YM
BIOSCIENCES INC.





WORK
ORDER





A
Phase II Open-Label, 2-Cohort Study of


Nimotuzumab
400 mg Weekly plus


Irinotecan
(Cohort 1) and Nimotuzumab


400
mg Every 2 weeks plus Irinotecan


(Cohort
2) in Patients with Irinotecan-


Refractory
Metastatic Colorectal Cancer





April 2,
2007













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Table
of Contents










1.
      Proposal Details
              32.
      Corporate Summary
              4Features
      & Benefits
              4Team
      & Location
              5Technology
              5Standards
              5Corporate
      & Clinical Organizational Chart
              7Services
              8Project
      Management
              8Regulatory
      Affairs
              8Clinical
      Monitoring
              8Operational
      Support
              9Medical
      Writing
              9Quality
      Assurance
              10Data
      Management
              10Training
              11Clinical
      Supply Logistics
              11Affiliate
      Services
              113.
      Therapeutic Experience
              124.
      ProjectTeam
              14Project
      Oversight
              14Project
      Management
              15Clinical
      Research Associates
              15Clinical
      Operations Associates
              16Quality
      Assurance
              165.
      Project Summary
              17Project
      Timelines
              21Roles
      and Rates
              21Project
      Details
              226.
      Estimate
              367.
      Pass-Through Cost Estimate
              388.
      Payment Schedule and Terms
              409.
      Standard Practices
              4010.
      Client Signatures
              4111.
      Letter of Intent
              42





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1.
Proposal Details





Title:
              A
      Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly plus
      Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks plus Irinotecan
      (Cohort 2) in Patients with Irinotecan-Refractory Metastatic Colorectal
      CancerProtocol
      #:
              YMB1000-015Customer:
              YM
      BioSciences Inc.MSA#:
              YMBO7-MSA-30APR2007-
      1.0Proposal
      No.:
              YMBO7-WOI-29MAR2007-2.3Customer
      Reference:
              YMBO7-WO1Confidentiality:
              Restricted –
      Commercial Copyright and ReproductionThis
      proposal is submitted by Allphase Clinical Research Inc. in response to
      the invitation issued by Ms. Nancy Cohen, Project Manager at YM
      BioSciences Inc. dated 28FEB2007, with revisions requested on 12 & 30
      MAR; 01 APR2007. It may not be used for any other purposes, reproduced in
      whole or in part, nor passed to any organization or person without the
      specific permission in writing of the President, Allphase Clinical
      Research Services Inc.Proposal
      Date:
              02APR2007Version:
              1.0Validity:
              90
      daysCRO
      Address:
              Allphase
      Clinical Research Services Inc.19
      Camelot DriveOttawa,
      ON Canada K2G 5W6P:
      (613) 228-1990F:
      (613) 228-8493C:
      (613) 291-2362Email:
      jsmith@allphaseclinical.com




Approved
      by:/s/ Jeff Smith
                
                22 May 2007Jeff
      Smith
                
                DatePresident





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2.
Corporate Summary





Allphase
Clinical Research was incorporated on January 5, 2001 to provide services to the
pharmaceutical and biotechnology industries, specifically related to the
development of therapeutic products and devices. Allphase Clinical Research was
founded with the mandate to provide reliable, high-quality service at rates in
line with disciplined corporate overhead. This is driven by a desire to conduct
clinical research more effectively by using the experience and best practices
developed by reputable professionals in the industry. Allphase Clinical Research
is a service organization dedicated to Helping You
Improve LifeTM.





The
corporate vision is designed around a self-perpetuating business model whereby
the quality of our work and reputation will continuously attract reputable
clients and employees. By keeping client costs appropriately in line with
overhead and not charging “what the market will bear”, the value created will
develop an environment where Allphase Clinical Research will be the common sense
solution for the pharmaceutical and biotechnology industries.





As a
testament to the company vision, Allphase Clinical Research continues to double
its revenue and personnel each year which is spurred entirely through repeat
business and the addition of new clients by word of mouth. In response to the
increasing demand for our services, we continue to invest in our infrastructure
purposefully, methodically, and prospectively. Allphase Clinical Research is
committed to providing our clients with consistent high-quality service and this
can only be achieved in conjunction with planned, organized growth. With this
approach, Allphase Clinical Research is able to continually offer additional
in-house services and complimentary adjunct business units.





Our
involvement in challenging projects has provided us with opportunities to expand
our knowledge base, improve our processes, and develop other services for the
benefit of our clients.





Features
& Benefits





At
Allphase Clinical Research, we thrive on challenge. By providing our accumulated
knowledge and applying standardized processes, we have assisted our clients in
achieving great success with their development programs. We also ally ourselves
with experts in various fields to keep abreast of current and evolving standards
of care to support our clients with the development of novel
therapies.





The
industry has established best practices and guidelines for the conduct of
clinical research, which we adhere to, and at the same time we offer additional
benefit by having:


t
            Established policies, practices,
      and standards to maximize client value and ensure client
      confidentiality;


t
            Experienced personnel with a
      solid foundation in clinical trial management, a disciplined work ethic,
      and an emphasis on customer
service;


t
            Access to premier clinical
      research sites and therapeutic experts across North
      America;


t
            A personable, team-focused
      approach; and


t
            Innovative, time-saving
      technologies.





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Allphase Clinical Research is an
ideal-sized organization to provide the most value to our clients. We are
large enough to maintain an infrastructure conducive to maximizing quality,
efficiency, and support, but small enough to be highly adaptive and to operate
without the added overhead of larger CROs. This translates into labour rates
significantly lower than larger companies, but with ample infrastructure to
ensure quality.





Our rates
are similar to those of independent consultants (i.e. CRAs and Project Managers)
in our industry, and are a true reflection of the operating costs needed to
maintain the appropriate infrastructure demanded by the industry.





Team
& Location





The
Allphase Clinical Research head office is located in the Camelot Business Park
of the nation’s capital, Ottawa, Ontario, Canada. This location is ideally
situated in close proximity to Health Canada, the McDonald-Cartier International
Airport, and all Ottawa campus hospitals, hotels, and business services. Our
6,044 square foot single-story office building accommodates the management team,
administrative and quality assurance personnel, project managers, and in-house
CRAs. The majority of our CRA team is regionally based within major centres
across North America, where they work from a home office. The organizational
chart (see next page) summarizes our corporate structure.





As a
significant proportion of our work is now in the United States, Allphase
Clinical Research opened its first office in the United States in December 2006,
at 140 Broadway, New York, New York. In order to provide our current and
prospective clients with more international services, we are expecting to open
an office in Europe in 2007.





Technology





By
continuously investing in state-of-the-art technologies, Allphase Clinical
Research has established a framework for dynamic growth that permits us to
provide additional and improved services to our clients. Specialized
communication tools such as our Voice-over-Internet-Protocol (VoIP) telephone
and computer systems enable every employee to function seamlessly as though they
are located in the same building. All corporate and trial-related information is
maintained in our monitored and access-controlled facility, in either hard copy
or electronic form. Access to the electronic documents by the field force is
through a secure, state-of-the-art server system employing 128-bit encryption
technology.





Standards





We
believe it is essential for a professional outsourcing partner to provide a
level of organization and infrastructure that ensures consistency and
dependency, with efficiency that will contain costs. Allphase Clinical Research
conducts vendor assessments on our outsourcing partners because our reputations
are interdependent. Similarly, we encourage prospective clients to do their due
diligence inspections of our facilities and references. Recognizing the
importance of credibility, we invest significantly in our systems and processes.
We have in place:


t
            Standard Operating Procedures and
      policies;


t
            Monitored, state-of-the-art
      security systems;


t
            Access-controlled
      facility;


t
            Access-controlled and
      independently alarmed clinical supply
  room;





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t
            Access-controlled Trial Master
      File room;


t
            Access-controlled secure server
      room;


t
            Appropriate data storage and
      redundancy systems;


t
            Robust anti-virus and firewall
      security;


t
            128-bit VPN
      encryption;


t
            VoIP communications
      system;


t
            Teleconferencing capability;
      and


t
            Proprietary data/document
      processing systems.





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Corporate & Clinical
Organizational Chart (currently 45 employees)







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Services





Project
Management





The role
of the Project Manager is critical to the success of every clinical trial. At
Allphase Clinical Research, our project managers are experienced professionals
trained to deliver superior service to our clients. Their collaborative approach
combined with exceptional organizational and interpersonal skills creates a
responsive, client-driven environment. Our services include:


t
            IND/CTA
      maintenance;


t
            Collaborative interaction with
      regulatory authorities and
IRBs;


t
            Investigator site selection and
      feasibility assessments;


t
            Regulatory document package
      design (site level);


t
            Contract and budget preparation,
      negotiation, and
administration;


t
            Investigator meeting organization
      and site training;


t
            CRA resourcing, mentoring, and
      co-monitoring support;


t
            Monitoring report
      review;


t
            SAE reporting
      coordination;


t
            Coordination of site/ vendor/
      client communications; and


t
            Managing client expectations for
      on-time and on-budget
performance.





Regulatory
Affairs





Regulatory
support is essential to the drug development process, and Allphase Clinical
Research is devoted to serving as your regulatory partner for the success of
your clinical development program. Our careful attention to detail and excellent
relationship with the regulatory authorities helps to expedite the regulatory
review process and to shorten drug development timelines.





Our
Regulatory Team is able to publish regulatory submissions in compliance with
FDA, Health Canada and European requirements. Our services include:


t
            Investigational New Drug
      Applications (INDs);


t
            New Drug Applications
      (NDAs);


t
            Abbreviated New Drug Applications
      (NDAs);


t
            Biologic License Applications
      (BLAs);


t
            New Drug Submissions
      (NDSs);


t
            Abbreviated New Drug Submissions
      (ANDSs);


t
            Clinical Trial Applications
      (CTAs).





Clinical
Monitoring





Our
Clinical Research Associates (CRAs) are appropriately qualified and industry
recognized for their outstanding reputation in customer service, in-depth
knowledge of industry regulations and guidelines, and therapeutic knowledge.
They ensure compliance with protocols, quality standards, data collection
requirements, and regulatory guidelines. The CRAs are regionally located across
North America, reducing travel time and expenses. Our CRAs truly enjoy their
profession, which we feel is ultimately reflected in their interactions with
clients, colleagues, and site staff as they perform their duties:


t
            Site initiation, routine
      monitoring, and close-out;


t
            Site personnel training,
      mentoring, and guidance;


t
            Assessing protocol compliance and
      data integrity;





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t
            Regulatory document
      review;


t
            Pharmacy training and drug
      accountability; and


t
            Ensuring GCP, consenting,
      confidentiality, and safety requirements are
  met.





