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

     

    


    
      
         


      

      
         


        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    Table
of Contents

     

    
      

    

    


    
      
        	
                1.
      Proposal Details

              	
                3

              
	
                2.
      Corporate Summary

              	
                4

              
	
                Features
      & Benefits

              	
                4

              
	
                Team
      & Location

              	
                5

              
	
                Technology

              	
                5

              
	
                Standards

              	
                5

              
	
                Corporate
      & Clinical Organizational Chart

              	
                7

              
	
                Services

              	
                8

              
	
                Project
      Management

              	
                8

              
	
                Regulatory
      Affairs

              	
                8

              
	
                Clinical
      Monitoring

              	
                8

              
	
                Operational
      Support

              	
                9

              
	
                Medical
      Writing

              	
                9

              
	
                Quality
      Assurance

              	
                10

              
	
                Data
      Management

              	
                10

              
	
                Training

              	
                11

              
	
                Clinical
      Supply Logistics

              	
                11

              
	
                Affiliate
      Services

              	
                11

              
	
                3.
      Therapeutic Experience

              	
                12

              
	
                4.
      ProjectTeam

              	
                14

              
	
                Project
      Oversight

              	
                14

              
	
                Project
      Management

              	
                15

              
	
                Clinical
      Research Associates

              	
                15

              
	
                Clinical
      Operations Associates

              	
                16

              
	
                Quality
      Assurance

              	
                16

              
	
                5.
      Project Summary

              	
                17

              
	
                Project
      Timelines

              	
                21

              
	
                Roles
      and Rates

              	
                21

              
	
                Project
      Details

              	
                22

              
	
                6.
      Estimate

              	
                36

              
	
                7.
      Pass-Through Cost Estimate

              	
                38

              
	
                8.
      Payment Schedule and Terms

              	
                40

              
	
                9.
      Standard Practices

              	
                40

              
	
                10.
      Client Signatures

              	
                41

              
	
                11.
      Letter of Intent

              	
                42

              


      

    

    


    CONFIDENTIAL


      
        

        
          
             


          

          
            Page 2 of
42

            
              

            

          

          
             


          

        

      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    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
      Cancer

              
	 
      	 
      
	
                Protocol
      #:

              	
                YMB1000-015

              
	 
      	 
      
	
                Customer:

              	
                YM
      BioSciences Inc.

              
	 
      	 
      
	
                MSA#:

              	
                YMBO7-MSA-30APR2007-
      1.0

              
	 
      	 
      
	
                Proposal
      No.:

              	
                YMBO7-WOI-29MAR2007-2.3

              
	 
      	 
      
	
                Customer
      Reference:

              	
                YMBO7-WO1

              
	 
      	 
      
	
                Confidentiality:

              	
                Restricted –
      Commercial Copyright and Reproduction

              
	 
      	 
      
	 
      	
                This
      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:

              	
                02APR2007

              
	 
      	 
      
	
                Version:

              	
                1.0

              
	 
      	 
      
	
                Validity:

              	
                90
      days

              
	 
      	 
      
	
                CRO
      Address:

              	
                Allphase
      Clinical Research Services Inc.

              
	 
      	
                19
      Camelot Drive

              
	 
      	
                Ottawa,
      ON Canada K2G 5W6

              
	 
      	
                P:
      (613) 228-1990

              
	 
      	
                F:
      (613) 228-8493

              
	 
      	
                C:
      (613) 291-2362

              
	 
      	
                Email:
      jsmith@allphaseclinical.com

              


      

    

     

    
      
        
          	
                  Approved
      by:

                	 
      	 
      	 
      	 
      
	 
      	 
      	
                  /s/ Jeff Smith

                	 
      	
                  22 May 2007

                
	 
      	 
      	
                  Jeff
      Smith

                	 
      	
                  Date

                
	 
      	 
      	
                  President

                	 
      	 
      


        

      

    

    


    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
        Page 3 of
42

        
          

        

      

      
         


      

    

    


    
      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

    

    


    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.

            


    

    


    CONFIDENTIAL


      
        

        
          
             


          

          
            Page 4 of
42

            
              

            

          

          
             


          

        

      

       

    

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    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;

            


    

    


    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
        Page 5 of
42

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    
      	
               
      

            	
              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.

            


    

    


    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
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42

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    Corporate & Clinical
Organizational Chart (currently 45 employees)

     

    


    CONFIDENTIAL


      
        

        
          
             


          

          
            Page 7 of
42

            
              

            

          

          
             


          

        

      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    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;

            


    

    


    CONFIDENTIAL


      
        

        
          
             


          

          
            Page 8 of
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                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    
      	
               
      

            	
              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.

            


    

     

    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
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                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    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 assessment of 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.

            


    

    


    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
        Page 10
of 42

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    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.

     

    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
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of 42

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    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

              	 
      	
                Indications

              
	
                Allergy/ Respiratory

              	 
      	
                7

              	 
      	
                Asthma

                Chronic
      Obstructive Pulmonary Disease

                Perennial
      Allergic Rhinitis

                Seasonal
      Allergic Rhinitis

              
	
                Cardiovascular

              	 
      	
                9

              	 
      	
                Atrial
      Fibrillation

                Deep
      Vein Thrombosis

                Intermittent
      Claudication

                Pulmonary
      Embolism

              
	
                CNS

              	 
      	
                6

              	 
      	
                Amyotrophic
      Lateral Sclerosis

                Alzheimer’s
      Disease

                Depression

                Multiple
      Sclerosis

                Smoking
      Cessation

              
	
                Endocrinology

              	 
      	
                5

              	 
      	
                Diabetes

                Dyslipidemia

              
	
                Infectious
      Disease

              	 
      	
                6

              	 
      	
                Hepatitis

                HIV

              
	
                Oncology

              	 
      	
                8

              	 
      	
                Brain

                Breast

                Head
      and Neck

                Ovarian

                Renal
      Cell Carcinoma

                Small
      Cell Lung

              
	
                Other

              	 
      	
                8

              	 
      	
                Alpha-1
      Antitrypsin Deficiency

                Chronic
      Idiopathic Urticaria

                Immunodeficiency

                Primary
      Immune Deficiency

                Rabies

              
	
                TOTAL

              	 
      	
                49

              	 
      	 
      


      

    

     

    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
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                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    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 Subjects

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Small
      Cell Lung Cancer

                	 
      	
                  I/Il

                	 
      	
                  5

                	 
      	
                  48

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Advanced
      Breast Cancer

                	 
      	
                  II

                	 
      	
                  5

                	 
      	
                  30

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Metastatic
      Renal Cell Carcinoma

                	 
      	
                  II

                	 
      	
                  1

                	 
      	
                  5

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Metastatic
      Breast Cancer

                	 
      	
                  II

                	 
      	
                  4

                	 
      	
                  37

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Squamous
      Cell Carcinoma

                	 
      	
                  II

                	 
      	
                  6

                	 
      	
                  20

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Squamous
      Cell Carcinoma

                	 
      	
                  II

                	 
      	
                  6

                	 
      	
                  10

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Pediatric
      Brain Tumors

                	 
      	
                  I

                	 
      	
                  1

                	 
      	
                   19

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Ovarian
      Cancer

                	 
      	
                  II

                	 
      	
                  7

                	 
      	
                  40

                


        

      

    

     

    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
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                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

     

    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.

     

    CONFIDENTIAL


      
        

      

    

    
      
         


      

      
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                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

     

    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

                    	 
      	
                      Indication

                    
	
                      2

                    	 
      	
                      III

                    	 
      	
                      Metastatic
      Colorectal

                    
	
                      1

                    	 
      	
                      II/III

                    	 
      	
                      Ovarian
      Cancer

                    
	
                      3

                    	 
      	
                      III

                    	 
      	
                      Cervical
      Dystonia

                    
	
                      1

                    	 
      	
                      I

                    	 
      	
                      Hemifacial
      Spasm

                    
	
                      I

                    	 
      	
                      III

                    	 
      	
                      International
      Melanoma

                    
	
                      1

                    	 
      	
                      III

                    	 
      	
                      AML

                    


            

          

        

      

    

     

    Her
therapeutic experience includes the following areas:

    


    
      
        	
                Therapy Area

              	 
      	
                Indication

              
	
                Hematology

              	 
      	
                Chemotherapy
      administration: AML, Hodgkin’s Disease, NHL and apharesis
      administration

              
	
                Infectious
      Diseases

              	 
      	
                Antiviral
      research: HIV

              
	
                Oncology

              	 
      	
                Breast,
      Ovarian, Acute Myeloid Leukemia, Colorectal, NSCL, SCL, Melanoma,
      Hodgkin’s Disease, Non Hodgkin’s Lymphoma

              
	
                Neurological

              	 
      	
                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


      
        

      

    

    
      
         


      

      
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                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                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.

