Document:

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-quailty 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

        
          
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          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

      
        
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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

            

    

    

    
      	
            	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

    
      
 Page
      6 of 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 42

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

    
      	
              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 channeled. 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

      
        
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        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.

     

    
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        11 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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        12 of 42

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

    
      	
              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

              

      

    

     

    
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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.

     

    
      
         

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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.

     

    
       

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

     

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

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

     

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

     

    Clinical
      Operations Associates

     

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

     

    Quality
      Assurance

     

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

     

    
       

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        16 of 42

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    
      

      
        	
                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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          17 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

                    	
                      [*]

                    	 
	
                      Location
                        of sites

                    	 	
                      
                        [*]

                      

                    
	
                      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

          
            
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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
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              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
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              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

              
	
                Enrollment
                  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

              	 	
                $

              	
                
                  [*]

                

              
	
                COA
                  

              	 	
                Clinical
                  Operations Associate

              	 	
                $

              	
                
                  [*]

                

              
	
                CRA
                  

              	 	
                Clinical
                  Research Associate

              	 	
                $

              	
                
                  [*]

                

              
	
                DM
                  

              	 	
                Data
                  Manager

              	 	
                $

              	
                
                  [*]

                

              
	
                MW
                  

              	 	
                Medical
                  Writing

              	 	
                $

              	
                
                  [*]

                

              
	
                PM

              	 	
                Project
                  Manager

              	 	
                $

              	
                
                  [*]

                

              
	
                RA

              	 	
                Regulatory
                  Affairs

              	 	
                $

              	
                
                  [*]

                

              
	
                DS

              	 	
                Drug
                  Safety

              	 	
                $

              	
                
                  [*]

                

              
	
                QA

              	 	
                Quality
                  Assurance Auditor

              	 	
                $

              	
                
                  [*]

                

              
	
                BlO

              	 	
                Biostatistician

              	 	
                $

              	
                
                  [*]

                

              
	
                ACE

              	 	
                Trainer

              	 	
                $

              	
                
                  [*]

                

              
	
                MM

              	 	
                Medical
                  Monitor

              	 	
                $

              	
                
                  [*]

                

              

      

    

     

    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

              	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                Montior
                  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 clarfication/ 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

              	 	 	 	 	 	 	 	 	 	 	 	 	 	
                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
                Reciept 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

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Vendors
                Selection

            	 	 	
              32

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Investigator’s
                Meeting

            	 	 	
              85

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Ethics

            	 	 	
              0

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Co-Initiation/IMV/COV

            	 	 	
              54

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Ad
                hoc meetings

            	 	 	
              72

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Safety
                - SAE

            	 	 	
              150

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Safety
                - DSMB

            	 	 	
              0

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              General

            	 	 	
              1287

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Sub
                Total

            	 	 	
              1,810

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Regulatory
                Affairs (RA) 

            	 	 	 	 	 	 	 	 	 	 
	
              Health
                Canada Submission

            	 	 	
              0

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Sub
                Total

            	 	 	
              0

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Clinical
                Monitoring (CRA)

            	 	 	 	 	 	 	 	 	 	 
	
              Pre-Study
                Activities

            	 	 	
              24

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Investigator’s
                Meeting

            	 	 	
              102

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Site
                Selection Visits

            	 	 	
              0

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Initiation
                Visit

            	 	 	
              209

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Interim
                Monitoring

            	 	 	
              4580

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Close-Out
                Visit

            	 	 	
              242

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Sub
                Total

            	 	 	
              5157

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Clinical
                Operations Associate (COA)

            	 	 	 	 	 	 	 	 	 	 
	
              Pre-Study
                Activities

            	 	 	
              65

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Investigator’s
                Meeting

            	 	 	
              84

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              DSMB

            	 	 	
              0

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              General

            	 	 	
              622

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Data
                Management

            	 	 	
              100

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 
	
              Sub
                Total

            	 	 	
              871

            	 	
              $

            	
              
                [*]

              

            	 	
              $

            	
              
                [*]

              

            	 

    

    

    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

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Site
                  Training

              	 	 	
                0

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                [Illegible]

              	 	 	
                [Illegible]

              	 	 	
                
                  [*]

                

              	 	 	
                
                  [*]

                

              	 
	
