ALLPHASE

      Clinical
Research

      


      YM
BIOSCIENCES INC.

      


      PROPOSAL
SUMMARY PR2

      (Detailed)

      


      Brain
Metastases from NSCLC

      


      A
Randomized Phase II, Double-Blind Study Nimotuzumab Plus Whole-

      Brain
Radiation Therapy (WBRT) Compared With WBRT Alone in Patient

      With
Brain Metastases From Non-Small Cell Lung Cancer.

      


      December
16th,
2008

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

      


      1.
Proposal Details

      


      
        
          
            	
                    Title:

                  	 
      	
                    A
      Randomized Phase II, Double-Blind Study Nimotuzumab Plus
      Whole-Brain
      Radiation Therapy (WBRT) Compared With WBRT Alone in Patient With
      Brain Metastases From Non-Small Cell Lung Cancer.

                  
	 
      	 
      	 
      
	
                    Customer:

                  	 
      	
                    YM
      BIOSCIENCES INC.

                  
	 
      	 
      	 
      
	
                    MSA
      #:

                  	 
      	
                    YMB07-MSA-17MAY2007

                  
	 
      	 
      	 
      
	
                    MSA
      Expiry Date:

                  	 
      	
                    Project
      Completion or Termination

                  
	 
      	 
      	 
      
	
                    Proposal
      No.:

                  	 
      	
                    YMB08-WO5-15DEC2008-3.0

                  
	 
      	 
      	 
      
	
                    Customer Reference:

                  	 
      	
                    YMB08-W04

                  
	 
      	 
      	 
      
	
                    Confidentiality:

                  	 
      	
                    Restricted
      - Commercial Copyright and Reproduction

                     

                    This
      proposal is submitted by Allphase Clinical Research Inc. in response to
      the invitation issued by Ryan Sukhoo MD, Clinical Project Manager, YM
      BIOSCIENCES INC. 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:

                  	 
      	
                    16DEC2008

                  
	 
      	 
      	 
      
	
                    Version:

                  	 
      	
                    3.0

                  
	 
      	 
      	 
      
	
                    Validity:

                  	 
      	
                    90
      days

                  
	 
      	 
      	 
      
	
                    CRO
      Address:

                  	 
      	
                    Allphase
      Clinical Research Services Inc.

                    1145
      Hunt Club Road, Suite 600

                    Ottawa,
      ON Canada K1V 0Y3

                    P:
      (613) 228-1990 x 100

                    F:
      (6l3) 228-8493

                    C:
      (613) 291-2362

                    Email:
      jsmith@allphaseclinical.com

                  
	 
      	 
      	 
      
	
                    Approved
      by:

                  	 
      	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	
                    Jeff
      Smith

                    President

                  	 
      	
                    Date

                  


          

        

      

       

      CONFIDENTIAL

      
        
          

        

        Page 2 of
36

         

        
          
            
            

          

          
            
            

            
              

            

          

          
            
            

          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      2.
Requested 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:

      
        	
                 
      

              	
                ·

              	
                IND/CTA
      maintenance;

              


      

      
        	
                 
      

              	
                ·

              	
                Collaborative
      interaction with regulatory authorities and
  IRBs;

              


      

      
        	
                 
      

              	
                ·

              	
                Investigator
      site selection and feasibility
assessments;

              


      

      
        	
                 
      

              	
                ·

              	
                Regulatory
      document package design (site
level);

              


      

      
        	
                 
      

              	
                ·

              	
                Contract
      and budget preparation, negotiation, and
  administration;

              


      

      
        	
                 
      

              	
                ·

              	
                Investigator
      meeting organization and site
training;

              


      

      
        	
                 
      

              	
                ·

              	
                CRA
      resourcing, mentoring, and co-monitoring
  support;

              


      

      
        	
                 
      

              	
                ·

              	
                Monitoring
      report review;

              


      

      
        	
                 
      

              	
                ·

              	
                SAE
      reporting coordination;

              


      

      
        	
                 
      

              	
                ·

              	
                Coordination
      of site/ vendor/ client communications;
and

              


      

      
        	
                 
      

              	
                ·

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

              


      

      


      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:

      
        	
                 
      

              	
                ·

              	
                Site
      initiation, routine monitoring, and
close-out;

              


      

      
        	
                 
      

              	
                ·

              	
                Site
      personnel training, mentoring, and
guidance;

              


      

      
        	
                 
      

              	
                ·

              	
                Assessing
      protocol compliance and data
integrity;

              


      

      
        	
                 
      

              	
                ·

              	
                Regulatory
      document review;

              


      

      
        	
                 
      

              	
                ·

              	
                Pharmacy
      training and drug accountability;
and

              


      

      
        	
                 
      

              	
                ·

              	
                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.

      
         

        CONFIDENTIAL

        
          
            

          

          Page 3 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      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.

      


      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:

      
        	
                 
      

              	
                ·

              	
                Evaluation
      and auditing of our 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).

              


      

      
        	
                 
      

              	
                ·

              	
                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.

              


      

      
         

        CONFIDENTIAL

        
          
            

          

          Page 4 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      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:

      
        	
                 
      

              	
                ·

              	
                Statistical
      Design and Analysis;

              


      

      
        	
                 
      

              	
                ·

              	
                Therapeutically
      aligned Medical Monitoring;

              


      

      
        	
                 
      

              	
                ·

              	
                DSMB;

              


      

      
        	
                 
      

              	
                ·

              	
                Clinical
      laboratory services;

              


      

      
        	
                 
      

              	
                ·

              	
                Investigational
      Product Distribution;

              


      

      
        	
                 
      

              	
                ·

              	
                IVRS;

              


      

      
        	
                 
      

              	
                ·

              	
                Home
      Health Care network;

              


      

      
        	
                 
      

              	
                ·

              	
                Ethics
      Review Boards;

              


      

      
        	
                 
      

              	
                ·

              	
                Translation
      services;

              


      

      
        	
                 
      

              	
                ·

              	
                Global
      provider network;

              


      

      
        	
                 
      

              	
                ·

              	
                DocStorage.ca

              


      

      


      Operational
Support and Web Portal

      


      Our
Clinical Operations Associates (COAs) fill a crucial supportive role to all
members of the team. COAs work to streamline the process of preparing clinical
documents. COAs assist the Medical Writing team to assemble the necessary
components of clinical documents and manage the communication with third party
publishing groups.

      


      As draft
documents are completed, they call be posted to a secure, client-specific web
site. Clients requesting this value-added service can access a secure
bi-directional web portal at their convenience, with a username and password.
Use of this system allows for efficient review of draft documents and alleviates
the need to transfer large attachments across email servers.

      


      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 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.

      
         

        CONFIDENTIAL

        
          
            

          

          Page 5 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      3.
Therapeutic Experience

       

      Allphase
Clinical Research has conducted studies in a variety of therapeutic areas
including:

      


      
        
          
            
              
                
                  
                    
                      
                        	
                                Therapeutic
      Area

                              	 
      	
                                Indications

                              
	
                                Oncology

                              	 
      	
                                Brain

                                Breast

                                Head
      and Neck

                                Ovarian

                                Renal
      Cell Carcinoma

                                Small
      Cell Lung

                                Colorectal

                                Pediatric
      Glioma

                                Bone
      Marrow Transplant

                                Reduction
      of Neurotoxicity

                              
	 	 	 
	
                                Allergy/Respiratory

                              	 
      	
                                Asthma

                                Chronic
      Obstructive Pulmonary Disease

                                Perennial
      Allergic Rhinitis

                                Seasonal
      Allergic Rhinitis

                              
	 	 	 
	
                                Cardiovascular

                              	 
      	
                                Atrial
      Fibrillation

                                Deep
      Vein Thrombosis

                                Intermittent
      Claudication

                                Pulmonary
      Embolism

                                Dyslipidemia

                                Atherosclerosis

                                Venous
      Leg Ulcers

                                Hypercholesterolemia

                              
	 	 	 
	
                                CNS

                              	 
      	
                                Amytrophic
      Lateral Sclerosis

                                Alzheimer’s
      Disease

                                Depression

                                Multiple
      Sclerosis

                                Smoking
      Cessation

                                Insomnia

                                Stroke

                              
	 	 	 
	
                                Endocrinology

                              	 
      	
                                Diabetes

                                Obesity

                              
	 	 	 
	
                                Infectious
      Disease

                              	 
      	
                                Hepatitis

                                HIV

                              
	 	 	 
	
                                Other

                              	 
      	
                                Alpha-1
      Antitrypsin Deficiency

                                Primary
      Immune Deficiency

                                Post-op
      Pediatric Aggregation Inhibition

                                Thrombotic
      Thrombocytopenic Purpura

                                Dilutional
      Hyponatremia

                                Atopic
      Dermatitis

                              


                      

                    

                  

                

              

            

          

        

      

      
         

        CONFIDENTIAL

        
          
            

          

          Page 6 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      Oncology
Experience

       

      
        
          
            
              
                	
                        Therapeutic
      Area

                      	 
      	
                        Phase

                      	 
      	
                        #
      of Sites

                      	 
      	
                        #
      of Subjects

                      
	
                        Small
      Cell Lung Cancer

                      	 
      	
                        I/II

                      	 
      	
                        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

                      	 
      	
                        I

                      	 
      	
                        19

                      
	
                        Ovarian
      Cancer

                      	 
      	
                        II

                      	 
      	
                        7

                      	 
      	
                        40

                      
	
                        Colorectal
      Cancer

                      	 
      	
                        II

                      	 
      	
                        14

                      	 
      	
                        61

                      
	
                        Multiple
      Myeloma

                      	 
      	
                        IIb

                      	 
      	
                        10

                      	 
      	
                        50

                      
	
                        Multiple
      Myeloma

                      	 
      	
                        III

                      	 
      	
                        10

                      	 
      	
                        50

                      
	
                        Pediatric
      Glioma

                      	
                          

                      	
                        II

                      	
                          

                      	
                        6

                      	
                          

                      	
                        44

                      


              

            

          

        

      

       

      
        CONFIDENTIAL

        
          
            

          

          Page 7 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      4.
Project Team

       

      YM
BioSciences Inc. has decided to outsource several aspects of their clinical
development plan, and has contacted Allphase Clinical Research Inc. for resource
support and to benefit from our expertise in the conduct of oncology 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 personnel,
Medical Writers, Drug Safety, Data Management and operational staff. The
proposed team members are noted below however, the availability of proposed
staff is dependent on project initiation timelines.

      


      Project
Management

      


      Wendy
Kerby, RN: Sr. Project Manager (Ottawa)

      


      Ms. Kerby
has over 20 years of research experience primarily in the CRO industry and as a
research nurse/study coordinator at a major Canadian University. Ms. Kerby
offers experience in Clinical Study Monitoring, Project Management, Audit
Preparation, SOP development, CRF development and vendor relations. She has an
excellent knowledge of Good Clinical Practices (GCP), FDA, Health Canada and ICH
guidelines and regulations. Ms. Kerby is a highly motivated individual with a
strong capability for multi-tasking and prioritizing. She has an excellent
working knowledge of the following therapeutic areas: oncology/haematology,
immunology, rheumatology, neurology and infectious diseases. She has also
presented at various Investigator meetings, conducted study specific training
and presented at internal/company meetings.

      


      Ms. Kerby
has over 15 years experience as a bedside nurse and clinic nurse, having worked
in the oncology clinic setting, haematology, paediatrics and emergency. She has
worked as a research nurse/study coordinator in oncology for 10 years, with
emphasis on Lung cancer, Colorectal Cancer, Melanoma, Breast and the various
Haematological disorders, both for industry conducted studies and co-operative
group studies.

      


      The CRO
experience has seen Ms. Kerby in the following roles: CRA, Lead CRA and Project
Manager. She brings over 7 years experience into the project management role and
has managed 4 international oncology studies in colorectal (2), melanoma and
ovarian cancer.

      
         

        CONFIDENTIAL

        
          
            

          

          Page 8 of
36

        

      

      


      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      
        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      Clinical
Research Associates

      


      Karry
Schenk (Ottawa, ON)

      


      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)

      


      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.

      


      Heather
Kimber, RN (Toronto, ON)

      


      Ms.
Kimber has a strong background in oncology, including 7 years of direct oncology
patient care in both an inpatient and ambulatory setting. She was an instructor
for the Oncology Certificate Program at Sheridan College and has 10 years of
clinical research coordinator experience. Ms. Kimber successfully completed the
Allphase Center of Excellence (ACE) CRA Training program in June, 2007 and has
been monitoring oncology studies since that time.

      


      Fredy
Perez, MD (Vancouver, BC)

      


      Dr. Perez
obtained his Medical Doctorate in Peru in 2002, followed by a Masters in Disease
Control. Dr. Perez has been a CRA for 4 years and has worked in multiple
therapeutic areas including colorectal and breast cancer. Dr. Perez is a member
of the Society of Clinical Research Associates (SoCRA) and the Clinical Research
Professionals of British Columbia (CRPBC). Dr. Perez' previous work experience
also includes being a clinical research coordinator and some work in Drug Safety
and Pharmacovigilance.