     

    CONFIDENTIAL

      
        

      

    

    
      
         


      

      
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                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      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:

      


      
        
          
            	
                    Protocol

                  	 
      	 
      
	
                    Drug

                  	 
      	
                    Nimotuzumab
      (TheraCIM®,
      YMB 1000, h-R3)

                  
	
                    Indication

                  	 
      	
                    Metastatic
      Colorectal Cancer

                  
	
                    Phase

                  	 
      	
                    II

                  
	
                    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
      Cancer

                  
	
                    Short
      Title

                  	 
      	
                    Nimotuzumab
      plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal
      Cancer

                  
	
                    Objectives

                  	 
      	
                    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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of 42

          
            

          

        

        
          
          

        

      

       

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      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 of

                  
	 
      	 
      	 	
                    nimotuzumab
      based on ORR and safety data

                  
	 
      	 
      	 	
                    which
      can serve as a reference for future studies.

                  
	
                    Sites

                  	 
      	 	 
      
	
                    No.
      of Investigator Meetings

                  	
                    1

                  	 	 
      
	
                    Investigator
      Meeting Location

                  	 
      	 	
                    TBD

                  
	
                    Number
      of Treatment Groups

                  	
                    2

                  	 	 
      
	
                    Local
      of Central IRB

                  	 
      	 	
                    Local

                  
	
                    Number
      of Sites

                  	
                    11

                  	 	 
      
	
                    Location
      of sites

                  	 
      	 	
                    Canada
      (9) & Australia (2); or Canada (11)

                  
	
                    Number
      of Site Selection Visits

                  	
                    0

                  	 	 
      
	
                    Number
      of Initiation Visits

                  	
                    11

                  	 	 
      
	
                    Est.
      # of Monitoring hrs/ SF CRF

                  	
                    0.5

                  	 	
                    assuming
      minimal data review & collection

                  
	
                    Est.
      # 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
      reconciliation

                  
	
                    Estimated
      Number of Monitoring Hour

                  	
                     1605 

                  	 	 
      
	
                    Estimated
      Number of Monitoring Days

                  	
                    229

                  	 	
                    7
      hour monitoring day (1hr for site administration)

                  
	
                    Estimated
      Number of Visits per Site

                  	
                    21

                  	 	
                    assumes
      1 day visit

                  
	
                    Estimated
      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

                  	
                    11

                  	 	 
      
	
                    Estimated
      Number of Ad-Hoc Visits

                  	
                    4

                  	 	
                    PM
      visits to YMB (approx every 6 months)

                  
	
                    Estimated
      Number of Co-Visits by PM

                  	
                    3

                  	 	 
      


          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 18
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                  MSA#:

                	
                  YMB07-MSA-30APR2007-l.0

                	
                  WO
      Version Code:

                	
                  YMB07-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

      


      
        
          
            	
                    Subjects

                  	 
      	 	 
      
	
                    Number
      of Subjects Screened

                  	
                    110

                  	 	 
      
	
                    Number
      of Subjects Randomized

                  	
                    100

                  	 	 
      
	
                    Enrolment
      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

                  	 	
                    weeks

                  
	
                    Total
      Study Duration (PM) Follow-Up Period

                  	
                    26

                  	 	
                    weeks

                  
	
                    Total
      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

                  	
                    100

                  	 	 
      
	
                    Medical
      Writing

                  	 
      	 	 
      
	
                    Number
      of Medical Reports

                  	
                    1

                  	 	 
      
	
                    SOP

                  	 
      	 	 
      
	
                    SOPs
      to be used

                  	 
      	 	
                    YM
      BioSciences

                  
	
                    Forms

                  	 
      	 	
                    YM
      BioSciences

                  
	
                    Data
      Management

                  	 
      	 	 
      
	
                    Allphase
      DM

                  	 
      	 	
                    paper
      CRF

                  
	
                    Quality
      Assurance

                  	 
      	 	 
      
	
                    Site
      Audits

                  	
                    4

                  	 	 
      
	
                    Vendor
      Audits

                  	
                    2

                  	 	
                    Central
      lab for PK samples & Radiology Lab

                  
	
                    QA
      Audit of Clinical Database

                  	
                    0

                  	 	 
      
	
                    QA
      Audit of Clinical Study Report

                  	
                    0

                  	 	 
      
	
                    QA
      Audit of Study File

                  	
                    0

                  	 	 
      
	
                    Vendors

                  	 
      	 	 
      
	
                    Number
      of Laboratories

                  	 
      	 	
                    Local
      & Central (PK)

                  
	
                    Investigational
      Product Distributor

                  	 
      	 	
                    YM
      BioSciences

                  
	
                    Radiology
      Review

                  	
                    120

                  	 	
                    based
      on 20% responders and 6 images/patient

                  
	
                    Services
      Requested

                  	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    Regulatory

                  
	 
      	 
      	 	
                    CTA
      prep, submission and maintenance

                  
	 
      	 
      	 	
                    Project
      Management

                  


          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 19
of 42

            
              

            

          

          
            
            

          

        

      

      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-30APR2007-l.0

                	
                  WO
      Version Code:

                	
                  YMB07-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            	 
      	
                    N/A

                  	 	
                    Site
      Contract Negotiation and Payment Facilitation

                  
	 
      	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    Regulatory
      Document Collection

                  
	 
      	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    ICF
      Preparation & Translation

                  
	 
      	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    IRB
      preparations and submissions - central

                  
	 
      	 
      	 	
                    IRB;
      or assistance with the submissions if

                  
	 
      	 
      	 	
                    local
      IRB.

                  
	 
      	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    Site
      Identification

                  
	 
      	 
      	 	
                    Multi-site
      Management

                  
	 
      	 
      	 	
                    CRA
      Management

                  
	 
      	 
      	 	
                    Teleconference
      and Project Updates

                  
	 
      	 
      	 	
                    Vendor
      Management (if applicable)

                  
	 
      	 
      	 	
                    General
      Administration

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Investigator
      Meeting

                  
	 
      	 
      	 	
                    Planning
      & Execution

                  
	 
      	 
      	 	
                    Presentations

                  
	 
      	 
      	 	
                    Travel
      Arrangements for Attendees

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Clinical
      Monitoring

                  
	 
      	
                    N/A

                  	 	
                    Pre-Study
      Visits

                  
	 
      	 
      	 	
                    Site
      Initiation

                  
	 
      	 
      	 	
                    Interim
      Monitoring & site management

                  
	 
      	 
      	 	
                    Site
      Close Out

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Safety

                  
	 
      	 
      	 	
                    Safety
      Database

                  
	 
      	 
      	 	
                    CIOMS/
      MedWatch report prep

                  
	 
      	 
      	 	
                    SAE
      alert reporting to authorities

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Data
      Management/Biostatistics

                  
	 
      	 
      	 	
                    CRF
      Design & build

                  
	 
      	 
      	 	
                    DM
      System Set Up (include edit checks)

                  
	 
      	 
      	 	
                    Data
      Validation and Review CRFs

                  
	 
      	 
      	 	
                    Data
      Query

                  
	 
      	 
      	 	
                    Coding
      AE & Medications

                  
	 
      	 
      	 	
                    Interim
      Analysis Plan

                  
	 
      	 
      	 	
                    Final
      Analysis Plan

                  


          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 20
of 42

            
              

            

          

          
            
            

          

        

      

      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-30APR2007-l.0

                	
                  WO
      Version Code:

                	
                  YMB07-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            	 
      	 
      	 	
                    Medical
      Monitoring

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Radiology
      Review

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Medical
      Writing

                  
	 
      	 
      	 	
                    Draft
      & Final Clinical Study Report

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Quality
      Assurance

                  
	 
      	 
      	 	
                    GCP
      Investigator/Site/ Vendor Audit

                  
	 
      	
                    N/A

                  	 	
                    QA
      Audit of Clinical Database

                  
	 