                Quality
                  Assurance (QA)

              	 	 	 	 	 	 	 	 	 	 
	
                Vendor
                  Audits

              	 	 	
                52

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Site
                  Audits

              	 	 	
                160

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                TMF
                  Audit

              	 	 	
                0

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                
                  [Illegible]

                

              	 	 	
                [Illegible]

              	 	 	
                
                  [*]

                

              	 	 	
                
                  [*]

                

              	 
	
                Drug
                  Safety – Management

              	 	 	 	 	 	 	 	 	 	 
	
                Drug
                  Safety

              	 	 	
                175

              	 	
                $

              	
                
                  [*]

                

              	 	 	
                
                  [*]

                

              	 
	
                
                  [Illegible]

                

              	 	 	
                [Illegible]

              	 	 	
                
                  [*]

                

              	 	 	
                
                  [*]

                

              	 
	
                Drug
                  Safety - Medical 

              	 	 	 	 	 	 	 	 	 	 
	
                Investigator’s
                  Meeting

              	 	 	
                26

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Medical
                  Monitoring

              	 	 	
                511

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                DSMB

              	 	 	
                0

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Data
                  Management

              	 	 	
                50

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                
                  [Illegible]

                

              	 	 	
                [Illegible]

              	 	 	
                
                  [*]

                

              	 	 	
                
                  [*]

                

              	 
	
                Medical
                  Writing

              	 	 	 	 	 	 	 	 	 	 
	
                Professional
                  Services

              	 	 	
                160

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                
                  [Illegible]

                

              	 	 	
                [Illegible]

              	 	 	
                
                  [*]

                

              	 	 	
                
                  [*]

                

              	 
	
                Data
                  Management

              	 	 	 	 	 	 	 	 	 	 
	
                Investigator’s
                  Meeting

              	 	 	
                0

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Double
                  Data Entry

              	 	 	
                700

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Professional
                  Services

              	 	 	
                401

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Site
                  Set-up (licenses)

              	 	 	
                
                  [*] sites

                

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                [Illegible]

              	 	 	
                [Illegible]

              	 	 	
                
                  [*]

                

              	 	 	
                
                  [*]

                

              	 
	
                Biostatistician

              	 	 	 	 	 	 	 	 	 	 
	
                Data
                  Management

              	 	 	
                0

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Professional
                  Services

              	 	 	
                246

              	 	
                $

              	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                
                  [Illegible]

                

              	 	 	
                [Illegible]

              	 	 	
                
                  [*]

                

              	 	 	
                
                  [*]

                

              	 
	
                Radiology
                  Review

              	 	 	 	 	 	
                
                  [*]

                

              	 	
                $

              	
                
                  [*]

                

              	 
	
                Radiology
                  Review

              	 	 	 	 	 	 	 	 	 	 
	
                Total
                  Project Services
                  Fees     

              	
                $

              	
                
                  [*]

                

              	 

      

    

    

    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

            	 	 	
              
                [*]

              

            	 	 	
              229.00

            	 	
              $

            	
              
                [*]

              

            	 
	
              Monitor
                Meal Expenses

            	 	 	
              per
                day

            	 	 	
              
                [*]

              

            	 	 	
              229.00

            	 	
              $

            	
              
                [*]

              

            	 
	
              Monitor
                Overnight Expenses (i.e. hotel)

            	 	 	
              30%

            	
               

            	 	
              
                [*]

              

            	 	 	
              69.00

            	 	
              $

            	
              
                [*]

              

            	 
	
              Monitor
                Meal Expenses (overnight)

            	 	 	
              per
                day

            	 	 	
              
                [*]

              

            	 	 	
              69.00

            	 	
              $

            	
              
                [*]

              

            	 
	
              Quality
                Assurance / Site Audit Travel

            	 	 	
              per
                trip

            	 	 	
              
                [*]

              

            	 	 	
              6.00

            	 	
              $

            	
              
                [*]

              

            	 
	
              Allphase
                & Client Meeting Expenses

            	 	 	
              per
                person

            	 	 	
              
                [*]

              

            	 	 	
              4.00

            	 	
              $

            	
              
                [*]

              

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

            	 	 	
              per
                month

            	 	 	
              
                [*]

              

            	 	 	
              26.00

            	 	
              $

            	
              
                [*]

              

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

            	 	 	
              per
                month

            	 	 	
              
                [*]

              

            	 	 	
              6.50

            	 	
              $

            	
              
                [*]

              

            	 
	
              Teleconferences

            	 	 	
              per
                conf.

