16
14 Duration and Termination 00
00 Xxxxx Xxxxxxx 00
00 Consequences of Termination 17
17 Assignment 18
18 Entire Agreement Modification and Waiver 18
19 Notices 18
20 Governing Law and Jurisdiction 19
21 Severance of Illegal Terms 19
22 Counterparts 20
23 Publicity 20
Schedule 1: Services
Schedule 2: Laboratory
Schedule 3: Timetable
Schedule 4: Attachments 1. Study Protocol
THIS AGREEMENT is made the 10th day of December 2001
BETWEEN:
(1) SkyePharma Inc a US company having its principal place of business at
00000 Xxxxxxx Xxxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx 00000, XXX
('Contractor').
(2) Astralis Limited, a company registered in Delaware with its principal
place of business and registered office at 135 Columbia Turnpike - Suite
000 Xxxxxxx Xxxx - Xxx Xxxxxx 00000, XXX ('Company').
Whereas:
(A) Company is a start-up phase biotechnology company formed to engage in
research and development of treatments for immune system disorders and
skin diseases
(B) Contractor is engaged in development, manufacture, distribution and sale
of pharmaceutical and other health care products and is also engaged in
providing certain development and related clinical trial services.
(C) Company wishes to engage Contractor to carry out the Services (as
hereinafter defined) upon the terms and conditions below and Contractor is
willing and has agreed to perform such Services.
THE PARTIES HEREBY AGREE as follows:
1 Interpretation
1.1 In this Agreement including the recitals hereto, the following terms shall
have the respective following meanings unless the context requires
otherwise:
'Guidelines' those guidelines regarding compensation to
volunteers and Subjects in clinical trials
as might be recognised and generally
applied in any territory where a Study
contemplated herein is carried out;
'Affiliate' any corporation, partnership or other
entity controlled by, controlling or under
common control with Company with 'control'
meaning direct or indirect beneficial
ownership of more than 50% of the voting
power of or more than 50% interest in the
income of such corporation,
partnership or other entity (in accordance
with Section 736 of the English Companies
Xxx 0000 as amended by the Companies Act
1989);
'Budget' the budget for performance of the Services
as may require to be agreed by the parties
in accordance herewith;
'Change Order' a document detailing a change to the
Services, Budget or any other matter
hereunder made in accordance with clause 7
and/or clause 11;
'Confidential Information' any information, oral, visual or written,
that is not generally known outside of one
party or its Affiliates acquired directly
or indirectly by the other party its
agents or employees and whether made
available directly or indirectly by or on
behalf of the first party or developed,
generated or derived by the other party,
CROs, Monitors, Investigators or Subjects
in the course of and relating to the Study
or as the case may be, in the course of
providing the Services including, but
without limitation:
i) information relating to a party's or
its Affiliates' existing or proposed
products, designs, methods of
manufacture, research, technology,
know-how, processes, practices
and/or business operations such as
marketing plans, customer lists and
pricing methods, finances as well as
personnel and organisational data;
ii) results and other information
resulting from any Study, the
content of any report or advice
prepared by or on behalf of
Contractor hereunder, and working
papers in relation thereto;
iii) information embodied in Materials.
'CRF' a case record form able to record all data
required by a Protocol relative to each
Subject and approved by Company for use in
a Study;
'CRO' a clinical research organisation (being an
independent third party experienced and
equipped to conduct clinical trials and
related services) advised by Contractors
to the Company as being able to conduct a
Study;
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'EMEA' the European Agency for the Evaluation of
Medicinal Products or its successor in
title;
'Ethics Committee' the body defined in ICH GCP with
responsibility for observance and
maintenance of ethical standards at the
Study Site, and whether locally referred
to as an Ethics Committee, an
Institutional Review Board or the
equivalent body in the country of the
Study Site;
'FDA' the United States Food and Drug
Administration or its successor in title;
'ICH GCP' ICH Harmonised Tripartite Guide Lines for
Good Clinical Practice dated 1 May 1996
(effective 17 January 1997) or updated
subsequently and GCP shall be interpreted
accordingly;
'IND' an Investigational New Drug Application
filed with the FDA, the EMEA or any other
regulatory approval that may be required
to be issued in order to commence a Study
in any country;
'Improvement' any improvement, invention or discovery
conceived, originated or made by
Contractor or its directors or employees
whether alone or jointly with others and
arising wholly or partly out of the
activities undertaken during the course of
and/or in any way whatsoever related to
the provision of the Services;
'Investigator(s)' those persons with appropriate
qualifications and experience selected by
CRO as able to conduct the practical
performance of the Study in strict
compliance with the Protocol including
responsibility for the integrity, health
and welfare of the Subjects during the
Study and to exercise all other
responsibilities of a clinical
investigator set out in ICH GCP;