      


      Clinical
Operations Associates

      


      Alison
Conley (Ottawa, ON)

      


      Ms.
Conley is our most senior Clinical Operations Associate with more than five
years of clinical research experience, primarily 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. A dedicated project specific COA will also be
assigned to manage the administrative aspect of the project including regulatory
document collection, minutes, document processing and Trial Master File
management.

      


      Litharitza
Vakopoulos (Ottawa, ON)

      


      Ms.
Vakopoulos has been providing Clinical Operations support for over 5 years. She
has thorough knowledge of ICH and local regulatory authority regulations
regarding clinical research and development. Ms. Vakopoulos has been responsible
for supporting study start-up activities, clinical status tracking, and
in-house site management on numerous oncology studies.

      
         

        CONFIDENTIAL

        
          
            

          

          Page 9 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      Compliance
and Quality Assurance

      


      Linda
Kraft, RN, Manager, Compliance and Quality Assurance (Ottawa, ON)

      


      Ms. Kraft
is based in Ottawa and brings with her more than 13years experience in clinical
research including project management and auditing. Mrs. Kraft has several years
of experience in conducting central file assessments, and site and sponsor
audits.

      


      Diane
Motink, MLT; Sr. Compliance and Quality Assurance Specialist (Mississauga,
ON)

      


      Ms.
Motink has 9 years experience in pharmaceutical related quality control roles, 5
of which are as a quality assurance professional.

      


      Consultants

      


      Medical
Monitoring and Biostatistics are the only Allphase managed outsourced functions
anticipated for this project. Client will be consulted regarding the choice of
sub-contractor if and as needed.

      


      Contacts


      


      
        
          
            	
                    Technical Contact

                  	 
      	
                    Administrative
      Contact

                  
	
                    Wendy
      Kirby, RN.,

                  	 
      	
                    Anne
      Gamache

                  
	
                    Sr.
      Project Manager

                  	 
      	
                    Project
      Analyst

                  
	
                    Allphase
      Clinical Research Inc.

                  	 
      	
                    Allphase
      Clinical Research Inc.

                  
	
                    1145
      Hunt Club K1V 0Y3

                  	 
      	
                    1145
      Hunt Club K1V 0Y3

                  
	
                    Tel:
      613-228-1990 x 117

                  	 
      	
                    Tel:
      613-228-1990 x 136

                  
	
                    Fax:
      613-228-8493

                  	 
      	
                    Fax:
      613-228-8493

                  
	
                    Cell: 613-808-4768

                  	 
      	
                    Email: agamache@allphaseclinical.com

                  
	
                    Email:
      wkerby@allphaseclinical.com

                  	 
      	 
      


          

        

      

      
         

        CONFIDENTIAL

        
          
            

          

          Page 10 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      4.
SOPs

       

      YM
BioSciences Inc. has decided to use the following Allphase SOPs for this
project:

      


      
        
          
            
              
                
                  	
                          Related
      Area

                        	 
      	
                          Title
      of SOP

                        	 
      	
                          Effective Date

                        
	
                          Quality
      Assurance (QA)

                        	 
      	 
      	 
      	 
      
	
                          QA
      006.01

                        	 
      	
                          Investigator
      Site Audits

                        	 
      	
                          03-DEC-2007

                        
	
                          QA
      008.00

                        	 
      	
                          Fraud
      or Scientific Misconduct

                        	 
      	
                          15-JUN-2007

                        
	
                          Clinical
      Research (CR or CO)

                        	 
      	 
      	 
      	 
      
	
                          CR
      100.00

                        	 
      	
                          Preparing,
      Maintaining and archiving of the Trial Master File

                        	 
      	
                          27-MAR-2006

                        
	
                          CR
      104.00

                        	 
      	
                          Investigator
      Site Selection

                        	 
      	
                          27-MAR-2006

                        
	
                          CO
      105.01

                        	 
      	
                          Translation
      of Clinical Study Documents

                        	 
      	
                          07-NOV-2008

                        
	
                          CO
      106.01

                        	 
      	
                          Investigator
      Meetings

                        	 
      	
                          18-SEP-2008

                        
	
                          CR
      107.00

                        	 
      	
                          Investigator
      Financial Agreements

                        	 
      	
                          15-JUN-2006

                        
	
                          CR
      108.00

                        	 
      	
                          Site
      Initiation Visit

                        	 
      	
                          01-JUN-2006

                        
	
                          CO
      109.03

                        	 
      	
                          Interim
      Monitoring Visit

                        	 
      	
                          31-OCT-2007

                        
	
                          CR
      110.00

                        	 
      	
                          Close-Out
      Visit

                        	 
      	
                          10-JUN-2006

                        
	
                          CO
      111.01

                        	 
      	
                          Source
      Document versus Case Report Form

                        	 
      	
                          06-MAY-2008

                        
	
                          CO
      112.00

                        	 
      	
                          Source
      Data Verification and Case Report Form Review

                        	 
      	
                          18-JUL-2008

                        
	
                          CO
      113.01

                        	 
      	
                          Protocol
      Deviations

                        	 
      	
                          11-JUL-2008

                        
	
                          CO
      114.01

                        	 
      	
                          Recording
      and Reporting Adverse Events

                        	 
      	
                          06-AUG-2008

                        
	
                          CO
      115.01

                        	 
      	
                          The
      Archiving and Shipping of the Trial Master File

                        	 
      	
                          09-SEP-2008

                        
	
                          CO
      118.00

                        	 
      	
                          Premature
      Termination or Suspension of a Clinical Trial

                        	 
      	
                          29-JUL-2008

                        
	
                          CO
      119.00

                        	 
      	
                          Data
      Clarification

                        	 
      	
                          03-APR-2008

                        
	
                          CO
      120.00

                        	 
      	
                          Investigational
      Product Accountability

                        	 
      	
                          09-OCT-2008

                        
	
                          CO
      121.00

                        	 
      	
                          Site
      Transfer between Clinical Research Associates

                        	 
      	
                          12-NOV-2008

                        
	
                          CO
      122.00

                        	 
      	
                          Monitoring
      Plan

                        	 
      	
                          24-JUN-2008

                        
	
                          CO
      123.00

                        	 
      	
                          Distribution
      and Tracking of Investigator’s Brochure

                        	 
      	
                          24-JUN-2008

                        
	
                          CO
      124.00

                        	 
      	
                          TMF
      Document Retrieval

                        	 
      	
                          09-SEP-2008

                        
	
                          CO
      126.00

                        	 
      	
                          Data
      safety Monitoring Boards

                        	 
      	
                          19-JAN-2009

                        
	
                          Scientific
      Affairs (SA)

                        	 
      	 
      	 
      	 
      
	
                          SA
      600.01

                        	 
      	
                          Clinical
      Study Report

                        	 
      	
                          19-NOV-2008

                        
	
                          SA
      601.01

                        	 
      	
                          Statistical
      Analysis Plan

                        	 
      	
                          19-NOV-2008

                        
	
                          Drug
      Safety (DS)

                        	
                            

                        	
                          Recording
      and Reporting of Serious Adverse Events and Reporting of Safety
      Information Externally

                        	
                            

                        	
                          10-NOV-2006

                        


                

              

            

          

        

      

      


      To be
determined in discussion with Client

      
         

        CONFIDENTIAL

        
          
            

          

          Page 11 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      5.
Project Summary

       

      The
following summary outlines the key elements of the study which have been
provided to date. This proposal is based on the accuracy of these items. Should
any facts and/or assumptions be incorrect, Allphase reserves the right to modify
this proposal to reflect any new information.

      


      
        
          
            
              
                
                  
                    
                      	
                              Protocol

                            	 
      	 
      	 
      	 
      
	
                              Sponsor

                            	 
      	 
      	 
      	
                              YM
      BIOSCIENCES INC.

                            
	
                              Protocol
      Number

                            	 
      	 
      	 
      	
                              YMB
      1000-08-0202

                            
	
                              Protocol
      Version

                            	 
      	 
      	 
      	
                              November
      18th,
      2008 - version 1.0

                            
	
                              Drug

                            	 
      	 
      	 
      	
                              Nimotuzumab
      (TheraCIM h-R3) from CIMYM

                            
	
                              Indication

                            	 
      	 
      	 
      	
                              Brain
      Metastases from Non-Small Cell Lung Cancer

                            
	
                              Phase

                            	 
      	 
      	 
      	
                              II

                            
	
                              Title

                            	 
      	 
      	 
      	
                              A
      Randomized Phase II, Double-Blind Study Nimotuzumab Plus Whole- Brain
      Radiation Therapy (WBRT) Compared With WBRT Alone in
      Patient  With Brain Metastases From Non-Small Cell Lung
      Cancer.

                            
	
                              Short
      Title

                            	 
      	 
      	 
      	
                              TBD

                            
	
                              Objectives
      for Phase II component

                            	 
      	 
      	 
      	
                              Primary: Intercranial
      disease progression at 2, 4, and 6 months.

                              Secondary: Overall
      survival (OS); time to neurologic progression (TNP) or death with evidence
      of neurologic progression; OS rate at 6 months; time to intracranial
      disease progression; time to overall progression.

                            
	
                              Sites
      & Start Up Meetings

                            	 
      	 
      	 
      	 
      
	
                              No.
      of Local Investigator Meetings

                            	 
      	
                              1

                            	 
      	
                              Ottawa

                            
	
                              Local
      Investigator Meeting Attendance (hrs)

                            	 
      	
                              16

                            	 
      	
                              2
      days; 1 day workshop with coordinators

                            
	
                              PM

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              CRA

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              Quality
      Assurance (ACE)

                            	 
      	
                              0

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              COA

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              Medical
      Monitor

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              Local
      Kick off Meeting

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              PM

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              CRA

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              COA

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              Medical
      Monitor

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              Protocol
      Review Process

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              PM

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              Director
      of Scientific Affairs

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              CRA

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              COA

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              Medical
      Monitor

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              Mid
      Study Local Team Meeting

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              PM

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes = 1

                            
	
                              CRA

                            	 
      	
                              1

                            	 
      	
                              No
      = 0; Yes =
1

                            


                    

                  

                

              

            

          

        

      

      
         

        CONFIDENTIAL

        
          
            

          

          Page 12 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      
        
          
            
              
                	
                        COA

                      	 
      	
                        1

                      	 
      	
                        No
      = 0; Yes = 1

                      
	
                        Medical
      Monitor

                      	 
      	
                        1

                      	 
      	
                        No
      = 0; Yes = 1

                      
	
                        #
      of Treatment Groups

                      	 
      	
                        2

                      	 
      	
                        2:1
      ratio

                      
	
                        Local
      or Central IRB

                      	 
      	
                        Local

                      	 
      	 
      
	
                        #
      of Sites to be Managed by Allphase

                      	 
      	
                        20

                      	 
      	 
      
	
                        #
      of Sites to be Monitored by Allphase

                      	 
      	
                        20

                      	 
      	 
      
	
                        Percentage
      of Subjects to be Monitored

                      	 
      	
                        100

                      	 
      	 
      
	
                        Feasibility
      Survey

                      	 
      	
                        Y

                      	 
      	
                        Y/N

                      
	
                        #
      of Sites for Feasibility Survey

                      	 
      	
                        20

                      	 
      	
                        YMB
      responsibility - Allphase to Assist

                      
	
                        #
      of Sites Selection Visits (CRA)

                      	 
      	
                        0

                      	 
      	
                        TBD

                      
	
                        #
      of Sites Selection Visits (PM)

                      	 
      	
                        0

                      	 
      	 
      
	
                        #
      of Sites Initiation Visits (CRA)

                      	 
      	
                        20

                      	 
      	 
      
	
                        #
      of Sites Initiation Visits (PM)

                      	 
      	
                        4

                      	 
      	
                        One
      per CRA

                      
	
                        Est.
      # of Monitoring Hrs/non-evaluable pt.

                      	 
      	
                        6

                      	 
      	 
      
	
                        Est.
      # of Monitoring Hrs/screen failure pt.