            	 	 	
              
                [*]

              

            	 	 	
              69.00

            	 	
              $

            	
              
                [*]

              

            	 
	
              Mailing

            	 	 	
              per
                letter

            	 	 	
              
                [*]

              

            	 	 	
              251.00

            	 	
              $

            	
              
                [*]

              

            	 
	
              Courier

            	 	 	
              per
                package

            	 	 	
              
                [*]

              

            	 	 	
              138.00

            	 	
              $

            	
              
                [*]

              

            	 
	
              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

            	 	 	
               

            	 	 	 	 	 	 	 	
              $

            	
              
                [*]

              

            	 
	
              Investigator’s
                Meeting

            	 	 	
               

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

            	 	 	
              per
                person

            	 	 	
              
                [*]

              

            	 	 	
              22

            	 	
              $

            	
              
                [*]

              

            	 
	
              Investigator
                Meeting Airfare - sponsor staff (all economy)

            	 	 	
              per
                person

            	 	 	
              
                [*]

              

            	 	 	
              9

            	 	
              $

            	
              
                [*]

              

            	 
	
              Investigator
                Meeting Hotel - site staff

              (5
                star x 3 nights)

            	 	 	
              per
                person

            	 	 	
              
                [*]

              

            	 	 	
              22

            	 	
              $

            	
              
                [*]

              

            	 

    

     

    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

            	 	 	
              
                [*]

              

            	 	 	
              9

            	 	
              $

            	
              
                [*]

              

            	 
	
              Transportation
                and meals

            	 	 	
              per
                person

            	 	 	
              
                [*]

              

            	 	 	
              31

            	 	
              $

            	
              
                [*]

              

            	 
	
              Sub-Total

            	 	 	 	 	 	 	 	 	 	 	
              $

            	
              
                [*]

              

            	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              Vendors
                (non-affiliated)

            	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              Translations

            	 	 	
              ICF

            	 	 	
              
                [*]

              

            	 	 	 	 	
              $

            	
              
                [*]

              

            	 
	
              Central
                Laboratory Service (PK Lab)

            	 	 	
              per
                patient

            	 	 	
              
                [*]

              

            	 	 	 	 	 	
              
                [*]

              

            	 
	
              IVRS
                Vendor

            	 	 	
              N/A

            	 	 	 	 	 	 	 	 	 	 
	
              Drug
                Distribution Vendor

            	 	 	
              N/A

            	 	 	 	 	 	 	 	 	 	 
	
              Sub-Total

            	 	 	 	 	 	 	 	 	 	 	
              $

            	
              
                [*]

              

            	 
	
              Total
                Pass-Through Expenses (CDN)

            	 	 	 	 	 	 	 	 	 	 	
              $

            	
              
                [*]

              

            	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
              Total
                Project (CDN)

            	 	 	 	 	 	 	 	 	 	 	
              $

            	
              
                [*]

              

            	 

    

    
       

      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 [*]% ([*]) 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	
              [*]%
                per month financing fee may be applied to outstanding balance
                owing.

            

    

    
      	o	
              Sponsor
                authorization will be obtained if budget exceeds [*]% 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
      endeavor 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 42Work
      Order #1

    Dated
      November 9, 2007

    

    The
      services described herein will be provided in accordance with the terms and
      conditions of the Master Services Agreement, dated August 24, 2007, between
      AAIPharma Inc., on behalf of itself and its subsidiaries (collectively,
‘AAIPharma’) and YM Biosciences USA Inc. (hereinafter referred to as “YMB
      USA”).

    

    The
      following documents are attached to this Work Order and shall be incorporated
      herein:

    

    
      	
              Attachment I

            	
              Final
                Scope of Work, including the description of Services to be provided
                and
                timeline

            

    

    

    
      	
              Attachment II

            	
              Budget
                and Payment Terms for the Final Scope of
                Work

            

    

    

    All
      terms
      and conditions provided in the Master Services Agreement executed by the parties
      with an Effective Date of August 24, 2007 remain unmodified and in full force
      and effect.