      	
                    N/A

                  	 	
                    QA
      Audit of Clinical Study
Report

                  


          

        

      

      


      Project
Timelines

       

      
        
          
            
              	
                      Activity

                    	 
      	
                      Date of Completion

                    
	
                      Contract
      or LOI executed

                    	 
      	
                      Apr-07

                    
	
                      Investigator
      Meeting

                    	 
      	
                      Apr-Jun-07

                    
	
                      First
      patient enrolled

                    	 
      	
                      Jun-07

                    
	
                      25%
      subjects enrolled

                    	 
      	
                      Nov-07

                    
	
                      50%
      subjects enrolled

                    	 
      	
                      Mar-07

                    
	
                      75%
      subjects enrolled

                    	 
      	
                      Aug-08

                    
	
                      Enrolment
      completed

                    	 
      	
                      Dec-08

                    
	
                      Last
      patient/ last visit (active period)

                    	 
      	
                      Jun-09

                    
	
                      Database
      Lock

                    	 
      	
                      Aug-09

                    
	
                      Final
      close out visit

                    	 
      	
                      Oct-09

                    


            

          

        

      

      


      Roles
and Rates

       

      
        
          
            
              	
                      Allphase Role

                    	  	
                      Allphase Resource

                    	  	
                      Hourly Rate

                    	 
	
                      DE

                    	 
      	
                      Data
      Entry Personnel

                    	 
      	$	
                      65

                    	 
	
                      COA

                    	 
      	
                      Clinical
      Operations Associate

                    	 
      	$	
                      75

                    	 
	
                      CRA

                    	 
      	
                      Clinical
      Research Associate

                    	 
      	$	
                      90

                    	 
	
                      DM

                    	 
      	
                      Data
      Manager

                    	 
      	$	
                      100

                    	 
	
                      MW

                    	 
      	
                      Medical
      Writing

                    	 
      	$	
                      100

                    	 
	
                      PM

                    	 
      	
                      Project
      Manager

                    	 
      	$	
                      100

                    	 
	
                      RA

                    	 
      	
                      Regulatory
      Affairs

                    	 
      	$	
                      100

                    	 
	
                      DS

                    	 
      	
                      Drug
      Safety

                    	 
      	$	
                      100

                    	 
	
                      QA

                    	 
      	
                      Quality
      Assurance Auditor

                    	 
      	$	
                      100

                    	 
	
                      BlO

                    	 
      	
                      Biostatistician

                    	 
      	$	
                      120

                    	 
	
                      ACE

                    	 
      	
                      Trainer

                    	 
      	$	
                      150

                    	 
	
                      MM

                    	 
      	
                      Medical
      Monitor

                    	 
      	$	
                      350

                    	 


            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 21
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      Project
Details

      
        
          
            	
                    x

                  	 
      	
                    Full
      Responsibility

                  
	
                    (x)

                  	 
      	
                    Partial
      Responsibility/ Input/ Advice

                  
	
                    ADM

                  	 
      	
                    Data
      Management

                  


          

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Pre-Study
      Activities

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Project
      Feasibility study

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Protocol
      Development 

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Synopsis

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Draft

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review

                                      	 	
                                        x

                                      	 	
                                        (x)

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Final

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Protocol
      Amendments

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Draft

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review

                                      	 	
                                        x

                                      	 	
                                        (x)

                                      	 	 
      	 	4	 	1	 	4	 	
                                        PM

                                      	 
	
                                        Final

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Compilation
      & update IB

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Draft

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Final

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Paper
      CRF Preparation

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Draft

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Final

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Printing

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CRF
      Design (CA3)

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CRF
      Design - Draft (17 unique forms, 60

                                        CRF
      pages/pt) - template provided by YMB

                                      	 	 	 	
                                        x

                                      	 	 
      	 	40	 	1	 	40	 	
                                        PM

                                      	 
	
                                        CRF
      Draft Review & Revisions

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        CRA

                                      	 
	
                                        Edit
      Check Development

                                      	 	 	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Review
      & Finalize Programmed Edit Checks

                                      	 	 	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Final
      Review and Final Revisions to CRF

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        PM

                                      	 
	
                                        CRF
      Completion Guidelines (revisions incl)

                                      	 	 	 	
                                        x

                                      	 	 
      	 	36	 	1	 	36	 	
                                        PM

                                      	 
	
                                        CRF
      Completion Guidelines - review

                                      	 	 	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        CRA

                                      	 
	
                                        CRF
      printing logistics and QC

                                      	 	 	 	
                                        x

                                      	 	 
      	 	4	 	1	 	4	 	
                                        PM

                                      	 
	
                                        Project
      Plan

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        SOPs
      assignment documentation

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	3	 	1	 	3	 	
                                        PM

                                      	 
	
                                        Responsibility
      assignment

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	3	 	1	 	3	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	24	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	130	 	
                                        PM

                                      	 


                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 22
of 42

            
              

            

          

          
            
            

          

        

      

       

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Submissions
      to FDA

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        US
      agent

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        amendment
      & maintenance

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CTA
      - Health Canada

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Canadian
      Agent

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      & Submission

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	
                                        Clarifax
      response

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	
                                        Review
      of Approval NOL & follow-up

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	
                                        Submission
      of CTSI forms to TPD

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	
                                        amendment
      & maintenance

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	0	 	
                                        RA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Vendors

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        ID
      & contracting lab

                                      	 	 	 	
                                        x

                                      	 	 
      	 	12	 	1	 	12	 	
                                        PM

                                      	 
	
                                        ID
      & contracting Radiology Review

                                      	 	 	 	
                                        x

                                      	 	 
      	 	12	 	1	 	12	 	
                                        PM

                                      	 
	
                                        Vendor
      Assessment

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Provide
      sites with manual

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Payment
      administration & tracking

                                      	 	 	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	32	 	
                                        PM

                                      	 
	
                                        Investigator’s
      Meeting

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Identify
      location and conduct preliminary investigation of costs;
      reservations

                                      	 	
                                        x

                                      	 	
                                        (x)

                                      	 	 
      	 	8	 	1	 	8	 	
                                        COA

                                      	 
	
                                        Organize
      travel & hotel for study team

                                      	 	 	 	
                                        x

                                      	 	 
      	 	14	 	1	 	14	 	
                                        COA

                                      	 
	
                                        Plan
      and organize IM

                                      	 	 	 	
                                        x

                                      	 	 
      	 	24	 	1	 	24	 	
                                        PM

                                      	 
	
                                        Prepare
      agenda

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	3	 	1	 	3	 	
                                        PM

                                      	 
	
                                        Prepare
      presentations

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Design
      Investigator Meeting materials

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Prepare
      Investigator Meeting materials

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	
                                        Prepare
      welcome letters, name tags, meeting materials

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	12	 	1	 	12	 	
                                        COA

                                      	 
	
                                        Ensure
      vendor/sponsor presentations are organized and appropriate

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Attendance
      and presentations at Investigator meeting

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 	 	 	 	 	 	 
      	 
	 
      	 	
                                         

                                      	 	 	 	 
      	 	 	 	 	 	 	 	
                                          

                                      	 
	
                                        PM
      prep

                                      	 	 	 	 	 	 
      	 	2	 	1	 	2	 	
                                        PM

                                      	 
	
                                        PM
      travel

                                      	 	 	 	 	 	 
      	 	16	 	1	 	16	 	
                                        PM

                                      	 
	
                                        PM
      presentation & attendance

                                      	 	 	 	 	 	 
      	 	16	 	1	 	16	 	
                                        PM

                                      	 


                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 23
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        CRA
      prep

                                      	 	 	 	 
      	 	 
      	 	2	 	3	 	6	 	
                                        CRA

                                      	 
	
                                        CRA
      travel

                                      	 	 	 	 
      	 	 
      	 	16	 	3	 	48	 	
                                        CRA

                                      	 
	
                                        CRA
      attendance

                                      	 	 	 	 
      	 	 
      	 	16	 	3	 	48	 	
                                        CRA

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        ACE
      Trainer prep

                                      	 	 	 	 
      	 	 
      	 	2	 	0	 	0	 	
                                        ACE

                                      	 
	
                                        ACE
      Trainer travel

                                      	 	 	 	 
      	 	 
      	 	16	 	0	 	0	 	
                                        ACE

                                      	 
	