'Investigator Fee' Schedule' the budget for payment of Investigators
based on Subject recruitment/visits/
completion of evaluable CRFs, as set out
in the Budget;
'Laboratory' the company engaged by CRO to provide
laboratory services as required during the
Study;
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'Materials' documents, products, drawings, designs,
models, records, reports, correspondence
(electronic or otherwise) specifications,
disks, tapes and all other tangible
materials;
'Monitor' Contractor personnel who will monitor the
performance of the Study at the Study Site
including support staff of the same and
all other personnel engaged by Contractor
to assist in the performance of the
Services;
'Net Sales' means the invoiced amount billed for sales
of products utilising the Technology to
third party purchasers, less the following
items to the extent they are paid or
allowed and included in the invoice price:
(i) quantity, trade and/or cash
discounts actually granted;
(ii) amounts refunded or credited for
Products which were rejected or
damaged;
(iii) taxes, tariffs, customs duties and
surcharges and other governmental
charges incurred in connection with
the sale, exportation or importation
of such products;
'NDA' a new drug application or its equivalent
filed with the FDA, a marketing
authorisation application filed with the
EMEA or a marketing authorisation
application or a product licence
application or equivalent filed in any
other country;
'Pre-Clinical Study' means any study, other than a Study,
carried out on Product including, without
limiting the generality of the foregoing,
ADME, toxicology, pharmacokinetics,
pathology, pharmaceutical formulation,
drug metabolism, stability and
pharmacology studies which are required or
advisable to be carried out in order to
obtain the grant of an IND to develop
Product;
'Project Manager' the person to be appointed by Contractor
in accordance with clause 3 to oversee the
conduct of the Services;
'Protocol' the statement of the rationale,
objectives, design and methodology of any
Study including the conditions under which
it is to be performed which shall be
agreed between the parties following
execution of this
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Agreement and attached to this Agreement
at Schedule 4;
'Regulatory Authority' any statutory or governmental body with
responsibility in relation to clinical
trials conducted or empowered to regulate
the dissemination, importation, production
or use of the Study Drug at the Study Site
or elsewhere in accordance with the
Protocol and references to 'regulatory'
shall be interpreted accordingly;
'Services' those Clinical Trial Services, Regulatory
Services and Development Services and such
other related advice and assistance to be
provided by Contractor for and on behalf
of Company as specified or described
herein;
'Standards' ICH GCP, Declaration of Helsinki (18th
World Medical Assembly 1964) as last
modified by the 52nd World Medical
Assembly Edinburgh Scotland October 2000,
all applicable national and/or local laws,
regulations and guidelines relating to the
protection of human subjects in the
conduct of clinical trials, all legal and
administrative requirements of the
Regulatory Authority relating to the Study
Drug, Good Laboratory Practices as set out
in the UK Compliance Program DoH, 1989 and
US Code of Federal Regulations 21, Part
58;
'Study' the clinical investigation performed as
described in the final version of the
Protocol;
'Study Costs' the actual cost to Contractor of those
items contained in the Budget as payable
by Contractor to third parties for such
specified goods and services necessary to
conduct the Study;
'Study Drug' the investigational drug(s) specified in
the Protocol including active and inactive
preparations and investigational and
standard devices all placebo and reference
compounds;
'Study Report' the final version of the report detailing
the conduct and results of the Study
including all statistical analysis and
reports which has been agreed by Company
and is suitable for submission to the
Regulatory Authority and to which the
Protocol shall be appended;
'Study Site' a hospital, clinic or office of a
practising physician selected by CRO and
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approved in writing by Company to
participate in the conduct of the Study,
and from which the Investigator will
conduct the practical performance of the
Study;
'Subject' any person eligible according to the
criteria in the Protocol (excluding screen
failures) for recruitment, inclusion (and
not for exclusion) and continued
participation in the Study and who has
signed an appropriate informed consent
form and who is enrolled to take part in
the Study;
1.2 In this Agreement the headings and table of contents are included only for
convenience and shall not affect its interpretation and where the context
so admits: reference to a person shall be deemed to include a natural
person, body corporate or incorporate, government or department or agency
thereof or any other legal entity; words importing the singular meaning
include the plural and vice versa; and reference to the masculine includes
the feminine and vice versa; also reference to a clause, Schedule or
attachment shall mean a clause in or a Schedule or attachment to this
Agreement and the provisions of the Schedules and of the documents
referred to in the Schedules/attachments (including without limitation,
the Protocol) shall be deemed terms of this Agreement.