    

    ACKNOWLEDGED,
      ACCEPTED AND AGREED TO:

    

    AAIPharma
      Inc.

    

    
      	 	 	 
	
              Signature

            	 	
              Date

            
	 	 	 
	 	 	 
	
              Name

            	 	 
	 	 	 
	 	 	 
	
              Title

            	 	 

    

    

    YM
      Biosciences USA Inc.  

    

    
      	
              
                /s/
                  David G.P. Allan

              

            	 	
              [ILLEGIBLE]

            
	
              Signature

            	 	
              Date

            
	 	 	 
	
              
                David
                  G.P. Allan

              

            	 	 
	
              Name

            	 	 
	 	 	 
	
              
                CHAIR
                  & CEO

              

            	 	 
	
              Title

            	 	 

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    ATTACHMENT
      I to Work Order #1

    Final
      Scope of Work

    

    Protocol
      No. YMB USA1000/009
      entitled
“Phase II Study of Safety and Efficacy of Nimotuzumab
      (TheraCIM®) In Pediatric Patients with Recurrent Diffuse Intrinsic Pontine
      Glioma”

    

    SCOPE
      OF WORK:

    

    
      	
              
                ·

              

            	
              Project
                Management (USA)

            	 	
              
                ·

              

            	
              Medical
                Monitoring (USA)

            
	
              
                ·

              

            	
              Clinical
                Monitoring (USA)

            	 	
              
                ·

              

            	
              Pharmacovigilance
                (inc OC AERS set-up/maintenance)

            
	
              
                ·

              

            	
              Data
                Management

            	 	
              
                ·

              

            	
              Medical
                Writing

            
	
              
                ·

              

            	
              Biostatistics

            	 	
              
                ·

              

            	
              Clinical
                Trial Material Distribution (USA)

            

    

    

    STUDY
      PARAMETERS:

     

    
      	PARAMETERS: 	 
	
              Number
                of Completed Patients:

            	
              44

            
	 	
              (30
                USA patients)

            
	
              Number
                of Investigative Sites: 

            	
              [*]

            
	 	
              (
                
                [*]
                  USA)

              

            
	
              Estimated
                Number of Total CRF Pages Per Patient: 

            	
              150

            
	
              Estimated
                Number of Unique CRF Pages Per Patient: 

            	
              25

            
	
              Total
                Number of CRF Pages: 

            	
              6,600

            
	
              Estimated
                Number of Queries: 

            	
              1,320

            
	
              Total
                Number of Serious Adverse Events: 

            	
              
                [*]

              

            
	
              Total
                Number of Face-to-Face Project Meetings

              (alternating
                between AAIPharma and YMB USA): 

            	
              4
                with PM 
                2
                  with Team

              

            
	
              Total
                Number of Teleconferences: 

            	
              47
                with PM/RA (24 inc. Team)

            
	
              USA
                SITES

            	 
	
              Total
                Number of Qualification Site Assessment (QSA)

            	 
	
              Visits:

            	
              To
                be performed during Initiation Visit

            
	 	 
	
              Total
                Number of Initiation Visits:

            	
              8

            
	 	 
	
              Total
                Number of Interim Visits:

            	
              Average
                5 two-day Visits per site

            
	 	 
	
              Total
                Number of Closeout Visits:

            	
              8

            
	 	 
	
              Total
                Number of Tables: 

            	
              30

            
	
              Total
                Number of Listings: 

            	
              25

            
	
              Total
                Number of Figures:

            	
              5

            
	
              Total
                Number of Outputs:

            	
              5

            

    

    

    
      	
              AAIPharma/YMB
                USA Work Order #1 R3

            	
              Page
                1 of 5

            
	
              Attachment
                I

            	 
	 	 

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    TIMELINE

    

    
      	TIME
              LINE	 
	
              Project
                Award (LOI executed):

            	
              August
                27, 2007

            
	
              Study
                Start-up:

            	
              3
                months

            
	
              Patient
                Enrollment Duration: 

            	
              14
                months

            
	
              Patient
                Treatment Duration:

            	
              Up
                to 4.5 months (18 weeks)

            
	
              Follow-up
                Duration:

            	
              Up
                to 4 months

            
	