Operational
Support





Our
Clinical Operations Associates (COAs) fill a crucial supportive role to all
members of the team. COAs work to streamline the process of managing a clinical
trial. A primary function of this role is acting as a central point through
which virtually all clinical documentation is channelled. As documents are
received, they are logged into a tracking system, scanned, and either filed in
our in- house Trial Master File or forwarded to the client using a transmittal
system. We have developed a proprietary process of managing regulatory
documentation that provides our CRAs with a tool to ensure that site regulatory
files accurately represent the Trial Master File, with a minimal amount of
administration. This means that the site regulatory file is kept up to date, and
our client costs are less than organizations that use more conventional
processes.





COAs also
compile regulatory and enrolment data from investigative sites, which can then
be posted to a secure, client-specific web site. Clients requesting this
value-added service can access a web portal at their convenience, with a
username and password.





The
Manager of Clinical Operations provides high-level quality control by managing
client expectations, employee workloads, oversee compliance with SOPs and
policies, employee performance evaluations, and providing guidance and support
to the team. This supervision creates an environment of consistency and
high-quality work for our clients.





Medical
Writing





Our
experienced medical writers have advanced degrees in the biological sciences and
related fields which allow them to deliver quality service. Our Scientific
Affairs team believes that medical writing is a multi-disciplinary and
collaborative process. We are committed to providing our clients with the
highest standards of scientific detail that meet all international guidelines,
regulations, and standards. Our diverse scientific team members are dedicated to
producing clear and comprehensive presentation formats. Services include the
development of:





t
            Phase I-IV study
      protocols;


t
            Investigational drug
      brochures;


t
            Informed consent
      forms;


t
            Case report form and diary card
      design;


t
            Clinical study reports and safety
      narratives;


t
            Presentation posters and
      PowerPoint Presentations;


t
            Technical briefs;
      and


t
            Training
      manuals.




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Quality
Assurance





Allphase
Clinical Research Quality Assurance Team strives to provide thorough coverage
for both our internal and external clients’ compliance oversight. Our team
brings practical application of the applicable regulations and guidance’s to
your attention through carefully planned audits and detailed reports. The
Allphase QA department is at arms-length to the clinical operations team and
reports directly to the President. Independent audits of clinical
investigational sites, in-house processes and documentation provide an objective assessmentof the
quality of the data collected and processed as part of a submission. Our
experienced staff provides a comprehensive Quality Assurance service program
including:


t
            Evaluation and auditing of GCP
      quality processes:


o
            Vendor qualification and due
      diligence audits (CROs, central IRBs, clinical/ diagnostic laboratories,
      centralized ECG/PFT readers, clinical data management, clinical supplies
      distributors);


o
            Clinical investigator site
      audits;


o
            Clinical data management process
      audits;


o
            Clinical study report and
      regulatory submission document
audits;


o
            Systems audits (pharmacovigilance
      and drug safety reporting, computer system validation documentation
      compliance, clinical research
  operations).


t
            Standard Operating Procedure
      (SOP) and policies
development:


o
            Clinical research SOP gap
      analyses and needs
assessment;


o
            Facilitation of SOP/policies
      development, approval process, distribution and training
      activities;


o
            Collaborative design and writing
      of customized SOPs and
policies.





Data
Management





Allphase
Clinical Research offers a full spectrum of data management services and
expertise to ensure the efficient and appropriate management of your clinical
trial data. Our team is experienced in clinical trial design, implementation and
execution at all levels. They are well trained and rigorously follow Standard
Operating Procedures (SOPs) that encompass security, industry regulations,
engineering and GCP. Using state-of-the-art data management system technology,
we are able to deliver a high-quality, unified database. Data management related
services include:


t
            CRF and database
      design;


t
            AE and medical coding and
      reporting;


t
            Clinical trial safety database/
      reconciliation;


t
            Lab data
      import;


t
            Single and double data
      entry;


t
            Query
      generation;


t
            Data validation, storage and
      archiving; and


t
            Biostatistics.





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Training





The Allphase Center of Excellence
(ACE) program has been developed with an emphasis on providing training
to individuals with clinical trial experience who would benefit from additional
training or refresher courses. The training focuses on the fundamentals of
clinical research, based on ICH/GCP guidelines, EU Directives, and FDA and HPFB
regulations. Course materials have been designed for the training of naïve and
experienced investigator site personnel, new monitors, and experienced monitors
in need of formal training. The training program format is flexible and
customizable. It can be conducted at the client’s place of business, thereby
offering a significant savings of both time and expense. If a more formal or
larger training venue is appropriate, our ACE trainers can host the training at
venues worldwide.





Clinical
Supply Logistics





Allphase
Clinical Research has recently added support services for clinical trial supply
storage, management, and distribution. We have the ability and capacity to store
and distribute pre-packaged investigational medication and CRF supplies for
clinical trials. Currently this service offering is only available for
non-narcotic and ambient temperature products. The scope of this service is
evolving to meet demand and we encourage prospective clients to enquire about
our capabilities.





Affiliate
Services





Allphase
Clinical Research is able to offer clients full-service CRO capabilities by
augmenting our in-house services with those of our affiliated partners to be
able to provide:


t
            Statistical
      Analysis;


t
            Medical
      Monitoring;


t
            DSMB.





Our
Team is Your Team


All of
our in-house services are provided by full-time employees of
Allphase Clinical Research. This permits us to carefully control the quality of
service that we provide, and ensure uniformity in our means and methods. This,
together with the in-house support infrastructure we have created at Allphase
Clinical Research, is the reason for the reliability our clients have come to
expect. As a result, our clients continue to provide us with repeat business
every year, 100% of the time!





To date
we have been successful in maintaining consistent personnel on the majority of
the trials we have worked on. This is largely due to a low personnel turnover of
less than 10% annually. Consistency is integral to efficiency.




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3.
Therapeutic Experience





Over the
past 6 years, Allphase Clinical Research has conducted studies in a variety of
therapeutic areas including:





Therapeutic Area
              
              # of studies
              
              IndicationsAllergy/ Respiratory
              
              7
              
              Asthma
                Chronic
      Obstructive Pulmonary Disease
                Perennial
      Allergic Rhinitis
                Seasonal
      Allergic RhinitisCardiovascular
              
              9
              
              Atrial
      Fibrillation
                Deep
      Vein Thrombosis
                Intermittent
      Claudication
                Pulmonary
      EmbolismCNS
              
              6
              
              Amyotrophic
      Lateral Sclerosis
                Alzheimer’s
      Disease
                Depression
                Multiple
      Sclerosis
                Smoking
      CessationEndocrinology
              
              5
              
              Diabetes
                DyslipidemiaInfectious
      Disease
              
              6
              
              Hepatitis
                HIVOncology
              
              8
              
              Brain
                Breast
                Head
      and Neck
                Ovarian
                Renal
      Cell Carcinoma
                Small
      Cell LungOther
              
              8
              
              Alpha-1
      Antitrypsin Deficiency
                Chronic
      Idiopathic Urticaria
                Immunodeficiency
                Primary
      Immune Deficiency
                RabiesTOTAL
              
              49




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Oncology
Experience





Allphase
has been contracted to manage and/or monitor 8 oncology clinical trials over the
past 6 years. Through selective hiring, our teams collective experience is
differentiating Allphase as an industry specialist in oncology, which is
creating an increasing demand for our services in this area.





Therapeutic Area
                
                Phase
                
                # of Sites
                
                # of SubjectsSmall
      Cell Lung Cancer
                
                I/Il
                
                5
                
                48Advanced
      Breast Cancer
                
                II
                
                5
                
                30Metastatic
      Renal Cell Carcinoma
                
                II
                
                1
                
                5Metastatic
      Breast Cancer
                
                II
                
                4
                
                37Squamous
      Cell Carcinoma
                
                II
                
                6
                
                20Squamous
      Cell Carcinoma
                
                II
                
                6
                
                10Pediatric
      Brain Tumors
                
                I
                
                1
                
                19Ovarian
      Cancer
                
                II
                
                7
                
                40




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4.
Project Team





YM
BioSciences Inc. has decided to outsource several aspects of their clinical
trial, “A Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly plus
Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks plus Irinotecan
(Cohort 2) in Patients with Irinotecan Refractory Metastatic Colorectal Cancer”,
and has contacted Allphase Clinical Research Inc. for resource support and to
benefit from our expertise in the conduct of clinical trials. The selection of
an outsourcing partner is a critical step in the successful execution of any
project, as well as integral to the external perception of the sponsor
company.





Allphase
has a proven track record of successfully conducting research trials for our
clients, as demonstrated by the 100% repeat business our clients provide. In
addition to task competence, Allphase also focuses on relationships, both with
our clients and with the investigative site staff. Establishing a positive
environment with future product prescribers is an important adjunct to the
marketing initiatives of our clients.





In order
to meet the objectives of your project, a qualified Project Manager will be
responsible for the overall execution of the trial. This person will be
supported by an experienced and multi-talented team of CRA’s, Regulatory
Affairs, Drug Safety, Data Management and operational staff.





Having
implemented a variety or clinical trials, from protocol development to database
lock, we have a clear understanding of the project requirements as set out in
the protocol and in an email provided on 01MAR2007 from Ms. Cohen, and
discussions on 12 and 30 MAR2007. Based on the specifications and our knowledge
of clinical research processes we have prepared an estimate which we feel is
reasonable at this time. Please be assured that Allphase strives to economize
appropriately whenever possible.





Project
Oversight





Thelma Spencer,
BScH: Director of Clinical Operations (Ottawa) – see attached CV.
Ms. Spencer has over 21 years experience fulfilling roles related to the
development of pharmaceutical products. As the Director of Clinical Operations,
she will be responsible for providing direction and guidance to the project
team, through her direct interaction with the Project Manager. Ms. Spencer’s
experience has included the areas of Oncology, Cardiovascular, CNS, Infectious
diseases, Metabolism, and Ob/GYN. Perhaps her most relevant experience as it
pertains to this project is her prior experience as the Project Manager at
Adherex Technologies, where she was responsible for the overall execution of the
clinical development program for their oncology therapy.





Sue Boyd, RN:
Manager, Allphase Center of Excellence; CRA Manager (Ottawa) – see
attached CV. Ms. Boyd has over 14 years experience related to the development of
pharmaceutical products. Prior to this she worked for 18 years as an oncology
nurse at ORCC (radiation, chemotherapy, radioactive implants, surgery), and 2
years as the charge nurse of the pharmacology unit conducting 12 studies, mainly
phase 1 and 2 colorectal, brain, breast and lung trials, all with PK sampling.
One of the last studies Ms. Boyd was in charge of was a phase II colorectal
study with CPT 11. Her site was one of the highest enrollers. Dr. Maroun and Ms.
Boyd were asked to present their experience to the marketing group for the
sponsor. As the corporate trainer and CRA Manager at Allphase, Ms. Boyd will
directly oversee and provide guidance to the CRAs assigned to this
project.