1.3 Any word or expression defined in the Protocol and used herein shall bear
the same meaning unless the context otherwise requires. In the event of a
conflict between any provisions in a Schedule and any term in the body of
this Agreement, the provisions of the Protocol shall prevail in respect of
any clinical or technical aspect of the conduct of the Study otherwise the
terms in the body of this Agreement shall apply in substitution for the
conflicting provision.
2 Appointment
2.1 Company hereby engages Contractor to provide the Services and Contractor
hereby accepts the engagement and agrees to perform the Services and to
conduct such other functions for and on behalf of Company in accordance
with and subject to the terms and conditions of this Agreement.
3 Joint Project Team and Project Manager
3.1 Within thirty (30) days of the date hereof, the parties shall establish
the Joint Project Team containing senior clinical research and/or
regulatory members from both parties. The Joint Project Team shall consist
of four (4) members, two (2) from each party. Each party shall designate
its members to the Joint Project Team and shall notify the other party in
writing if it substitutes or replaces any of its members, whether on a
permanent or temporary basis.
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3.2 The Contractor shall appoint the Project Manager, who shall be a senior
clinical research and/or regulatory employee of the Contractor, and who
may be a member of the Joint Project Team.
3.3 The Joint Project Team together with the Project Manager shall meet at
least four (4) times per year unless otherwise agreed by the parties.
Meetings may be held by telephone or video conference or in person and
members may participate in any of the foregoing ways it being recognised
that it is the current intention that the Joint Project Team should meet
in person at least twice a year, at venues to be agreed by the parties.
All costs relating to participation by each member in the activities of
the Joint Project Team shall be borne by the party appointing such member.
3.4 The presence of at least two (2) members, one (1) from each party,
including the Project Manager, shall constitute a quorum for the purpose
of consideration and action by the Joint Project Team. Where necessary,
decisions of the Joint Project Team shall be put to the vote. Each party
shall have one (1) vote, irrespective of the number of attendees at such
meeting. Any deadlock on any such vote shall be referred to the Chief
Executive Officer of the Company who shall have the casting vote, or
failing his decision, the board of directors of the Company, who shall
have the casting vote.
3.5 The Joint Project Team shall keep minutes of meetings and circulate these
to the members within fifteen (15) days following the conclusion of the
meeting for approval and adoption.
3.6 The Project Manager shall update the Company with progress on the Project
on a monthly basis, and will provide the Company with a written report
following, and in respect of, each Joint Project Team meeting.
3.7 Additional non-voting representatives or consultants may be invited by
either party to attend and participate in Joint Project Team meetings (for
example, to evaluate and advise on business or scientific issues) subject
to compliance with the confidentiality provisions of Clause 10. Each party
shall be responsible for the costs and expenses incurred in connection
with the attendance and participation in Joint Project Team meetings of
representatives or consultants invited by such party.
3.8 The Joint Project Team shall be responsible, without limitation, for
monitoring and co-ordinating certain of the parties' activities regarding
the conduct of the Services.
3.9 The Joint Project Team shall remain in existence until the termination of
the Agreement or until disbanded by agreement of the parties.
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4 Clinical Services
4.1 Contractor shall use all reasonable endeavours to perform the Clinical
Services, which shall comprise the following:
4.1.1 managing and administering clinical trials in the US and in
Europe as appropriate;
4.1.2 collaborating with the Company in selecting a CRO with which the
Client shall contract direct;
4.1.3 managing and directing the activities of the chosen CRO in
conduct of the Study;
4.1.4 monitoring Subject enrolment to ensure as far as reasonably
possible that the project timelines for enrolment are met;
4.1.5 reviewing the CRO's Voice Activated Response System (VARS) and
advising the Company of its apparent suitability;
4.1.6 providing assistance and direction to recruit and qualify an
Investigator capable of conducting a Study, with whom the
Company shall contract direct;
4.1.7 managing the development of the Investigator's brochure.
Contractor will also schedule and run the Investigator's
meetings at appropriate times throughout the Study;
4.1.8 managing the process of Study Site selection, assisting Company
with negotiating Study Site contracts, qualifying the Study
Sites and co-ordinating with the CRO the activities to be
undertaken at the Study Site;
4.1.9 providing input and expertise in the design of the Protocol to
the Company's specifications, such input to include Study design
criteria such as packaging and dosage in conjunction with the
Company's packaging contractor;
4.1.10 arranging for an indemnity by Company of Study Sites and
procuring clinical trial insurance in an amount of cover
mutually agreeable to the parties. Company shall contract direct
with Study Sites regarding such indemnity and shall contract
direct with the relevant insurers for such clinical trial
insurance.;
4.1.11 providing a qualified medical doctor to co-ordinate and lead the
Tolerance Assessment Panel (TAP) on behalf of the Company;
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4.1.12 providing such other necessary clinical services as may
reasonably be required with the aim of completing the Chemistry,
Manufacturing and Controls (CMC) section of any IND for Study
Drugs.