                      	 
      	
                        1

                      	 
      	
                        Assuming
      minimal data collection

                      
	
                        Est.
      # of Monitoring Hrs/Completed CRF

                      	 
      	
                        20

                      	 
      	 
      
	
                        Est.
      # of Hrs/Visit Report

                      	 
      	
                        5

                      	 
      	 
      
	
                        Estimated
      # of Monitoring Hours

                      	 
      	
                        1769

                      	 
      	 
      
	
                        Estimated
      # of Monitoring Days

                      	 
      	
                        253

                      	 
      	 
      
	
                        Estimated
      # of Monitoring Visits

                      	 
      	
                        177

                      	 
      	
                        Assume
      30% of visits can be multi-day visits considering both projects (1000-10
      & 1000-08-0202) having many of the same sites

                      
	
                        Estimated
      % of 1 day Monitoring Visits

                      	 
      	
                        70%

                      	 
      	 
      
	
                        Estimated
      Monitoring Frequency

                      	 
      	
                        6

                      	 
      	
                        Weeks

                      
	
                        Estimated
      # of CRAs

                      	 
      	
                        4

                      	 
      	
                        Regionally
      based in Canada

                      
	
                        Estimated
      # of Close-out Visits

                      	 
      	
                        20

                      	 
      	 
      
	
                        Subjects

                      	 
      	 
      	 
      	 
      
	
                        Number
      of Subjects Randomized locally

                      	 
      	
                        88

                      	 
      	 
      
	
                        Screen
      Failure Rate

                      	 
      	
                        10%

                      	 
      	 
      
	
                        Drop
      Out Rate (once Randomized)

                      	 
      	
                        0%

                      	 
      	 
      
	
                        #
      of Subjects Evaluable locally

                      	 
      	
                        88

                      	 
      	 
      
	
                        #
      of Subjects Screened locally

                      	 
      	
                        97

                      	 
      	 
      
	
                        Enrolment
      Period

                      	 
      	
                        52

                      	 
      	 
      
	
                        Duration
      of Each Subject

                      	 
      	
                        52

                      	 
      	 
      
	
                        Total
      Study Duration (all subjects)

                      	 
      	
                        104

                      	 
      	 
      
	
                        Project
      Administration

                      	 
      	 
      	 
      	 
      
	
                        #
      PMs for project

                      	 
      	
                        1

                      	 
      	
                        No
      = 0; Yes = 1

                      
	
                        #
      COAs for project

                      	 
      	
                        1

                      	 
      	 
      
	
                        #
      of collaborating CROs

                      	 
      	
                        0

                      	 
      	 
      


              

            

          

        

      

      
         

        CONFIDENTIAL

        
          
            

          

          Page 13 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      
        
          
            
              	
                      Total
      Study Duration (PM)

                    	 
      	
                      122

                    	 
      	
                      weeks

                    
	
                      Estimated
      # PM hours/week/site

                    	 
      	
                      0.5

                    	 
      	 
      
	
                      Estimated
      # PM hours/week

                    	 
      	
                      10

                    	 
      	 
      
	
                      Estimated
      # CRA Admin Hrs/week/site

                    	 
      	
                      0.5

                    	 
      	 
      
	
                      Estimated
      # CRA Admin Hrs/week

                    	 
      	
                      10

                    	 
      	 
      
	
                      Estimated
      # COA Admin Hrs/week/site

                    	 
      	
                      0.75

                    	 
      	 
      
	
                      Estimated
      # COA Admin Hrs/week

                    	 
      	
                      15

                    	 
      	 
      
	
                      Estimated
      # Doc Man. Admin Hrs/Site/Week

                    	 
      	
                      0.5

                    	 
      	 
      
	
                      Estimated
      # Doc Man. Admin Hrs/Week

                    	 
      	
                      10

                    	 
      	 
      
	
                      Team
      Teleconferences

                    	 
      	
                      2

                    	 
      	
                      1=Weekly;
      2=bi-weekly, 4=monthly

                    
	
                      #
      of Teleconferences

                    	 
      	
                      61

                    	 
      	 
      
	
                      Estimated
      # Hrs/Teleconference/CRA

                    	 
      	
                      0.75

                    	 
      	 
      
	
                      PM
      Teleconferences (with Sponsor)

                    	 
      	
                      1

                    	 
      	
                      1=Weekly;
      2=bi-weekly, 4=monthly

                    
	
                      Number
      of PM Teleconferences (Sponsor)

                    	 
      	
                      122

                    	 
      	 
      
	
                      Estimated
      # Hrs/Teleconference (Sponsor)

                    	 
      	
                      1

                    	 
      	 
      
	
                      PM
      Ad hoc visits/quarter

                    	 
      	
                      1

                    	 
      	 
      
	
                      Estimated
      # of PM Ad-Hoc Visits

                    	 
      	
                      10

                    	 
      	 
      
	
                      Estimated
      # of Co-Visits by PM

                    	 
      	
                      4

                    	 
      	 
      
	
                      Medical
      Writing

                    	 
      	 
      	 
      	 
      
	
                      Medical
      Writing Research and Therapeutic Training

                    	 
      	
                      0

                    	 
      	
                      No
      = 0; Yes = 1

                    
	
                      Regulatory
      Affairs

                    	 
      	 
      	 
      	 
      
	
                      Pre
      CTA Meeting with Health Canada

                    	 
      	
                      0

                    	 
      	
                      No
      = 0; Yes = 1

                    
	
                      Submission
      to Health Canada

                    	 
      	
                      0

                    	 
      	
                      No
      = 0; Yes = 1

                    
	
                      Estimated
      # of HC Amendments

                    	 
      	
                      0

                    	 
      	 
      
	
                      Safety

                    	 
      	 
      	 
      	 
      
	
                      Medical
      Oversight by Allphase

                    	 
      	
                      1

                    	 
      	
                      No
      = 0; Yes = 1

                    
	
                      #
      of subjects for Safety

                    	 
      	
                      88

                    	 
      	 
      
	
                      Estimated
      Percentage of SAEs

                    	 
      	
                      50%

                    	 
      	 
      
	
                      Estimated
      # of SAEs

                    	 
      	
                      44

                    	 
      	 
      
	
                      Estimated
      Percentage of Reportable SAEs

                    	 
      	
                      20%

                    	 
      	
                      Percentage
      of SAEs requiring regulatory reporting

                    
	
                      Estimated
      # of Reportable SAEs

                    	 
      	
                      9

                    	 
      	 
      
	
                      Teleconferences

                    	 
      	
                      13

                    	 
      	
                      1=Weekly;
      2=bi-weekly, 4=monthly, 8=bi-monthly, 13=quarterly

                    
	
                      #
      of Teleconferences with Sponsor

                    	 
      	
                      9

                    	 
      	 
      
	
                      Management
      of DSMB

                    	 
      	
                      1

                    	 
      	
                      No
      = 0; Yes = 1

                    


            

          

        

      

      
         

        CONFIDENTIAL

        
          
            

          

          Page 14 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      
        
          
            
              	
                      #
      of DSMB meetings

                    	 
      	
                      3

                    	 
      	 
      
	
                      Estimated
      AEs/Randomized Subject

                    	 
      	
                      10

                    	 
      	 
      
	
                      Estimated
      Medical terms for Manual Coding/Subject

                    	 
      	
                      10

                    	 
      	 
      
	
                      Data
      Management

                    	 
      	 
      	 
      	 
      
	
                      Data
      Management Involvement?

                    	 
      	
                      0

                    	 
      	
                      No
      = 0; Yes = 1

                    
	
                      BioStatistics

                    	 
      	 
      	 
      	 
      
	
                      Biostatistics
      Involvement?

                    	 
      	
                      0

                    	 
      	
                      No
      = 0; Yes = 1

                    
	
                      Quality
      Assurance

                    	 
      	 
      	 
      	 
      
	
                      Site
      Audits

                    	 
      	
                      3

                    	 
      	 
      
	
                      TMF
      Audit

                    	 
      	
                      0

                    	 
      	 
      
	
                      Vendor
      Management

                    	 
      	 
      	 
      	 
      
	
                      Central
      Lab Managed by Allphase?

                    	 
      	
                      0

                    	 
      	
                      No
      = 0; Yes = Number of labs

                    
	
                      Imaging
      Lab Managed by Allphase?

                    	 
      	
                      0

                    	 
      	
                      No
      = 0; Yes = Number if labs

                    
	
                      Investigational
      Product Distributor Managed by Allphase?

                    	 
      	
                      0

                    	 
      	
                      No
      = 0; Yes = 1

                    
	
                      SOP

                    	 
      	 
      	 
      	 
      
	
                      Allphase
      SOPs to be used?

                    	 
      	
                      1

                    	 
      	
                      No
      = 0; Yes = 1 (expand group)

                    
	
                      Allphase
      Forms?

                    	 
      	
                      1

                    	 
      	
                      No
      = 0; Yes = 1 (expand group)

                    
	
                      Services
      Requested

                    	 
      	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	
                      Regulatory

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      CTA
      prep, submission and maintenance

                    
	 
      	 
      	 
      	 
      	
                      Project
      Management

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Site
      Contract Negotiation

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Site
      Payment Facilitation

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Regulatory
      Document Collection

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Trial
      Master File Set-up & Maintenance

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      ICF
      Preparation & Translation

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      IRB
      preparations and submissions - central IRB; or assistance with the
      submissions if local IRB.

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Site
      Identification

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Multi-site
      Management

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      CRA
      Management

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Teleconference
      and Project Updates

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Vendor
      Management (if applicable)

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      General
      Administration

                    
	 
      	 
      	 
      	 
      	
                      Investigator
      Meeting - North America

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Attendance

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Planning
      & Execution

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Presentations

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Travel
      Arrangements for Attendees

                    
	 
      	 
      	 
      	 
      	
                      Clinical
      Monitoring

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Pre-Study
      Visits (new sites only)

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Site
      Initiation

                    


            

          

        

        
           

          CONFIDENTIAL

          
            
              

            

            Page 15 of
36

          

        

         

        
          
            
            

          

          
            
            

            
              

            

          

          
            
            

          

        

        
          


          
            
              	
                      MSA#:

                    	
                      YMB07-MSA-17MAY2007

                    	
                      WO
      Version Code:

                    	
                      YMB08-WO5-15DEC2008-3.0

                    
	
                      Version
      Date:

                    	
                      16DEC2008

                    	
                      Work
      Order #:

                    	
                      WO5

                    


            

          

        

         

        
          
            
              	 
      	 
      	
                      ACR

                    	 
      	
                      Interim
      Monitoring & Site management

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Site
      Close Out

                    
	 
      	 
      	 
      	 
      	
                      Safety

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Safety
      Plan

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      CIOMS/MedWatch
      report prep

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      SAE
      alert reporting to authorities

                    
	 
      	 
      	 
      	 
      	
                      Data
      Management/Biostatistics

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      CRF
      Design & Build

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      DM
      System Set Up (include edit checks)

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Data
      Validation and Review CRFs

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Data
      Query

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Coding
      AE & Medications

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Interim
      Analysis Plan

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Final
      Analysis Plan

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Randomization
      Services

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Medical
      Monitoring

                    
	 
      	 
      	 
      	 
      	
                      Data
      Monitoring Committee

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      Establish
      Committee and Organize Meetings

                    
	 
      	 
      	 
      	 
      	
                      Medical
      Writing

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Protocol
      Development

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Interim
      & Final Clinical Study Reports

                    
	 
      	 
      	
                      YMB

                    	 
      	
                      Manuscripts

                    
	 
      	 
      	 
      	 
      	
                      Quality
      Assurance

                    
	 
      	 
      	
                      ACR

                    	 
      	
                      GCP
      Investigator/Site/Vendor Audit

                    
	 
      	 
      	
                      TBD

                    	 
      	
                      QA
      Audit of Clinical Database

                    
	 
      	
                        

                    	
                      TBD

                    	
                        

                    	
                      QA
      Audit of Clinical Study
Report

                    


            

          

        

         

      

      Project
Timelines

      


      
        
          
            	
                    Activity

                  	 
      	
                    Date
      of Completion

                  
	
                    Executed
      LOI

                  	 
      	
                    Dec-08

                  
	
                    Fully
      Executed Contract

                  	 
      	
                    Dec-08

                  
	
                    Kick-off
      Meeting

                  	 
      	
                    Jan-08

                  
	
                    Site
      Selection

                  	 
      	
                    Jan-08

                  
	
                    IRB
      Submissions

                  	 
      	
                    Jan-09

                  
	
                    Investigator
      Agreements

                  	 
      	
                    Jan-09

                  
	
                    Investigator
      Meeting

                  	 
      	
                    Feb-09

                  
	
                    First
      SIV

                  	 
      	
                    Mar-09

                  
	
                    First
      Subject First Visit

                  	 
      	
                    Mar-09

                  
	
                    Last
      Subject First Visit

                  	 
      	
                    Mar-10

                  
	
                    Last
      Subject Last Visit

                  	 
      	
                    Mar-11

                  
	
                    Data
      Base Lock

                  	 
      	
                    May-11

                  
	
                    Final
      Close-Out Visit

                  	 
      	
                    Jul-11

                  
	
                    Final
      Clinical Study Report

                  	
                      

                  	
                    Jul-11

                  


          

        

      

      
         

        CONFIDENTIAL

        
          
            

          

          Page 16 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

       

      
        	
                Start-Up
      Duration

              	 
      	
                9

              
	
                Enrolment

              	 
      	
                52

              
	
                Treatment
      period

              	 
      	
                52

              
	
                Close
      Out (DBL to CSR)

              	 
      	
                9

              
	