                                        ACE
      Trainer presentation & attendance

                                      	 	 	 	 
      	 	 
      	 	8	 	0	 	0	 	
                                        ACE

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        COA
      prep

                                      	 	 	 	 
      	 	 
      	 	2	 	1	 	2	 	
                                        COA

                                      	 
	
                                        COA
      travel

                                      	 	 	 	 
      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	
                                        COA
      attendance

                                      	 	 	 	 
      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        DM
      prep

                                      	 	 	 	 
      	 	 
      	 	2	 	0	 	0	 	
                                        DM

                                      	 
	
                                        DM
      travel

                                      	 	 	 	 
      	 	 
      	 	16	 	0	 	0	 	
                                        DM

                                      	 
	
                                        DM
      presentation & attendance

                                      	 	 	 	 
      	 	 
      	 	8	 	0	 	0	 	
                                        DM

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        MM
      prep

                                      	 	 	 	 
      	 	 
      	 	2	 	1	 	2	 	
                                        MM

                                      	 
	
                                        MM
      travel

                                      	 	 	 	 
      	 	 
      	 	16	 	1	 	16	 	
                                        MM

                                      	 
	
                                        MM
      presentation & attendance

                                      	 	 	 	 
      	 	 
      	 	8	 	1	 	8	 	
                                        MM

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total
      - PM

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	85	 	
                                        PM

                                      	 
	
                                        Sub-Total
      - CRA

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	102	 	
                                        CRA

                                      	 
	
                                        Sub-Total
      - ACE

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	0	 	
                                        ACE

                                      	 
	
                                        Sub-Total
      - COA

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	84	 	
                                        COA

                                      	 
	
                                        Sub-Total
      - DM

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	0	 	
                                        DM

                                      	 
	
                                        Sub-Total
      - MM

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	26	 	
                                        MM

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ethics

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of ICF template (PIPEDA)

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	16	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Customization
      of ICF (PIPEDA)

                                      	 	
                                        n/a

                                      	 	 
      	 	 
      	 	8	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Preparation
      of other subject materials

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	12	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Assist
      sites with submissions

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	3	 	0	 	0	 	
                                        PM

                                      	 
	
                                        IRB
      approval review & action if needed

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	2	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Translation
      of ICF & materials

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	6	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Subsequent
      ICF revisions (amendments)

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	8	 	0	 	0	 	
                                        PM

                                      	 
	
                                        IND
      Safety alert reporting to sites

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	2	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Annaul
      re-approval documentation

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	4	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Study/
      site closure documentation

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	4	 	0	 	0	 	
                                        PM

                                      	 
	
                                        IRB
      payment facilitation

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	1	 	0	 	0	 	
                                        PM

                                      	 
	
                                        IRB
      payment

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	0	 	
                                        PM

                                      	 


                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 24
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        CRA

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Site
      Selection Visits

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Contact
      sites and confirm date for visit

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Send
      confirmation letter

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Interview
      PI and site staff regarding experience

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      project requirements and expectations

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Tour
      facility and assess site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prepare
      report and make recommendation of site suitability

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	0	 	0	 	
                                        CRA

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	8	 	0	 	0	 	
                                        CRA

                                      	 
	
                                        On-Site

                                      	 	 	 	 	 	 
      	 	3	 	0	 	0	 	
                                        CRA

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	4	 	0	 	0	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	0	 	
                                        CRA

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Site
      Initiation Visit

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Contact
      sites and confirm date for visit and provide an agenda

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Send
      confirmation letter

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Complete
      Monitors’ Sign-In Log

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      regulatory documentation

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      Study protocol and CRF including:

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Inclusion
      /exclusion criteria

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Efficacy
      parameters and measurement

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Study
      schedule

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Complete/evaluable
      patient definitions

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Study
      medication procedures

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Lab
      requirements

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CRF
      completion instructions

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      adverse event reporting, including:

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Definition
      of AEs and SAEs.

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Requirements
      for documentation collection

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Proper
      procedures for reporting SAEs to Sponsor and REB.

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Follow-up
      requirements

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      Investigational Brochure

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      communication channels

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      requirements for source documentation

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        IRB/site
      responsibilities

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 


                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 25
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  	
                                          List of Tasks

                                        	 	
                                          YM

                                        	 	
                                          Allphase

                                        	 	
                                          ADM

                                        	 	
                                          Task

                                          Hours

                                        	 	
                                          Units

                                        	 	
                                          Total

                                          Hours

                                        	 	
                                          Resp

                                        	 
	
                                          Review
      monitoring schedule

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      study site documentation

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Train
      study coordinators

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      PI contract and payment schedule

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Prepare
      study initiation visit report

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Send
      site SIV report and ackg. form

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Prep

                                        	 	 
      	 	 	 	 
      	 	2	 	1	 	2	 	
                                          CRA

                                        	 
	
                                          Travel

                                        	 	 
      	 	 	 	 
      	 	8	 	1	 	8	 	
                                          CRA

                                        	 
	
                                          On-Site

                                        	 	 
      	 	 	 	 
      	 	5	 	1	 	5	 	
                                          CRA

                                        	 
	
                                          Admin

                                        	 	 
      	 	 	 	 
      	 	4	 	1	 	4	 	
                                          CRA

                                        	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Sub-Total/site

                                        	 	 
      	 	 	 	 
      	 	19	 	1	 	19	 	
                                          CRA

                                        	 
	
                                          Total

                                        	 	 
      	 	 	 	 
      	 	19	 	11	 	209	 	
                                          CRA

                                        	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Interim
      Monitoring

                                        	 	 
      	 	
                                          x

                                        	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Send
      confirmation letter

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Complete
      Monitors’ Sign-In Log

                                        	 	 
      	 	
                                           

                                        	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Verify
      proper Informed Consent procedures

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Monitor
      in accordance with protocol/ICH/GCP

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          100%
      source document verification vs. CRF

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Assess
      patient eligibility (protocol inclusion / exclusion / randomization
      criteria)

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Provide
      site with written query records to be retained with each
    CRF

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      study-related regulatory documents

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      monitoring & discrepancy report queries

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Source
      verify data clarification/ correction forms

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      of laboratory data

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      and verify SAEs (100% SDV)

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Verify
      study drug inventory and storage

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Verify
      proper accountability and destruction of IP and study supplies per
      protocol

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Maintain
      protocol violation list

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Monitoring
      of other variables as specified

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Prepare
      monitoring visit reports following each monitoring visit

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Provide
      monitoring follow-up reports to sites following each visit

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Regular
      contacts with sites & TC reports

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Ongoing
      training of site personnel

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          CRF
      and query management

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 


                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 26
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        CRA

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	6	 	1	 	6	 	
                                        CRA

                                      	 
	
                                        On-Site

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        CRA

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	5	 	1	 	5	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	20	 	1	 	20	 	
                                        CRA

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	20	 	229	 	4580	 	
                                        CRA

                                      	 
	 
      	 	 	 	
                                         

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Close
      Out Visit

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        COV
      within 6 weeks post data base lock

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Contact
      potential sites, confirm date for visit

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Send
      confirmation letter

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Complete
      Monitors’ Sign-In Log

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ensure
      site regulatory documentation is complete and accessible for future
      audits

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ensure
      that the investigator is aware of his/her responsibilities

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ensure
      that any remaining clinical trial material is removed from the study
      site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prepare
      COV report following visit

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Provide
      follow-up report to sites

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Follow-up
      with sites to resolve open issues

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        CRA

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        CRA

                                      	 
	
                                        On-Site

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        CRA

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	5	 	1	 	5	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	22	 	1	 	22	 	
                                        CRA

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	22	 	11	 	242	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CRA
      Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	5031	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Overall
      Project Management

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        In-house
      study management

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Selection
      - US sites

                                      	 	
                                        N/A

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Selection
      - CDN site

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Identification
      & contracting of vendors

                                      	 	
                                        N/A

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Feasibility
      form admin (incl. initial contact)

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Confidential
      Discl. Agreement - template

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CDA
      Approval

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CTRA
      template

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CTRA
      template approval

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CTRA
      negotiation

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 


                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 27
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        	
                                                List of Tasks

                                              	 	
                                                YM

                                              	 	
                                                Allphase

                                              	 	
                                                ADM

                                              	 	
                                                Task

                                                Hours

                                              	 	
                                                Units

                                              	 	
                                                Total

                                                Hours

                                              	 	
                                                Resp

                                              	 
	