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Project
Management





Wendy Kirby, RN:
Project Manager (Ottawa)– see attached CV.


Ms. Kirby
has over 19 years experience in the pharmaceutical industry, the last 5 years of
which have been in a Project Management role. Prior to entering the
pharmaceutical industry, Ms. Kirby was a nurse for 16 years. Ms. Kirby has been
a Project Manager for the following clinical trials:





# of
                      Studies
                    
                    Phase
                    
                    Indication2
                    
                    III
                    
                    Metastatic
      Colorectal1
                    
                    II/III
                    
                    Ovarian
      Cancer3
                    
                    III
                    
                    Cervical
      Dystonia1
                    
                    I
                    
                    Hemifacial
      SpasmI
                    
                    III
                    
                    International
      Melanoma1
                    
                    III
                    
                    AML




Her
therapeutic experience includes the following areas:





Therapy Area
              
              IndicationHematology
              
              Chemotherapy
      administration: AML, Hodgkin’s Disease, NHL and apharesis
      administrationInfectious
      Diseases
              
              Antiviral
      research: HIVOncology
              
              Breast,
      Ovarian, Acute Myeloid Leukemia, Colorectal, NSCL, SCL, Melanoma,
      Hodgkin’s Disease, Non Hodgkin’s LymphomaNeurological
              
              Alzheimer’s
      Disease, Cervical Dystonia




Clinical
Research Associates





Karry Schenk
(Ottawa, ON)– (see attached CV).


Ms.
Schenk has been a CRA for over 10 years and has monitored 7 oncology studies.
Prior to this she worked for 4 years as a study coordinator at a cancer clinic.
Ms. Schenk worked on more than 100 oncology studies during this time, 15 of
which were colorectal studies. She also worked on a part time basis for 1 year
with the NCIC doing randomizations.





Faye Aspelund
(Ottawa, ON)– (see attached CV).


Ms.
Aspelund has been a CRA for 2.5 years. Prior to this she worked for 15 years as
an oncology study coordinator. Ms. Aspelund worked on more than 200 oncology
studies during this time, 30 of which were colorectal studies.




CONFIDENTIAL


Page 15
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      Version Code:
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      Date:
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              Work
      Order #:
              01




Isabelle Keeley,
REN (Ottawa, ON)– (see attached CV).


Ms.
Keeley has been a CRA for 8 years and has monitored 4 oncology trials during
this time. Prior to this she worked for 19 years as registered
nurse.




Moira MacDonald,
RN (Toronto, ON)– (see attached CV).


Ms.
MacDonald has been a CRA for 9 years and has monitored 6 oncology trials during
this time (Non-Small Cell Lung, Ovarian, Endometrial and Breast Cancer). Prior
to this she worked for 12 years as an oncology study coordinator, and 7 years as
a primary care/ chemotherapy staff nurse.




Andrea Murphy, RN
(Vancouver, BC)– (see attached CV).


Ms.
Murphy has been a CRA for 6 years and has monitored trials in a number of
therapeutic areas, however none in oncology. Prior to this she worked as a
Research Coordinator for 12 years and a nurse for 14 years. Although Ms. Murphy
does not have Oncology experience, she has significant industry and nursing
experience and has demonstrated rapid learning. In discussions with Ms. Cohen of
YM BioSciences, it was felt that Ms. Murphy would be an appropriate choice for
the west coast CRA.




The five
CRA’s proposed above are appropriately experienced and currently available. The
CRA workload represented in this proposal can be managed by two CRAs however, YM
BioSciences Inc. may prefer to have more than two CRAs assigned in order to
decrease travel costs. In this case we would recommend that all participating
CRAs attend the Investigator’s Meeting.




Clinical
Operations Associates




Alison Conley;
Litharitza Vakopoulos; Ewa Lifsches (Ottawa, ON) - Ms. Conley is our
most senior Clinical Operations Associate with more than four years of clinical
research experience. In addition to operational support, Ms. Conley is
responsible for organizing Investigator Meetings. Ms. Conley is an
administrative professional who possesses strong organizational skills and is
praised by existing clients for her proactive, friendly approach. Ms. Conley
will oversee the administrative aspects of this trial, and will be supported by
Ms. Vakopoulos and Ms. Lifsches.




Quality
Assurance




Linda Kraft, RN,
Quality Assurance Auditor (Ottawa, ON) – Mrs. Krafti is based in
Ottawa and brings with her more than 13 years experience in clinical research
including project management and auditing. Mrs. Krafti has several years of
experience in conducting central file assessments, and site and sponsor
audits.







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      Order #:
                01
  5.
Project Summary
  
 Based on
the information received to date and the noted assumptions, the following
summary of tasks has been identified for outsourcing:
 
 ProtocolDrug
                  
                  Nimotuzumab
      (TheraCIM®,
      YMB 1000, h-R3)Indication
                  
                  Metastatic
      Colorectal CancerPhase
                  
                  IITitle
                  
                  A
      Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly plus
      Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks plus Irinotecan
      (Cohort 2) in Patients with Irinotecan-Refractory Metastatic Colorectal
      CancerShort
      Title
                  
                  Nimotuzumab
      plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal
      CancerObjectives
                  
                  Primary:
                    To
      evaluate whether the combination of Irinotecan and nimotuzumab will result
      in a lower incidence of Grade 2 or greater acneform rash or infusion
      reaction, allergic reaction or anaphylactoid reaction AEs in patients with
      irinotecan-refractory metastatic colorectal cancer.Secondary:
                    •
      To evaluate whether the combination of irinotecan and one of the 2
      different dosing schedules of nimotuzumab will result in an objective
      response rate (ORR) in patients with irinotecan-refractory metastatic
      colorectal cancer.•
      To compare progression-free survival (PFS), defined as time from date of
      randomization until date of disease progression (clinical or radiological)
      or death due to any cause, in each nimotuzumab
  arm;
  CONFIDENTIAL
 
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      Order #:
                01
 
 •
      To compare the rate and duration of Stable Disease (SD) in each treatment
      arm;•
      To compare the time to disease progression (TTP) in each treatment
      arm;•
      To compare ORR in patients who are identified as having “primary”
      irinotecan resistance according to stratification criteria at the time of
      randomization in each treatment arm;•
      To compare overall survival in each tx arm;•
      To compare the overall safety and toxicity profiles of 2 dose regimens of
      nimotuzumab plus irinotecan;•
      To compare incidence of symptomatic rash, defined as any rash or pain in
      each treatment arm,•
      To define the biologically effective dose ofnimotuzumab
      based on ORR and safety datawhich
      can serve as a reference for future studies.SitesNo.
      of Investigator Meetings
                  1Investigator
      Meeting Location
                  
                  
                  TBDNumber
      of Treatment Groups
                  2Local
      of Central IRB
                  
                  
                  LocalNumber
      of Sites
                  11Location
      of sites
                  
                  
                  Canada
      (9) & Australia (2); or Canada (11)Number
      of Site Selection Visits
                  0Number
      of Initiation Visits
                  11Est.
      # of Monitoring hrs/ SF CRF
                  0.5
                  
                  assuming
      minimal data review & collectionEst.
      # of Monitoring hrs/ Completed CRF
                  16
                  
                  Based
      on 60 CRF pages per patient. Also includes: query resolution (monitoring
      & DM generated); drug accountability; proportional share of regulatory
      reconciliationEstimated
      Number of Monitoring Hour
                  1605Estimated
      Number of Monitoring Days
                  229
                  
                  7
      hour monitoring day (1hr for site administration)Estimated
      Number of Visits per Site
                  21
                  
                  assumes
      1 day visitEstimated
      Monitoring Frequency
                  6
                  
                  every
      6 weeks (1 day visits)Estimated
      Number of Monitors
                  3
                  
                  Workload
      estimated at 1.3 FTE. 3 CRAs regionally distributed will save travel
      costs.Estimated
      Number of Close-out Visits
                  11Estimated
      Number of Ad-Hoc Visits
                  4
                  
                  PM
      visits to YMB (approx every 6 months)Estimated
      Number of Co-Visits by PM
                  3
  CONFIDENTIAL
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      Date:
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      Order #:
                01
 
 SubjectsNumber
      of Subjects Screened
                  110Number
      of Subjects Randomized
                  100Enrolment
      Period
                  78
                  
                  weeks
      (FPFV 06/2007 to LPFV 12/2008)Duration
      of Each Subject
                  26
                  
                  weeks
      (Scr; 26 wk Tx)Follow
      Up of Each Subject
                  26
                  
                  Weeks(26
      wk FU)Total
      Study Duration (all subjects - active)
                  104
                  
                  weeks
      (FPFV 06/2007 to LPLV (active period) 06/2009)Total
      Study Duration (all subjects)
                  130
                  
                  weeks
      (30 mo)Total
      Study Duration (PM) Active Period
                  104
                  
                  weeksTotal
      Study Duration (PM) Follow-Up Period
                  26
                  
                  weeksTotal
      Study Duration (PM)
                  138
                  
                  weeks
      (total study duration + 8 weeks F/U)Estimated
      # PM hours/week (active period)
                  11
                  
                  hours
      (1hr/wk/site)Estimated
      # PM hours/week (F/U period)
                  5.5
                  
                  hours
      (0.5hr/wk/site)Estimated
      Number of SAE
                  100Medical
      WritingNumber
      of Medical Reports
                  1SOPSOPs
      to be used
                  
                  
                  YM
      BioSciencesForms
                  
                  
                  YM
      BioSciencesData
      ManagementAllphase
      DM
                  
                  
                  paper
      CRFQuality
      AssuranceSite
      Audits
                  4Vendor
      Audits
                  2
                  
                  Central
      lab for PK samples & Radiology LabQA
      Audit of Clinical Database
                  0QA
      Audit of Clinical Study Report
                  0QA
      Audit of Study File
                  0VendorsNumber
      of Laboratories
                  
                  
                  Local
      & Central (PK)Investigational
      Product Distributor
                  
                  
                  YM
      BioSciencesRadiology
      Review
                  120
                  
                  based
      on 20% responders and 6 images/patientServices
      RequestedN/A
                  
                  RegulatoryCTA
      prep, submission and maintenanceProject
      Management
  CONFIDENTIAL
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      Order #:
                01
  N/A
                  