                Total
      Subject Duration

              	 
      	
                104

              
	
                Total
      Study Duration (PM)

              	 
      	
                122

              
	
                Data
      Management Duration

              	
                  

              	
                125

              


      

      


      Roles
and Rates

      


      
        
          
            
              
                
                  
                    
                      
                        	
                                Allphase
      Role

                              	 	
                                Allphase
      Resource

                              	 	
                                Hourly
      Rate (CDN)

                              	 
	
                                DE

                              	 	
                                Data
      Entry Personnel

                              	 	$	65	 
	
                                DOC

                              	 	
                                Document
      Management

                              	 	$	75	 
	
                                COA

                              	 	
                                Clinical
      Operations Associate

                              	 	$	75	 
	
                                CRA

                              	 	
                                Clinical
      Research Associate

                              	 	$	90	 
	
                                LCRA

                              	 	
                                Lead
      Clinical Research Associate

                              	 	$	95	 
	
                                DM

                              	 	
                                Data
      Manager

                              	 	$	100	 
	
                                MW

                              	 	
                                Medical
      Writing

                              	 	$	100	 
	
                                PM

                              	 	
                                Project
      Manager

                              	 	$	100	 
	
                                RA

                              	 	
                                Regulatory
      Affairs

                              	 	$	100	 
	
                                DS

                              	 	
                                Drug
      Safety

                              	 	$	100	 
	
                                QA

                              	 	
                                Quality
      Assurance Auditor

                              	 	$	100	 
	
                                DIR

                              	 	
                                Director
      Scientific Affairs

                              	 	$	120	 
	
                                BIO

                              	 	
                                Biostatistician

                              	 	$	130	 
	
                                ACE

                              	 	
                                Trainer

                              	 	$	150	 
	
                                MMD

                              	 	
                                Medical
      Monitor Data Management

                              	 	$	200	 
	
                                MM

                              	 	
                                Medical
      Monitor

                              	 	$	350	 


                      

                    

                  

                

              

            

          

        

      

      


      Project
Details

      


      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              	
                                                      List
      of Tasks

                                                    	 
      	
                                                      YMB

                                                    	 
      	
                                                      Allphase

                                                    	 
      	
                                                      ADM

                                                    	 
      	
                                                      Task Hours

                                                    	 
      	
                                                      Units

                                                    	 
      	
                                                      Total Hours

                                                    	 
      	
                                                      Resp

                                                    	 
	
                                                      Pre-Study
      Activities

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Project
      Feasibility Study

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Identify
      sites

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Contact
      sites

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Draft
      CDA for sites

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Develop
      Feasibility Survey

                                                    	 
      	
                                                      (X)

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	
                                                      4

                                                    	 
      	
                                                      1

                                                    	 
      	
                                                      4

                                                    	 
      	
                                                      PM

                                                    	 
	
                                                      Distribute
      CDA to sites

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Distribute
      Feasibility to sites

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Collect
      and review CDA/Feasibilities from sites

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Review
      Feasibilities from sites

                                                    	 
      	
                                                      (X)

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	
                                                      0.5

                                                    	 
      	
                                                      20

                                                    	 
      	
                                                      10

                                                    	 
      	
                                                      PM

                                                    	 
	
                                                      Compile
      Feasibility Report

                                                    	 
      	
                                                      X

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	
                                                      8

                                                    	 
      	
                                                      1

                                                    	 
      	
                                                      8

                                                    	 
      	
                                                      PM

                                                    	 
	
                                                      Protocol
      Development

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Protocol
      Ammendments (if required)

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                                                      Compilation
      & update IB

                                                    	 
      	
                                                      X

                                                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 


                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      
        CONFIDENTIAL

        
          
            

          

          Page 17 of
36

        

      

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      
        


        
          
            	
                    MSA#:

                  	
                    YMB07-MSA-17MAY2007

                  	
                    WO
      Version Code:

                  	
                    YMB08-WO5-15DEC2008-3.0

                  
	
                    Version
      Date:

                  	
                    16DEC2008

                  	
                    Work
      Order #:

                  	
                    WO5

                  


          

        

      

      

        
          
            	
                    Kick-off
      meeting

                  	 
      	
                    X

                  	 
      	
                    X

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    PM
      attendance

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    1

                  	 
      	
                    8

                  	 
      	
                    PM

                  	 
	
                    PM
      travel time

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    0

                  	 
      	
                    0

                  	 
      	
                    0

                  	 
      	
                    PM

                  	 
	
                    CRA
      attendance

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    4

                  	 
      	
                    32

                  	 
      	
                    CRA

                  	 
	
                    CRA
      travel time (average)

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    4

                  	 
      	
                    32

                  	 
      	
                    CRA

                  	 
	
                    COA
      attendance

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    1

                  	 
      	
                    8

                  	 
      	
                    COA

                  	 
	
                    COA
      travel time

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    0

                  	 
      	
                    0

                  	 
      	
                    0

                  	 
      	
                    COA

                  	 
	
                    Medical
      Monitor attendance

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    4

                  	 
      	
                    1

                  	 
      	
                    4

                  	 
      	
                    MM

                  	 
	
                    Medical
      Monitor travel time

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    3

                  	 
      	
                    1

                  	 
      	
                    3

                  	 
      	
                    MM

                  	 
	
                    International
      Kick-Off Meeting

                  	 
      	
                    N/A

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Mid
      Study Local Team Meeting

                  	 
      	
                    X

                  	 
      	
                    X

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    PM
      attendance

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    1

                  	 
      	
                    8

                  	 
      	
                    PM

                  	 
	
                    PM
      travel time

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    0

                  	 
      	
                    0

                  	 
      	
                    0

                  	 
      	
                    PM

                  	 
	
                    CRA
      attendance

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    4

                  	 
      	
                    32

                  	 
      	
                    CRA

                  	 
	
                    CRA
      travel time (average)

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    4

                  	 
      	
                    32

                  	 
      	
                    CRA

                  	 
	
                    COA
      attendance

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    1

                  	 
      	
                    8

                  	 
      	
                    COA

                  	 
	
                    COA
      travel time

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    0

                  	 
      	
                    0

                  	 
      	
                    0

                  	 
      	
                    COA

                  	 
	
                    Medical
      Monitor attendance

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    4

                  	 
      	
                    1

                  	 
      	
                    4

                  	 
      	
                    MM

                  	 
	
                    Medical
      Monitor travel time

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    3

                  	 
      	
                    1

                  	 
      	
                    3

                  	 
      	
                    MM

                  	 
	
                    Protocol
      Review Process

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    PM

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    4

                  	 
      	
                    1

                  	 
      	
                    4

                  	 
      	
                    PM

                  	 
	
                    Director
      Scientific Affairs

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    4

                  	 
      	
                    1

                  	 
      	
                    4

                  	 
      	
                    DIR

                  	 
	
                    CRA

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    4

                  	 
      	
                    4

                  	 
      	
                    16

                  	 
      	
                    CRA

                  	 
	
                    COA

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    4

                  	 
      	
                    1

                  	 
      	
                    4

                  	 
      	
                    COA

                  	 
	
                    Medical
      Monitor

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    4

                  	 
      	
                    1

                  	 
      	
                    4

                  	 
      	
                    MM

                  	 
	
                    Regulatory
      Management – study

                  	 
      	
                    N/A

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Vendor
      Management

                  	 
      	
                    N/A

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Local
      Investigator Meeting

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Identify
      location and conduct preliminary investigation of costs;
      reservations

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    8

                  	 
      	
                    1

                  	 
      	
                    8

                  	 
      	
                    COA

                  	 
	
                    Organize
      travel & hotel for study team

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    12

                  	 
      	
                    1

                  	 
      	
                    12

                  	 
      	
                    COA

                  	 
	
                    Plan
      and organize IM

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    40

                  	 
      	
                    1

                  	 
      	
                    40

                  	 
      	
                    PM

                  	 
	
                    Teleconferences
      – PM

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    1

                  	 
      	
                    5

                  	 
      	
                    5

                  	 
      	
                    PM

                  	 
	
                    Teleconferences
      – COA

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    1

                  	 
      	
                    5

                  	 
      	
                    5

                  	 
      	
                    COA

                  	 
	
                    Prepare
      agenda

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    4

                  	 
      	
                    1

                  	 
      	
                    4

                  	 
      	
                    PM

                  	 
	
                    Prepare
      presentations

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    16

                  	 
      	
                    1

                  	 
      	
                    16

                  	 
      	
                    PM

                  	 
	
                    Design
      Investigator Meeting materials

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    12

                  	 
      	
                    1

                  	 
      	
                    12

                  	 
      	
                    PM

                  	 
	
                    Prepare
      Investigator Meeting materials

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    24

                  	 
      	
                    1

                  	 
      	
                    24

                  	 
      	
                    COA

                  	 
	
                    Prepare
      welcome letters, name tags, materials

                  	 
      	
                    (X)

                  	 
      	
                    X

                  	 
      	 
      	 
      	
                    16

                  	 
      	
                    1

                  	 
      	
                    16

                  	 
      	
                    COA

                  	 
	
                    Attendance
      &  presentations at Meeting

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 


          

        

      

    

    
       

      CONFIDENTIAL

      
        
          

        

        Page 18 of
36

      

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    
      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

    

     

    
      
        	
                PM
      prep

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                2

              	 
      	
                1

              	 
      	
                2

              	 
      	
                PM

              	 
	
                PM
      travel

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                2

              	 
      	
                1

              	 
      	
                2

              	 
      	
                PM

              	 
	
                PM
      Presentation & Attendance

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                16

              	 
      	
                1

              	 
      	
                16

              	 
      	
                PM

              	 
	
                CRA
      prep

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                2

              	 
      	
                4

              	 
      	
                8

              	 
      	
                CRA

              	 
	
                CRA
      travel

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                8

              	 
      	
                4

              	 
      	
                32

              	 
      	
                CRA

              	 
	
                CRA
      attendance

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                16

              	 
      	
                4

              	 
      	
                64

              	 
      	
                CRA

              	 
	
                ACE
      Trainer prep

              	 
      	 
      	 
      	
                N/A

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                QA

              	 
	
                ACE
      Trainer travel

              	 
      	 
      	 
      	
                N/A

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                QA

              	 
	
                ACE
      Trainer presentation & attendance

              	 
      	 
      	 
      	
                N/A

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                QA

              	 
	
                COA
      prep & oversight

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                24

              	 
      	
                1

              	 
      	
                24

              	 
      	
                COA

              	 
	
                COA
      travel

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                2

              	 
      	
                1

              	 
      	
                2

              	 
      	
                COA

              	 
	
                COA
      attendance

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                16

              	 
      	
                1

              	 
      	
                16

              	 
      	
                COA

              	 
	
                Medical
      Monitor prep

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                2

              	 
      	
                1

              	 
      	
                2

              	 
      	
                MM

              	 
	
                Medical
      Monitor travel

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                2

              	 
      	
                1

              	 
      	
                2

              	 
      	
                MM

              	 
	
                Medical
      Monitor Presentation & Attendance

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                8

              	 
      	
                1

              	 
      	
                8

              	 
      	
                MM

              	 
	
                Ethics

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                Preparation
      of ICF template

              	 
      	
                X

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                Customization
      of ICF (PIPEDA)

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                1

              	 
      	
                20

              	 
      	
                20

              	 
      	
                PM

              	 
	
                Preparation
      of other subject materials

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                12

              	 
      	
                1

              	 
      	
                12

              	 
      	
                PM

              	 
	
                Assist
      sites with submissions

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                1

              	 
      	
                20

              	 
      	
                20

              	 
      	
                PM

              	 
	
                IRB
      approval review & action if needed

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                1

              	 
      	
                20

              	 
      	
                20

              	 
      	
                PM

              	 
	
                Translation
      of ICF & materials

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                6

              	 
      	
                1

              	 
      	
                6

              	 
      	
                PM

              	 
	
                Subsequent
      ICF revisions (amendments)

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                6

              	 
      	
                1

              	 
      	
                6

              	 
      	
                PM

              	 
	
                IND
      Safety alert reporting to sites

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                0.75

              	 
      	
                13

              	 
      	
                6.75

              	 
      	
                PM

              	 
	
                Annual
      re-approval documentation

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                1

              	 
      	
                20

              	 
      	
                20

              	 
      	
                PM

              	 
	
                Study/site
      closure documentation

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                2

              	 
      	
                20

              	 
      	
                40

              	 
      	
                PM

              	 
	
                IRB
      payment facilitation

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                0.5

              	 
      	
                20

              	 
      	
                10

              	 
      	
                PM

              	 
	
                IRB
      payment

              	 
      	
                (X)

              	 
      	
                X

              	 
      	 
      	 
      	
                0.5

              	 
      	
                20

              	 
      	
                10

              	 
      	
                PM

              	 
	
                CRA

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                Training
      – protocol, project & therapy area

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                Initial
      CRA training

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                8

              	 
      	