                                                CTRA
      - site sign off

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Preparation
      of initial project specific reg pkg

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Review
      received reg docs:

                                              	 	
                                                x

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                site
      - 1572

                                              	 	 	 	
                                                 

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                site
      - QIU

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                REBA

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                CTSI

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Consent
      to Use Personal Data

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Protocol
      signature page

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                IB
      distribution to sites

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Financial
      Disclosure

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                CV

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                biosketch

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                MD
      qualification

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                lab
      ref ranges & license

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Internal
      monthly project team meetings

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Site
      level management

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Regular
      status reports for client

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Liaise
      bi-weekly with sponsor

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                TMF
      Set-up & Maintenance

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Track
      CRF completion & queries and manage deficiencies

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Site
      budget set-up

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Payment
      calculation

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Payment
      tracking

                                              	 	
                                                x

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Payment
      issuance

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                 Preparation
      of Project Plan

                                              	 	
                                                (x)

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Preparation
      of Monitoring Plan

                                              	 	
                                                (x)

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Prep.
      of initiation Visit Booklet

                                              	 	
                                                (x)

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                  

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Prep.
      of Study specific forms

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Prep.
      study specific tracking tools

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                CRF
      Transmittal Logs

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                QoL,
      questionnaires and/or patient diaries, patient (alert)
    cards

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Drug
      Accountability Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Individual
      Subject Drug logs

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Drug
      Return & Reconciliation Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Clinical
      Re-Supplies Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Drug
      Receipt Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Release
      of IP (RIP) Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 


                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        

      

      
        
          
          

        

        
          Page 28
of 42

          
            

          

        

        
          
          

        

      

       

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List
      of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Destruction
      of IP (DIP) Form

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                         Study
      specific tracking tools

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Investigational
      Product (IP) and other Clinical Study Supplies

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Labeling,
      coding and packing of IP (including provision of sample
      labels)

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Identification
      of Drug Distribution Vendor

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Comparator
      Procurement

                                      	 	
                                        N/A

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of written instructions for handling and storage of IP

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Request
      for import/export approvals for IP

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of custom clearance(s)

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Storage
      of IP

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Development/maintenance
      Randomization System/Codes

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        DM

                                      	 
	
                                        Request
      for authorization to release IP to sites

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Authorization
      to distribute drug

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Packaging/labeling
      of Clinical Supplies

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Distribution
      of Clinical Study Supplies to sites

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Tracking
      of IP

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        PM

                                      	 
	
                                        Tracking
      of Clinical Study Supplies

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        PM

                                      	 
	
                                        Organization
      of return of unused Clinical Study Supplies

                                      	 	
                                         

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        CRA

                                      	 
	
                                        Organization
      of destruction of unused Clinical Study Supplies

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Study
      Completion/Study Termination

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Notification
      to national/local authorities of study termination

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Final
      recon of TMF

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        PM

                                      	 
	
                                        Archiving
      of Sponsor’s TMF

                                      	 	
                                        x

                                      	 	
                                         

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total
      (est. hours/ week x # wks)

                                        Active
      Period

                                      	 	 	 	
                                        x

                                      	 	 
      	 	11	 	104	 	1144	 	
                                        PM

                                      	 
	 
      	 	 	 	
                                         

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total
      (est. hours/week x # wks)

                                        Follow-Up
      Period

                                      	 	 	 	
                                        x

                                      	 	 
      	 	5.5	 	26	 	143	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ex-house
      Project Management

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Site
      Selection Visits

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	2	 	0	 	0	 	
                                        PM

                                      	 


                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 29
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	14	 	0	 	0	 	
                                        PM

                                      	 
	
                                        On-Site

                                      	 	
                                         

                                      	 	
                                         

                                      	 	
                                          

                                      	 	3	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	5	 	0	 	0	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	0	 	
                                        PM

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Co-Initiation/Monitoring/COV

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        PM

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        On-Site
      (average)

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	18	 	
                                        PM

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	18	 	3	 	54	 	
                                        PM

                                      	 
	 
      	 	 	 	
                                         

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ad
      hoc meetings (4 trips)

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        PM

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	6	 	1	 	6	 	
                                        PM

                                      	 
	
                                        On-Site
      (average)

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	3	 	1	 	8	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	18	 	
                                        PM

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	18	 	4	 	72	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	1413	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Administration
      - COA

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Assemble
      site reg. packages

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Courier
      packages to sites

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Receive,
      log, scan & file initial reg docs

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Follow-up
      on reg doc errors & omissions

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Courier
      - second round

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Receive,
      log, scan & file 2nd round reg docs

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Assemble
      PI Site Files (ISF) for TMF

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Courier
      site ISF to PI

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Assemble
      TMF

                                      	 	 	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	
                                        Assemble
      In-House site File (IHF) for TMF

                                      	 	 	 	
                                        x

                                      	 	 
      	 	3	 	11	 	33	 	
                                        COA

                                      	 
	
                                        CRF
      related admin

                                      	 	
                                         

                                      	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	
                                        CDA
      - send to sites; review; send to Client

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        CTRA
      - 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-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        COA
      Pre-Study Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	65	 	
                                        COA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        General
      Admin

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Post
      tracking tools to web for client

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Assist
      with IRB/ reg. authority submissions

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ongoing
      regulatory doc. tracking/ scanning

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Trial
      Master File maintenance

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Contact
      sites for enrolment updates

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        High
      level site support

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Assist
      with query resolution

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        TC
      minutes

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Return
      of Sponsor’s TMF

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        COA
      General Admin (Active) Total

                                      	 	 	 	 	 	 
      	 	5	 	104	 	520	 	
                                        COA

                                      	 
	
                                        COA
      General Admin (Follow-up) Total

                                      	 	 	 	 	 	 
      	 	3	 	34	 	102	 	
                                        COA

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	622	 	
                                        COA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Allphase
      Center of Excellence (ACE) Training

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Site
      level GCP/ICH CRF training

                                      	 	 	 	
                                        n/a

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Source
      documentation

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Drug
      accountability

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        DM
      insight for reducing queries

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        ACE
      Trainer prep

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        ACE

                                      	 
	
                                        ACE
      Trainer travel

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        ACE

                                      	 
	
                                        ACE
      Trainer attendance

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        ACE

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	0	 	
                                        ACE

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Medical
      Writing

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      of therapeutic area/medication

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      of protocol/related study documents

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Integration
      of tables/statistical analysis plan

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of draft report #1

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	60	 	1	 	60	 	
                                        MW

                                      	 
	
                                        Preparation
      of draft report #2

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	40	 	1	 	40	 	
                                        MW

                                      	 
	
                                        Preparation
      of draft report #3

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	30	 	1	 	30	 	
                                        MW

                                      	 
	
                                        Preparation
      of final report

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	30	 	1	 	30	 	
                                        MW

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	160	 	
                                        MW

                                      	 


                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL 

      
        

      

      
        
          
          

        

        
          Page 31
of 42

          
            

          

        

        
          
          

        

      

       

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Quality
      Assurance

                                      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Familiarization
      with client SOPs (if applicable)

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Familiarization
      with protocol

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Inspection
      of site regulatory files

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      and assessment of site SOPs

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Random
      sampling of source and CRF data

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Discussion
      with site personnel re: processes and findings.

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Inspection
      of client TMF regulatory files

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      of vendor facilities, SOPs, processes

                                      	 	 
      	 	
                                        N/A

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Discussion
      with vendor personnel re: processes and findings.