4.2 The parties shall agree a timetable for implementation and completion of
any Study and Contractor shall use reasonable endeavours to procure
compliance by the CRO with the same.
4.3 Contractor shall report to Company regarding progress of the Services
regularly as required but at least monthly as specified in Schedule 1 and
shall before the Completion of the Services use reasonable endeavours to
procure the provision by the CRO of a management report to Company of any
Study specifying in respect of each Study Site that the Study has been
completed in accordance with the Protocol and that CRO has overseen and is
satisfied that all data collected in relation to the Study has been
properly recorded on the CRFs in accordance with the requirements of the
Protocol and that CRO is satisfied that the production of the statistical
tabulations has all been completed in compliance with ICH GCP.
4.4 Company shall make available to Contractor clinical supplies of the Study
Drug for onward despatch to the CRO and Investigator and such other
materials facilities, equipment and information as may be in Company's
possession from time to time and which Company considers reasonably
necessary to the conduct of the Study or to assist in the performance of
the Services.
5 Regulatory Services
5.1 Contractor shall use all reasonable endeavours to perform the Regulatory
Services, which shall comprise the following:
5.1.1 managing the process of obtaining an IND to conduct Studies in the
United States and Europe;
5.1.2 providing, on behalf of the Company which shall be the holder of
the IND for the Product:
5.1.2.1 guidance and preparation for the IND and NDA (including
the preparation of the manufacturing and CMC section of
an IND);
5.1.2.2 guidance for an NDA submission by Company as required by
Company;
5.1.2.3 co-ordination of the regulatory requirements for the
Company;
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5.1.3 updating the IND on behalf of Company for any formulation changes
which may occur to the Study Drug covered by the IND.
6 Development Services
6.1 Contractor shall use all reasonable endeavours to perform the Development
Services, which shall comprise the following:
6.1.1 providing drug development expertise (which expertise shall, where
Company has exercised its option under the Technology Access
Option Agreement of even date herewith and between, among others,
Contractor and Company ("the Technology Agreement"), include
application of Contractor's drug delivery expertise) to assist the
transfer of technology to enable pilot-scale manufacturing by
third party manufacturers and conducting feasibility studies
including all analytical and stability analysis in preparation for
the Product to enable transition to development studies and
commercial scale manufacturing;
6.1.2 assisting in the identification and selection of a third party
toll manufacturer capable of manufacturing and/or assembling the
Product, including appropriate due diligence of the prospective
manufacturer's ability and facilities;
6.1.3 notwithstanding the provisions of clauses 6.1.1 and 6.1.2, Company
shall consider in good faith any offer by Contractor to provide to
the Company such pilot-scale manufacturing and/or toll
manufacturing services, upon such commercial terms as the parties
may agree.
7 Changes to the Service
7.1 Any material change to the Services to be conducted by the Contractor
shall be agreed between the parties.
7.2 Any change to the Protocol shall be documented and dated so that it can be
uniquely identified as an amendment. Upon receiving a Protocol amendment
(or an amended Protocol as the case may be) Contractor will use reasonable
endeavours to procure that the CRO shall complete all necessary
documentation to support an application for approval of the same to the
Ethics Committee and, if costs are to be incurred, these will be agreed by
the parties in writing prior to any such submission and thereafter
Contractor will use reasonable endeavours to procure that the amended
Protocol is provided by the CRO to and signed by each of the
Investigators.
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7.3 Contractor shall advise CRO to proceed with any change to the Services as
specified in a written Change Order signed by the parties.
8 Investor Relations
8.1 The Contractor will provide reasonable investor relations services to the
Company in respect of the Company's European operations in accordance with
a schedule of services to be agreed by the parties on or before 31st
December 2001 for the year commencing 1st January 2002. All external costs
and expenses incurred by the Contractor in providing such services shall
be the responsibility of the Company and shall be reimbursed to the
Contractor upon presentation of valid invoices therefor.
9 Confidentiality
9.1 Each party ('the Recipient') agrees to receive and maintain Confidential
Information of the other ('the Discloser') in strict confidence and shall
not without the prior written consent of the Discloser publish or disclose
Confidential Information of the Discloser to anyone (nor allow such
publication or disclosure) except such Confidential Information to such
persons as may be expressly authorised in accordance with this Agreement.