                4

              	 
      	
                32

              	 
      	
                CRA

              	 
	
                Periodic
      CRA training (i.e. amendments, forms, SOPs, other new
      information)

              	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                8

              	 
      	
                4

              	 
      	
                32

              	 
      	
                CRA

              	 
	
                Team
      Teleconference

              	 
      	 
      	 
      	
                X

              	 
      	 
      	 
      	
                0.8

              	 
      	
                244

              	 
      	
                183

              	 
      	
                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

              	
                  

              	 
      	
                  

              	 
      	
                  

              	 
      	
                  

              	 
      	
                  

              	 
      	
                  

              	 
      	
                  

              	 
      	 


      

    

    
       

      CONFIDENTIAL

      
        
          

        

        Page 19 of
36

      

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    
      
        
          
            
              	
                      Prepare
      report and make recommendation of site suitability

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                      Prep

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      1

                    	 
      	
                      1

                    	 
      	
                      1

                    	 
      	
                      CRA

                    	 
	
                      Travel

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      8

                    	 
      	
                      1

                    	 
      	
                      8

                    	 
      	
                      CRA

                    	 
	
                      On-Site

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      3

                    	 
      	
                      1

                    	 
      	
                      3

                    	 
      	
                      CRA

                    	 
	
                      Report
      Writing and Follow-up

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      4

                    	 
      	
                      1

                    	 
      	
                      4

                    	 
      	
                      CRA

                    	 
	
                      Total

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      16

                    	 
      	
                      0

                    	 
      	
                      0

                    	 
      	
                      CAA

                    	 
	
                      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

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                      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

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      1

                    	 
      	
                      1

                    	 
      	
                      1

                    	 
      	
                      CRA

                    	 
	
                      Travel

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      8

                    	 
      	
                      1

                    	 
      	
                      8

                    	 
      	
                      CRA

                    	 
	
                      On-Site

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      5

                    	 
      	
                      1

                    	 
      	
                      5

                    	 
      	
                      CRA

                    	 
	
                      Report
      Writing and Follow-up

                    	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                      5

                    	 
      	
                      1

                    	 
      	
                      5

                    	 
      	
                      CRA

                    	 


            

          

        

      

    

    


    CONFIDENTIAL


      
        

      

    

    Page
20 of 36


    
      
         


      

      
        
        

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    
      
        
          
            	
                    Sub-Total/site

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    19

                  	 
      	
                    CRA

                  	 
	
                    Total

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    19

                  	 
      	
                    20

                  	 
      	
                    380

                  	 
      	
                    CRA

                  	 
	
                    Interim
      Monitoring

                  	 
      	 
      	 
      	
                    X

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Send
      confirmation letter

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Complete
      Monitors’ Sign-in Log

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Verify
      proper Informed Consent procedures

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Monitor
      in accordance with protocol/ICH/GCP

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    100%
      source document verification vs. CRF

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

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

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Review
      study-related regulatory documents

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Review
      monitoring & discrepancy report queries

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Source
      verify data clarification/correction forms

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Review
      of laboratory data

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Review
      and verify SAEs (100% SDV)

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Verify
      study drug inventory and storage

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

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Maintain
      protocol violation list

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Monitoring
      of other variables as specified

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Prepare
      monitoring visit reports following each monitoring visit

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Provide
      monitoring follow-up reports to sites following each visit

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Regulator
      contacts with sites & TC reports

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Ongoing
      training of site personnel

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    CRF
      and query management

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Prep

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    2

                  	 
      	
                    1

                  	 
      	
                    2

                  	 
      	
                    CRA

                  	 
	
                    Travel

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    1

                  	 
      	
                    8

                  	 
      	
                    CRA

                  	 
	
                    On-Site

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    8

                  	 
      	
                    1

                  	 
      	
                    8

                  	 
      	
                    CRA

                  	 
	
                    Report
      Writing and Follow-up

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    5

                  	 
      	
                    1

                  	 
      	
                    5

                  	 
      	
                    CRA

                  	 
	
                    Sub-Total/site

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    23

                  	 
      	
                    CRA

                  	 
	
                    Total

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                    23

                  	 
      	
                    177

                  	 
      	
                    4073

                  	 
      	
                    CRA

                  	 
	
                    Un-Blinded
      CRA

                  	 
      	
                    N/A

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Close
      Out Visit

                  	 
      	 
      	 
      	
                    X

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    COV
      within 6 weeks post data base lock

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Contact
      potential sites, confirm data for visit

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Send
      confirmation letter

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                    Complete
      Monitors’ Sign-in Log

                  	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 


          

        

      

    

    


    CONFIDENTIAL


      
        

      

    

    Page 21
of 36


    
      
         


      

      
        
        

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    
      
        
          	
                  Ensure
      site regulatory documentation is complete and accessible future
      audits

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Ensure
      that the investigator is aware of his/her responsibilities

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Financial
      Disclosure documentation

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  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

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  2

                	 
      	
                  1

                	 
      	
                  2

                	 
      	
                  CRA

                	 
	
                  Travel

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  CRA

                	 
	
                  On-Site

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  CRA

                	 
	
                  Report
      Writing and Follow-up

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  5

                	 
      	
                  1

                	 
      	
                  5

                	 
      	
                  CRA

                	 
	
                  Sub-Total/site

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  23

                	 
      	
                  CRA

                	 
	
                  Total

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  23

                	 
      	
                  20

                	 
      	
                  460

                	 
      	
                  CRA

                	 
	
                  Site
      Management/Interaction (1hr/site/week)

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  10

                	 
      	
                  134

                	 
      	
                  1340

                	 
      	
                  CRA

                	 
	
                  Lead
      CRA

                	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Overall
      Project Management

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Training
      – protocol, project & therapy area

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Initial
      PM training

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

                	 
	
                  Periodic
      PM training

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  In-house
      study management

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Selection
      – CDN site

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  PM

                	 
	
                  Feasibility
      from admin

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  PM

                	 
	
                  Confidential
      Disc. Agreement

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  PM

                	 
	
                  CDA
      approval

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  PM

                	 
	
                  CRTRA
      template

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  PM

                	 
	
                  CTRA
      template approval

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  PM

                	 
	
                  CTRA
      negotiation

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  PM

                	 
	
                  CTRA
      site sign off

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  PM

                	 
	
                  Preparation
      of initial project specific reg pkg

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Review
      received reg docs:

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  site
      – QUI

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  PM

                	 
	
                  REBA

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  PM

                	 
	
                  CTSI

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  PM

                	 
	
                  Consent
      to Use Personal Data

                	 
      	 
      	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Protocol
      signature page

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  PM

                	 
	
                  Financial
      Disclosure

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  PM

                	 
	
                  CV

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  PM

                	 
	
                  MD
      qualification

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  PM

                	 


        

      

    

    


    CONFIDENTIAL


      
        

      

    

    Page 22 of
36


    
      
         


      

      
        
        

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    
      
        
          	
                  Internal
      project team meetings – biweekly

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  1

                	 
      	
                  61

                	 
      	
                  61

                	 
      	
                  PM

                	 
	
                  Site
      level management

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  20

                	 
      	
                  160

                	 
      	
                  PM

                	 
	
                  Weekly
      Regular status reports for client

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  1

                	 
      	
                  122

                	 
      	
                  122

                	 
      	
                  PM

                	 
	
                  Liaise
      weekly with sponsor

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  1

                	 
      	
                  122

                	 
      	
                  122

                	 
      	
                  PM

                	 
	
                  TMF
      set-up and maintenance oversight

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Site
      budge set-up

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Payment
      calculation (quarterly)

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  1

                	 
      	
                  160

                	 
      	
                  160

                	 
      	
                  PM

                	 
	
                  Payment
      tracking

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.5

                	 
      	
                  160

                	 
      	
                  80

                	 
      	
                  PM

                	 
	
                  Payment
      issuance

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  0.25

                	 
      	
                  160

                	 
      	
                  40

                	 
      	
                  PM

                	 
	
                  SOPs
      assignment documentation

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  3

                	 
      	
                  1

                	 
      	
                  3

                	 
      	
                  PM

                	 
	
                  Responsibility
      assignment

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  PM

                	 
	
                  Preparation
      of Project Plan (1 review)

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Preparation
      of Monitoring Plan (1 review)

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Preparation
      of Visit Booklet (1 review)

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

                	 
	
                  Development
      of Pharmacy Manual (1 review)

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

                	 
	
                  Development
      of SAE Plan

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  16

                	 
      	
                  1

                	 
      	
                  16

                	 
      	
                  PM

                	 
	
                  Development
      of Recruitment Plan

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

                	 
	
                  Review
      of Monitoring Trip Reports

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  1

                	 
      	
                  177

                	 
      	
                  178

                	 
      	
                  PM

                	 
	
                  Prep.
      Of Study specific forms

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Prep.
      Study specific tracking tools

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

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

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

                	 
	
                  Drug
      Accountability Form

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  4

                	 
      	
                  1

                	 
      	
                  4

                	 
      	
                  PM

                	 
	
                  Individual
      Subject Drug logs

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  4

                	 
      	
                  1

                	 
      	
                  4

                	 
      	
                  PM

                	 
	
                  Drug
      Return & Reconciliation Form

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  4

                	 
      	
                  1

                	 
      	
                  4

                	 
      	
                  PM

                	 
	
                  Clinical
      Re-supplies Form

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  PM

                	 
	
                  Drug
      Receipt Form

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  PM

                	 
	
                  Release
      of IP (RIP) Form

                	 
      	
                  X

                	 
      	
                  (X)

                	 
      	 
      	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  PM

                	 
	
                  Destruction
      of IP (DIP) Form

                	 
      	
                  X

                	 
      	
                  (X)

                	 
      	 
      	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  PM

                	 
	
                  Study
      specific tracking tools

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Investigational
      Product (IP) and other Clinical Study Supplies

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

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Comparator
      Procurement

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  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 oversight

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Request
      for authorization to release IP oversight

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 


        

      

    

    


    CONFIDENTIAL


      
        

      

    

    Page 23
of 36


    
      
         


      

      
        
        

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    
      
        
          	
                  Authorization
      to distribute drug

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Packaging/labelling
      of Clinical Supplies Oversight

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Distribution
      of Clinical Study Supplies to sites

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Tracking
      of IP

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Tracking
      of Clinical Study Supplies

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Organization
      of destruction of unused Clinical Study Supplies

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

                	 
	
                  Study
      Completion/Study Termination

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Notification
      to national/local authorities of study termination

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Final
      recon of TMF

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Archiving
      of Sponsor’s TMF

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  PM
      – Pre-Study/Specific Task Sub-Total

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1158

                	 
      	
                  PM

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

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  10

                	 
      	
                  104

                	 
      	
                  1040

                	 
      	
                  PM

                	 
	
                  Ex-house
      Project Management

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Co-Initiation/Monitoring/COV

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Prep

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  PM

                	 
	
                  Travel

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

                	 
	
                  On-Site
      (average)

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Admin

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  3

                	 
      	
                  1

                	 
      	
                  3

                	 
      	
                  PM

                	 
	
                  Sub-Total/site

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  24

                	 
      	
                  PM

                	 
	
                  Total

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  24

                	 
      	
                  4

                	 
      	
                  96

                	 
      	
                  PM

                	 
	
                  Ad
      hoc meetings

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Prep

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  PM

                	 
	
                  Travel

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  12

                	 
      	
                  1

                	 
      	
                  12

                	 
      	
                  PM

                	 
	
                  On-Site
      (average)

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  PM

                	 
	
                  Admin

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  3

                	 
      	
                  1

                	 
      	
                  3

                	 
      	
                  PM

                	 
	
                  Sub-Total/Mtg

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  24

                	 
      	
                  PM

                	 
	
                  Total

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  24

                	 
      	
                  12

                	 
      	
                  240

                	 
      	
                  PM

                	 
	
                  Administration
      – COA & Document Management

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Start
      Up Documentation Activities

                	 
      	
                  (X)

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Assemble
      site reg. packages

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1.25

                	 
      	
                  20

                	 
      	
                  25

                	 
      	
                  COA

                	 
	
                  Courier
      packages to sites

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  COA

                	 
	
                  Initial
      review of Regulatory Documents

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1.5

                	 
      	
                  20

                	 
      	
                  30

                	 
      	
                  COA

                	 
	
                  Receive,
      log, scan & file initial reg docs

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1.5

                	 
      	
                  20

                	 
      	
                  30

                	 
      	
                  COA

                	 
	
                  Follow-up
      on reg doc errors & omissions

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.5

                	 
      	
                  15

                	 
      	
                  7.5

                	 
      	
                  COA

                	 
	
                  Courier
      – second round

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.25

                	 
      	
                  15

                	 
      	
                  3.75

                	 
      	
                  COA

                	 
	
                  Second
      review of regulatory documents

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.5

                	 
      	
                  15

                	 
      	
                  7.5

                	 
      	