              Database
                Lock:

            	
              1
                month after last CRF in-house

            
	
              Draft
                Tables, Listings and Figures1:

            	
              3
                Weeks from Database Lock

            
	
              Final
                Tables, Listings and Figures1:

            	
              2
                Weeks from Receipt of YMB USA’s
                Comments

            
	
              Draft
                Report1:

            	
              4
                Weeks from Final Tables, Listings and Figures

            
	
              Final
                Report1:

            	
              2
                Weeks from Receipt of YMB USA’s Comments

            
	
              TOTAL
                PROJECT DURATION

            	
              29
                months

            

    

    

    1Assumes
      an optimized collaborative process between AAIPharma and YMB USA during
      statistical analysis, results reviews, and report planning and
      generation.

    

    TASK
      OWNERSHIP

    

    Study
      Setup (services to achieve the “First Patient Enrolled”
milestone)

    

    
      	
              Service

            	 	
              YMB
                USA

              Responsibility

            	 	
              AAIPharma

              Responsibility

            
	
              Kickoff
                Meeting

            	 	
              ü

            	 	
              ü

            
	
              Prepare
                Project Operational Plan (POP)

            	 	 	 	
              ü

            
	
              CRF
                Design

            	 	 	 	
              ü

            
	
              CRF
                Printing and Shipping

            	 	 	 	
              ü

            
	
              Develop
                Model Informed Consent Form

            	 	 	 	
              ü

            
	
              Investigator
                Selection

            	 	
              ü

            	 	 
	
              Conduct
                Qualifying Site Assessment Visits (USA Sites)

            	 	 	 	
              Performed
                at

              Initiation
                Visit

            
	
              Collect/Review
                Regulatory Documents (USA Sites)

            	 	 	 	
              ü

            

    

    

    
      	
              AAIPharma/YMB
                USA Work Order #1 R3

            	
              Page
                2 of 5

            
	
              Attachment
                I

            	 

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

    
      	Service	 	
              YMB
                USA

              Responsibility

            	 	
              AAIPharma

              
                Responsibility

              

            
	
              Maintain
                Trial Master File (USA Sites)

            	 	 	 	
              ü

            
	
              File
                Regulatory Documents with FDA

            	 	
              ü

            	 	 
	
              Coordinate
                Investigational Product Packaging/Shipping 

            	 	
              ü

            	 	
              US
                Sites

            
	
              
                ·    Client
                  will provide ready-to distribute clinical supplies

              

            	 	 	 	 
	
              
                ·    storage
                  at
                  2-8C

              

            	 	 	 	 
	
              
                ·    Distribution
                  performed at 2-8C w/ temperature monitoring required

              

            	 	 	 	 
	
              
                ·    Drug
                  return
                  activities and destruction not required

              

            	 	 	 	 
	
              Assist
                sites with IRB requirements

            	 	 	 	
              ü

            
	
              Negotiate
                Site Agreements

            	 	
              ü

            	 	 
	
              Execute
                Site Agreements

            	 	
              ü

            	 	 
	
              Plan
                and Coordinate Investigators’ Meeting

            	 	
              ü

            	 	 
	
              Attend
                Investigators’ Meeting

            	 	
              ü

            	 	
              ü

            
	 	 	 	 	
              5
                attendees

            
	
              Attend
                Training Meeting

            	 	
              ü

            	 	
              ü

            
	
              Conduct
                Initiation Visits with Medical Monitor

            	 	 	 	
              US
                Sites

            
	
              Develop
                Monitor Guidelines and Source Document Verification Plan
                (SDVP)

            	 	 	 	
              ü

            
	
              Database
                Design

            	 	 	 	
              ü

            
	
              Data
                Management Operational Plan (DMOP)

            	 	 	 	
              ü

            
	
              Generate
                Statistical Analysis Plan

            	 	 	 	
              ü

            

    

    

    Ongoing
      Study Management (Services from First Patient Enrolled through Database
      Lock)  

    

    
      	Service	 	
              YMB
                USA

              Responsibility

            	 	
              AAIPharma

              
                Responsibility

              

            
	
              Provide
                Interim Monitoring Visits (USA Sites)

            	 	 	 	
              ü

            
	
