Master Service Agreement
MSA_
___________ – OCT Group LLC dd. ____, 2010
This
Agreement, entered into on the __th of
_____ 2010 by and between Adherex, Inc., duly
established and validly existing under the laws of Deleware, having its seat at
000 Xxxxxxxx Xxxxx, Xxxxx 000, Xxxxxx Xxxx, XX legally represented by Xxxxxx
Xxxxxxx, acting on the basis of Operating Agreement (hereinafter referred to as
"Adherex”), and OCT Group,
LLC, whose principal office is at 000 Xxxxx Xxxxxx, 0xx Xxxxx, Xxx Xxxx,
XX, 00000, XXX (hereinafter referred to as ‘’OCT’’) represented by President
Xxxxxx Xxxxxx, acting on the basis of Operating Agreement and Resolution to
appoint President.
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1.0
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Definitions
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1.1
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‘Agreement’
means this Master Service Agreement (MSA) and any of the Project-Specific
Addenda (PSA) and Work Orders executed by both parties in writing and
attached thereto.
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1.2
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Clinical Study/Trial:
Any investigation in human subjects intended to discover or verify the
clinical, pharmacological and/or other pharmacodynamic effects of an
Investigational Product(s), and/or to identify any adverse reactions to an
Investigational Product(s), and/or to study absorption, distribution,
metabolism, and excretion of an Investigational Product(s) with the object
of ascertaining its safety and/or efficacy. The terms “Clinical Trial” and
“Clinical Study”
are synonymous.
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1.3
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‘Confidential
Information’ means any and all information which is now or at any time
hereafter in the possession of one party and which is disclosed (whether
orally or in any material form) to the other party or of which the other
party becomes aware and which relates to the general business or financial
affairs or Intellectual Property Rights of the disclosing party, including
without limitation, information relating to the Services, the Materials,
the Protocol, data, databases, know-how, formulae, processes, designs,
photographs, drawings, specifications, prices, results, software programs
and samples and any other material bearing or incorporating any
information relating to the disclosing party’s business, business affairs,
products, employees, consultants, contractors and marketing
information.
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1.4
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Regulations for Good Clinical
Practice: Order # 266 of the Ministry of Healthcare of the Russian
Federation “On the enactment of the Clinical Practice rules in the Russian
Federation” as of 19 June 2003, Federal Law as of 12 April 2010
# 61-FZ “On Medical Drugs”, National Standard GOST R 52379-2005 of the
Russian Federation (approved by the Order of the Federal Agency of
Technical Harmonization and Metrology), identical to the ICH GCP –
Guidelines for Good Clinical Practice of the International Conference on
Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (Note for guidance on Good Clinical Practice
(CPMP/ICH/135/95)).
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1.5
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‘Intellectual
Property Rights’ means any and all industrial property rights, including
patents, know-how, trade marks (whether registered or unregistered),
design rights (whether registered or unregistered), utility models,
applications for and rights to apply for any of the same, rights to
prevent passing off, copyright, database rights, topography rights and any
other rights in any invention, discovery or process in any jurisdiction in
the world.
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1.6
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Materials means
compound(s) or medical devices and documents as referred to in the
Protocol and provided to OCT to enable it to perform the Services under
this MSA.
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1.7
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‘Protocol’
means the clinical trial protocol and other protocols if required,
describing the objective(s), design, methodology, statistical
considerations and organization of the Clinical
Trials.
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OCT:_________
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Page
1 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
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1.8
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Monitoring: The act of
overseeing the progress of the Clinical Study, and of
ensuring that it is conducted, recorded, and reported in accordance with
the Protocol, Standard
Operating Procedures, Regulations for Good Clinical Practice, and
the Applicable
Regulatory Requirements.
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1.9
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Services means services
on organization and carrying out of the Clinical Trial, as further
specified in the Work Orders attached to this
MSA.
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1.10
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‘Product’
– the Investigational product
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1.11
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Sponsor
– a legal entity which takes responsibility for the initiation and/or
management and financing of the Clinical Study; the developer and/or owner
of the Product; the company Adherex.