                  COA

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

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1

                	 
      	
                  15

                	 
      	
                  15

                	 
      	
                  COA

                	 


        

      

    

    


    CONFIDENTIAL


      
        

      

    

    Page 24
of 36


    
      
         


      

      
        
        

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    
      
        
          	
                  Identify
      Table of Contents for ISF/IHF/GSF

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  1

                	 
      	
                  COA

                	 
	
                  Assemple
      PI Site Files (ISF) for TMF

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1.5

                	 
      	
                  20

                	 
      	
                  30

                	 
      	
                  COA

                	 
	
                  Courier
      site ISF to PI

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.25

                	 
      	
                  20

                	 
      	
                  5

                	 
      	
                  COA

                	 
	
                  Assemble
      In-House site File (IHF) (GSF) for TMF

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1

                	 
      	
                  20

                	 
      	
                  20

                	 
      	
                  COA

                	 
	
                  Crease
      eTMF folders

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  COA

                	 
	
                  CRF
      related admin

                	 
      	 
      	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  CDA
      – send to sites; review; send to Client

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  CTRA
      – send to sites; review; send to Client

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  General
      Admin

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Post
      tracking tools to web for client

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Assist
      with IRB/reg. authority submissions

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Ongoing
      regulatory doc. tracking /scanning

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Contact
      sites for enrolment updates

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  High
      level site support

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Assist
      with query resolution

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  TC
      minutes

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  COA
      General Admin Total

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  15

                	 
      	
                  122

                	 
      	
                  1830

                	 
      	
                  COA

                	 
	
                  General
      –TMF (Document Management)

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Document
      receipt & sorting

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Document
      review for completeness

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Management
      of deficiencies

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Scanning
      & hard copy filing

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  e-naming
      & e-filing

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Maintenance
      of document tracking tool

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Ongoing
      review of TMF for completeness

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Ongoing
      document retrieval and re-filing

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Fax,
      email or courier docs to CRAs/Sponsor

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Return
      of Sponsor’s TMF

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Document
      Management General TMF Total (hrs/week)

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  10

                	 
      	
                  122

                	 
      	
                  1220

                	 
      	
                  DOC

                	 
	
                  Allphase
      Center of Excellence (ACE) Training

                	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Medical
      Writing

                	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  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 & CRF data

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Discussion
      with site personnel re: processes and findings

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 


        

      

    

    


    CONFIDENTIAL


      
        

      

    

    Page 25 of
36


    
      
         


      

      
        
        

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    
      
        
          	
                  Inspection
      of client TMF regulatory files

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Review
      of vendor facilities, SOPs, processes

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Discussion
      with vendor personnel re: processes and findings

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Preparation
      of audit report

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Follow-up
      resolutions

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Vendor
      Audits

                	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Site
      Audits

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Prep

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Travel

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  12

                	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  On-Site

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  16

                	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Admin/Report
      Writing

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  12

                	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Sub-Total

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  48

                	 
      	
                  3

                	 
      	
                  144

                	 
      	
                  QA

                	 
	
                  TMF
      Audit

                	 
      	 
      	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Prep

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Travel

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  On-Site

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  32

                	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Admin/Report
      Writing

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  12

                	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Sub-Total

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  60

                	 
      	
                  0

                	 
      	
                  0

                	 
      	
                  QA

                	 
	
                  Safety

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Overall
      Medical Oversight

                	 
      	
                  (X)

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  24/7
      coverage

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.25

                	 
      	
                  104

                	 
      	
                  26

                	 
      	
                  MM

                	 
	
                  Consultation
      with sites

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.25

                	 
      	
                  88

                	 
      	
                  22

                	 
      	
                  MM

                	 
	
                  Consultation
      with Client

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1

                	 
      	
                  9

                	 
      	
                  9

                	 
      	
                  MM

                	 
	
                  Protocol
      deviation decision making and management (as required)

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.75

                	 
      	
                  9

                	 
      	
                  6.75

                	 
      	
                  MM

                	 
	
                  SAE
      Trend Analysis

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  MM

                	 
	
                  Lab
      alert review

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1

                	 
      	
                  4

                	 
      	
                  4

                	 
      	
                  MM

                	 
	
                  Protocol
      deviation processing and tracking

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.75

                	 
      	
                  88

                	 
      	
                  66

                	 
      	
                  PM

                	 
	
                  AE/SAE
      Database Setup

                	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  SAE
      Collection, Processing & Reporting

                	 
      	
                  (X)

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Review
      of SAE Plan

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  4

                	 
      	
                  1

                	 
      	
                  4

                	 
      	
                  MM

                	 
	
                  SAE
      report receipt, processing & follow-up

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  3

                	 
      	
                  44

                	 
      	
                  132

                	 
      	
                  DS

                	 
	
                  CIOMs
      generation

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  3

                	 
      	
                  9

                	 
      	
                  27

                	 
      	
                  DS

                	 
	
                  Submit
      Alert Reports to Reg. Agencies/IRB/Sponsor

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  2

                	 
      	
                  9

                	 
      	
                  18

                	 
      	
                  DS

                	 
	
                  Submit
      SAE Reports to Sites

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  1.5

                	 
      	
                  9

                	 
      	
                  13.5

                	 
      	
                  DS

                	 
	
                  Annual
      safety reporting

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  16

                	 
      	
                  2

                	 
      	
                  32

                	 
      	
                  PM

                	 
	
                  Teleconferences
      with Sponsor

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  2

                	 
      	
                  9

                	 
      	
                  18

                	 
      	
                  MM

                	 
	
                  SAE
      Medical Evaluation

                	 
      	
                  (X)

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  MM

                	 


        

      

    

     

    CONFIDENTIAL


      
        

      

    

    Page 26 of
36


    
      
         


      

      
        
        

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    
      
        
          	
                  SAE
      review of report & supporting info

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.75

                	 
      	
                  44

                	 
      	
                  33

                	 
      	
                  MM

                	 
	
                  SAE
      Narrative

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  0.75

                	 
      	
                  44

                	 
      	
                  33

                	 
      	
                  MM

                	 
	
                  Data
      Safety Monitoring Board

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Formation
      and Management

                	 
      	
                  (X)

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Provide
      3 suitable board members (2MD; 1 Biostat) & facilitate (3) meetings by
      teleconference

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  24

                	 
      	
                  1

                	 
      	
                  24

                	 
      	
                  PM

                	 
	
                  Organize
      DSMB meetings

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  12

                	 
      	
                  3

                	 
      	
                  36

                	 
      	
                  PM

                	 
	
                  Interact
      with sponsor regarding conclusions

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  3

                	 
      	
                  24

                	 
      	
                  PM

                	 
	
                  Implement
      next steps

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  3

                	 
      	
                  24

                	 
      	
                  PM

                	 
	
                  Charter,
      SOPs, Meeting #1

                	 
      	
                  (X)

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Creation
      of draft & final SOP, Charter, Open & Closed Report format;
      provide support/advice for creating DSMB and defining its duties &
      responsibilities for the project

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  24

                	 
      	
                  1

                	 
      	
                  24

                	 
      	
                  PM

                	 
	
                  Meeting
      #1 (PM): discussion of protocol, procedures, role & functioning of
      DSMB

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  6

                	 
      	
                  1

                	 
      	
                  6

                	 
      	
                  PM

                	 
	
                  Meeting
      #1 (COA): Attendance & Minutes

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  1

                	 
      	
                  8

                	 
      	
                  COA

                	 
	
                  Meeting
      #1 (MM): discussion of protocol, procedures, role & functioning of
      DSMB

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  6

                	 
      	
                  1

                	 
      	
                  6

                	 
      	
                  MM

                	 
	
                  Meeting
      #1 (BIO): discussion of protocol, procedures, role & functioning of
      DSMB

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  BIO

                	 
	
                  Administration

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Distribute
      meeting materials

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  2

                	 
      	
                  3

                	 
      	
                  6

                	 
      	
                  COA

                	 
	
                  MM:
      Review of protocol & related changes, SAP, minutes, reports,
      etc.

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  16

                	 
      	
                  1

                	 
      	
                  16

                	 
      	
                  MM

                	 
	
                  BIO:
      Review of protocol & related changes, SAP, minutes, reports,
      etc.

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  BIO

                	 
	
                  Board
      Member Participation & Evaluation

                	 
      	 
      	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  MM x
      2: Meetings #2 (closed) & #3 (open) by teleconference

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  12

                	 
      	
                  2

                	 
      	
                  24

                	 
      	
                  MM

                	 
	
                  BIO:
      Meetings #2 (closed) & #3(open) by teleconference

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  BIO

                	 
	
                  Preparation
      of Open & Closed minutes (non-CRO personnel)

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  8

                	 
      	
                  2

                	 
      	
                  16

                	 
      	
                  COA

                	 
	
                  BIO:
      preparation of Open & Closed reports

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  BIO

                	 
	
                  DM:
      preparation of database extract for Open & Closed
    reports

                	 
      	
                  X

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	
                  DM

                	 
	
                  Data
      Management

                	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Biostatistical
      Services

                	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
	
                  Data
      Management – Licenses and Fees

                	 
      	
                  N/A

                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 


        

      

    

    


    CONFIDENTIAL


      
        

      

    

    Page 27 of
36


    
      
         


      

      
        
        

        
          

        

      

      
         


      

    

    


    
      
        	
                MSA#:

              	
                YMB07-MSA-17MAY2007

              	
                WO
      Version Code:

              	
                YMB08-WO5-15DEC2008-3.0

              
	
                Version
      Date:

              	
                16DEC2008

              	
                Work
      Order #:

              	
                WO5

              


      

    

    


    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 Canadian dollars. Travel related expenses are to be reimbursed by
the client separately. Allphase reserves the right to revise this estimate if
the assumptions provided herein change. Once executed, revisions to this Work
Order will be documented using a Scope Change process. If the accumulated
Scope Change value exceeds 10% of the estimated labour total, a Change
Order will be processed.

    


    6
a. Summary – Client Template

    


    
      
        	
                YM
      BioSciences Inc.

              	
                5045
      Orbitor Drive, Building 11, Suite 400

                Mississauga,
      Ontario, Canada L4W 4Y4

                Telephone:
      905.629.9761

                Facsimile:
      905.629.4959

                Website:
      www.ymbiosciences.com

              


      

    

    


    CRO-Estimated Project Cost
Outline

    Executive
Summary

    


    CRO Name: Allphase Clinical
Research Inc.

    Project: Palliative
Radiotherapy

    Date: 10DEC2008

    


    
      
        
          
            
              
                
                  	
                          Project
      Start-up/Initiation:

                        	 	
                          Cost

                        	 
	 
      	 	 	 
	
                          CRF
      Design

                        	 	
                          Included under DM
      estimate

                        	 
	 
      	 	 	 
	
                          Grant
      Payment Administration

                        	 	 	28,000.00	 
	 
      	 	 	 	 
	
                          Critical
      Document Collection/TMF Set-up/QA/Site ID &
Feasibility

                        	 	 	21,381.25	 
	 
      	 	 	 	 
	
                          Monitoring
      Plan/CRA manual

                        	 	 	2,000.00	 
	 
      	 	 	 	 
	
                          Site
      Binders/Study Procedures (reference) Manual

                        	 	 	1,200.00	 
	 
      	 	 	 	 
	
                          Sub-Total:

                        	 	$	52,631.25	 


                

              

            

          

        

      

    

     

    
      
        
          
            
              
                
                  	
                          Investigator
      Meeting:

                        	 	
                          Cost

                        	 
	 
      	 	 	 
	
                          Investigator
      meeting set-up/Coordination

                        	 	 	12.575.00	 
	 
      	 	 	 	 
	
                          Investigator
      meeting preparation/Attendance

                        	 	 	18,710.00	 
	 
      	 	 	 	 
	
                          Sub-Total:

                        	 	$	31,285.00	 


                

              

            

          

        

      

    

    


    CONFIDENTIAL


      
        

      

    

    Page 28 of
36

    

      
        
           


        

        
          
          

          
            

          

        

        
           


        

      

      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

       

      
        
          
            
              
                
                  
                    	
                            Clinical
      Site Monitoring and Site Management:

                          	 	
                            Cost

                          	 
	 
      	 	 	 
	
                            Project
      team training/Familiarization

                          	 	 	10,380.00	 
	 
      	 	 	 	 
	
                            Site
      Selection Visits

                          	 	 	0.00	 
	 
      	 	 	 	 
	
                            Site
      Initiation Visits

                          	 	 	34,200.00	 
	 
      	 	 	 	 
	
                            Interim
      Site Monitoring Visits

                          	 	 	366,597.00	 
	 
      	 	 	 	 
	
                            Interim
      Site Monitoring Visits (follow-up)

                          	 	
                            included in
      above

                          	 
	 
      	 	 	 	 
	
                            Site
      Close-out Visits

                          	 	 	41,400.00	 
	 
      	 	 	 	 
	
