Document:

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
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                    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
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                    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
36

      
        
           

        

        
          
          

          
            

          

        

        
           

        

      

      

      
        
          	
                  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
36MASTER
SERVICES AGREEMENT

      

      This
Master Services Agreement ("Agreement") is entered into as of August 24th, 2007
(the "Effective Date") by and between YM Biosciences USA Inc., a
corporation incorporated in Delaware located at 701 Lee Road, Suite 201, Wayne,
PA 19087 (hereinafter “YMB USA USA”) and AAIPharma Inc., having offices
at 2320 Scientific Drive, Wilmington, North Carolina 28405, including its
subsidiaries (“AAIPharma”). YMB USA USA and AAIPharma are referred to singly as
"Party" and jointly as "Parties" throughout this Agreement.

      

      WITNESSETH

      

      WHEREAS, AAIPharma is a
contract research organization that provides the implementation, management and
monitoring of clinical studies and related services (hereinafter, "Services");
and

      

      WHEREAS, the YMB USA desires
to obtain Services from AAIPHARMA throughout the Term of this Agreement in
accordance with the terms set forth herein and in accordance with a defined
specification and scope of work to be mutually agreed upon by the Parties in
writing (hereinafter the "Work Order") substantially in the form of Attachment A
which is herein incorporated by reference; and,

      

      NOW THEREFORE, for and in
consideration of the mutual covenants and agreements set Forth hereinafter and
for other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, the parties hereto do hereby agree as
follows:

      

      Article
1

      DEFINITIONS

      

      For
purposes of this Agreement and the Protocol, each capitalized term shall have
the meaning ascribed to it in this Agreement. Each capitalized tern not defined
in this Agreement shall have the meaning ascribed to that term in the Protocol.
In the event of a discrepancy in the meaning ascribed to a term in the body of
this Agreement and the meaning ascribed to that term in the Protocol, the
definition utilized in the body of this Agreement shall control.

      

      1.1  "Case Report Form" or "CRF" means the record of
pertinent information collected on each subject who participates in the
Study;

      

      1.2  "Cause" means a Defaulting
Party's failure to correct a default or to provide a schedule for correcting a
default which is acceptable to the Non-Defaulting Party, within five (5)
business days after being given notice of default for failure to perform a
material obligation under this agreement.

      

      1.3  "Change Order" means of an
adjustment in fees, timeline, Protocol, performance milestones, budget, payment
schedule, duties, deliverables or matters related to Out of Scope
Services.

      

      1.4  "Clinical Research Associate"
or "CRA" means the
person assigned by AAIPharma to monitor one or more Study Sites.

      

      1.5  "Clinical Trial Agreement"
means the agreement between YMB USA and an Investigator that details the
respective rights and obligations of both parties in relation to the
Study;

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      1.6  "Clinical Trial Materials"
means the printed Case Report Forms, CRF monitoring conventions, the Protocol,
the investigational drug brochure, informed consent form, guidelines for use of
the Investigational
Product, and all other materials provided by YMB USA to conduct the
Study.

      

      1.7  "Closeout Services" means
those services described in Section 10.4 to be performed by AAIPharma upon
termination of this Agreement.

      

      1.8  "Confidential Information"
means all information relating to the Investigational Product and Study
including but not limited to YMB USA's business, operations, methods of
operating, customers, affairs, processes, inventions, know-how, research, trade
secrets, personnel, and financial, production, scientific and technical data and
information, whether written, graphic, electronic, digital or oral, as well as
samples and specimens thereof, howsoever or whensoever obtained by AAIPharma,
whether from YMB USA or otherwise and whether directly or indirectly and all
clinical data, including Case Report Forms, underlying data and all scientific
and technical information generated as a result of the Study and copies, notes
or summaries prepared with the Confidential Information.

      

      1.9  "Effective Date" means the
effective date of this Agreement as set forth in the initial paragraph of this
Agreement.

      

      1.10  "FDA" means United States Food
and Drug Administration.