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2.0
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Scope
of Agreement
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2.1
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ОСТ agrees to
perform at the request of Adherex tasks with regard to the organization
and monitoring of the Clinical trial, gathering and processing data,
regulatory and the logistical activities connected with implementation of
the services to the extent described in detail in the PSAs and Work Orders
hereto, being the exhibits to the Agreement and forming its integral part.
The Clinical trial will be carried in the territory of the Russian
Federation.
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2.1
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This
MSA forms the basis for a working relationship between Adherex and OCT. This
Agreement will be supplemented, in the form of PSAs and Work Orders, as
the need arises. The PSA or the Work Order will contain the detailed
requirements for the Services that are contracted to
OCT.
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3.0
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OCT
Obligations and Rights
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3.1
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ОСТ undertakes to
perform the Services under the Protocol, the terms of this MSA, in
accordance with GCP and pursuant to the applicable local
regulations.
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3.2
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OCT
has the necessary contracted consultants with the capability, skills and
expertise to carry out the services set forth in the PSA in accordance
with the Protocol, GCP and all other relevant laws, regulations and
guidelines.
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3.3
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OCT
agrees to provide to Adherex regular reports on
the services performed and the status of the ongoing
trial.
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3.4
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OCT
agrees to offer assistance of any kind in professional, organizational and
administrative issues as well as in any other aspects relating to conduct
of the Clinical Trial.
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3.5
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OCT
agrees to provide the delivery of the investigational product to the
Investigation Sites. Amount of the Product and order of the shipment of
the Product to the Investigation Sites will be agreed upon by the Parties
additionally, after OCT submits and Adherex approves the elaborated
Protocol.
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3.6
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Project
Team. Xxxxxxxxx Xxxxxxxxx will serve as Project Manager for the duration
of the trial unless Xx. Xxxxxxxxx employment is terminated with OCT or
Adherex is not satisfied with Xx. Xxxxxxxxx'x performance. Xxxxx Xxxxxxx
will serve as Project Supervisor for the duration of the trial unless Xx.
Xxxxxxx'x employment is terminated with OCT or Adherex is not satisfied
with Xx. Xxxxxxx'x performance. Any change in key project team members,
(e.g. Project Manager/Supervisor or CRAs) will be approved by
Adherex.
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OCT:_________
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Page 2 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
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3.7
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OCT
undertakes to return to Adherex all Materials
provided earlier by Adherex after the end of the Clinical Trial.
Adherex shall
cover the expenses connected with the return of the
Materials.
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3.8
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OCT
shall have the right to require from Adherex any additional information
necessary to perform the Services under this MSA. In case the required
information is not provided or provided not in full, OCT shall have the
right to postpone the Services under this
MSA.
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4.0
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Adherex Obligations
and Rights
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4.1
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Adherex shall provide all
the required documents on the basis of which OCT shall conduct the
Clinical Trial.
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4.2
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Adherex
shall ensure the on-time supply of the product and other relevant
medicines and Materials to be used in the Clinical Trial as per the study
protocol.
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4.3
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Adherex
shall ensure the timely response to any enquiry of OCT for any additional
documents necessary for the performance of the services under this
Agreement. The service performance in the part connected with the
requested Materials may be put on hold for the time period from the date
of inquiry till the date of Materials receipt.
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4.4
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Adherex is responsible for
the on time wire transfer to the account of OCT amount of the payments for
the Services. Adherex shall be responsible
for the on-time wire transfers of the investigators’ and sites’ fee and
other pass-through-costs payments.
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4.5
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Adherex
may request from the Service Provider any information related to the
Services under this MSA.
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5.0
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Compensation
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5.1
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The
Total cost of the MSA is stated in the PSA which should be considered the
integral part of the Agreement. Changes in scope may be incorporated into
this Agreement upon the written consent of both parties provided that both
parties agree on any additional costs associated with the performance of
the changed Services. Agreement regarding changes in scope should be
agreed upon in writing before the work is
performed.
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5.2
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Due
to the specific nature of the following Services: Drug import, Ongoing
Regulatory submissions, Protocol Amendments, SAE and SUSAR submission and
inability to know the possible number of units may occur, the Parties
agree that the cost of one unit shall be stated in the PSA. Shall there be
more than one unit of the services performed, any and all such services
shall be invoiced at the factual occurrence of units, provided that such
services are preliminary approved by Adherex. These shall not be
considered as the increase of the total cost of the MSA. Corresponding
pass-through expenses for the abovementioned activities also will be
invoiced to Adherex on actual
basis.