                  Site
      Contract Negotiation and Payment FacilitationN/A
                  
                  Regulatory
      Document CollectionN/A
                  
                  ICF
      Preparation & TranslationN/A
                  
                  IRB
      preparations and submissions - centralIRB;
      or assistance with the submissions iflocal
      IRB.N/A
                  
                  Site
      IdentificationMulti-site
      ManagementCRA
      ManagementTeleconference
      and Project UpdatesVendor
      Management (if applicable)General
      AdministrationInvestigator
      MeetingPlanning
      & ExecutionPresentationsTravel
      Arrangements for AttendeesClinical
      MonitoringN/A
                  
                  Pre-Study
      VisitsSite
      InitiationInterim
      Monitoring & site managementSite
      Close OutSafetySafety
      DatabaseCIOMS/
      MedWatch report prepSAE
      alert reporting to authoritiesData
      Management/BiostatisticsCRF
      Design & buildDM
      System Set Up (include edit checks)Data
      Validation and Review CRFsData
      QueryCoding
      AE & MedicationsInterim
      Analysis PlanFinal
      Analysis Plan
  CONFIDENTIAL
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      Order #:
                01
  Medical
      MonitoringRadiology
      ReviewMedical
      WritingDraft
      & Final Clinical Study ReportQuality
      AssuranceGCP
      Investigator/Site/ Vendor AuditN/A
                  
                  QA
      Audit of Clinical DatabaseN/A
                  
                  QA
      Audit of Clinical Study
Report
 
 Project
Timelines
  Activity
                    
                    Date of CompletionContract
      or LOI executed
                    
                    Apr-07Investigator
      Meeting
                    
                    Apr-Jun-07First
      patient enrolled
                    
                    Jun-0725%
      subjects enrolled
                    
                    Nov-0750%
      subjects enrolled
                    
                    Mar-0775%
      subjects enrolled
                    
                    Aug-08Enrolment
      completed
                    
                    Dec-08Last
      patient/ last visit (active period)
                    
                    Jun-09Database
      Lock
                    
                    Aug-09Final
      close out visit
                    
                    Oct-09
 
 Roles
and Rates
  Allphase Role
                    
                    Allphase Resource
                    
                    Hourly RateDE
                    
                    Data
      Entry Personnel
                    
                    $
                    65COA
                    
                    Clinical
      Operations Associate
                    
                    $
                    75CRA
                    
                    Clinical
      Research Associate
                    
                    $
                    90DM
                    
                    Data
      Manager
                    
                    $
                    100MW
                    
                    Medical
      Writing
                    
                    $
                    100PM
                    
                    Project
      Manager
                    
                    $
                    100RA
                    
                    Regulatory
      Affairs
                    
                    $
                    100DS
                    
                    Drug
      Safety
                    
                    $
                    100QA
                    
                    Quality
      Assurance Auditor
                    
                    $
                    100BlO
                    
                    Biostatistician
                    
                    $
                    120ACE
                    
                    Trainer
                    
                    $
                    150MM
                    
                    Medical
      Monitor
                    
                    $
                    350
  CONFIDENTIAL
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      Order #:
                01
  Project
Details
 x
                  
                  Full
      Responsibility(x)
                  
                  Partial
      Responsibility/ Input/ AdviceADM
                  
                  Data
      Management
  List of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespPre-Study
      Activities
                                      
                                      xProject
      Feasibility study
                                      
                                      xProtocol
      Development
                                      
                                      xSynopsis
                                      
                                      xDraft
                                      
                                      xReview
                                      
                                      x
                                      
                                      (x)
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMFinal
                                      
                                      xProtocol
      AmendmentsDraft
                                      
                                      xReview
                                      
                                      x
                                      
                                      (x)
                                      
                                      
                                      
                                      4
                                      
                                      1
                                      
                                      4
                                      
                                      PMFinal
                                      
                                      xCompilation
      & update IBDraft
                                      
                                      xReview
                                      
                                      xFinal
                                      
                                      xPaper
      CRF PreparationDraft
                                      
                                      n/aReview
                                      
                                      n/aFinal
                                      
                                      n/aPrinting
                                      
                                      n/aCRF
      Design (CA3)CRF
      Design - Draft (17 unique forms, 60
                                        CRF
      pages/pt) - template provided by YMB
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      40
                                      
                                      1
                                      
                                      40
                                      
                                      PMCRF
      Draft Review & Revisions
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      CRAEdit
      Check Development
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMReview
      & Finalize Programmed Edit Checks
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMFinal
      Review and Final Revisions to CRF
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      PMCRF
      Completion Guidelines (revisions incl)
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      36
                                      
                                      1
                                      
                                      36
                                      
                                      PMCRF
      Completion Guidelines - review
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      CRACRF
      printing logistics and QC
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      4
                                      
                                      1
                                      
                                      4
                                      
                                      PMProject
      PlanSOPs
      assignment documentation
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      3
                                      
                                      1
                                      
                                      3
                                      
                                      PMResponsibility
      assignment
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      3
                                      
                                      1
                                      
                                      3
                                      
                                      PMTotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      24
                                      
                                      CRA130
                                      
                                      PM
  CONFIDENTIAL
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      Order #:
                01
  List of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespSubmissions
      to FDA
                                      
                                      n/aUS
      agentamendment
      & maintenanceCTA
      - Health Canada
                                      
                                      xCanadian
      AgentPreparation
      & Submission
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      RAClarifax
      response
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      RAReview
      of Approval NOL & follow-up
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      RASubmission
      of CTSI forms to TPD
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      RAamendment
      & maintenance
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      RATotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      RAVendorsID
      & contracting lab
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      12
                                      
                                      1
                                      
                                      12
                                      
                                      PMID
      & contracting Radiology Review
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      12
                                      
                                      1
                                      
                                      12
                                      
                                      PMVendor
      Assessment
                                      
                                      
                                      
                                      xProvide
      sites with manual
                                      
                                      n/aPayment
      administration & tracking
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMTotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      32
                                      
                                      PMInvestigator’s
      MeetingIdentify
      location and conduct preliminary investigation of costs;
      reservations
                                      
                                      x
                                      
                                      (x)
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      COAOrganize
      travel & hotel for study team
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      14
                                      
                                      1
                                      
                                      14
                                      
                                      COAPlan
      and organize IM
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      24
                                      
                                      1
                                      
                                      24
                                      
                                      PMPrepare
      agenda
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      3
                                      
                                      1
                                      
                                      3
                                      
                                      PMPrepare
      presentations
                                      
                                      x
                                      
                                      x
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMDesign
      Investigator Meeting materials
                                      
                                      x
                                      
                                      x
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMPrepare
      Investigator Meeting materials
                                      
                                      x
                                      
                                      x
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      COAPrepare
      welcome letters, name tags, meeting materials
                                      
                                      x
                                      
                                      x
                                      
                                      
                                      
                                      12
                                      
                                      1
                                      
                                      12
                                      
                                      COAEnsure
      vendor/sponsor presentations are organized and appropriate
                                      
                                      x
                                      
                                      x
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMAttendance
      and presentations at Investigator meeting
                                      
                                      x
                                      
                                      x
                                      
                                      xPM
      prep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      1
                                      
                                      2
                                      
                                      PMPM
      travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      PMPM
      presentation & attendance
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      PM
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      Order #:
                01
  List of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespCRA
      prep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      3
                                      
                                      6
                                      
                                      CRACRA
      travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      3
                                      
                                      48
                                      
                                      CRACRA
      attendance
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      3
                                      
                                      48
                                      
                                      CRAACE
      Trainer prep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      0
                                      
                                      0
                                      
                                      ACEACE
      Trainer travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      0
                                      
                                      0
                                      
                                      ACEACE
      Trainer presentation & attendance
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      0
                                      
                                      0
                                      
                                      ACECOA
      prep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      1
                                      
                                      2
                                      
                                      COACOA
      travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      COACOA
      attendance
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      COADM
      prep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      0
                                      
                                      0
                                      
                                      DMDM
      travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      0
                                      
                                      0
                                      
                                      DMDM
      presentation & attendance
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      0
                                      
                                      0
                                      
                                      DMMM
      prep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      1
                                      
                                      2
                                      
                                      MMMM
      travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      MMMM
      presentation & attendance
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      MMSub-Total
      - PM
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      85
                                      
                                      PMSub-Total
      - CRA
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      102
                                      
                                      CRASub-Total
      - ACE
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      ACESub-Total
      - COA
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      84
                                      
                                      COASub-Total
      - DM
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      DMSub-Total
      - MM
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      26
                                      
                                      MMEthicsPreparation
      of ICF template (PIPEDA)
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      16
                                      
                                      0
                                      
                                      0
                                      
                                      PMCustomization
      of ICF (PIPEDA)
                                      
                                      n/a
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      0
                                      
                                      0
                                      
                                      PMPreparation
      of other subject materials
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      12
                                      
                                      0
                                      
                                      0
                                      
                                      PMAssist
      sites with submissions
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      3
                                      
                                      0
                                      
                                      0
                                      
                                      PMIRB
      approval review & action if needed
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      0
                                      
                                      0
                                      
                                      PMTranslation
      of ICF & materials
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      6
                                      
                                      0
                                      
                                      0
                                      
                                      PMSubsequent
      ICF revisions (amendments)
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      0
                                      
                                      0
                                      
                                      PMIND
      Safety alert reporting to sites
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      0
                                      
                                      0
                                      
                                      PMAnnaul
      re-approval documentation
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      4
                                      
                                      0
                                      
                                      0
                                      
                                      PMStudy/
      site closure documentation
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      4
                                      
                                      0
                                      
                                      0
                                      
                                      PMIRB
      payment facilitation
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      1
                                      
                                      0
                                      
                                      0
                                      
                                      PMIRB
      payment
                                      
                                      xTotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      PM
  CONFIDENTIAL
 Page 24
of 42
 MSA#:
                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
  List of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespCRASite
      Selection Visits
                                      
                                      xContact
      sites and confirm date for visitSend
      confirmation letterInterview
      PI and site staff regarding experienceReview
      project requirements and expectationsTour
      facility and assess sitePrepare
      report and make recommendation of site suitabilityPrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      1
                                      
                                      0
                                      
                                      0
                                      
                                      CRATravel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      0
                                      
                                      0
                                      
                                      CRAOn-Site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      3
                                      
                                      0
                                      
                                      0
                                      
                                      CRAAdmin
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      4
                                      
                                      0
                                      
                                      0
                                      
                                      CRASub-Total/site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      CRATotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      CRASite
      Initiation Visit
                                      
                                      
                                      