                            Site
      Interaction (Telephone Contact)

                          	 	 	93,600.00	 
	 
      	 	 	 	 
	
                            Query
      Management

                          	 	
                            included in site
      visits

                          	 
	 
      	 	 	 	 
	
                            Essential
      Document/Site file Maintenance

                          	 	
                            included in site
      visits

                          	 
	 
      	 	 	 	 
	
                            Trial
      Master File reconciliations

                          	 	
                            included in site
      visits

                          	 
	 
      	 	 	 	 
	
                            Clinical
      Monitoring Oversight (PM)

                          	 	 	17,800.00	 
	 
      	 	 	 	 
	
                            Project
      Kick-off meeting

                          	 	 	7,160.00	 
	 
      	 	 	 	 
	
                            Mid-Study
      project team meeting

                          	 	 	7,160.00	 
	 
      	 	 	 	 
	
                            Teleconferences
      with YM BioSciences

                          	 	 	28,670.00	 
	 
      	 	 	 	 
	
                            Internal
      Team Meetings

                          	 	 	6,100.00	 
	 
      	 	 	 	 
	
                            Sub-Total:

                          	 	$	613,067.00	 


                  

                

              

            

          

        

      

       

      
        
          
            
              
                
                  
                    	
                            Medical
      Management:

                          	 	
                            Cost

                          	 
	 
      	 	 	 
	
                            Project
      Team training/Familiarization

                          	 	 	1,400.00	 
	 
      	 	 	 	 
	
                            Medical
      Monitoring (includes DSMB involvement)

                          	 	 	49,212.50	 
	 
      	 	 	 	 
	
                            Review
      of AE Coding

                          	 	
                            included under DM
      estimate

                          	 
	 
      	 	 	 	 
	
                            Annual
      Safety Reporting

                          	 	 	11,200.00	 
	 
      	 	 	 	 
	
                            Project
      Kick-off meeting

                          	 	 	2,450.00	 
	 
      	 	 	 	 
	
                            Teleconferences
      with YM BioSciences

                          	 	 	6,300.00	 
	 
      	 	 	 	 
	
                            Internal
      Team meetings

                          	 	 	2,450.00	 
	 
      	 	 	 	 
	
                            Sub-Total:

                          	 	$	73,012.50	 


                  

                

              

            

          

        

      

      


      CONFIDENTIAL


        
          

        

      

      Page 29 of
36


      
        
           


        

        
          
          

          
            

          

        

        
           


        

      

       

      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

       

      
        
          
            
              
                
                  	
                          Pharmacovigilance:

                        	 	
                          Cost

                        	 
	 
      	 	 	 
	
                          Project
      Team Training/Familiarization

                        	 	
                          included in Med Mgmt
      above

                        	 
	 
      	 	 	 
	
                          Create
      SAE Management Plan

                        	 	 	1,400.00	 
	 
      	 	 	 	 
	
                          SAE
      Processing

                        	 	 	27,900.00	 
	 
      	 	 	 	 
	
                          Safety
      Narratives Writing

                        	 	 	14,250.00	 
	 
      	 	 	 	 
	
                          SAE
      Reconciliation

                        	 	
                          Included under DM
      estimate

                        	 
	 
      	 	 	 	 
	
                          Sub-Total:

                        	 	$	43,550.00	 


                

              

            

          

        

      

       

      
        
          
            
              
                
                  	
                          Quality
      Assurance Site Audits:

                        	 	
                          Cost

                        	 
	 
      	 	 	 
	
                          QA
      Site Audits

                        	 	 	14,400.00	 
	 
      	 	 	
                            

                        	 
	
                          Sub-Total:

                        	 	$	14,400.00	 


                

              

            

          

        

      

       

      
        
          
            
              
                
                  
                    
                      	
                              Project
      Management and Administrative Support:

                            	 	
                              Cost

                            	 
	 
      	 	 	 
	
                              Project
      Management and Support

                            	 	 	349,325.00	 
	 
      	 	 	 	 
	
                              Regulatory
      Document/Site File Maintenance

                            	 	 	91,500.00	 
	 
      	 	 	 	 
	
                              Sub-Total:

                            	 	$	440,875.00	 


                    

                  

                

              

            

          

        

      

      
        
          
            
              
                
                  
                    	 	 	 	 	 
	
                            Total
      Labour:

                          	 	$	1,268,770.75	 
	 
      	 	 	 	 
	
                            Pass-Through
      Expenses:

                          	 	$	286,913.50	 
	 
      	 	 	 	 
	
                            ACTUAL
      TOTAL ESTIMATED PROJECT COST:

                          	 	$	1,555,684.25	 


                  

                

              

            

          

        

      

       

      CONFIDENTIAL


        
          
Page 30 of
36

      


      
        
           


        

        
          
          

          
            

          

        

        
           


        

      

       

      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

       

      6
b. Summary – Allphase Template

      


      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                
                                                  
                                                    
                                                      
                                                        
                                                          
                                                            
                                                              
                                                                
                                                                  
                                                                    
                                                                      
                                                                        
                                                                          
                                                                            
                                                                              
                                                                                
                                                                                  
                                                                                    
                                                                                      
                                                                                        
                                                                                          
                                                                                            
                                                                                              
                                                                                                
                                                                                                  
                                                                                                    
                                                                                                      
                                                                                                        
                                                                                                          
                                                                                                            
                                                                                                              
                                                                                                                
                                                                                                                  
                                                                                                                    
                                                                                                                      
                                                                                                                        
                                                                                                                          
                                                                                                                            	
                                                                                                                                    Service

                                                                                                                                  	 	
                                                                                                                                    Resp.

                                                                                                                                  	 	
                                                                                                                                    Approx.

                                                                                                                                    # hours

                                                                                                                                  	 	 	
                                                                                                                                    Hourly

                                                                                                                                    Rate

                                                                                                                                  	 	 	
                                                                                                                                    TOTALS

                                                                                                                                  	 
	
                                                                                                                                    Project
      Management (PM)

                                                                                                                                  	 
	
                                                                                                                                    Pre-Study
      Activities

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	1,200	 	 	$	100	 	 	$	120,000	 
	
                                                                                                                                    Local
      Investigator’s Meeting

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	97	 	 	$	100	 	 	$	9,700	 
	
                                                                                                                                    Ethics

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	170.75	 	 	$	100	 	 	$	17,075	 
	
                                                                                                                                    Co-Initiation/IMV/COV

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	96	 	 	$	100	 	 	$	9,600	 
	
                                                                                                                                    Ad
      hoc meetings

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	240	 	 	$	100	 	 	$	24,000	 
	
                                                                                                                                    Safety
      - SAE

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	80	 	 	$	100	 	 	$	7,950	 
	
                                                                                                                                    Safety
      – DSMB

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	138	 	 	$	100	 	 	$	13,800	 
	
                                                                                                                                    Local
      Management

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	1,040	 	 	$	100	 	 	$	104,000	 
	
                                                                                                                                    Sub-Total

                                                                                                                                  	 	
                                                                                                                                    PM

                                                                                                                                  	 	 	3,061	 	 	$	100	 	 	$	306,125	 
	
                                                                                                                                    Scientific
      Affairs

                                                                                                                                  	 
	
                                                                                                                                    Pre-Study
      Activities

                                                                                                                                  	 	
                                                                                                                                    DIR

                                                                                                                                  	 	 	4	 	 	$	120	 	 	$	480	 
	
                                                                                                                                    Sub-Total

                                                                                                                                  	 	
                                                                                                                                    DIR

                                                                                                                                  	 	 	4	 	 	$	120	 	 	$	480	 
	
                                                                                                                                    Clinical
      Monitoring (CRA)

                                                                                                                                  	 
	
                                                                                                                                    Pre-Study
      Activities

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	144	 	 	$	90	 	 	$	12,960	 
	
                                                                                                                                    Local
      Investigator’s Meeting

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	104	 	 	$	90	 	 	$	9,360	 
	
                                                                                                                                    Teleconferences

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	183	 	 	$	90	 	 	$	16,470	 
	
                                                                                                                                    Training

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	64	 	 	$	90	 	 	$	5,760	 
	
                                                                                                                                    Site
      Selection Visits

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	0	 	 	$	90	 	 	$	0	 
	
                                                                                                                                    Initiation
      Visits

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	380	 	 	$	90	 	 	$	34,200	 
	
                                                                                                                                    Interim
      Monitoring

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	4073	 	 	$	90	 	 	$	366,597	 
	
                                                                                                                                    Close-Out
      Visit

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	460	 	 	$	90	 	 	$	41,400	 
	
                                                                                                                                    Site
      Management/Interaction

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	1040	 	 	$	90	 	 	$	93,600	 
	
                                                                                                                                    Sub-Total

                                                                                                                                  	 	
                                                                                                                                    CRA

                                                                                                                                  	 	 	6448	 	 	$	90	 	 	$	580,347	 
	
                                                                                                                                    Clinical
      Operations Associate (COA)

                                                                                                                                  	 
	
                                                                                                                                    Pre-Study
      & Specific Tasks

                                                                                                                                  	 	
                                                                                                                                    COA

                                                                                                                                  	 	 	208	 	 	$	75	 	 	$	15,581	 
	
                                                                                                                                    Local
      Investigator’s Meeting

                                                                                                                                  	 	
                                                                                                                                    COA

                                                                                                                                  	 	 	107	 	 	$	75	 	 	$	8,025	 
	
                                                                                                                                    DSMB

                                                                                                                                  	 	
                                                                                                                                    COA

                                                                                                                                  	 	 	30	 	 	$	75	 	 	$	2,250	 
	
                                                                                                                                    General

                                                                                                                                  	 	
                                                                                                                                    COA

                                                                                                                                  	 	 	1,830	 	 	$	75	 	 	$	137,250	 
	
                                                                                                                                    Sub-Total

                                                                                                                                  	 	
                                                                                                                                    COA

                                                                                                                                  	 	 	2175	 	 	$	75	 	 	$	163,106	 
	
                                                                                                                                    Document
      Management Associate (DOC)

                                                                                                                                  	 
	
                                                                                                                                    General
      TMF Maintenance

                                                                                                                                  	 	
                                                                                                                                    DOC

                                                                                                                                  	 	 	1220	 	 	$	75	 	 	$	91,500	 
	
                                                                                                                                    Sub-Total

                                                                                                                                  	 	
                                                                                                                                    DOC

                                                                                                                                  	 	 	1220	 	 	$	75	 	 	$	91,500	 
	
                                                                                                                                    Quality
      Assurance (QA)

                                                                                                                                  	 
	
                                                                                                                                    Site
      Audits

                                                                                                                                  	 	
                                                                                                                                    QA

                                                                                                                                  	 	 	144	 	 	$	100	 	 	$	14,400	 
	
                                                                                                                                    TMF
      Audit

                                                                                                                                  	 	
                                                                                                                                    QA

                                                                                                                                  	 	 	0	 	 	$	100	 	 	$	0	 
	
                                                                                                                                    Sub-Total

                                                                                                                                  	 	
                                                                                                                                    QA

                                                                                                                                  	 	 	144	 	 	$	100	 	 	$	14,400	 
	
                                                                                                                                    Drug
      Safety - Management

                                                                                                                                  	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                                                                                                    Drug
      Safety

                                                                                                                                  	 	
                                                                                                                                    DS

                                                                                                                                  	 	 	177	 	 	$	100	 	 	$	17,700	 
	
                                                                                                                                    Sub-Total

                                                                                                                                  	 	
                                                                                                                                    DS

                                                                                                                                  	 	 	177	 	 	$	100	 	 	$	17,700	 
	
                                                                                                                                    Medical
      Monitoring

                                                                                                                                  	 
	
                                                                                                                                    Pre-Study
      Activities

                                                                                                                                  	 	
                                                                                                                                    MM

                                                                                                                                  	 	 	18	 	 	$	350	 	 	$	6,300	 
	
                                                                                                                                    Local
      Investigator’s Meeting

                                                                                                                                  	 	
                                                                                                                                    MM

                                                                                                                                  	 	 	12	 	 	$	350	 	 	$	4,200	 
	
                                                                                                                                    Medical
      Monitoring

                                                                                                                                  	 	
                                                                                                                                    MM

                                                                                                                                  	 	 	196	 	 	$	350	 	 	$	68,513	 
	
                                                                                                                                    DSMB

                                                                                                                                  	 	
                                                                                                                                    MM

                                                                                                                                  	 	 	46	 	 	$	350	 	 	$	16,100	 
	
                                                                                                                                    Sub-Total

                                                                                                                                  	 	
                                                                                                                                    MM

                                                                                                                                  	 	 	272	 	 	$	350	 	 	$	95,113	 
	
                                                                                                                                    Estimated
      Project Operational – Sub-Total

                                                                                                                                  	 	 	$	1,268,771	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                                                                                                    Estimated
      Project Pass-Through Costs – Sub-Total