Therefore the Recipient shall:
9.1.1 use Confidential Information for the sole purpose of the proper
performance of their duties in relation to this Agreement and in
accordance with such directions as Discloser may give from time to
time and not for any other purpose;
9.1.2 restrict access to Confidential Information and allow access only
to CROs, Monitors and Investigators and those other (if any) of
its directors, employees, contractors, affiliates and agents, that
must use such part of the Confidential Information for the purpose
of the conduct of the Study or the performance of the Services and
who have been advised of the restrictions hereby accepted by
Recipient in relation to the Confidential Information and provided
that Recipient shall ensure that each such director, employee,
agent, contractor or affiliate is prior to disclosure of
Confidential Information to them bound and obligated in writing by
provisions of confidentiality in relation to the Confidential
Information at least equal to those in this Agreement.
9.2 If necessary to perform the Services and subject to clause 9.1, Contractor
shall be permitted to disclose Confidential Information of Company to
CROs, Monitors, Investigators and Subjects who have a need to know the
information to perform the Services or to authorise such disclosure
provided that Contractor ensures that each such disclosure is made in the
manner that will best fit with these confidentiality obligations.
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9.3 Without limiting or affecting the obligations of confidentiality herein,
where it is a requirement of GCP that participation in the Study be
documented in a Subjects' medical records (as this may have some bearing
on their clinical management) information (which may include Confidential
Information) bearing direct relevance to that Subject and strictly
necessary to comply with GCP requirements may be disclosed to the
Subject's clinician provided that such disclosures will be limited to that
necessary for the clinical management of the Subjects and are made in the
manner that will best fit with these confidentiality obligations.
9.4 Upon termination of this Agreement for whatever reason or on request
whether before or after termination Recipient shall immediately surrender
and return to Discloser all Materials in its possession or control whether
or not they embody Confidential Information without retaining any copy,
notes, extracts or derivations therefrom.
9.5 The foregoing obligations of this clause 9 will apply to both Confidential
Information disclosed to or generated by Discloser or otherwise acquired
directly or indirectly through the performance of the Services and shall
not apply only to information which Recipient can show by competent
written records maintained in the ordinary course of business was:
9.5.1 prior to disclosure or generation hereunder publicly available, or
otherwise lawfully in its possession and was known to Recipient
without restrictions to its use;
9.5.2 becomes publicly available through sources independent of and not
by any act or omission of Recipient, its employees, agents,
sub-contractors or affiliates;
9.5.3 subsequent to disclosure or generation hereunder, disclosed to
Recipient by a third party who did not receive such information
directly or indirectly from Discloser or any of its Affiliates or
in violation of Discloser's rights and which third party was
entitled to and did disclose the same without restriction.
9.6 Recipient may disclose such Confidential Information as is necessary
pursuant to a legal or regulatory requirement provided that as soon as
Recipient is aware of each of the same it notifies Discloser of the
requirement and the relevant Confidential Information and gives all
reasonable assistance and co-operates to take such measures as may be
available to limit the disclosure and preserve the confidentiality of the
Confidential Information nevertheless required to be disclosed.
9.7 Nothing in this Agreement shall oblige Discloser to disclose any
information to Recipient nor shall it be construed as granting any rights
by licence or otherwise in any product Invention or other property of
Discloser or any of its Affiliates.
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9.8 Recipient's obligations of confidentiality shall continue even if
Confidential Information has been returned to Discloser and shall in any
event survive termination of this Agreement.
10 Ownership of Materials and Inventions
10.1 Each party shall retain ownership of its Materials and Confidential
Information and the other party shall have no proprietary claim thereto.
10.2 Contractor acknowledges and agrees that as between Company and Contractor,
Company shall be or if the case requires shall be deemed to be the sole
and exclusive owner of the entire interest, title, and intellectual
property rights and rights of like nature in any Improvement (whether
patentable or not) developed by Contractor as a result of performing
Services insofar and to the extent that such Improvement is to Company's
existing products which comprise leishmania extract for immunotherapy for
psoriasis and leishmaniasis ("the Base Product") and which do not use or
exploit the Technology (as defined in the Technology Agreement) or is an
Improvement comprising use of the Base Product in any other indication and
which does not use or exploit the Technology. For all other Improvements
and their uses in respect of the Technology and any Improvement to the
Technology, Contractor shall be and remain the sole and exclusive owner
thereof.
10.3 Contractor shall promptly disclose to Company in writing any Improvement
of which it becomes aware arising wholly or partly out of the activities
undertaken in the course of or in any way whatsoever related to the
Service and/or Study.
10.4 At Company's request, Contractor shall assign and/or execute such
documents and/or take such other action as may be reasonably necessary to
ensure that the rights referred to in clause 10.2 above are properly
vested in Company and in connection with establishing, maintaining,
extending and defending such rights.