              Provide
                Ongoing Site Management Services (USA

            	 	 	 	
              ü

            
	
              Sites)

            	 	 	 	 
	
              Administer
                Payments of Investigator Grants

            	 	
              ü

            	 	 
	
              Provide
                Status Reports to YMB USA

            	 	
              ü

            	 	 
	
              Provide
                Medical Management (USA)

            	 	 	 	
              ü

            
	
              Set-up
                and Maintain Oracle AERS Database

            	 	 	 	
              ü

            
	
              Provide
                SAE Management

            	 	 	 	
              ü

            
	
              Preparation
                of SAE narratives

            	 	 	 	
              ü

            

    

    

    
      	
              AAIPharma/YMB
                USA Work Order #1 R3

              Attachment
                I

            	
              Page
                3 of 5

            

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

    
      	Service	 	
              YMB
                USA

              Responsibility

            	 	
              AAIPharma

              
                Responsibility

              

            
	
              Filing
                of SAE Reports with the FDA

            	 	
              ü

            	 	 
	
              Participate
                in Project Team Meetings

            	 	
              ü

            	 	
              ü

            
	
              Participate
                in Teleconferences

            	 	
              ü

            	 	
              ü

            
	
              Provide
                Quality Assurance Site Audits

            	 	 	 	
              ü

            
	
              CRF
                and Query Scanning, Tracking, and Storage

            	 	 	 	
              ü

            
	
              Data
                Entry

            	 	 	 	
              ü

            
	
              Data
                Verification

            	 	 	 	
              ü

            
	
              Integration
                of External Electronic Data

            	 	 	 	
              ü

            
	
              Data
                Validation

            	 	 	 	
              ü

            
	
              Data
                Coding

            	 	 	 	
              ü

            
	
              SAE
                Report Reconciliation against CRF Data

            	 	 	 	
              ü

            
	
              Database
                Quality Control Audit

            	 	 	 	
              ü

            
	
              Provide
                Clean, Locked Database to YMB USA

            	 	 	 	
              ü

            
	
              Quality
                Assurance Site Audits

            	 	 	 	
              ü

            
	 	 	 	 	
              Optional

            
	
              Advance
                Planning for Study Report 

            	 	
              ü

            	 	
              ü

            

    

    

    
      	
              AAIPharma/YMB
                USA Work Order #1 R3

            	
              Page
                4 of 5

            
	
              Attachment
                I

            	 

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    Study
      Closeout Services (Services from Database Lock to final
      Deliverable)

    

    
      	Service	 	
              YMB
                USA

              Responsibility

            	 	
              AAIPharma

              Responsibility

            
	
              Conduct
                Study Closeout Visits (USA Sites)

            	 	 	 	
              ü

            
	
              Generate
                Statistical Tables, Listings, and Figures

            	 	 	 	
              ü

            
	
              Attend
                Results Review Meeting

            	 	
              ü

            	 	
              ü

            
	
              Generate
                Draft Clinical Study Report (CSR)

            	 	 	 	
              ü

            
	
              Comment
                on Draft CSR

            	 	
              ü

            	 	 
	
              Finalize
                Clinical Study Report

            	 	 	 	
              ü

            
	
              Prepare
                and Transfer SAS Code

            	 	 	 	
              ü

            
	
              Study
                Closeout Meeting

            	 	
              ü

            	 	
              ü

            

    

    

    
      	
              AAIPharma/YMB
                USA Work Order #1 R3

              Attachment
                I

            	
              Page
                5 of 5

            

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    ATTACHMENT
      II to Work Order #1

    Budget
      and Payment Terms for the Final Scope of Work

     

    ESTIMATED
      BUDGET

    

    [Intentionally
      Left Blank]

    

    
      	
              AAIPharma/YMB
                USA Work Order #1 R2

            	 
	
              Attachment
                II

            	 

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

    ESTIMATED
      BUDGET

    

    YM
      Biosciences - 07-138.R3 dated November 8, 2007

    #Sites

    #CRFs

    

    
      	
              44

            	 	
              Total
                Enrolled Patients

            
	
              30

            	 	
              Total
                US Patients

            
	
              8

            	 	
              US
                Sites

            
	
              6,600

            	 	
              Total
                CRF Pages

            
	
              29

            	 	
              Months
                Study Duration

            