      

      1.11
"GCPs" means established
ethical, medical and scientific standards, including without limitation good
clinical practices, including as described in the ICH Guidelines, the
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and
the Declaration of Helsinki and all applicable regulatory
requirements.

      

      1.12
"GLPs" means good
laboratory practices as established by TPD and the FDA for the commercialization
of pharmaceutical products in Canada and the United States.

      

      1.13
"ICH Guidelines" means
the guidelines of the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use, providing for a
unified standard for Canada, the European Union, Japan and the United States
with respect to the interpretation and application of technical guidelines and
requirements for pharmaceutical product registration.

      

      1.14  "Institutional Review Board"
or "IRB" means the
independent group of professionals designated to ensure that the Study is safe
and effective for human participation and that the Study adheres to the
regulations issued by Health Canada and any other applicable country- specific
laws, regulations or guidelines.

      

      1.15
"Intellectual Property"
means all information, data, works of authorship, discoveries, concepts,
designs, processes, software, algorithms and inventions, whether patentable or
not, including, without limitation, those that could be the subject of patent,
copyright, industrial design, trade secret or other forms of
protection.

      

      1.16  "Investigational New Drug
Application'' or "IND"
means the petition filed by YMB USA with Health Canada requesting Health
Canada to allow human testing on the Investigational Product.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      1.17  "Investigational Product"
means the monoclonal antibody to Epidermal Growth Factor Receptor named
nimotuzumab or otherwise referred to as hR3 as described in the Protocol that
will be evaluated in this Study.

      

      1.18  "Investigator" means an
individual who actually conducts a clinical investigation, i.e., under whose
immediate direction the Investigational Product is administered or dispensed to,
or used involving a subject, or, in the event of an investigation conducted by a
team of individuals, is the responsible leader of that team.

      

      1.19  "Laws" means all applicable:
(a) laws, statutes, codes, rules, regulations and Regulatory Requirements; (b)
judgments, orders, decisions, rulings, and words of a regulatory authority; and
(c) pharmaceutical guidelines, policies and standards relating to or having
jurisdiction over a Project.

      

      1.20  "Out of Scope Services" are
changes to a Project or Services that are not specifically provided for in an
executed Work Order.

      

      1.21  "Project Manager" means the
manager assigned by AAIPharma to be the primary contact person between AAIPharma
and YMB USA during the Study.

      

      1.22  "Project" means the Services
described by a Protocol and Work Order, conducted under this
Agreement.

      

      1.23  "Protocol" means the plan that
describes the objectives, study design, and methodology of a Study and any
approved amendments thereto, which is herein incorporated by
reference.

      

      1.24  "Regulatory Requirements"
means those laws, regulations, and professional and ethical standards and
guidelines then in effect in the countries in which the Study is conducted that
apply to the Investigational Product or clinical trials in general and as
specified in the individual Work Order.

      

      1.25  "Results" shall mean all
materials, samples, specimens or compounds, including sub-samples or progeny
thereof, all data, information, reports, slides, or presentations; conclusions
and interpretations created or arising in connection with a
Project.

      

      1.26  "Serious Adverse Event" shall
take the meaning given this term in the Protocol.

      

      1.27  "Services" means the
activities and work provided by AAIPharma in connection with the Study as set
out in this Agreement.

      

      1.28  "Service Documents" means all
Work Orders or Change Orders executed by both Parties under this
Agreement.

      

      1.29  "Standard Operating
Procedures" or "SOP's" means internal
procedures for the management of a clinical trial designed to ensure that the
trial is carried out in a consistent, controlled, and effective
manner.

      

      1.30
"Study" means the
clinical trial of the Investigational Product, the details of which are set out
in the Schedules.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      1.31  "Study Documents" means the
documents produced by AAIPharma in connection with the Study.

      

      1.32  "Subject" means a human
patient enrolled in the Study.

      

      1.33  "Term" means the duration or
this Agreement as set out in Section 10.1.