                                                                                                                                  	 	 	$	286,914	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                                                                                                    Estimated
      Project - Total

                                                                                                                                  	 	 	$	1,555,684	 
	
                                                                                                                                    Estimated
      Project – Total/patient (Labour only)

                                                                                                                                  	 	 	$	14,418	 
	
                                                                                                                                    Estimated
      Project – Total/patient (Labour and pass-through)

                                                                                                                                  	 	 	$	17,678	 


                                                                                                                          

                                                                                                                        

                                                                                                                      

                                                                                                                    

                                                                                                                  

                                                                                                                

                                                                                                              

                                                                                                            

                                                                                                          

                                                                                                        

                                                                                                      

                                                                                                    

                                                                                                  

                                                                                                

                                                                                              

                                                                                            

                                                                                          

                                                                                        

                                                                                      

                                                                                    

                                                                                  

                                                                                

                                                                              

                                                                            

                                                                          

                                                                        

                                                                      

                                                                    

                                                                  

                                                                

                                                              

                                                            

                                                          

                                                        

                                                      

                                                    

                                                  

                                                

                                              

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL


        
          

        

      

      Page 31 of
36


      
        
           


        

        
          
          

          
            

          

        

        
           


        

      

      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

       

      7.
Estimated Pass-Through Expenses

       

      
        
          
            
              	 
      	 	 	 	 	 	 	 	
                      TOTALS
      (CDN)

                    	 	 	 	 
	
                      Pass-Through
      Expenses

                    	 	 	 	 	
                      Unit
      Cost

                    	 	 	
                      #
      Units

                    	 	 	
                      Total
      Cost

                    	 
	
                      Travel
      Expenses (1 Day Trip)

                    	 
      	 
      	75	%	 	 	200.00	 	 	 	190	 	 	$	38,000
      	 
	
                      Travel
      Expenses (2 Day Trip)

                    	 	 	25	%	 	 	800.00	 	 	 	63	 	 	$	50,400	 
	
                      Meal
      Expenses - day trip

                    	 	
                      per
      day

                    	 	 	 	30.00	 	 	 	190	 	 	$	5,700	 
	
                      Monitor
      Overnight Expenses (ie. Hotel)

                    	 	
                      per
      trip

                    	 	 	 	200.00	 	 	 	126	 	 	$	25,200	 
	
                      Meal
      Expenses - overnight

                    	 	 	 	 	 	 	60.00	 	 	 	126	 	 	$	7,560	 
	
                      Quality
      Assurance / Site Audit

                    	 	
                      per
      trip

                    	 	 	 	1,500.00	 	 	 	3	 	 	$	4,500	 
	
                      Allphase
      & Client Meeting Expenses

                    	 	
                      per
      person

                    	 	 	 	600.00	 	 	 	10	 	 	$	6,000	 
	
                      Miscellaneous
      Expenses (consumables* and communication costs) = $120 pp/month (active
      period)/CRA

                    	 	
                      per
      month

                    	 	 	 	120.00	 	 	 	97	 	 	$	11,640	 
	
                      Miscellaneous
      Expenses (consumables* and communication costs) = $120 pp/month for the
      entire study duration: 1PM & 1 COA

                    	 	
                      per
      month

                    	 	 	 	120.00	 	 	 	57	 	 	$	6,840	 
	
                      CRF
      Printing

                    	 	
                      per
      CRF

                    	 	 	 	50.00	 	 	 	0	 	 	$	0	 
	
                      Diaries
      in French and English

                    	 	 	 	 	 	
                      TBD

                    	 	 	 	 	 	 	 	 	 
	
                      Translation

                    	 	 	 	 	 	
                      TBD

                    	 	 	 	 	 	 	 	 	 
	
                      Teleconferences

                    	 	
                      per
      conf.

                    	 	 	 	25.00	 	 	 	61.00	 	 	$	1,525	 
	
                      Mailing

                    	 	
                      per
      letter

                    	 	 	 	2.00	 	 	 	293.00	 	 	$	586	 
	
                      Courier

                    	 	
                      per
      package

                    	 	 	 	25.00	 	 	 	122.00	 	 	$	3,050	 
	
                      Finance
      Couriers (expenses)

                    	 	
                      per
      package

                    	 	 	 	25.00	 	 	 	30.50	 	 	$	763	 
	
                      Newsletters

                    	 	
                      per
      newsletter

                    	 	 	 	2.00	 	 	 	0	 	 	$	0	 
	
                      TMF
      Regulatory Binders

                    	 	
                      per
      site

                    	 	 	 	50.00	 	 	 	20	 	 	$	1,000	 
	
                      Regulatory
      Binders

                    	 	
                      per
      site

                    	 	 	 	50.00	 	 	 	20	 	 	$	1,000	 
	
                      Study
      Reference Binders

                    	 	
                      per
      site

                    	 	 	 	50.00	 	 	 	20	 	 	$	1,000	 
	
                      Investigator
      Grants

                    	 	
                      per
      patient

                    	 	 	
                      TBD

                    	 	 	 	88	 	 	 	 	 
	
                      Ethics
      Committee/IRB Fees

                    	 	
                      per
      site

                    	 	 	
                      TBD

                    	 	 	 	0	 	 	 	 	 
	
                      Insurance

                    	 	
                      per
      site

                    	 	 	
                      TBD

                    	 	 	 	0	 	 	 	 	 
	
                      Advertising

                    	 	
                      per
      site

                    	 	 	
                      TBD

                    	 	 	 	0	 	 	 	 	 
	
                      Pharmacy
      Set up fees

                    	 	
                      per
      site

                    	 	 	
                      TBD

                    	 	 	 	0	 	 	 	 	 


            

          

        

      

      


      CONFIDENTIAL


        
          

        

      

      Page 32 of
36


      
        
           


        

        
          
          

          
            

          

        

        
           


        

      

      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

      


      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	 
      	 	 	 
      	 	 	 	 	
                                        Sub-Total:

                                      	 	 	$	164,764	 
	
                                        Local
      Investigator’s Meeting

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

                                      	 	 	
                                        per
      site

                                      	 	 	 	1,950.00	 	 	 	40	 	 	$	78,000	 
	
                                        Investigator
      Meeting Airfare - Allphase staff (all economy)

                                      	 	 	
                                        per
      person

                                      	 	 	 	900.00	 	 	 	3	 	 	$	2,700	 
	
                                        Investigator
      Meeting Hotel - site staff (3 nights)

                                      	 	 	
                                        per
      person

                                      	 	 	 	750.00	 	 	 	40	 	 	$	30,000	 
	
                                        Investigator
      Meeting Hotel - Allphase staff (3 nights)

                                      	 	 	
                                        per
      person

                                      	 	 	 	750.00	 	 	 	3	 	 	$	2,250	 
	
                                        Transportation
      and meals

                                      	 	 	
                                        per
      person

                                      	 	 	 	200.00	 	 	 	46	 	 	$	9,200	 
	 
      	 	 	 
      	 	 	 	 	 	 	
                                        Sub-Total:

                                      	 	 	$	122,150	 
	 
      	 	 	 
      	 	 	 	 	 	 	
                                        Total

                                      	 	 	$	286,914	 


                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      Note:
*Consumable volume limited to 500 B&W and 100 colour copies/prints per
month. Excess will be billed at $0.05 per page for B&W; $0.25 per page for
colour.

      


      CONFIDENTIAL


        
          

        

      

      Page 33 of
36


      
        
           


        

        
          
          

          
            

          

        

        
           


        

      

      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

       

      8.
Payment Schedule and Terms

       

      A deposit
of 15% ($190,316 CDN) of
the estimated project total is to be paid upon initiation of this contract.
Detailed invoices will be submitted to Client monthly.

      


      
        	
                 
      

              	
                ·

              	
                Monthly
      labour invoices will be issued

              


      

      
        	
                 
      

              	
                ·

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

              


      

      
        	
                 
      

              	
                ·

              	
                Expenses
      related to courier, teleconferencing, and communication & consumables
      will be summarized on expense invoices. Original documentation will not be
      provided but is available for review for an additional fee (labour
      required to anonymize).

              


      

      
        	
                 
      

              	
                ·

              	
                Applicable
      taxes on labor will be indicated on
invoice.

              


      

      
        	
                 
      

              	
                ·

              	
                Payment
      terms are 30 days from receipt of
invoice.

              


      

      
        	
                 
      

              	
                ·

              	
                2%
      per month financing fee may be applied to outstanding balance
      owing.

              


      

      
        	
                 
      

              	
                ·

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

              


      

      
        	
                 
      

              	
                ·

              	
                The
      Client acknowledges that upon execution of the full Work Order, Allphase
      will dedicate personnel to this Project, on a full time or part time basis
      as appropriate. If after 90 days following the date of execution of this
      Work Order (exclusive of the letter of Intent provisions) the project is
      delayed for greater than 30 days for reasons beyond the control of
      Allphase (e.g. regulatory hold), if Client wishes to retain the assigned
      project team, Client agrees to pay Allphase its direct costs per assigned
      employee. This value will be calculated based on the average number of
      hours billed per individual over the preceding 3 months. This will be a
      daily calculation starting on day 31 post written notification of the
      effective date of the delay. If billable work continues during the delay
      period and the value of this work is at least equal to Allphase direct
      costs, then no additional fee will be levied. Alternately, Allphase may
      re-assign personnel to other Projects, or Client and Allphase may
      negotiate alternate arrangements to minimize the economic impact on both
      Parties.

              


      

      


      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. The client
will be consulted regarding the possibility of deviating from the scope of work
defined within this proposal.

      


      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 34 of
36


      
        
           


        

        
          
          

          
            

          

        

        
           


        

      

      


      
        
          	
                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

       

      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 2.2
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:

                    	
                         

                    	 	
                      Signature:

                    	 
      
	 
      	 	 
      
	
                      Date:
      December 24, 2008

                    	 	
                      Date:
      January 5, 2009

                    
	 
      	 	 
      
	
                      Name/Title:
      David Allan/Chairman & 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 11of this Work Order may be executed.

      


      CONFIDENTIAL


        
          

        

      

      Page 35 of
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                  MSA#:

                	
                  YMB07-MSA-17MAY2007

                	
                  WO
      Version Code:

                	
                  YMB08-WO5-15DEC2008-3.0

                
	
                  Version
      Date:

                	
                  16DEC2008

                	
                  Work
      Order #:

                	
                  WO5

                


        

      

       

      11.
Letter of Intent

       

      Further
to contact regarding the "A Randomized, Phase II, Double-Blind Study Nimotuzumab
Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patient
With Brian Metastases From Non-Small Cell Lung Cancer.” Study, YM BioSciences
(YMB) confirms the intent to place a contract with ALLPHASE Clinical Research
Inc. (ALLPHASE) for clinical services in relation to this project.

      


      As the
above referenced Work Order for this project is being negotiated between YMB and
ALLPHASE, YMB authorises ALLPHASE to begin the necessary preparations for the
project upon written approval of individual tasks.

      


      YMB will
prepay 15% equal to $190,316 Canadian dollars of
the estimated project total under this Letter of Intent. It is understood that
ALLPHASE will not make any financial commitments extending beyond the above
mentioned value, before a signed Work Order has been executed by the parties.
The prepaid amount under this Letter of Intent will be reconciled against
subsequent payments for this study as agreed in the final contract.

      


      ALLPHASE
agrees that all information disclosed under this Letter of Intent is
confidential and property of YMB and agrees not to disclose or use such
information without prior written approval of YMB.

      


      In the
event that no final contract can be executed between YMB and ALLPHASE by 31
January 2009, ALLPHASE shall remit YMB the amount already paid having deducted
any fees or expenses already incurred by ALLPHASE at the time of such decision.
YMB shall have the right to audit ALLPHASE records regarding this
project.

      


      This
Letter of intent is to be signed by the parties.

      


      
        
          
            
              	
                      Agreed
      and accepted

                    	 	
                      Agreed
      and accepted

                    
	
                      YM
      BioSciences Inc.

                    	 	
                      ALLPHASE
      Clinical Research Inc.

                    
	 
      	 	 
      
	
                      Date:
      December 24, 2008

                    	 	
                      Date:
      January 5, 2009

                    
	 
      	 	 
      
	
                      Signature:

                    	
                         

                    	 	
                      Signature:

                    	
                         

                    
	 
      	 	 
      
	
                      Name/Title:
      David Allan/Chairman & CEO

                    	 	
                      Name/Title:
      Jeff Smith/President

                      I
      have the authority to bind the
corporation.

                    


            

          

        

      

      


      
        
          
            	
                    Date:

                  	
                       

                  	 
      


          

        

      

      


      
        
          
            
              
                
                  	
                          Signature:

                        	
                             

                        	 
      
	 	 	 
	
                          Name/Title:

                        	
                             

                        	 
      


                

              

            

          

        

      

       

      We have
the authority to bind the corporation.

      


      CONFIDENTIAL


        
          

        

      

      Page 36 of
36