                                      xContact
      sites and confirm date for visit and provide an agendaSend
      confirmation letterComplete
      Monitors’ Sign-In LogReview
      regulatory documentationReview
      Study protocol and CRF including:Inclusion
      /exclusion criteriaEfficacy
      parameters and measurementStudy
      scheduleComplete/evaluable
      patient definitionsStudy
      medication proceduresLab
      requirementsCRF
      completion instructionsReview
      adverse event reporting, including:Definition
      of AEs and SAEs.Requirements
      for documentation collectionProper
      procedures for reporting SAEs to Sponsor and REB.Follow-up
      requirementsReview
      Investigational BrochureReview
      communication channelsReview
      requirements for source documentationIRB/site
      responsibilities
  CONFIDENTIAL
 Page 25
of 42
 MSA#:
                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
  List of Tasks
                                        
                                        YM
                                        
                                        Allphase
                                        
                                        ADM
                                        
                                        Task
                                          Hours
                                        
                                        Units
                                        
                                        Total
                                          Hours
                                        
                                        RespReview
      monitoring scheduleReview
      study site documentationTrain
      study coordinatorsReview
      PI contract and payment schedulePrepare
      study initiation visit reportSend
      site SIV report and ackg. formPrep
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        2
                                        
                                        1
                                        
                                        2
                                        
                                        CRATravel
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        8
                                        
                                        1
                                        
                                        8
                                        
                                        CRAOn-Site
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        5
                                        
                                        1
                                        
                                        5
                                        
                                        CRAAdmin
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        4
                                        
                                        1
                                        
                                        4
                                        
                                        CRASub-Total/site
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        19
                                        
                                        1
                                        
                                        19
                                        
                                        CRATotal
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        19
                                        
                                        11
                                        
                                        209
                                        
                                        CRAInterim
      Monitoring
                                        
                                        
                                        
                                        xSend
      confirmation letterComplete
      Monitors’ Sign-In LogVerify
      proper Informed Consent proceduresMonitor
      in accordance with protocol/ICH/GCP100%
      source document verification vs. CRFAssess
      patient eligibility (protocol inclusion / exclusion / randomization
      criteria)Provide
      site with written query records to be retained with each
    CRFReview
      study-related regulatory documentsReview
      monitoring & discrepancy report queriesSource
      verify data clarification/ correction formsReview
      of laboratory dataReview
      and verify SAEs (100% SDV)Verify
      study drug inventory and storageVerify
      proper accountability and destruction of IP and study supplies per
      protocolMaintain
      protocol violation listMonitoring
      of other variables as specifiedPrepare
      monitoring visit reports following each monitoring visitProvide
      monitoring follow-up reports to sites following each visitRegular
      contacts with sites & TC reportsOngoing
      training of site personnelCRF
      and query management
  CONFIDENTIAL
 Page 26
of 42
 MSA#:
                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
  List of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespPrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      1
                                      
                                      1
                                      
                                      1
                                      
                                      CRATravel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      6
                                      
                                      1
                                      
                                      6
                                      
                                      CRAOn-Site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      CRAAdmin
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      5
                                      
                                      1
                                      
                                      5
                                      
                                      CRASub-Total/site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      20
                                      
                                      1
                                      
                                      20
                                      
                                      CRATotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      20
                                      
                                      229
                                      
                                      4580
                                      
                                      CRAClose
      Out Visit
                                      
                                      
                                      
                                      xCOV
      within 6 weeks post data base lockContact
      potential sites, confirm date for visitSend
      confirmation letterComplete
      Monitors’ Sign-In LogEnsure
      site regulatory documentation is complete and accessible for future
      auditsEnsure
      that the investigator is aware of his/her responsibilitiesEnsure
      that any remaining clinical trial material is removed from the study
      sitePrepare
      COV report following visitProvide
      follow-up report to sitesFollow-up
      with sites to resolve open issuesPrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      1
                                      
                                      1
                                      
                                      1
                                      
                                      CRATravel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      CRAOn-Site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      CRAAdmin
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      5
                                      
                                      1
                                      
                                      5
                                      
                                      CRASub-Total/site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      22
                                      
                                      1
                                      
                                      22
                                      
                                      CRATotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      22
                                      
                                      11
                                      
                                      242
                                      
                                      CRACRA
      Total
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      5031
                                      
                                      CRAOverall
      Project ManagementIn-house
      study managementSelection
      - US sites
                                      
                                      N/ASelection
      - CDN site
                                      
                                      xIdentification
      & contracting of vendors
                                      
                                      N/AFeasibility
      form admin (incl. initial contact)
                                      
                                      xConfidential
      Discl. Agreement - template
                                      
                                      xCDA
      Approval
                                      
                                      xCTRA
      template
                                      
                                      xCTRA
      template approval
                                      
                                      xCTRA
      negotiation
                                      
                                      x
  CONFIDENTIAL
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of 42
 MSA#:
                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
  List of Tasks
                                              
                                              YM
                                              
                                              Allphase
                                              
                                              ADM
                                              
                                              Task
                                                Hours
                                              
                                              Units
                                              
                                              Total
                                                Hours
                                              
                                              RespCTRA
      - site sign off
                                              
                                              xPreparation
      of initial project specific reg pkg
                                              
                                              xReview
      received reg docs:
                                              
                                              x
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMsite
      - 1572site
      - QIUREBACTSIConsent
      to Use Personal DataProtocol
      signature pageIB
      distribution to sitesFinancial
      DisclosureCVbiosketchMD
      qualificationlab
      ref ranges & licenseInternal
      monthly project team meetings
                                              
                                              
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMSite
      level management
                                              
                                              
                                              
                                              xRegular
      status reports for client
                                              
                                              
                                              
                                              xLiaise
      bi-weekly with sponsor
                                              
                                              
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMTMF
      Set-up & Maintenance
                                              
                                              
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMTrack
      CRF completion & queries and manage deficiencies
                                              
                                              
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMSite
      budget set-up
                                              
                                              xPayment
      calculation
                                              
                                              
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMPayment
      tracking
                                              
                                              x
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMPayment
      issuance
                                              
                                              xPreparation
      of Project Plan
                                              
                                              (x)
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMPreparation
      of Monitoring Plan
                                              
                                              (x)
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMPrep.
      of initiation Visit Booklet
                                              
                                              (x)
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMPrep.
      of Study specific forms
                                              
                                              x
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              PMPrep.
      study specific tracking tools
                                              
                                              xCRF
      Transmittal Logs
                                              
                                              xQoL,
      questionnaires and/or patient diaries, patient (alert)
    cards
                                              
                                              xDrug
      Accountability Form
                                              
                                              xIndividual
      Subject Drug logs
                                              
                                              xDrug
      Return & Reconciliation Form
                                              
                                              xClinical
      Re-Supplies Form
                                              
                                              xDrug
      Receipt Form
                                              
                                              xRelease
      of IP (RIP) Form
                                              
                                              x
  CONFIDENTIAL
 
 Page 28
of 42
  MSA#:
                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
  List
      of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespDestruction
      of IP (DIP) Form
                                      
                                      xStudy
      specific tracking tools
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      PMInvestigational
      Product (IP) and other Clinical Study Supplies
                                      
                                      xLabeling,
      coding and packing of IP (including provision of sample
      labels)
                                      
                                      xIdentification
      of Drug Distribution Vendor
                                      
                                      xComparator
      Procurement
                                      
                                      N/APreparation
      of written instructions for handling and storage of IP
                                      
                                      xRequest
      for import/export approvals for IP
                                      
                                      xPreparation
      of custom clearance(s)
                                      
                                      xStorage
      of IP
                                      
                                      xDevelopment/maintenance
      Randomization System/Codes
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      DMRequest
      for authorization to release IP to sites
                                      
                                      xAuthorization
      to distribute drug
                                      
                                      xPackaging/labeling
      of Clinical Supplies
                                      
                                      xDistribution
      of Clinical Study Supplies to sites
                                      
                                      xTracking
      of IP
                                      
                                      x
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      PMTracking
      of Clinical Study Supplies
                                      
                                      x
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      PMOrganization
      of return of unused Clinical Study Supplies
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      CRAOrganization
      of destruction of unused Clinical Study Supplies
                                      
                                      xStudy
      Completion/Study TerminationNotification
      to national/local authorities of study termination
                                      
                                      xFinal
      recon of TMF
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      PMArchiving
      of Sponsor’s TMF
                                      
                                      xSub-Total
      (est. hours/ week x # wks)
                                        Active
      Period
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      11
                                      
                                      104
                                      
                                      1144
                                      
                                      PMSub-Total
      (est. hours/week x # wks)
                                        Follow-Up
      Period
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      5.5
                                      
                                      26
                                      
                                      143
                                      
                                      PMEx-house
      Project ManagementSite
      Selection Visits
                                      
                                      
                                      
                                      xPrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      2
                                      
                                      0
                                      
                                      0
                                      
                                      PM
  CONFIDENTIAL
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of 42
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                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
  List of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespTravel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      14
                                      
                                      0
                                      
                                      0
                                      
                                      PMOn-Site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      3
                                      
                                      0
                                      
                                      0
                                      
                                      PMAdmin
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      5
                                      
                                      0
                                      
                                      0
                                      
                                      PMSub-Total/site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      PMTotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      PMCo-Initiation/Monitoring/COV
                                      
                                      
                                      
                                      xPrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      1
                                      
                                      1
                                      
                                      1
                                      
                                      PMTravel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMOn-Site
      (average)
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMAdmin
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      1
                                      
                                      1
                                      
                                      1
                                      
                                      PMSub-Total/site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      18
                                      
                                      PMTotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      18
                                      
                                      3
                                      
                                      54
                                      
                                      PMAd
      hoc meetings (4 trips)
                                      
                                      
                                      
                                      xPrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      1
                                      
                                      1
                                      
                                      1
                                      
                                      PMTravel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      6
                                      
                                      1
                                      
                                      6
                                      
                                      PMOn-Site
      (average)
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8
                                      
                                      1
                                      
                                      8
                                      
                                      PMAdmin
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      3
                                      
                                      1
                                      
                                      8
                                      
                                      PMSub-Total/site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      18
                                      
                                      PMTotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      18
                                      
                                      4
                                      
                                      72
                                      
                                      PMTotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      1413
                                      
                                      PMAdministration
      - COA
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COAAssemble
      site reg. packages
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COACourier
      packages to sites
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COAReceive,
      log, scan & file initial reg docs
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COAFollow-up
      on reg doc errors & omissions
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COACourier
      - second round
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COAReceive,
      log, scan & file 2nd round reg docs
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COAAssemble
      PI Site Files (ISF) for TMF
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COACourier
      site ISF to PI
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COAAssemble
      TMF
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      COAAssemble
      In-House site File (IHF) for TMF
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      3
                                      