      

      1.34  "Test Materials" shall mean
all pharmaceutical compounds, Investigational Product, materials or other
substances provided by YMB USA to AAIPharma and administered or utilized as part
of this Study.

      

      1.35  ''TPD'' means Therapeutic
Products Directorate of Health
Canada (or whatever such agency might be called from time to time), or
any successor agency having regulatory jurisdiction over the manufacture,
distribution and sale of drugs in Canada from time to time.

      

      1.36  "Work Order" means a completed
and executed document in the form attached hereto as Appendix A, for a Study and
will include a description of the Project, details of the Services, Protocol,
specifications, deliverables, budget, payment schedule, and timelines, and other
terms agreed to by the Parties.

      

      ARTICLE
II

      SCOPE OF
AGREEMENT

      

      2.1  The
purpose of this Agreement is to set forth the terms, conditions and
administrative procedures applicable to Services provided by AAIPharma to YMB
USA. The Parties hereby agree that AAIPharma will provide such Services to YMB
USA, as set forth in each attached Work Order (which shall be attached hereto
and incorporated herein by reference). This Agreement and the Work Order,
attached as an Appendix, shall collectively constitute the entire agreement for
a Project. To the extent there is any discrepancy between the provisions of this
Agreement and any Work Order, the terms and conditions of this Agreement shall
govern unless otherwise explicitly set forth and mutually agreed upon by the
Parties.

      

      2.2  In
the event AAIPharma is requested or required to perform Out of Scope Services on
a Project after execution of the Work Order, AAIPharma will provide YMB USA with
a written Change Order. The Parties agree to act in good faith when considering
a Change Order requested by the other Party. Any Change Order will be effective
only upon written execution by both Parties, and the Out of Scope Services
agreed to in the Change Order shall be deemed to be Services pursuant to this
Agreement.

      

      2.3  Should
any Laws be amended, and compliance with the new requirements necessitates a
change in the Protocol or Work Order, AAIPharma will submit a Change Order to
YMB USA for acceptance prior to making any changes in the Protocol, Work Order
or the Project. AAIPharma agrees that no changes shall be made without the prior
written approval of YMB USA. In the event of a conflict in government
regulations, AAIPharma shall notify YMB USA to obtain clarification and guidance
regarding compliance with the regulations.

      

      2.4  AAIPharma
shall at all times be an independent contractor of YMB USA, and nothing in this
Agreement is intended, nor shall be construed, to create between YMB USA and
AAIPharma the relationship of principal and agent, employer and employee,
partnership, or joint venture, and the parties shall not represent themselves
otherwise. AAIPharma shall be liable for its own debts, obligations, acts or
omissions, including but not limited to the payment of all required
compensation, withholding, social security and other taxes or benefits for
AAIPharma's employees relative to Services provided under this
Agreement.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      2.5  The
Parties agree that this Agreement is executed subject to the condition that
AAIPharma receive a letter from the attorney named Richard Popkin, who
specializes in Cuban: US government issues, stating that AAIPharma may provide
services to YMB USA under YMB USA’s OFAC license, if necessary for a specific
Work Order. In such case where AAIPharma cannot obtain such assurances,
AAIPharma may terminate that Work Order upon thirty (30) days written notice to
YMB USA, and in no event shall AAIPharma be obligated to perform services under
a Work Order which violates the US laws or regulations governing products of
Cuban Origin.

      

      ARTICLE
III

      PROJECT
IMPLEMENTATION

      

      3.1  Representations of
AAIPharma.

      

      3.1.1  AAIPharma
represents and warrants that it has or shall procure and maintain consents,
approvals, licenses and operating certificate as required to perform its
obligations pursuant to this Agreement and in accordance with Regulatory
Requirements.

      

      3.1.2  AAIPharma
acknowledges, warrants and represents that it and all of the employees and
agents it assigns to perform Services hereunder possess the necessary
qualifications, knowledge, skills, expertise and experience. AAIPharma shall, at
all times during this Agreement, act in the best interests of YMB
USA.