    

    

    
      	
            	 	
              ESTIMATED
                BUDGET

            	 
	
              PROJECT
                MANAGEMENT

            	 	 	 	 	 	
              
                [*]

              

            	 
	
              PROJECT
                COORDINATION (29 months)

            	 	 	
              
                [*]

              

            	 	 	
            	 
	
              PROJECT
                MEETINGS AND CONFERENCE CALLS

            	 	 	
              
                
                  [*]

                

              

            	 	 	 	 
	 	 	 	 	 	 	 	 
	
              STUDY
                SETUP

            	 	 	 	 	 	
              
                [*]

              

            	 
	
              REGULATORY
                DOCUMENT COLLECTION AND PROCESSING

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              PROJECT
                TEAM TRAINING AND KICK-OFF MEETING

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              INVESTIGATORS
                MEETINGS (US Sites Face-to-Face)

            	 	 	 	 	 	 	 
	
              ATTENDANCE
                & PARTICIPATION

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              COORDINATION
                FEE

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              CRF
                DESIGNS AND INSTRUCTIONS

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              ADMINISTRATION
                & PAYMENT OF LABORATORY

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              ADMINISTRATION
                OF INVESTIGATOR GRANTS

            	 	 	
              
                [*]

              

            	 	 	 	 
	 	 	 	 	 	 	 	 
	
              CLINCAL/MEDICAL
                AFFAIRS

            	 	 	 	 	 	
              
                [*]

              

            	 
	
              QSA/INITIATION
                VISITS (8)

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              MEDICAL
                MONITOR TO ATTEND QSA/INITIATION VISITS

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              INTERIM
                MONITORING VISITS (Average 5 two-day visits per site)

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              CLOSEOUT
                VISITS (8)

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              STATUS
                REPORTS

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              MEDICAL
                MANAGEMENT

            	 	 	
              
                [*]

              

            	
            	 	 	 
	
              SAE
                MANAGEMENT SET-UP AND MAINTENANCE (Oracle AERS)

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              SAE
                MANAGEMENT

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              SAE
                NARRATIVES (Includes MedWatch/CIOMS reports)

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              SITE
                MANAGEMENT

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              CLINICAL
                REGULATORY SITE SUPPORT

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              CLINICAL
                PROJECT COORDINATION

            	 	 	
              
                [*]

              

            	 	 	 	 
	 	 	 	 	 	 	 	 
	
              DATA
                MANAGEMENT & CLINICAL DATA SYSTEMS

            	 	 	 	 	 	
              
                [*]

              

            	 
	
              DATA
                MANAGEMENT OPERATIONAL PLAN

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              DATABASE
                DESIGN, PROGRAMMING AND TESTING

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              DATA
                ENTRY AND VERIFICATION

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              DICTIONARY
                CODING

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              CRF
                AND QUERY TRACKING & INVENTORY VIA SCANNING

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              DATA
                VALIDATION INCLUDING QUERY GENERATION & RESOLUTION

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              MEDICAL
                REVIEW OF CRFs

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              DATABASE
                QUALITY CONTROL AUDIT

            	 	 	
              
                [*]

              

            	
            	 	 	 
	
              EXTERNAL
                DATA INTEGRATION

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              DATA
                MANAGEMENT PROJECT COORDINATION

            	 	 	
              
                [*]

              

            	 	 	 	 
	
              ADMINISTRATIVE

            	 	 	
              
                [*]

              

            	 	 	 	 
	 	 	 	 	 	 	 	 
	
              BIOSTATISTICAL/REPORT
                PREPARATION SERVICES

            	 	 	 	 	 	
              
                [*]

              

            	 
	
              STATISTICAL
                ANALYSIS PLAN

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              STATISTICAL
                TABLES, LISTINGS & PROGRAMMING

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              ANALYSIS
                PRODUCTION

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              INTEGRATED
                CLINICAL/STATISTICAL REPORT

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              RESULTS
                REVIEW MEETING

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              BIOSTATISTICAL/REPORT
                PROJECT COORDINATION

            	
               

            	 	
              
                [*]

              

            	 	 	 	 
	 	 	 	 	 	 	 	 
	
              TOTAL
                ESTIMATED BUDGET

            	 	 	
              
                [*]

              