                                      11
                                      
                                      33
                                      
                                      COACRF
      related admin
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      16
                                      
                                      1
                                      
                                      16
                                      
                                      COACDA
      - send to sites; review; send to Client
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COACTRA
      - send to sites; review; send to Client
                                      
                                      x
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      COA
  CONFIDENTIAL
 Page 30
of 42
 MSA#:
                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
  List of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespCOA
      Pre-Study Total
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      65
                                      
                                      COAGeneral
      AdminPost
      tracking tools to web for client
                                      
                                      
                                      
                                      xAssist
      with IRB/ reg. authority submissions
                                      
                                      xOngoing
      regulatory doc. tracking/ scanning
                                      
                                      
                                      
                                      xTrial
      Master File maintenance
                                      
                                      
                                      
                                      xContact
      sites for enrolment updates
                                      
                                      
                                      
                                      xHigh
      level site support
                                      
                                      
                                      
                                      xAssist
      with query resolution
                                      
                                      
                                      
                                      xTC
      minutes
                                      
                                      
                                      
                                      xReturn
      of Sponsor’s TMF
                                      
                                      
                                      
                                      xCOA
      General Admin (Active) Total
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      5
                                      
                                      104
                                      
                                      520
                                      
                                      COACOA
      General Admin (Follow-up) Total
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      3
                                      
                                      34
                                      
                                      102
                                      
                                      COATotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      622
                                      
                                      COAAllphase
      Center of Excellence (ACE) TrainingSite
      level GCP/ICH CRF training
                                      
                                      
                                      
                                      n/aSource
      documentationDrug
      accountabilityDM
      insight for reducing queriesACE
      Trainer prep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      ACEACE
      Trainer travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      ACEACE
      Trainer attendance
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      0
                                      
                                      0
                                      
                                      ACETotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0
                                      
                                      ACEMedical
      WritingReview
      of therapeutic area/medication
                                      
                                      xReview
      of protocol/related study documents
                                      
                                      xIntegration
      of tables/statistical analysis plan
                                      
                                      xPreparation
      of draft report #1
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      60
                                      
                                      1
                                      
                                      60
                                      
                                      MWPreparation
      of draft report #2
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      40
                                      
                                      1
                                      
                                      40
                                      
                                      MWPreparation
      of draft report #3
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      30
                                      
                                      1
                                      
                                      30
                                      
                                      MWPreparation
      of final report
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      30
                                      
                                      1
                                      
                                      30
                                      
                                      MWTotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      160
                                      
                                      MW
  CONFIDENTIAL
 
 Page 31
of 42
  MSA#:
                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
  List of Tasks
                                      
                                      YM
                                      
                                      Allphase
                                      
                                      ADM
                                      
                                      Task
                                        Hours
                                      
                                      Units
                                      
                                      Total
                                        Hours
                                      
                                      RespQuality
      AssuranceFamiliarization
      with client SOPs (if applicable)
                                      
                                      
                                      
                                      xFamiliarization
      with protocol
                                      
                                      
                                      
                                      xInspection
      of site regulatory files
                                      
                                      
                                      
                                      xReview
      and assessment of site SOPs
                                      
                                      
                                      
                                      xRandom
      sampling of source and CRF data
                                      
                                      
                                      
                                      xDiscussion
      with site personnel re: processes and findings.
                                      
                                      
                                      
                                      xInspection
      of client TMF regulatory files
                                      
                                      
                                      
                                      xReview
      of vendor facilities, SOPs, processes
                                      
                                      
                                      
                                      N/ADiscussion
      with vendor personnel re: processes and findings.
                                      
                                      
                                      
                                      N/APreparation
      of audit report
                                      
                                      
                                      
                                      xFollow-up
      of resolutions
                                      
                                      
                                      
                                      xVendor
      Audits
                                      
                                      
                                      
                                      N/APrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      6Travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      6On-Site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8Report
      Writing
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      6Sub-Total
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      26
                                      
                                      2
                                      
                                      52
                                      
                                      QASite Audits (ü(n+1))
                                      
                                      
                                      
                                      xPrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8Travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8On-Site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16Report
      Writing
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8Sub-Total
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      40
                                      
                                      4
                                      
                                      160
                                      
                                      QATMF
      Audit
                                      
                                      
                                      
                                      xPrep
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      2Travel
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      0On-Site
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      16Report
      Writing
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      8Sub-Total
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      26
                                      
                                      0
                                      
                                      0
                                      
                                      QATotal
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      
                                      212
                                      
                                      QASafetyOverall
      Medical Oversight
                                      
                                      (x)
                                      
                                      xManage
      site questions
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      0.5
                                      
                                      110
                                      
                                      55
                                      
                                      MMreview
      patient eligibility
                                      
                                      
                                      
                                      x
                                      
                                      
                                      
                                      0.5
                                      
                                      110
                                      
                                      55
                                      
                                      MMProtocol
      deviation decision making and management (as required)
                                      
                                      (x)
                                      
                                      x
                                      
                                      
                                      
                                      0.75
                                      
                                      100
                                      
                                      75
                                      
                                      MM
 
 CONFIDENTIAL
 Page 32
of 42
 MSA#:
                YMBO7-MSA-30APR2007-1.0
                WO
      Version Code:
                YMBO7-WO1-29MAR2007-2.3Version
      Date:
                02APR2007
                Work
      Order #:
                01
 
 List of Tasks
                                            
                                            YM
                                            
                                            Allphase
                                            
                                            ADM
                                            
                                            Task
                                              Hours
                                            
                                            Units
                                            
                                            Total
                                              Hours
                                            
                                            RespSAE
      Trend Analysis
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            8
                                            
                                            2
                                            
                                            16
                                            
                                            MMProtocol
      deviation processing and tracking
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            0.75
                                            
                                            100
                                            
                                            75
                                            
                                            PMAE/SAE
      Database Setup
                                            
                                            
                                            
                                            xAE/SAE
      Coding and Reporting
                                            
                                            
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            DMMedications
      Coding
                                            
                                            
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            DMSAE
      Collection, Processing & Reporting
                                            
                                            
                                            
                                            xSAE
      report receipt, processing & follow-up
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            1
                                            
                                            100
                                            
                                            100
                                            
                                            DSSubmit
      Alert Reports to Reg. Agencies/ IRB/ Sponsor
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            0.75
                                            
                                            100
                                            
                                            75
                                            
                                            DSSubmit
      SAE Reports to Sites
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            0.75
                                            
                                            100
                                            
                                            75
                                            
                                            PMSAE
      Evaluation
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            0.5
                                            
                                            100
                                            
                                            50
                                            
                                            MM24/7
      phone coverage (2hrs/wk)
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            2
                                            
                                            130
                                            
                                            260
                                            
                                            MMSub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            150
                                            
                                            PMSub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            175
                                            
                                            DSSub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            511
                                            
                                            MMRadiology
      ReviewProvider:
      TBDDatabase
      DevelopmentImage
      Receipt and ProcessingImage
      ReviewData
      Transfer FilesProgram
      ManagementDSMBFormation
      and Management
                                            
                                            
                                            
                                            N/AProvide
      suitable board members & facilitate (3) meetings by
      teleconference
                                            
                                            
                                            
                                            N/AOrganize
      & Conduct DSMB meetings
                                            
                                            
                                            
                                            N/AInteract
      with sponsor regarding conclusions
                                            
                                            
                                            
                                            N/Aimplement
      next steps.
                                            
                                            
                                            
                                            N/ACharter
      & SOPs
                                            
                                            
                                            
                                            N/AProvide
      support/advice for creating DSMB and defining its duties & resp. for
      the project
                                            
                                            
                                            
                                            N/AAdministration
                                            
                                            
                                            
                                            N/ADistribute
      meeting materials (Send Safety Data)
                                            
                                            
                                            
                                            N/APrepare
      minutes
                                            
                                            
                                            
                                            N/AMD
      Participation & Evaluation
                                            
                                            
                                            
                                            N/ATotalSub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            0
                                            
                                            PMSub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            0
                                            
                                            COASub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            0
                                            
                                            MM
 
 CONFIDENTIAL
 Page 33
of 42




MSA#:
              YMBO7-MSA-30APR2007-1.0
              WO
      Version Code:
              YMBO7-WO1-29MAR2007-2.3Version
      Date:
              02APR2007
              Work
      Order #:
              01





List of Tasks
                                                      
                                                      YM
                                                      
                                                      Allphase
                                                      
                                                      ADM
                                                      
                                                      Task
                                                        Hours
                                                      
                                                      Units
                                                      
                                                      Total
                                                        Hours
                                                      
                                                      RespData
      ManagementData
      Management PlanProject
      specific DM standards & SOPs
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      16
                                                      
                                                      1
                                                      
                                                      16
                                                      
                                                      DMPreparation
      of Data Management Plan
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      8
                                                      
                                                      1
                                                      
                                                      8
                                                      
                                                      DMDatabase
      DesignDB
      definition
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      4
                                                      
                                                      1
                                                      
                                                      4
                                                      
                                                      DMDB
      security
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      4
                                                      
                                                      1
                                                      
                                                      4
                                                      
                                                      DMCRF
      review
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      8
                                                      
                                                      1
                                                      
                                                      8
                                                      
                                                      DMCA3
      - Coding data entry screens (17 unique forms, 60 CRF
    pages/pt)
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      40
                                                      
                                                      1
                                                      
                                                      40
                                                      
                                                      DMDefine
      & code edit checks
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      24
                                                      
                                                      1
                                                      
                                                      24
                                                      
                                                      DMFinalize
      data entry screens, edit checks, validation
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      16
                                                      
                                                      1
                                                      
                                                      16
                                                      
                                                      DMData
      Validation Plan
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      xInitial
      programming & query wording
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      8
                                                      
                                                      1
                                                      
                                                      8
                                                      
                                                      DMTesting
      and locking DVP (sign off)
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      4
                                                      
                                                      1
                                                      
                                                      4
                                                      
                                                      DMPeriodic
      re-testing
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      8
                                                      
                                                      1
                                                      
                                                      8
                                                      
                                                      DMCRF
      Completion Guidelines
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      PMCRF
      Completion Guidelines review
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      CRASite
      training
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      CRAData
      Entry and CleaningDouble
      Data Entry of all paper CRF data
                                                        (60
      CRF pages/pt)
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      0.1
                                                      
                                                      6000
                                                      
                                                      600
                                                      
                                                      DEData
      Query: Review of listings; query generation (Data Clarification
      Forms)
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      1
                                                      
                                                      100
                                                      
                                                      100
                                                      
                                                      DMAdministration
      of DCFs
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      
                                                      