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5.3
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All
additionally required services will respectively cause increase in the
total cost of the services.
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5.4
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In
the event of conflict between the terms of this Agreement and the Work
Order the terms of this MSA shall
prevail.
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5.5
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The
Services rendered by OCT under this MSA will be paid for by Adherex on the
basis of the invoices issued by OCT in the course of the Service
performance under this Agreement.
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5.6
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Adherex
will reimburse OCT for reasonable expenses (PTCs) with appropriate
supporting documentation incurred by OCT in the performance of Services at
the rates specified in the PSA. Travel costs incurred as a result of
monitoring the trial should adhere to OCT’s travel guideline /
policy.
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OCT:_________
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Page 3 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
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5.7
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The
Parties hereby agree that the PTCs estimation in the PSA Budget enclosed
does not include the expenses that can’t be foreseen before the start of
the work. Any and all such expenses shall be subject to the approval of
Adherex and will be invoiced in accordance with additional agreements
between parties.
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5.8
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All
fees/costs in the PSA Budget enclosed are net charges and all applicable
taxes like Custom duty on import of drugs, VAT, service tax, taxes from
PTCs, goods and services tax, if any, would be charged
extra.
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6.0
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Invoicing
and payment procedure
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6.1
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The
Parties hereby agree on the following invoicing procedure during the
course of the Service Rendering under this
MSA:
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6.1.1
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The
invoices for the Services (excluding Warehouse) rendered within the
framework of the Clinical Trial will be invoiced at the fulfillment of the
milestones as set forth below:
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a)
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Within
30 calendar days from the effective date of this MSA, Adherex agrees to
make an advance payment to OCT in the amount of 10% of the Total Service
cost.
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b)
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5%
of the cost of the Services - upon all sites evaluated and approved by
Adherex.
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c)
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10%
of the cost of the Services – after obtaining of regulatory
approval
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d)
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10%
of the cost of the Services – 25% patients
enrolled
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e)
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5%
of the cost of the Services - 50% patients
enrolled
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f)
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5%
of the cost of the Services – 75% patients
enrolled
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g)
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15%
of the cost of the Services – 100% patients
enrolled
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h)
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5%
of the cost of the Services – 25% of patients completed treatment, case
report forms monitored and queries
resolved.
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i)
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5%
of the cost of the Services – 50% of patients completed treatment, case
report forms monitored and queries
resolved.
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j)
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10%
of the cost of the Services – 75% of patients completed treatment, case
report forms monitored and queries
resolved.
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k)
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10%
of the cost of the Services – 100% of patients completed treatment, case
report forms monitored and queries
resolved.
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l)
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5%
of the cost of the ServicesDatabase
Lock
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In case
Database is not locked within two (2) months of milestone k) above (“100% of
patients completed treatment, case report forms monitored and queries resolved”)
not due to the fault of OCT, OCT shall have the right to invoice the total
amount for this “Database lock” milestone in 2 (two) months after “100% of
patients completed treatment, case report forms monitored and queries resolved”
is completed.
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m)
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5%
All Sites Closed
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OCT:_________
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Page 4 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
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6.2
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The
service invoice will itemize the total number of hours and/or days applied
to the clinical trial during the period of the milestone
fulfillment.
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6.3
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The
invoices for the PTCs incurred within the framework of Service Performance
will be invoiced on monthly basis as
follows:
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At the
beginning of the month, but not later than within 15 (fifteen) days of the
beginning of the month, OCT will submit an invoice for services
and PTCs incurred within the framework of service performance within the
previous month.
Warehouse
expenses shall be considered PTCs and shall be invoiced
accordingly.
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6.4
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Payment
of each invoice is due upon receipt by Adherex and is past due thirty (30)
calendar days from receipt of invoice. If Adherex has any valid reason
for disputing any part of the invoice supplied by OCT they will notify OCT
within fourteen (14) calendar days of receipt by Adherex, and if no such
notification is given the invoice will be deemed valid. The portion of
OCT’s invoice, which is not in dispute, will be paid in accordance with
the procedures set forth herein.