10.5 Contractor shall provide advisory services to Company in respect of the
protection, defence and exploitation of those patents and other
intellectual property rights in those products services or processes as
might be generated or acquired during the conduct of the Services and to
which the Company is entitled. Such services shall include a review of all
patents and other intellectual property rights currently subsisting in
Company and will be in accordance with a schedule of services to be agreed
by the parties on or before 31st December 2001 for the year commencing 1st
January 2002. All external costs and expenses incurred by the Contractor
in providing such services shall be the responsibility of the Company and
shall be reimbursed to the Contractor upon presentation of valid invoices
therefor.
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11 Fees and Budgets
11.1 In consideration of the performance of the Services Company shall pay to
Contractor the fees as specified herein.
11.2 Company acknowledges and agrees that Contractor has commenced conduct of
the Services prior to signature of this Agreement Accordingly, upon
signature, Contractor shall present to Company invoices for Services
conducted to date of this Agreement. The fees payable to the Contractor
for the year to December 31st 2001 shall be $US3,000,000, payable in equal
instalments of $US1,500,000 for the period to the date of this Agreement
and for the month of December 2001.
11.3 The fees payable to the Contractor for the year to December 31st 2002
shall be $US8,000,000, payable in equal instalments of $US665,000 in each
month of 2002.
11.4 The fees payable to the Contractor for the year 2003 and beyond shall be
the subject of negotiation between the parties. During the fourth calendar
quarter of 2002 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 suitable financial terms, which shall be
based upon Contractor's usual financial terms for providing like services.
11.5 The Contractor and the Company shall agree on the Budget for Study Costs
for the period to 31st December 2002. . The Budget for Study Costs for the
year 2003 and beyond shall be agreed between the parties during the fourth
calendar quarter of 2002, and the Budget shall be reviewed thereafter
annually.
11.6 Company shall be responsible for payment of all Study Costs and all
payments to CROs Investigators or Study Sites direct. Notwithstanding the
foregoing, Contractor may make payment for Study Costs necessarily and
reasonably incurred by Contractor in performance of the Services provided
that Contractor shall not incur any cost materially in excess of aggregate
specified in the Budget without first obtaining the written consent of
Company. For this purpose Contractor shall report to the Company's Chief
Executive Officer or such other person as Company shall from time to time
nominate. Company shall reimburse Contractor for all such costs incurred
by Contractor.
11.7 Contractor shall present invoices to Company for Fees due to be paid in
accordance with clauses 11.2, 11.3 and 11.4 above and monthly in arrears
for those costs incurred under clause 11.6 during the preceding month
together with such evidence of such Study Costs and expenses as Company
may reasonably require. Each invoice shall describe in reasonable detail
the matters to
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which the invoice relates. Payment of proper and correct invoices shall be
made by Company within 30 days of the date of invoice.
11.8 Should any payment hereunder be paid after its due date, Contractor may
charge interest on any amount unpaid at LIBOR plus 5% from the date
payment is first due until the date of actual payment. In addition to the
right to charge interest, in the event any amount remains unpaid 45 days
or more from the invoice date, the Contractor may suspend the conduct of
the Project or any of the Services.
11.9 All payments to be made by Company to Contractor hereunder shall be made
to the following account:
Pay to: FC - Silicon Valley Bank
0000 Xxxxxx Xxxxx
Xxxxx Xxxxx, XX 00000, XXX
Routing & Transit No: \\FW:000000000
--------------
Swift Code: SVBKUS6SA
For Credit of: SkyePharma Inc
Final Credit Account No: FNC - 3300161686
12 Relationship of Parties
12.1 Contractor is engaged as and shall provide the Services as an independent
contractor to Company and nothing in this Agreement or any subsequent
document entered into by the parties shall be construed as implying or
creating any employment, partnership or other relationship between Company
or its Affiliates, and Contractor or anyone used by Contractor in the
performance of the Services including without limitation, CROs, Monitors
and Investigators.
12.2 Notwithstanding the remainder of this clause 12.2, any part of this
Agreement or the terms of any power of attorney or other document entered
into by either or both of the parties, unless this clause is specifically
overridden by reference Contractor shall have no authority to bind or
commit Company in any manner whatsoever and shall not at any time hold
itself out to as having the authority to enter into or incur any
commitment, expense, liability or obligation of any nature on behalf of
Company, except to the limited extent to which this Agreement authorises
Contractor in performance of the Services to identify CROs, Investigators
and Study Sites, and to incur Study Costs and then only provided that
nothing in any agreement entered into between Contractor and any other
person shall bind Company in any way to directly make any payment or to
provide any service on behalf of Contractor.