      

      3.1.3  AAIPharma
certifies that to the best of its knowledge after investigation and inquiry,
that none of its employees or agents performing or affiliated with a Project or
Work Order is under investigation by a medical licensing board, TPD, a
regulatory authority, or the FDA for debarment action or is presently debarred,
and shall notify YMB USA immediately upon any inquiry or the commencement of any
proceeding concerning any such person(s).  AAIPharma represents and
warrants that it has not and will not use in any capacity the services of any
person debarred under such law with respect to Services to be performed under
this Agreement.

      

      3.1.4  AAIPharma
warrants that all Services provided by AAIPharma and the conduct of this Study
shall comply with the Protocol, YMB USA's instructions, and according to
established ethical, medical and scientific standards, including without
limitation, all applicable Good Laboratory Practices, Good Clinical Practices,
the requirements of the IRB, and all Laws governing or pertaining to clinical
trials and studies, and any amendments thereto or any successor documents
thereof.

      

      3.1.5  AAIPharma
represents that it has the requisite facilities, equipment and personnel with
the requisite expertise, experience and skill to render the desired Services in
a timely, competent and efficient manner, as specified in the Protocol and/or
Work Order and in accordance with the terms of this Agreement.

      

      3.1.6  Conflict
of Interest. AAIPharma certifies that:

      

      (a)  no
collateral benefit has been offered to it, or its employees or agents, for
participating in this

      Agreement
such as promises of gifts, future employment, or travel that is not related to
this Agreement; and

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      (b)  the
performance of the work specified in this Agreement does not violate any
other

      agreement
AAIPharma may have with any other party; and

      (c)  no
gifts or other benefits have been offered to any family members;
and

      (d)  there
is no conflict of interest between AAIPharma and any other party that would
inhibit or

      affect
the performance of the work specified in this Agreement, and

      (e)  it
shall promptly inform YMB USA in writing in the event of any conflict of
interest that arises

      during
this Agreement.

      

      3.2  Obligations of
AAIPharma.

      

      3.2.1  AAIPharma
shall provide all labour and work required for the performance of the Services,
and agrees to perform such Services within the time limits set forth in the Work
Orders. YMB USA understands and agrees that completing the Services as set forth
in the Work Order assumes the full cooperation of YMB USA as well as other
necessary third parties. YMB USA will not hold AAIPharma responsible for any
occurrences outside AAIPharma's control that may delay the completion
of Services. YMB USA acknowledges that, if YMB USA materially delays or suspends
performance of the Services, then the personnel and/or resources originally
allocated to the Project may be re-allocated, and AAIPharma will not be
responsible for delays due to required re-staffing or re-allocation of
resources.

      

      3.2.2  AAIPharma
shall not engage any third party for any of the Services as set forth in Service
Documents without the prior written consent of YMB USA. AAIPharma shall be
responsible for all subcontractors performing any Services hereunder and
AAIPharma will not be relieved of any of its duties and obligations under this
Agreement in the event a subcontractor performs any Services. However, contract
CRAs, medical writers and biostatisticians shall not require such prior written
consent.

      

      3.2.3  Before
commencement of the Study, AAIPharma shall assign to the Study a Project Manager
and sufficient personnel, including CRAs, with suitable experience and training
to fulfill AAIPharma's obligations under this Agreement. Any change in the
Project Manager thereafter must be reasonably acceptable to YMB
USA.

      

      3.2.4  AAIPharma
shall apply to the Study systems of quality control and SOP's designed to ensure
that, as far as is reasonably practicable, YMB USA and the Investigators conduct
the Study; generate data; and record and report data, all in compliance with the
Regulatory Requirements, Good Clinical Practice, the Protocol, and this
Agreement, in that order.