                                      	 	 
      	 	
                                        N/A

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of audit report

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Follow-up
      of resolutions

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Vendor
      Audits

                                      	 	 
      	 	
                                        N/A

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 
      	 	 	 	 
      	 	6	 	 	 	 	 	 
      	 
	
                                        Travel

                                      	 	 
      	 	 	 	 
      	 	6	 	 	 	 	 	 
      	 
	
                                        On-Site

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        Report
      Writing

                                      	 	 
      	 	 	 	 
      	 	6	 	 	 	 	 	 
      	 
	
                                        Sub-Total

                                      	 	 
      	 	 	 	 
      	 	26	 	2	 	52	 	
                                        QA

                                      	 
	
                                        Site Audits (ü(n+1))

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        Travel

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        On-Site

                                      	 	 
      	 	 	 	 
      	 	16	 	 	 	 	 	 
      	 
	
                                        Report
      Writing

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        Sub-Total

                                      	 	 
      	 	 	 	 
      	 	40	 	4	 	160	 	
                                        QA

                                      	 
	
                                        TMF
      Audit

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 
      	 	
                                         

                                      	 	 
      	 	2	 	 	 	 	 	 
      	 
	
                                        Travel

                                      	 	 
      	 	 	 	 
      	 	0	 	 	 	 	 	 
      	 
	
                                        On-Site

                                      	 	 
      	 	 	 	 
      	 	16	 	 	 	 	 	 
      	 
	
                                        Report
      Writing

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        Sub-Total

                                      	 	 
      	 	 	 	 
      	 	26	 	0	 	0	 	
                                        QA

                                      	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 
      	 	 	 	 
      	 	 	 	 	 	212	 	
                                        QA

                                      	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Safety

                                      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Overall
      Medical Oversight

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Manage
      site questions

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	0.5	 	110	 	55	 	
                                        MM

                                      	 
	
                                        review
      patient eligibility

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	0.5	 	110	 	55	 	
                                        MM

                                      	 
	
                                        Protocol
      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-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                


        

      

      


      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      	
                                              List of Tasks

                                            	 	
                                              YM

                                            	 	
                                              Allphase

                                            	 	
                                              ADM

                                            	 	
                                              Task

                                              Hours

                                            	 	
                                              Units

                                            	 	
                                              Total

                                              Hours

                                            	 	
                                              Resp

                                            	 
	
                                              SAE
      Trend Analysis

                                            	 	 	 	
                                              x

                                            	 	 	 	8	 	2	 	16	 	
                                              MM

                                            	 
	
                                              Protocol
      deviation processing and tracking

                                            	 	 	 	
                                              x

                                            	 	 	 	0.75	 	100	 	75	 	
                                              PM

                                            	 
	
                                              AE/SAE
      Database Setup

                                            	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              AE/SAE
      Coding and Reporting

                                            	 	 	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	
                                              DM

                                            	 
	
                                              Medications
      Coding

                                            	 	 	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	
                                              DM

                                            	 
	
                                              SAE
      Collection, Processing & Reporting

                                            	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              SAE
      report receipt, processing & follow-up

                                            	 	 	 	
                                              x

                                            	 	 	 	1	 	100	 	100	 	
                                              DS

                                            	 
	
                                              Submit
      Alert Reports to Reg. Agencies/ IRB/ Sponsor

                                            	 	 	 	
                                              x

                                            	 	 	 	0.75	 	100	 	75	 	
                                              DS

                                            	 
	
                                              Submit
      SAE Reports to Sites

                                            	 	 	 	
                                              x

                                            	 	 	 	0.75	 	100	 	75	 	
                                              PM

                                            	 
	
                                              SAE
      Evaluation

                                            	 	 	 	
                                              x

                                            	 	 	 	0.5	 	100	 	50	 	
                                              MM

                                            	 
	
                                              24/7
      phone coverage (2hrs/wk)

                                            	 	 	 	
                                              x

                                            	 	 	 	2	 	130	 	260	 	
                                              MM

                                            	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	150	 	
                                              PM

                                            	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	175	 	
                                              DS

                                            	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	511	 	
                                              MM

                                            	 
	
                                              Radiology
      Review

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Provider:
      TBD

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Database
      Development

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Image
      Receipt and Processing

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Image
      Review

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Data
      Transfer Files

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Program
      Management

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              DSMB

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Formation
      and Management

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Provide
      suitable board members & facilitate (3) meetings by
      teleconference

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Organize
      & Conduct DSMB meetings

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Interact
      with sponsor regarding conclusions

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              implement
      next steps.

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Charter
      & SOPs

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Provide
      support/advice for creating DSMB and defining its duties & resp. for
      the project

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Administration

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Distribute
      meeting materials (Send Safety Data)

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Prepare
      minutes

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              MD
      Participation & Evaluation

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Total

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	0	 	
                                              PM

                                            	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	0	 	
                                              COA

                                            	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	0	 	
                                              MM

                                            	 


                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

      


      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 33
of 42

            
              

            

          

          
            
            

          

        

         

      

    

     

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                	
                                                        List of Tasks

                                                      	 	
                                                        YM

                                                      	 	
                                                        Allphase

                                                      	 	
                                                        ADM

                                                      	 	
                                                        Task

                                                        Hours

                                                      	 	
                                                        Units

                                                      	 	
                                                        Total

                                                        Hours

                                                      	 	
                                                        Resp

                                                      	 
	
                                                        Data
      Management

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Data
      Management Plan

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Project
      specific DM standards & SOPs

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	16	 	1	 	16	 	
                                                        DM

                                                      	 
	
                                                        Preparation
      of Data Management Plan

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        Database
      Design

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        DB
      definition

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	4	 	1	 	4	 	
                                                        DM

                                                      	 
	
                                                        DB
      security

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	4	 	1	 	4	 	
                                                        DM

                                                      	 
	
                                                        CRF
      review

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        CA3
      - Coding data entry screens (17 unique forms, 60 CRF
    pages/pt)

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	40	 	1	 	40	 	
                                                        DM

                                                      	 
	
                                                        Define
      & code edit checks

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	24	 	1	 	24	 	
                                                        DM

                                                      	 
	
                                                        Finalize
      data entry screens, edit checks, validation

                                                      	 	 
      	 	 	 	 	 	16	 	1	 	16	 	
                                                        DM

                                                      	 
	
                                                        Data
      Validation Plan

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 
      	 
	
                                                        Initial
      programming & query wording

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        Testing
      and locking DVP (sign off)

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	4	 	1	 	4	 	
                                                        DM

                                                      	 
	
                                                        Periodic
      re-testing

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        CRF
      Completion Guidelines

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	
                                                        PM

                                                      	 
	
                                                        CRF
      Completion Guidelines review

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	
                                                        CRA

                                                      	 
	
                                                        Site
      training

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	
                                                        CRA

                                                      	 
	
                                                        Data
      Entry and Cleaning

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Double
      Data Entry of all paper CRF data

                                                        (60
      CRF pages/pt)

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	0.1	 	6000	 	600	 	
                                                        DE

                                                      	 
	
                                                        Data
      Query: Review of listings; query generation (Data Clarification
      Forms)

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	1	 	100	 	100	 	
                                                        DM

                                                      	 
	
                                                        Administration
      of DCFs

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	1	 	100	 	100	 	
                                                        COA

                                                      	 
	
                                                        Closing
      of DCFs

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	1	 	100	 	100	 	
                                                        DE

                                                      	 
	
                                                        Medical/Science
      Review

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Clinical
      Review

                                                      	 	 
      	 	 	 	 	 	0.5	 	100	 	50	 	
                                                        MM

                                                      	 
	
                                                        AE/SAE
      Database Setup

                                                      	 	
                                                        (x)

                                                      	 	 	 	
                                                        x

                                                      	 	16	 	1	 	16	 	
                                                        DM

                                                      	 
	
                                                        SAE
      Reconciliation

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Reconciliation
      based on central SAE DB vs. study DB

                                                      	 	 
      	 	 	 	 	 	16	 	1	 	16	 	
                                                        DM

                                                      	 
	
                                                        Medical
      Coding

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 
      	 
	
                                                        Coding
      AE’s (MedDRA, WHO-ART, COSTART)

                                                      	 	 
      	 	 	 	 	 	0.06	 	200	 	12	 	
                                                        DM

                                                      	 
	
                                                        Coding
      of Con Meds (WHODRUG)

                                                      	 	 
      	 	 	 	 	 	0.06	 	200	 	12	 	
                                                        DM

                                                      	 
	
                                                        Data
      Validation & Management

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 
      	 
	
                                                        Periodic
      validation of CRF data

                                                      	 	 
      	 	 	 	 	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        Flexible
      query routing

                                                      	 	 
      	 	 	 	 	 	0.1	 	100	 	10	 	
                                                        DM

                                                      	 
	
                                                        Accommodating
      3rd party queries

                                                      	 	 
      	 	 	 	 	 	0.1	 	50	 	5	 	
                                                        DM

                                                      	 
	
                                                        Central
      Lab DB imports

                                                      	 	 
      	 	
                                                        n/a

                                                      	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Reconcile
      Clinical End-Point & CRF

                                                        Database

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 


                                              

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    


    CONFIDENTIAL 

    
      

    

    
      
         


      

      
        Page 34
of 42

        
          

        

      

      
         


      

    

     

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

     

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      	
                                              List of Tasks

                                            	 	
                                              YM

                                            	 	
                                              Allphase

                                            	 	
                                              ADM

                                            	 	
                                              Task

                                              Hours

                                            	 	
                                              Units

                                            	 	
                                              Total

                                              Hours

                                            	 	
                                              Resp

                                            	 
	
                                              Preparation
      of the Interim Analysis Plan

                                            	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Preparation
      of the Final Analysis Plan

                                            	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Biostats
      & Programming for Interim and Final Analysis

                                            	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              DB
      lock & audit

                                            	 	 
      	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	 
      	 
	
                                              Interim
      & final DB locks with assoc.