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13 Indemnities
13.1 Company shall indemnify Contractor, CRO, the Study Site and Investigators
in respect of legal liability to third parties for claims for death or
bodily injury caused by the administration of Study Drug supplied by
Company for use in the Study where such liability is attributable to the
negligence or wilful misconduct of Company (except where the same arises
due to the negligent act, omission or breach of this Agreement by
Contractor provided that:
13.1.1 Company is notified in writing within twenty one (21) days of
receipt by Contractor of notice of any claim to which Company's
indemnity may apply and Company or its insurers if Company so
requests is permitted full care and control (including settlement)
of such claims; and
13.1.2 Contractor does not take any material step in relation to or
settle such claims and co-operates fully by providing to Company
all reasonable assistance (at Company's expense) in the
investigation and defence of such claims, and mitigation of any
loss.
13.2 Company acknowledges and agrees that it will abide by any applicable
Guidelines.
14 Duration and Termination
14.1 This Agreement shall commence on the date written above and shall continue
(unless terminated earlier in accordance with any other provision hereof,
or extended by agreement of the parties) until 31st December 2002.
Termination or expiration of this Agreement shall not absolve the parties
from liability to complete obligations that should have been completed
prior to the date of termination or from the subsequent loss and effect of
that failure on the other party.
14.2 Company may terminate this Agreement at any time upon 30 days written
notice to Contractor and immediately if Contractor is guilty of gross
misconduct.
14.3 Either party may terminate the Study at any time by written notice to the
other for reasons of Subject safety or efficacy of the Study Drug and in
such circumstances termination of the Study shall be carried out
immediately upon notification (by telephone or otherwise) and termination
of the Agreement shall be within one week of such notification however
such emergency notification always shall be followed by a written
confirmation of termination or if that other party:
14.3.1 is in breach of any of the terms of this Agreement and, in the
case of breach capable of remedy, does not remedy such breach
within 10 days of receipt of a notice specifying the breach and
requiring its remedy; or
16
14.3.2 becomes insolvent or makes an arrangement with its creditors, or
otherwise ceases or threatens to cease business.
14.4 Should the Agreement be terminated, Company shall continue to be obliged
to pay, and shall pay to the Contractor the fees specified in clause 11,
and Contractor shall provide the Services in respect of an alternative
product candidate as might be nominated by Company.
15 Force Majeure
15.1 The parties shall not be liable for non-performance of obligations under
this Agreement (except obligations of confidentiality) to the extent that
such performance is hindered or prevented by reason of legislation,
government prohibition, natural physical disaster, invasion, war, acts of
terrorism, civil commotion, 'Act of God', the refusal, withholding or
withdrawal of any necessary approval by the Regulatory Authority or any
other contingency beyond the control of such party ('Force Majeure')
provided that the party affected gives written notice of the event of
Force Majeure to the other.
15.2 Should an event of Force Majeure continue for a period exceeding two
months, this Agreement may be terminated by the party not claiming the
benefit of Force Majeure giving written notice of termination to the other
party.
16 Consequences of Termination
16.1 Upon termination or where specified below upon notice of termination of
this Agreement or the Study for any reason:
16.1.1 at Company's option, Contractor shall either manage the
termination of the Study or transfer responsibility for any
remaining work as expeditiously as possible and in accordance with
Company's instructions and all applicable national and local laws,
regulations and guidelines;
16.1.2 Contractor shall within thirty days of notice of termination
return to Company all Materials in Contractor's possession or
control including but not limited to all Confidential Information;
16.1.3 the accrued rights and obligations of the parties in relation to
this Agreement or any breach of this Agreement shall not be
affected;
16.1.4 Company shall reimburse to Contractor all Study Costs to the
extent reasonably incurred and that cannot be cancelled, reduced
or applied elsewhere. Contractor
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shall perform no further work within the given notice period
except as may be reasonably necessary in accordance with clause
16.1.1 and 16.1.2 to close down the Study and/or to transfer
responsibility safely;
16.1.5 the provisions of clauses 9, 10, 11, 13, 14 and this clause 16 and
any other right or obligation which by its nature is intended to
come into effect, continue or that is necessary to give effect to
such surviving provisions shall not be affected.
17 Assignment
17.1 The rights and obligations of Contractor under this Agreement are personal
to Contractor and shall not be assigned sub-contracted or delegated except
as contemplated therein, without the prior written consent of the Company
(which consent shall not be unreasonably withheld).
18 Entire Agreement Modification and Waiver
18.1 This Agreement (including the Schedules and attachments hereto) set out
and constitute the entire understanding, warranties and agreement of the
parties. The parties acknowledge that no reliance is placed on any prior
agreement, representation or understanding whether written or oral
relating to its subject matter.