      

      3.2.5  AAIPharma
will review all informed consents, Study related forms and CRFs to ensure their
accuracy and completeness and provide these forms and any other Study data or
samples to YMB USA in the format and manner requested by YMB USA. AAIPharma
agrees to use commercia1ly reasonable efforts to resolve any discrepancies or
errors in the informed consents and CRFs and perform audit requirements
pertaining to original case records, laboratory reports and/or other raw data
sources underlying the data recorded on the CRFs, as may be required by YMB USA
or Regulatory Requirements.

      

      3.2.6  AAIPharma
shall be responsible, at no cost to YMB USA, to provide such additional services
as may be necessary to remedy any defects or deficiencies in the Services caused
by the negligent acts or omissions of AAIPharma or by the failure to materially
perform the Services in accordance with the provisions of this Agreement or a
Work Order.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      3.2.7  AAIPharma
and its personnel shall cooperate with any other contractors or consultants
retained by YMB USA to undertake related work or programs for the
Project.

      

      3.2.8  AAIPharma
agrees to manage and review the use of the Test Materials by Study sites to
assure that Test Materials are being used in the manner provided in the Protocol
and in accordance with YMB USA's instructions, and shall not use the Test
Materials for any other purpose whatsoever. Upon completion of the Project, or
at any other time upon YMB USA's written request and YMB USA's expense,
AAIPharma agrees to promptly return to YMB USA all Test Materials in its
possession, other than those that AAIPharma is required to store in accordance
with applicable Laws. YMB USA will notify AAIPharma within sixty (60) days after
completion of a Project whether the remaining samples are to be returned to YMB
USA, stored or destroyed.

      

      3.2.9  AAIPharma
will provide YMB USA with written status reports in accordance with either YMB
USA or AAIPharma SOP’s (as mutually agreed by the Parties and as set forth in
the applicable Work Order).

      

      3.2.10  AAIPharma
shall notify YMB USA by phone immediately after becoming aware of a Serious
Adverse Event and shall submit an initial written report to YMB USA regarding
that Serious Adverse Event via facsimile within 24 hours after AAIPharma becomes
aware of any such event.

      

      3.3  Representations of YMB
USA.

      

      3.3.1  YMB
USA represents and warrants that the execution, delivery and performance of this
Agreement (a) has been duly authorized by all necessary corporate action; (b)
does not conflict with, or result in a material breach of, its articles of
incorporation or by-laws and any material agreement by which it is bound, or any
Laws and (c) this Agreement has been duly executed by it and constitutes its
valid and legally binding obligation enforceable in accordance with its
terms.

      

      3.3.2 YMB
USA certifies that to the best of its knowledge after investigation and inquiry,
that none of its employees or agents is under investigation by a medical
licensing board, TPD, a regulatory authority, or the FDA for debarment action or
is presently debarred and shall notify AAIPharma immediately upon any inquiry or
the commencement of any proceeding concerning any such person(s).

      

      3.3.3  YMB
USA represents and warrants that the delivery of the Investigational Product to
AAIPharma, its use in accordance with the Protocol and the performance of the
Services by AAIPharma in accordance with this Agreement, are permitted by YMB
USA’s OFAC license (if applicable), will not violate any applicable Laws, cause
a breach of any agreements with any third parties, or infringe upon any patent
or other intellectual property rights of third parties.

      

      3.4  Obligations of YMB
USA.

      

      3.4.1  YMB
USA shall procure and maintain all consents, approvals, licenses, and operating
certificates required to conduct the Study, including but not limited to, the
approval of the Protocol by TPD. YMB USA shall also develop, comply with, and
require staff to comply with, policies and procedures designed to assure, at all
times, that such consents, approvals, licenses, and operating certificates
remain in effect throughout the Term.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      3.4.2 YMB
USA shall provide AAIPharma, at no expense to AAIPharma (i) with all information
and documentation reasonably necessary for AAIPharma to perform its duties
hereunder, including but not limited to; (ii) all Clinical Trial Materials; and
(iii) with all advice, guidance, and assistance reasonably requested by
AAIPharma to fulfill its duties under this Agreement. Notwithstanding the
foregoing, AAIPharma will provide the CRF’s.