                                              documentation

                                            	 	 
      	 	 	 	 	 	24	 	1	 	24	 	
                                              DM

                                            	 
	
                                              08
      documentation & release

                                            	 	 
      	 	 	 	 	 	8	 	1	 	8	 	
                                              DM

                                            	 
	
                                              DB
      transfer in sponsor defined formats (ASCII, SAS, XML as per CDISC specs)
      with detailed docs.

                                            	 	 
      	 	 	 	 	 	4	 	1	 	4	 	
                                              DM

                                            	 
	
                                              Randomization
      Services

                                            	 	 
      	 	
                                              x

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Sample-Size
      Justification and Calculation,

                                            	 	 
      	 	 	 	 	 	6	 	0	 	0	 	
                                              BIO

                                            	 
	
                                              Randomization
      Codes - Specification and programming of the randomization
      lists

                                            	 	 
      	 	 	 	 	 	8	 	0	 	0	 	
                                              BIO

                                            	 
	
                                              24/7
      Un-blinding of Patients for 30 months

                                            	 	 
      	 	 	 	 	 	
                                              as
      needed

                                            	 	 	 	 	 	
                                              DM

                                            	 
	
                                              One
      (1) Study Specific SOP pertaining to the un-blinding of
      Patients

                                            	 	 
      	 	 	 	 	 	3	 	0	 	0	 	
                                              DM

                                            	 
	
                                              Set-up
      (Annual Licenses) and Maintenance

                                            	 	 
      	 	 	 	
                                              x

                                            	 	3	 	11	 	33	 	
                                              DM

                                            	 
	
                                              Associated
      Project Management

                                            	 	 
      	 	 	 	
                                              x

                                            	 	2	 	11	 	22	 	
                                              DM

                                            	 
	
                                              Project
      Close-Out & Archiving of database

                                            	 	 
      	 	 	 	
                                              x

                                            	 	24	 	1	 	24	 	
                                              DM

                                            	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	401	 	
                                              DM

                                            	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	700	 	
                                              DE

                                            	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	100	 	
                                              COA

                                            	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	50	 	
                                              MM

                                            	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	0	 	
                                              BIO

                                            	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Biostatistical
      Services

                                            	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Statistical
      Analysis Plan (SAP) including mock-up tables, listings and graphs
      (optional)

                                            	 	 
      	 	
                                              x

                                            	 	 	 	40	 	1	 	40	 	
                                              BIO

                                            	 
	
                                              Statistical
      Analyses for all tables, listings and graphs outlined in the
      SAP

                                            	 	 
      	 	
                                              x

                                            	 	 	 	152	 	1	 	152	 	
                                              BIO

                                            	 
	
                                              Statistical
      Report (optional)

                                            	 	 
      	 	
                                              x

                                            	 	 	 	30	 	1	 	30	 	
                                              BIO

                                            	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Interim
      Analysis (Limited)

                                            	 	 
      	 	
                                              x

                                            	 	 	 	24	 	1	 	24	 	
                                              BIO

                                            	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	246	 	
                                              BIO

                                            	 


                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    


    CONFIDENTIAL 

    
      

    

    
      
         


      

      
        Page 35
of 42

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      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)

                  	 	 	
                    TOTALS

                  	 
	
                    Project
      Management (PM)

                  	 	 	 	 	 	 	 	 	 
	
                    Pre-Study
      Activities

                  	 	 	130	 	 	$	100	 	 	$	13,000	 
	
                    Vendors
      Selection

                  	 	 	32	 	 	$	100	 	 	$	3,200	 
	
                    Investigator’s
      Meeting

                  	 	 	85	 	 	$	100	 	 	$	8,500	 
	
                    Ethics

                  	 	 	0	 	 	$	100	 	 	$	0	 
	
                    Co-Initiation/IMV/COV

                  	 	 	54	 	 	$	100	 	 	$	5,400	 
	
                    Ad
      hoc meetings

                  	 	 	72	 	 	$	100	 	 	$	7,200	 
	
                    Safety
      - SAE

                  	 	 	150	 	 	$	100	 	 	$	15,000	 
	
                    Safety
      - DSMB

                  	 	 	0	 	 	$	100	 	 	$	0	 
	
                    General

                  	 	 	1287	 	 	$	100	 	 	$	128,700	 
	
                    Sub
      Total

                  	 	 	1,810	 	 	$	100	 	 	$	181,000	 
	
                    Regulatory
      Affairs (RA)

                  	 	 	 	 	 	 	 	 	 	 	 	 
	
                    Health
      Canada Submission

                  	 	 	0	 	 	$	100	 	 	$	0	 
	
                    Sub
      Total

                  	 	 	0	 	 	$	100	 	 	$	0	 
	
                    Clinical
      Monitoring (CRA)

                  	 	 	 	 	 	 	 	 	 	 	 	 
	
                    Pre-Study
      Activities

                  	 	 	24	 	 	$	90	 	 	$	2,160	 
	
                    Investigator’s
      Meeting

                  	 	 	102	 	 	$	90	 	 	$	9,180	 
	
                    Site
      Selection Visits

                  	 	 	0	 	 	$	90	 	 	$	0	 
	
                    Initiation
      Visit

                  	 	 	209	 	 	$	90	 	 	$	18,810	 
	
                    Interim
      Monitoring

                  	 	 	4580	 	 	$	90	 	 	$	412,200	 
	
                    Close-Out
      Visit

                  	 	 	242	 	 	$	90	 	 	$	21,780	 
	
                    Sub
      Total

                  	 	 	5157	 	 	$	90	 	 	$	464,130	 
	
                    Clinical
      Operations Associate (COA)

                  	 	 	 	 	 	 	 	 	 	 	 	 
	
                    Pre-Study
      Activities

                  	 	 	65	 	 	$	75	 	 	$	4,875	 
	
                    Investigator’s
      Meeting

                  	 	 	84	 	 	$	75	 	 	$	6,300	 
	
                    DSMB

                  	 	 	0	 	 	$	75	 	 	$	0	 
	
                    General

                  	 	 	622	 	 	$	75	 	 	$	46,650	 
	
                    Data
      Management

                  	 	 	100	 	 	$	75	 	 	$	7,500	 
	
                    Sub
      Total

                  	 	 	871	 	 	$	75	 	 	 	65,325	 


          

        

      

    

    


    CONFIDENTIAL

    
      

    

    
      
         


      

      
        Page 36
of 42

        
          

        

      

      
         


      

    

     

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              	
                                      Service

                                    	 	
                                      Approx. #

                                      Hours

                                    	 	 	
                                      Hourly Rate

                                      (CDN)

                                    	 	 	
                                      TOTALS

                                    	 
	
                                      Training
      (ACE)

                                    	 	 	 	 	 	 	 	 	 
	
                                      Investigator’s
      Meeting

                                    	 	 	0	 	 	$	150	 	 	$	0	 
	
                                      Site
      Training

                                    	 	 	0	 	 	$	150	 	 	$	0	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Quality
      Assurance (QA)

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Vendor
      Audits

                                    	 	 	52	 	 	$	100	 	 	$	5,200	 
	
                                      Site
      Audits

                                    	 	 	160	 	 	$	100	 	 	$	16,000	 
	
                                      TMF
      Audit

                                    	 	 	0	 	 	$	100	 	 	$	0	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Drug
      Safety – Management

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Drug
      Safety

                                    	 	 	175	 	 	$	100	 	 	$	17,500	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Drug
      Safety - Medical