18.2 No amendment or waiver of this Agreement or of any right herein shall be
deemed effective unless made in writing and agreed to in writing by a duly
authorised officer of each of the parties.
19 Notices
19.1 Any notice or communication given under or in connection with this
Agreement by either party to the other shall be in writing and shall be
served by sending the same by registered post or recorded delivery or
personally delivered to the address specified below for such party or to
such other address as the relevant party may have previously notified to
the party giving notice in accordance with this clause as its address for
service:
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19.2 All notices shall be addressed as follows:
To Company: Astralis Limited
000 Xxxxxxxx Xxxxxxxx
Xxxxx 000 Xxxxxxx Xxxx
Xxx Xxxxxx 00000, XXX
Tel:
Fax:
Attention: Xxxx Ajnsztajn CEO
With a copy to: Xxxxxx Xxx Xxxxxxxxx
Xxxxx Danzig Xxxxxxx Xxxxxx & Xxxxxxxx, LLP
0 Xxxxxxxxx Xxxxxx
Xxxxxxxxxx, XX 00000
(973) 538-0800 ext. 882
(000) 000-0000 (fax)
To Contractor: XxxxXxxxxx Xxx, 000 Xxxxxxxxxx, Xxxxxx X0X 0XX
Tel: x00 00 0000 0000
Fax: x00 00 0000 0000
Attention: Xxxxxxx Xxxxxx, CEO and Xxxxxx Xxxxxxxxx, CFO.
19.3 Notices which are given in accordance with this Agreement will be deemed
to have been received by the addressee:
19.3.1 in the case of personal delivery, at the time of such delivery;
19.3.2 in the case of communication by first class pre-paid post, three
working days after despatch;
19.3.3 in the case of communication by facsimile, at the time
transmission is confirmed to the sender provided a hard copy of
such notice is subsequently sent.
20 Governing Law and Jurisdiction
20.1 This Agreement is governed by and shall be construed in all respects with
the laws of New York.
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21 Severance of Illegal Terms
21.1 If any provision of this Agreement is agreed by the parties to be illegal,
void or unenforceable or if any regulatory body or court of competent
jurisdiction in a final decision so determines, this Agreement shall
continue in force save that such provision shall be deemed to be severable
and excised herefrom with effect from the date of such agreement or
decision or such earlier date as the parties may agree provided that if
such materially affects the commercial terms of this Agreement the parties
shall negotiate in good faith to agree amendment of the Agreement to
maintain and preserve as far as possible the originally intended
commercial effect.
22 Counterparts
22.1 This Agreement shall have two identical original documents, namely the
duly signed and dated top copy version one of which is to be held by each
of the parties. Each counterpart may be deemed as an original but all of
which shall constitute one and the same instrument.
23 Publicity
23.1 The parties agree that neither of them will make any official press
release, announcement or other formal publicity relating to the subject
matter of this Agreement without first obtaining in each case the prior
written consent of the other party, which consent will not be unreasonably
withheld.
20
IN WITNESS whereof the duly authorised representative of the parties have
executed this Agreement the day and year first above written.
Signed by:
/s/ SKYEPHARMA INC
....................................................................
duly authorised for and on behalf of
SKYEPHARMA INC
Title: ...........................................................
Date: ...........................................................
Signed by:
/s/ ASTRALIS LIMITED
....................................................................
duly authorised for and on behalf of
ASTRALIS LIMITED
Title: ...........................................................
Date: ...........................................................
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SCHEDULE 1
Services
Organising and co-ordinating meetings
Finalizing Budgets for Study Costs
XXXXX chart production for development of Product
22
SCHEDULE 1 Part II
To be finalised
23
SCHEDULE 2
Laboratory
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SCHEDULE 3 Timetable
DELETE THOSE PARTS NOT APPLICABLE
Estimated Completion
Event Period Date
Agreement of Proposal:
Study preparation and planning
Final approved protocol
Regulatory submission
Selection of Sites/Pre-study visits
Local Research Ethics Committee Submissions
First Ethics Committee Approval
Distribute supplies to Study Site
Study Site initiation visits
Commence screening
First Patient enrolled
Commence Clinical Phase - first visit
Interim safety data provided (if applicable)
Enrollment of Last Subject
Last Patient last visit/Last Patient complete
End of Clinical Phase
Close Out
Submission of last CRF to data management
Results of laboratory assays analysis
Database locked
Statistical Analysis: All Statistical tables and listings available to Company
Draft integrated Study report provided to Company
Provision of CRFs and comments on Study Report
Final integrated Study report
Latest date for Completion of Services
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SCHEDULE 4
ATTACHMENT 1 - Study Protocols
NWK3: 659810.01
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