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6.5
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OCT
will provide confirmation documents for all project expenses incurred and
invoiced to Adherex except amounts specified in PSA as fixed. Fixed
amounts and translation cost will be invoiced without supporting
documentation.
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6.6
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Adherex
agrees to make the advanced payments for the following PTCs, shall the
need arise:
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6.6.1
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Purchase
of concomitant medication. In case advanced payment for purchase of the
concomitant medication is required by the vendor (the drug supplier,
Adherex agrees to pay expenses for purchase of the concomitant medication
within 14 (fourteen) working days from receipt of invoice from OCT,
provided that OCT will provide Adherex with request of forthcoming payment
and tentative payment date not later than 15 (fifteen) working days prior
to day of expected payment.
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6.6.2
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Customs
payments. Adherex agrees to make the advanced payments for the customs and
brokers’ fees. The invoices for such payments shall be paid within 14
(fourteen) working days of the receipt date by
Adherex.
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6.6.3
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Investigators’
fees and Study Sites’ fees. Adherex agrees to make the advanced payments
for investigators’ fees and study sites’ fees provided that OCT shall
submit an invoice with a detailed report on the services performed by the
investigators and the study sites. Such invoice shall be paid within 14
(fourteen) days within the receipt by
Adherex.
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6.7
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For
any delays with the payments Adherex shall be charged a late fee of 1% of
the total amount overdue for each month of the
delay.
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OCT
has the right to suspend work if payments remain outstanding on undisputed
invoices.
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6.9
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The
currency of the Agreement is USD. All the payments are to be made in
USD.
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7.0
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Period
of the Agreement
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7.1
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This
Agreement shall take effect on ______, 2010 and shall terminate on June
31, 2013 unless either terminated earlier or extended by the parties
pursuant to the terms of clause 8.0. of this
MSA.
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OCT:_________
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Page 5 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
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7.2
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The
period of the Clinical Trial shall be specified in the Protocol. In case
the duration of the Clinical Trial is prolonged above the termination date
of this MSA stated in article 7.1., the MSA shall be considered prolonged
accordingly.
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7.3
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Adherex
acknowledges that the deadlines of the Clinical Trial and this MSA might
be postponed not due to the fault of OCT. Adherex agrees to postpone all
the deadlines for a time period equal to the duration of the delays that
may incur.
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8.0
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Termination
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8.1
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For
a period of fourteen (14) days prior to the exercise of the termination
rights in clauses 8.2 or 8.3 below, the parties agree that there will be
full discussion at senior management level between Adherex and OCT to
discuss the relevant issues and to explore alternatives to
termination.
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8.2
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This
MSA or a PSA and/or Work Order may be terminated by either party by giving
thirty (30) days written notice to the other
party.
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8.3
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In
the event of termination by Adherex for reasons other than default by OCT,
Adherex shall pay all sums owing to OCT, but unpaid, for work performed to
date of receipt of termination notice, and all agreed and documentally
supported costs associated with the termination itself or with the
payments that OCT is committed to make for the invoices from its
subcontractors and partners that have not been billed at the moment of
Termination of the Agreement and are connected with the service
performance under this Agreement, including but not limited to the
expenses for the booked hotels and tickets, courier services, customs and
logistical expenses, all necessary payments to the medical
representatives, Investigators and the Institutions.
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8.4
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Either
party shall be entitled forthwith to terminate this Agreement or any
PSA/Work Order by written notice to the other if that other is adjudged
insolvent or goes into liquidation (other than for bona fide
reconstruction) or has a receiver appointed over any of its property or
assets.
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8.5
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If
this Agreement is terminated, all WORK ORDERs in existence at the date of
termination shall also terminate unless the parties agree
otherwise.
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8.6
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In
the event of termination of this Agreement for any reason OCT shall
promptly return to Adherex all Information (including unused study drug)
provided to OCT or generated by OCT in connection with the provision of
the Services. On termination of this Agreement for any reason, OCT shall
only retain any Information to the extent and for the duration required by
any applicable law, and shall notify Adherex in writing before destroying
such Information.
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9.0
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Warranties
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OCT
warrants to Adherex that the Services will be performed in accordance with
the standard of care usually and reasonably expected in the performance of
such services.