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Investigator’s
      Meeting

                                    	 	 	26	 	 	$	350	 	 	$	9,100	 
	
                                      Medical
      Monitoring

                                    	 	 	511	 	 	$	350	 	 	$	178,850	 
	
                                      DSMB

                                    	 	 	0	 	 	$	350	 	 	$	0	 
	
                                      Data
      Management

                                    	 	 	50	 	 	$	350	 	 	$	17,500	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Medical
      Writing

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Professional
      Services

                                    	 	 	160	 	 	$	100	 	 	$	16,000	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Data
      Management

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Investigator’s
      Meeting

                                    	 	 	0	 	 	$	100	 	 	$	0	 
	
                                      Double
      Data Entry

                                    	 	 	700	 	 	$	65	 	 	$	45,500	 
	
                                      Professional
      Services

                                    	 	 	401	 	 	$	100	 	 	$	40,100	 
	
                                      Site
      Set-up (licenses)

                                    	 	
                                      11 sites

                                    	 	 	$	2,300	 	 	$	75,900	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Biostatistician

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Data
      Management

                                    	 	 	0	 	 	$	120	 	 	$	0	 
	
                                      Professional
      Services

                                    	 	 	246	 	 	$	120	 	 	$	29,520	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Radiology
      Review

                                    	 	 	 	 	 	
                                      unconfirmed

                                    	 	 	$	161,292	 
	
                                      Radiology
      Review

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Total
      Project Services Fees

                                    	 	 	$	1,322,917	 


                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    


    CONFIDENTIAL 

    
      

    

    
      
         


      

      
        Page 37
of 42

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

    


    7.
Pass-Through Cost Estimate

    


    
      
        
          
            
              
                
                  
                    
                      
                        
                          	 
      	 	 
      	 
      	
                                  TOTALS

                                	 
      
	
                                  Pass-Through Expenses

                                	 	
                                            

                                	 
      	
                                  Unit Cost

                                	 
      	
                                  #

                                  Units

                                	 
      	
                                  Total Cost

                                	 
      
	
                                  Monitor
      Travel Expenses (incl. $0.44/km)

                                	 	
                                  per
      trip

                                	 
      	 
      	
                                  250.00

                                	 
      	
                                  229.00

                                	 
      	$	
                                  57,250

                                	 
      
	
                                  Monitor
      Meal Expenses

                                	 	
                                  per
      day

                                	 
      	 
      	
                                  30.00

                                	 
      	
                                  229.00

                                	 
      	$	
                                  6,870

                                	 
      
	
                                  Monitor
      Overnight Expenses (i.e. hotel)

                                	 	
                                  30%

                                	 
      	 
      	
                                  165.00

                                	 
      	
                                  69.00

                                	 
      	$	
                                  11,385

                                	 
      
	
                                  Monitor
      Meal Expenses (overnight)

                                	 	
                                  per
      day

                                	 
      	 
      	
                                  60.00

                                	 
      	
                                  69.00

                                	 
      	$	
                                  4,140

                                	 
      
	
                                  Quality
      Assurance / Site Audit Travel

                                	 	
                                  per
      trip

                                	 
      	 
      	
                                  300.00

                                	 
      	
                                  6.00

                                	 
      	$	
                                  1,800

                                	 
      
	
                                  Allphase
      & Client Meeting Expenses

                                	 	
                                  per
      person

                                	 
      	 
      	
                                  800.00

                                	 
      	
                                  4.00

                                	 
      	$	
                                  3,200

                                	 
      
	
                                  Miscellaneous
      Expenses (consumables and communication costs) = $100 pp /month (active
      period): 2CRA, 1COA & 1PM

                                	 	
                                  per
      month

                                	 
      	 
      	
                                  400.00

                                	 
      	
                                  26.00

                                	 
      	$	
                                  10,400

                                	 
      
	
                                  Miscellaneous
      Expenses (consumables and communication costs) = $50 pp /month (follow-up
      period): 2CRA, 1COA & 1PM

                                	 	
                                  per
      month

                                	 
      	 
      	
                                  200.00

                                	 
      	
                                  6.50

                                	 
      	$	
                                  1,300

                                	 
      
	
                                  Teleconferences

                                	 	
                                  per
      conf.

                                	 
      	 
      	
                                  40.00

                                	 
      	
                                  69.00

                                	 
      	$	
                                  2,760

                                	 
      
	
                                  Mailing

                                	 	
                                  per
      letter

                                	 
      	 
      	
                                  1.50

                                	 
      	
                                  251.00

                                	 
      	$	
                                  377

                                	 
      
	
                                  Courier

                                	 	
                                  per
      package

                                	 
      	 
      	
                                  20.00

                                	 
      	
                                  138.00

                                	 
      	$	
                                  2,760

                                	 
      
	
                                  Newsletters

                                	 	
                                  per
      newsletter

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Regulatory
      Binders

                                	 	
                                  per
      site

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Study
      Reference Binders

                                	 	
                                  per
      site

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Investigator
      Grants

                                	 	
                                  per
      patient

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Ethics
      Committee / IRB Fees

                                	 	
                                  per
      site

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Insurance

                                	 	
                                  per
      site

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Sub-Total

                                	 	 
      	 
      	 
      	 
      	 
      	 
      	 
      	$	
                                  102,242

                                	 
      
	
                                  Investigator’s
      Meeting

                                	 	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Investigator
      Meeting Airfare - site staff (PI business, CRC economy)

                                	 	
                                  per
      person

                                	 
      	 
      	
                                  1,706.00

                                	 
      	
                                  22

                                	 
      	$	
                                  37,532

                                	 
      
	
                                  Investigator
      Meeting Airfare - sponsor staff (all economy)

                                	 	
                                  per
      person

                                	 
      	 
      	
                                  1,341.00

                                	 
      	
                                  9

                                	 
      	$	
                                  12,069

                                	 
      
	
                                  Investigator
      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-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              


      

    

     

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    	
                                            Investigator
      Meeting Hotel - sponsor staff (5 star x 3 nights)

                                          	 	
                                            per
      person

                                          	 	 	900.00	 	9	 	$	8,100	 
	
                                            Transportation
      and meals

                                          	 	
                                            per
      person

                                          	 	 	600.00	 	31	 	$	18,600	 
	
                                            Sub-Total

                                          	 	 	 	 	 	 	 	 	$	96,101	 
	 
      	 	 	 	 	 	 	 	 	 	 	 
	
                                            Vendors
      (non-affiliated)

                                          	 	 	 	 	 	 	 	 	 	 	 
	
                                            Translations

                                          	 	
                                            ICF

                                          	 	 	
                                            unsourced

                                          	 	 	 	$	4,500	 
	
                                            Central
      Laboratory Service (PK Lab)

                                          	 	
                                            per
      patient

                                          	 	 	
                                            unsourced

                                          	 	 	 	
                                            unk

                                          	 
	
                                            IVRS
      Vendor

                                          	 	
                                            N/A

                                          	 	 	 	 	 	 	 	 	 
	
                                            Drug
      Distribution Vendor

                                          	 	
                                            N/A

                                          	 	 	 	 	 	 	 	 	 
	
                                            Sub-Total

                                          	 	 	 	 	 	 	 	 	$	165,792	 
	
                                            Total
      Pass-Through Expenses (CDN)

                                          	 	 	 	 	 	 	 	 	$	202,843	 
	 
      	 	 	 	 	 	 	 	 	 	 	 
	
                                            Total
      Project (CDN)

                                          	 	 	 	 	 	 	 	 	$	1,525,760	 


                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    CONFIDENTIAL 

    
      

    

    
      
         


      

      
        Page 39
of 42

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      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 15th of 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-WO1-29MAR2007-2.3

              
	
                Version
      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 2007

              
	 
      	 
      	 
      	 
      	 
      
	
                Name/Title: 

              	
                CHAIR
      & CEO

              	 
      	
                Name/Title: 

              	
                Jeff
      Smith/President

              
	 
      	 
      	 
      	 
      	 
      
	
                I 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-WO1-29MAR2007-2.3

                  
	
                    Version
      Date:

                  	
                    02APR2007

                  	
                    Work
      Order #:

                  	
                    01

                  


          

        

      

    

    


    11.
Letter of Intent

     

    
      

    

     

    CONFIDENTIAL

    
      

    

    
      
         


      

      
        Page 42
of 42