                                                      1
                                                      
                                                      100
                                                      
                                                      100
                                                      
                                                      COAClosing
      of DCFs
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      1
                                                      
                                                      100
                                                      
                                                      100
                                                      
                                                      DEMedical/Science
      Review
                                                      
                                                      
                                                      
                                                      xClinical
      Review
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      0.5
                                                      
                                                      100
                                                      
                                                      50
                                                      
                                                      MMAE/SAE
      Database Setup
                                                      
                                                      (x)
                                                      
                                                      
                                                      
                                                      x
                                                      
                                                      16
                                                      
                                                      1
                                                      
                                                      16
                                                      
                                                      DMSAE
      Reconciliation
                                                      
                                                      
                                                      
                                                      xReconciliation
      based on central SAE DB vs. study DB
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      16
                                                      
                                                      1
                                                      
                                                      16
                                                      
                                                      DMMedical
      Coding
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      xCoding
      AE’s (MedDRA, WHO-ART, COSTART)
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      0.06
                                                      
                                                      200
                                                      
                                                      12
                                                      
                                                      DMCoding
      of Con Meds (WHODRUG)
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      0.06
                                                      
                                                      200
                                                      
                                                      12
                                                      
                                                      DMData
      Validation & Management
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      xPeriodic
      validation of CRF data
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      8
                                                      
                                                      1
                                                      
                                                      8
                                                      
                                                      DMFlexible
      query routing
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      0.1
                                                      
                                                      100
                                                      
                                                      10
                                                      
                                                      DMAccommodating
      3rd party queries
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      
                                                      0.1
                                                      
                                                      50
                                                      
                                                      5
                                                      
                                                      DMCentral
      Lab DB imports
                                                      
                                                      
                                                      
                                                      n/aReconcile
      Clinical End-Point & CRF
                                                        Database





CONFIDENTIAL





Page 34
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MSA#:
              YMBO7-MSA-30APR2007-1.0
              WO
      Version Code:
              YMBO7-WO1-29MAR2007-2.3Version
      Date:
              02APR2007
              Work
      Order #:
              01




List of Tasks
                                            
                                            YM
                                            
                                            Allphase
                                            
                                            ADM
                                            
                                            Task
                                              Hours
                                            
                                            Units
                                            
                                            Total
                                              Hours
                                            
                                            RespPreparation
      of the Interim Analysis PlanPreparation
      of the Final Analysis PlanBiostats
      & Programming for Interim and Final AnalysisDB
      lock & audit
                                            
                                            
                                            
                                            
                                            
                                            xInterim
      & final DB locks with assoc.
                                              documentation
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            24
                                            
                                            1
                                            
                                            24
                                            
                                            DM08
      documentation & release
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            8
                                            
                                            1
                                            
                                            8
                                            
                                            DMDB
      transfer in sponsor defined formats (ASCII, SAS, XML as per CDISC specs)
      with detailed docs.
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            4
                                            
                                            1
                                            
                                            4
                                            
                                            DMRandomization
      Services
                                            
                                            
                                            
                                            xSample-Size
      Justification and Calculation,
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            6
                                            
                                            0
                                            
                                            0
                                            
                                            BIORandomization
      Codes - Specification and programming of the randomization
      lists
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            8
                                            
                                            0
                                            
                                            0
                                            
                                            BIO24/7
      Un-blinding of Patients for 30 months
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            as
      needed
                                            
                                            
                                            
                                            
                                            
                                            DMOne
      (1) Study Specific SOP pertaining to the un-blinding of
      Patients
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            3
                                            
                                            0
                                            
                                            0
                                            
                                            DMSet-up
      (Annual Licenses) and Maintenance
                                            
                                            
                                            
                                            
                                            
                                            x
                                            
                                            3
                                            
                                            11
                                            
                                            33
                                            
                                            DMAssociated
      Project Management
                                            
                                            
                                            
                                            
                                            
                                            x
                                            
                                            2
                                            
                                            11
                                            
                                            22
                                            
                                            DMProject
      Close-Out & Archiving of database
                                            
                                            
                                            
                                            
                                            
                                            x
                                            
                                            24
                                            
                                            1
                                            
                                            24
                                            
                                            DMSub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            401
                                            
                                            DMSub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            700
                                            
                                            DESub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            100
                                            
                                            COASub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            50
                                            
                                            MMSub-Total
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            0
                                            
                                            BIOBiostatistical
      ServicesStatistical
      Analysis Plan (SAP) including mock-up tables, listings and graphs
      (optional)
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            40
                                            
                                            1
                                            
                                            40
                                            
                                            BIOStatistical
      Analyses for all tables, listings and graphs outlined in the
      SAP
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            152
                                            
                                            1
                                            
                                            152
                                            
                                            BIOStatistical
      Report (optional)
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            30
                                            
                                            1
                                            
                                            30
                                            
                                            BIOInterim
      Analysis (Limited)
                                            
                                            
                                            
                                            x
                                            
                                            
                                            
                                            24
                                            
                                            1
                                            
                                            24
                                            
                                            BIOTotal
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            
                                            246
                                            
                                            BIO





CONFIDENTIAL





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MSA#:
              YMBO7-MSA-30APR2007-1.0
              WO
      Version Code:
              YMBO7-WO1-29MAR2007-2.3Version
      Date:
              02APR2007
              Work
      Order #:
              01





6.
Estimate









Based on
the information provided, we have prepared an estimate which we feel is
reasonable at this time. Please be assured that Allphase Clinical Research
strives to economize appropriately whenever possible. Based on the preceding
section of this proposal, the following labour costs have been estimated, in CDN
dollars. All travel related expenses are to be reimbursed by the client
separately, without mark-up.




Service
                  
                  Approx. #
                    hours
                  
                  
                  Hourly Rate
                    (CDN)
                  
                  
                  TOTALSProject
      Management (PM)Pre-Study
      Activities
                  
                  
                  130
                  
                  
                  $
                  100
                  
                  
                  $
                  13,000Vendors
      Selection
                  
                  
                  32
                  
                  
                  $
                  100
                  
                  
                  $
                  3,200Investigator’s
      Meeting
                  
                  
                  85
                  
                  
                  $
                  100
                  
                  
                  $
                  8,500Ethics
                  
                  
                  0
                  
                  
                  $
                  100
                  
                  
                  $
                  0Co-Initiation/IMV/COV
                  
                  
                  54
                  
                  
                  $
                  100
                  
                  
                  $
                  5,400Ad
      hoc meetings
                  
                  
                  72
                  
                  
                  $
                  100
                  
                  
                  $
                  7,200Safety
      - SAE
                  
                  
                  150
                  
                  
                  $
                  100
                  
                  
                  $
                  15,000Safety
      - DSMB
                  
                  
                  0
                  
                  
                  $
                  100
                  
                  
                  $
                  0General
                  
                  
                  1287
                  
                  
                  $
                  100
                  
                  
                  $
                  128,700Sub
      Total
                  
                  
                  1,810
                  
                  
                  $
                  100
                  
                  
                  $
                  181,000Regulatory
      Affairs (RA)Health
      Canada Submission
                  
                  
                  0
                  
                  
                  $
                  100
                  
                  
                  $
                  0Sub
      Total
                  
                  
                  0
                  
                  
                  $
                  100
                  
                  
                  $
                  0Clinical
      Monitoring (CRA)Pre-Study
      Activities
                  
                  
                  24
                  
                  
                  $
                  90
                  
                  
                  $
                  2,160Investigator’s
      Meeting
                  
                  
                  102
                  
                  
                  $
                  90
                  
                  
                  $
                  9,180Site
      Selection Visits
                  
                  
                  0
                  
                  
                  $
                  90
                  
                  
                  $
                  0Initiation
      Visit
                  
                  
                  209
                  
                  
                  $
                  90
                  
                  
                  $
                  18,810Interim
      Monitoring
                  
                  
                  4580
                  
                  
                  $
                  90
                  
                  
                  $
                  412,200Close-Out
      Visit
                  
                  
                  242
                  
                  
                  $
                  90
                  
                  
                  $
                  21,780Sub
      Total
                  
                  
                  5157
                  
                  
                  $
                  90
                  
                  
                  $
                  464,130Clinical
      Operations Associate (COA)Pre-Study
      Activities
                  
                  
                  65
                  
                  
                  $
                  75
                  
                  
                  $
                  4,875Investigator’s
      Meeting
                  
                  
                  84
                  
                  
                  $
                  75
                  
                  
                  $
                  6,300DSMB
                  
                  
                  0
                  
                  
                  $
                  75
                  
                  
                  $
                  0General
                  
                  
                  622
                  
                  
                  $
                  75
                  
                  
                  $
                  46,650Data
      Management
                  
                  
                  100
                  
                  
                  $
                  75
                  
                  
                  $
                  7,500Sub
      Total
                  
                  
                  871
                  
                  
                  $
                  75
                  
                  
                  
                  65,325





CONFIDENTIAL





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MSA#:
              YMBO7-MSA-30APR2007-1.0
              WO
      Version Code:
              YMBO7-WO1-29MAR2007-2.3Version
      Date:
              02APR2007
              Work
      Order #:
              01





Service
                                    
                                    Approx. #
                                      Hours
                                    
                                    
                                    Hourly Rate
                                      (CDN)
                                    
                                    
                                    TOTALSTraining
      (ACE)Investigator’s
      Meeting
                                    
                                    
                                    0
                                    
                                    
                                    $
                                    150
                                    
                                    
                                    $
                                    0Site
      Training
                                    
                                    
                                    0
                                    
                                    
                                    $
                                    150
                                    
                                    
                                    $
                                    0[Illegible]
                                    
                                    [Illegible]
                                    
                                    
                                    
                                    [*
                                    ]
                                    
                                    
                                    [*
                                    ]Quality
      Assurance (QA)Vendor
      Audits
                                    
                                    
                                    52
                                    
                                    
                                    $
                                    100
                                    
                                    
                                    $
                                    5,200Site
      Audits
                                    
                                    
                                    160
                                    
                                    
                                    $
                                    100
                                    
                                    
                                    $
                                    16,000TMF
      Audit
                                    
                                    
                                    0
                                    
                                    
                                    $
                                    100
                                    
                                    
                                    $
                                    0[Illegible]
                                    
                                    [Illegible]
                                    
                                    
                                    
                                    [*
                                    ]
                                    
                                    
                                    [*
                                    ]Drug
      Safety – ManagementDrug
      Safety
                                    
                                    
                                    175
                                    
                                    
                                    $
                                    100
                                    
                                    
                                    $
                                    17,500[Illegible]
                                    
                                    [Illegible]
                                    
                                    
                                    