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9.2
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Adherex
warrants that it is the legal and beneficial owner and has full title and
interest in the Protocol and to the Materials, or is otherwise licensed to
use the Protocol and Materials, and that OCT’s performance of its
obligations under this Agreement, provided they are undertaken in
accordance with this Agreement and the Protocol and OCT’s use or
possession of the Materials for the purposes of this Agreement will not
infringe the rights (including the Intellectual Property Rights) of any
third party.
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OCT:_________
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Page 6 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
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10.0
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Liabilities
and Indemnities
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10.1
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Subject
to the provisions of clause 10.3 below, Adherex shall fully indemnify and
keep indemnified, OCT against any and all claims, liability, losses,
damage, costs and/or expenses of any nature (including, without
limitation, legal costs and expenses) incurred or suffered by OCT which
arise directly out of any allegation or claim that performance of the
Services in accordance with the terms of this Agreement by OCT constitutes
infringement of any third party Intellectual Property Rights (“IP
Claims”).
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10.2
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Subject
to the provisions of clause 10.3 below, Adherex shall indemnify and hold
OCT harmless from any third party liability, expenses, costs (including
legal costs), suffered or incurred in connection with any claim, suit or
proceeding brought against OCT so far as it is based on a claim for
personal injury suffered by patients and directly resulting from the
performance of the Services (“Injury
Claims”).
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10.3
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The indemnities set out in
Clauses 10.1 and 10.2 above shall only apply provided
that:
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the
Services are, at all times, conducted strictly according to the Protocol and any
written instructions delivered by Adherex concerning the administration of the
Materials;
the IP
Claims and/or Injury Claims do not arise from or are contributed to by the
negligence, willful default or breach of the terms of this Agreement by OCT, its Affiliates, their representatives or any
subcontractors;
Adherex
is promptly notified in writing of any matter which may give rise to an IP Claim
or an Injury Claim to which these indemnities may apply no later than 10
business days after OCT becomes aware of any such
matters.
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OCT
shall cooperate with Adherex and its legal representatives in the
investigation and defense of any IP Claim or Injury Claim under this MSA.
In the event an IP Claim or Injury Claim is asserted, OCT may elect to
choose counsel independent from that representing Adherex, in which case
Adherex shall be responsible to reimburse to OCT any costs and expenses
associated with the IP Claim or Injury Claim including, but not limited
to, legal costs, expert fees and all related
costs.
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OCT
shall indemnify and hold harmless Adherex as a result of a claim or claims
arising from any negligent act, error or omission committed by OCT or by
an employee of OCT or any person or organization acting on behalf of OCT,
when so acting, in the course of services or contractual obligations
undertaken by OCT.
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11.0
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Confidential
Information
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In regard
to the Confidential Information the Parties shall bear the responsibility
expressly set forth in the Confidentiality and Non-disclosure Agreement executed
by the Parties.
The
obligations set out in this clause 11 will survive the expiry or termination of
this Agreement.
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OCT:_________
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Page 7 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
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12.0
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Medical
and Regulatory
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12.1
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Both
parties shall promptly notify the other party of any governmental
regulatory inspections of which it becomes aware and which relate to the
project. OCT by no means will limit the right of Adherex to be present at
any such inspections. Adherex in accordance with this MSA may delegate OCT
the responsibility for preparation of answers to all questions aroused
during inspection. In such occasion Adherex will provide OCT with all
information necessary to prepare such
answers.
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12.2
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Adherex
may designate representatives who shall, upon reasonable notice to OCT,
have access to and shall be permitted to review all documents,
information, data and/or Materials specifically related to the conduct of
the clinical trial under this MSA.
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13.0
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Independent
Contractor Status
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13.1
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It
is understood and agreed that OCT is an independent contractor and will
not have any rights to any of Adherex’s benefits. OCT agrees to make any
payments or withholding required by the Inland Revenue, social security
and any related statutes or
regulations.
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13.2
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It
is further understood that OCT is not an agent of Adherex and Adherex is
not an agent of OCT and neither party is authorized to bind the other
party with respect to any third
party.