            	 	 	 	 
	 	 	 	 	 	 	 	 
	
              ADDITIONAL
                SERVICES

            	 	 	 	 	 	 	 
	
              CLINICAL
                TRIAL MATERIAL DISTRIBUTION TO US SITES

            	 	 	
              
                [*]

              

            	 	 	 	 
	 	 	 	 	 	 	 	 
	
              TOTAL
                ESTIMATED BUDGET EXCLUSIVE OF PASS THROUGH
                EXPENSES

            	 	 	
              
                [*]

              

            	 	 	 	 
	 	 	 	 	 	 	 	 
	
              ESTIMATED
                PASS THROUGH EXPENSES

            	
               

            	
               

            	
               

            	
               

            	
               

            	
              
                [*]

              

            	
               

            
	
              INVESTIGATOR
                MEETING (incidentals @$100/attendee)

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              MONITOR
                TRAVEL

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              MEDICAL
                MONITOR TRAVEL (8 VISITs)

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              CRF
                PRINTING AND SHIPPING

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              PROJECT
                MEETING EXPENSES

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            
	
              TOTAL
                ESTIMATED BUDGET

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            
	
              OPTIONAL
                COSTS

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            
	
              CLINICAL
                INTERIM MONITORING

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            
	
              ADDITIONAL
                VISIT PER PATIENT (From 1 to 2 Visits per Patient)

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              SITE
                VISIT TRAVEL

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              QUALITY
                ASSURANCE

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            	
               

            
	
              INVESTIGATOR
                SITE VISITS

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	
               

            	
               

            
	
              SITE
                VISIT TRAVEL

            	
               

            	
               

            	
              
                [*]

              

            	
               

            	
               

            	 	 

    

    

    AAIPharma/YMB
      USA Work Order #1 R2

    Attachment
      II

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    Payment
      Schedule

    YM
      Biosciences

    YMB1000/009

    

    
      	 	 	
              First
                Budget

            	 
	
              Direct
                Costs:

            	 	
              USD

            	 
	 	 	 	 
	
              Execution
                of WorkOrder  

            	 	$	
              [*]

            	 
	
              Milestones:

            	 	 	 	 
	
              Monthly
                Maintence Fee (Project Management, Site Management, PVG, QA and Medical
                Overview)

            	 	 	 	 
	
              $[*]month
                for [*]
                months (Sept-07-Jan-07)  

            	 	$	
              [*]

            	 
	
              Clinical:

            	 	 	 	 
	
              Completion
                of Base Documents 

            	 	
              $

            	
              
                [*]

              

            	 
	
              First
                Site Initiated 

            	 	
              $

            	
              
                [*]

              

            	 
	
              100%
                Sites Initiated 

            	 	
              $

            	
              
                [*]

              

            	 
	
              First
                Patient Enrolled 

            	 	
              $

            	
              
                [*]

              

            	 
	
              20%
                Monitoring Visits Completed 

            	 	
              $

            	
              
                [*]

              

            	 
	
              40%
                Monitoring Visits Completed 

            	 	
              $

            	
              
                [*]

              

            	 
	
              60%
                Monitoring Visits Completed 

            	 	
              $

            	
              
                [*]

              

            	 
	
              80%
                Monitoring Visits Completed 

            	 	
              $

            	
              
                [*]

              

            	 
	
              100%
                Monitoring Visits Completed 

            	 	
              $

            	
              
                [*]

              

            	 
	
              All
                Sites Closed-out 

            	 	
              $

            	
              
                [*]

              

            	 
	
              Database
                Set-Up 

            	 	
              $

            	
              
                [*]

              

            	 
	
              50%
                CRFs Completed 

            	 	
              $

            	
              
                [*]

              

            	 
	
              100%
                CRFs Completed 

            	 	
              $

            	
              
                [*]

              

            	 
	
              Database
                Lock 

            	 	
              $

            	
              
                [*]

              

            	 
	
              Clinical
                Study Report 

            	 	
              $

            	
              
                [*]

              

            	 
	
              Total
                Direct Costs

            	 	
              $

            	
              
                [*]

              

            	 

    

    

    AAIPharma/YMB
      USA Work Order #1 R2

    Attachment
      II

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00147-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00147-of-00352.parquet"}]]