                                    [*
                                    ]
                                    
                                    
                                    [*
                                    ]Drug
      Safety - MedicalInvestigator’s
      Meeting
                                    
                                    
                                    26
                                    
                                    
                                    $
                                    350
                                    
                                    
                                    $
                                    9,100Medical
      Monitoring
                                    
                                    
                                    511
                                    
                                    
                                    $
                                    350
                                    
                                    
                                    $
                                    178,850DSMB
                                    
                                    
                                    0
                                    
                                    
                                    $
                                    350
                                    
                                    
                                    $
                                    0Data
      Management
                                    
                                    
                                    50
                                    
                                    
                                    $
                                    350
                                    
                                    
                                    $
                                    17,500[Illegible]
                                    
                                    [Illegible]
                                    
                                    
                                    
                                    [*
                                    ]
                                    
                                    
                                    [*
                                    ]Medical
      WritingProfessional
      Services
                                    
                                    
                                    160
                                    
                                    
                                    $
                                    100
                                    
                                    
                                    $
                                    16,000[Illegible]
                                    
                                    [Illegible]
                                    
                                    
                                    
                                    [*
                                    ]
                                    
                                    
                                    [*
                                    ]Data
      ManagementInvestigator’s
      Meeting
                                    
                                    
                                    0
                                    
                                    
                                    $
                                    100
                                    
                                    
                                    $
                                    0Double
      Data Entry
                                    
                                    
                                    700
                                    
                                    
                                    $
                                    65
                                    
                                    
                                    $
                                    45,500Professional
      Services
                                    
                                    
                                    401
                                    
                                    
                                    $
                                    100
                                    
                                    
                                    $
                                    40,100Site
      Set-up (licenses)
                                    
                                    11 sites
                                    
                                    
                                    $
                                    2,300
                                    
                                    
                                    $
                                    75,900[Illegible]
                                    
                                    [Illegible]
                                    
                                    
                                    
                                    [*
                                    ]
                                    
                                    
                                    [*
                                    ]BiostatisticianData
      Management
                                    
                                    
                                    0
                                    
                                    
                                    $
                                    120
                                    
                                    
                                    $
                                    0Professional
      Services
                                    
                                    
                                    246
                                    
                                    
                                    $
                                    120
                                    
                                    
                                    $
                                    29,520[Illegible]
                                    
                                    [Illegible]
                                    
                                    
                                    
                                    [*
                                    ]
                                    
                                    
                                    [*
                                    ]Radiology
      Review
                                    
                                    
                                    
                                    
                                    
                                    unconfirmed
                                    
                                    
                                    $
                                    161,292Radiology
      ReviewTotal
      Project Services Fees
                                    
                                    
                                    $
                                    1,322,917





CONFIDENTIAL





Page 37
of 42





MSA#:
              YMBO7-MSA-30APR2007-1.0
              WO
      Version Code:
              YMBO7-WO1-29MAR2007-2.3Version
      Date:
              02APR2007
              Work
      Order #:
              01





7.
Pass-Through Cost Estimate





TOTALSPass-Through Expenses
                                
                                
                                
                                Unit Cost
                                
                                #
                                  Units
                                
                                Total CostMonitor
      Travel Expenses (incl. $0.44/km)
                                
                                per
      trip
                                
                                
                                250.00
                                
                                229.00
                                
                                $
                                57,250Monitor
      Meal Expenses
                                
                                per
      day
                                
                                
                                30.00
                                
                                229.00
                                
                                $
                                6,870Monitor
      Overnight Expenses (i.e. hotel)
                                
                                30%
                                
                                
                                165.00
                                
                                69.00
                                
                                $
                                11,385Monitor
      Meal Expenses (overnight)
                                
                                per
      day
                                
                                
                                60.00
                                
                                69.00
                                
                                $
                                4,140Quality
      Assurance / Site Audit Travel
                                
                                per
      trip
                                
                                
                                300.00
                                
                                6.00
                                
                                $
                                1,800Allphase
      & Client Meeting Expenses
                                
                                per
      person
                                
                                
                                800.00
                                
                                4.00
                                
                                $
                                3,200Miscellaneous
      Expenses (consumables and communication costs) = $100 pp /month (active
      period): 2CRA, 1COA & 1PM
                                
                                per
      month
                                
                                
                                400.00
                                
                                26.00
                                
                                $
                                10,400Miscellaneous
      Expenses (consumables and communication costs) = $50 pp /month (follow-up
      period): 2CRA, 1COA & 1PM
                                
                                per
      month
                                
                                
                                200.00
                                
                                6.50
                                
                                $
                                1,300Teleconferences
                                
                                per
      conf.
                                
                                
                                40.00
                                
                                69.00
                                
                                $
                                2,760Mailing
                                
                                per
      letter
                                
                                
                                1.50
                                
                                251.00
                                
                                $
                                377Courier
                                
                                per
      package
                                
                                
                                20.00
                                
                                138.00
                                
                                $
                                2,760Newsletters
                                
                                per
      newsletterRegulatory
      Binders
                                
                                per
      siteStudy
      Reference Binders
                                
                                per
      siteInvestigator
      Grants
                                
                                per
      patientEthics
      Committee / IRB Fees
                                
                                per
      siteInsurance
                                
                                per
      siteSub-Total
                                
                                
                                
                                
                                
                                
                                
                                
                                $
                                102,242Investigator’s
      MeetingInvestigator
      Meeting Airfare - site staff (PI business, CRC economy)
                                
                                per
      person
                                
                                
                                1,706.00
                                
                                22
                                
                                $
                                37,532Investigator
      Meeting Airfare - sponsor staff (all economy)
                                
                                per
      person
                                
                                
                                1,341.00
                                
                                9
                                
                                $
                                12,069Investigator
      Meeting Hotel - site staff(5
      star x 3 nights)
                                
                                per
      person
                                
                                
                                900.00
                                
                                22
                                
                                $
                                19,800




CONFIDENTIAL





Page 38
of 42





MSA#:
              YMBO7-MSA-30APR2007-1.0
              WO
      Version Code:
              YMBO7-WO1-29MAR2007-2.3Version
      Date:
              02APR2007
              Work
      Order #:
              01




Investigator
      Meeting Hotel - sponsor staff (5 star x 3 nights)
                                          
                                          per
      person
                                          
                                          
                                          900.00
                                          
                                          9
                                          
                                          $
                                          8,100Transportation
      and meals
                                          
                                          per
      person
                                          
                                          
                                          600.00
                                          
                                          31
                                          
                                          $
                                          18,600Sub-Total
                                          
                                          
                                          
                                          
                                          
                                          
                                          
                                          
                                          $
                                          96,101Vendors
      (non-affiliated)Translations
                                          
                                          ICF
                                          
                                          
                                          unsourced
                                          
                                          
                                          
                                          $
                                          4,500Central
      Laboratory Service (PK Lab)
                                          
                                          per
      patient
                                          
                                          
                                          unsourced
                                          
                                          
                                          
                                          unkIVRS
      Vendor
                                          
                                          N/ADrug
      Distribution Vendor
                                          
                                          N/ASub-Total
                                          
                                          
                                          
                                          
                                          
                                          
                                          
                                          
                                          $
                                          165,792Total
      Pass-Through Expenses (CDN)
                                          
                                          
                                          
                                          
                                          
                                          
                                          
                                          
                                          $
                                          202,843Total
      Project (CDN)
                                          
                                          
                                          
                                          
                                          
                                          
                                          
                                          
                                          $
                                          1,525,760




CONFIDENTIAL





Page 39
of 42





MSA#:
              YMBO7-MSA-30APR2007-1.0
              WO
      Version Code:
              YMBO7-WO1-29MAR2007-2.3Version
      Date:
              02APR2007
              Work
      Order #:
              01





8.
Payment Schedule and Terms







A deposit
of 10% ($152,576) of the estimated project cost is to be paid upon initiation of
this contract. Detailed monthly invoices will be submitted to YM BioSciences
Inc.




o
              Monthly labour invoices to be
      issued by the 15thof the following
      month


o
            Expense invoices to be issued
      once original receipts have been collected from
      personnel


o
            Applicable taxes on labor will be
      indicated on invoice.


o
            Payment terms are 30 days from
      receipt of monthly invoice.


o
            1.5% per month financing fee may
      be applied to outstanding balance
owing.


o
            Sponsor authorization will be
      obtained if budget exceeds 10% of
  estimate.


o
            Retainer based payment schedule
      is also available if
preferred.





9.
Standard Practices









Allphase
Clinical Research will manage the project using industry best practice and will
endeavour to perform the work at or below cost and schedule. Please be assured
that Allphase strives to economize appropriately whenever possible. To this end,
multiple destination monitoring trips will be arranged when possible to reduce
travel time and expenses. The client will be consulted regarding the possibility
of deviating from the prescribed protocol defined monitoring frequency if sites
are not enrolling sufficiently to justify the expense. The least expensive means
of transportation will be used, in consideration of travel time, efficiency and
safety.





Allphase
Standard Operating Procedures (SOP) or client SOPs can be used for this
project.





Allphase
Clinical Research is an insured and incorporated company.




CONFIDENTIAL





Page 40
of 42




MSA#:
              YMBO7-MSA-30APR2007-1.0
              WO
      Version Code:
              YMBO7-WO1-29MAR2007-2.3Version
      Date:
              02APR2007
              Work
      Order #:
              01





10.
Client Signatures









The
details as described in the version on the Work Order referenced in the header
of this document are acceptable. Any significant change in the terms or
requirements of this Work Order will be managed in accordance with section 3.2
of the above referenced Master Services Agreement.





IN
WITNESS WHEREOF, this Agreement has been executed by the Parties hereto through
their duly authorized officers on the date(s) set forth
below.





Agreed
and accepted





YM
      BioSciences Inc.Signature:
              [ILLEGIBLE]
              
              Signature:
              [ILLEGIBLE]Date:
              May
      16/07
              
              Date:
              22
      May 2007Name/Title:
              CHAIR
      & CEO
              
              Name/Title:
              Jeff
      Smith/PresidentI have the authority to bind the
      corporation.
              
              I
      have the authority to bind the
corporation.





If
the details of this Work Order require further refining and the parties wish to
initiate work on the project prior to finalizing the Work Order, the Letter of
Intent of section 11 of this Work Order may be executed.





CONFIDENTIAL





Page 41
of 42




MSA#:
                  YMBO7-MSA-30APR2007-1.0
                  WO
      Version Code:
                  YMBO7-WO1-29MAR2007-2.3Version
      Date:
                  02APR2007
                  Work
      Order #:
                  01





11.
Letter of Intent









CONFIDENTIAL





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