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14.0
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Conflicts
of Interest
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OCT
represents that there is no conflict of interest between performance of
this MSA and the performance of services by OCT for any other party. In
the event that OCT believes that there is any such conflict, or any such
conflict arises during the term of this MSA, OCT will immediately notify
Adherex, which may, at its sole discretion, immediately terminate this
Agreement without liability to OCT.
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15.0
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Force
Majeure
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15.1
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Neither
party shall be liable for delay in performing or failure to perform
obligations under this Agreement if such delay or failure results from
circumstances outside its reasonable control (“Force Majeure”). In such
circumstances, the party affected by the event of Force Majeure shall
promptly notify the other party of the Force Majeure and shall take all
reasonable steps to mitigate its
effects.
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15.2
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Subject
to compliance with the provisions of clause 15.1 above, an incident of
Force Majeure shall not constitute a breach of this MSA and the time for
performance shall be extended accordingly; however, if it persists for
more than 30 days:
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a)
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the
parties may enter into discussions with a view to alleviating its effects
and, if possible, agreeing on such alternative arrangements as may be
reasonable in the circumstances; or
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b)
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the
party not in default may immediately, on notice to the other party,
terminate this MSA and the provisions of clause 8.0 shall
apply.
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16.0
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Notices
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16.1
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Any
notice will be in writing and will be given by registered mail, return
receipt requested, or hand delivered to the other party at the address
given on this agreement or to such other address as may be substituted by
notice. If sent by mail, notice will be effective on the date of receipt.
Other communication may be by a variety of means including telephone, fax,
email, etc.
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OCT:_________
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Page 8 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
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17.0
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General
Provisions
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17.1
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This
Agreement and the obligations of the parties shall be governed by and
construed in accordance with the governing law of USA. All controversies
on this agreement should be solved under the jurisdiction of the New York
City courts.
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17.2
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Neither
party may subcontract or assign any of its obligations or rights under
this MSA without the prior written consent of the other party, save that
each Party may assign its rights and/or obligations hereunder to any of
its Associated Companies. Save for such permitted assignees, no person who
is not a party to this agreement shall be conferred any rights under
it.
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17.3
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The
headings in this Agreement are for reference purposes only; they will not
affect the meaning or construction of the terms of this
Agreement.
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17.4
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If
any parts or part of this Agreement are held to be invalid, the remaining
parts of the Agreement will continue to be valid and
enforceable.
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17.5
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Any
action of any kind by either party arising out of this Agreement must be
commenced within one (1) years from the date the right, claim, demand, or
cause of action shall first arise.
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17.6
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This
Agreement contains the complete and exclusive understanding of the parties
with respect to the subject matter hereof. No waiver, alteration or
modification of any of the provisions hereof will be binding unless in
writing and signed by a duly authorized representative of the party to be
bound. Neither the course of conduct between the parties nor trade usage
will act to modify or alter the provisions of this
Agreement.
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17.7
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This
Agreement has been executed and signed in two counterparts, one for each
Party. The
counterparts have equal juridical
force.
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18.0
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Exhibits
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18.1
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This
MSA has the
following exhibits attached hereto and incorporated
herein:
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1.
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EXHIBIT 1. - PSA to MSA_
Adherex – OCT Group LLC dd. ____,
2010
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19.0
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Legal
Address and Banking Details of the
parties
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20.1. OCT Legal Address and
Banking Details
OCT
Group, LLC
000 Xxxxx
Xxxxxx, 0xx Xxxxx,
Xxx Xxxx,
XX 00000, XXX
20.2 Adherex Legal Address and
Banking Details
Adherex,
Inc.
000
Xxxxxxxx Xxxxx, Xxxxx 000
Xxxxxx
Xxxx, XX 00000, XXX
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OCT:_________
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Page 9 of 10
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Adherex:
_________
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MSA_
___________ – OCT Group LLC dd. ____, 2010
Bank
Swift/Bic:
Iban:
Signatures
of the Parties
OCT
Group, LLC
Signature:
/s/ Xxxxxxx Xxxxxx
Name:
Xxxxxxx Xxxxxx
Title:
President
Adherex
Signature:
/s/ Xxxxx Xxxxxx
Name:
Xxxxx Xxxxxx
Title:
Chief Executive Officer
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OCT:_________
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Page
10 of 10
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Adherex:
_________
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