      

      3.4.3  YMB
USA will provide AAIPharma with sufficient amounts of Test Materials to perform
the Services. Prior to or concurrent with delivery of Test Materials, YMB USA
will provide information pertaining to stability, proper storage, safety and
other characteristics and requirements of the Test Materials. YMB USA will be
solely responsible for providing AAIPharma with the Test Materials in a manner
that complies with applicable laws, including but not limited to regulatory
permits or licenses to ship or test the Test Materials and/or labelling
requirements.

      

      3.4.4  YMB
USA shall have the right to visit and co-monitor a Study site or inspect and
audit any of the Study Documents maintained by AAIPharma consistent with Laws
regulating the review of study data and information. All such visits and
inspections must be conducted during normal working hours on regular business
days with reasonable written notice and at mutually agreed upon times, unless
otherwise agreed. AAIPharma shall arrange access to the Study site as soon as
reasonably practicable following notification by YMB USA.

      

      ARTICLE
IV

      PAYMENT FOR SERVICES
RENDERED

      

      4.1  YMB
USA agrees to pay to AAIPharma for Services provided, and all expenses incurred
by AAIPharma pursuant to this Agreement and properly executed Service
Documents.

      

      4.2  YMB
USA shall reimburse AAIPharma for all reasonable airfare, hotel, and other
travel expenses incurred by AAIPharma in its performance of the Services,
including but not limited to, expenses incurred by AAIPharma in connection with
site selection visits, initiation visits, monitoring visits, and closeout visits
and in connection with attendance at Project Meetings and Investigators'
Meetings. YMB USA shall also reimburse AAIPharma for all photocopying, courier,
and other similar expenses incurred by AAIPharma in its performance of its
duties under this Agreement. Original receipts will not accompany pass-through
invoices. All original and pass-through receipts will be housed at AAIPharma and
will be available for YMB USA's audit upon request. Notwithstanding the
foregoing, YMB USA shall not be responsible for any costs described in this
Paragraph 4.2 that exceed the amount budgeted for such expenses in Service
Documents, without prior written approval being obtained from YMB. Any amounts
approved by YMB USA in excess of those specified in Service Documents, shall be
separately invoiced to YMB USA and YMB USA shall pay these invoices according to
the terms of Paragraph 4.3 and 4.4 below.

      

      4.3  Unless
otherwise agreed by the Parties in writing, AAIPharma shall provide to YMB USA
one or more appropriate invoices on a calendar month basis for Services rendered
as set forth in the respective Service Documents. Invoices are due and payable
net thirty (30) days of receipt, unless YMB USA notifies AAIPharma of any
disputes with the invoiced amounts. All payments to AAIPharma shall be made in
the currency mutually agreed upon and set forth in a respective Work Order.
Invoice balances not remitted within thirty (30) days of YMB USA's receipt of
each invoice shall be subject to a one and one-half percent (1.5%) per month
interest charge. Should any part of the invoice be in dispute, the YMB USA shall
pay the balance of the undisputed amount according to the terms and conditions
described herein while said dispute is being resolved.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      4.4  All
payment will be made payable to AAIPharma Inc. Payments shall be sent to the
following address:

      

      Attn.
Accounts Receivable

      AAIPharma
Inc.

      PO Box
404120

      Atlanta,
GA 30384-4120

      Wire
Transfers: Bank of America ABA #0260-0959-3, Account # 3756316029

      

      4.5  If
advances or other payments by YMB USA exceed the amount owed for work actually
performed under the Protocol and Service Documents, AAIPharma agrees to return
the excess balance to YMB USA within thirty (30) days of the effective date of
termination or completion of Closeout Services by AAIPharma.

      

      4.6  In
the event of a dispute regarding payment or the performance of Services pursuant
to this Agreement or a Service Document (each, a “Dispute”),the Parties shall
endeavour to negotiate in good faith an agreeable solution. If after ten (l0)
business days following receipt of a Party's written notification of a Dispute
such Dispute has not been resolved, the Dispute shall be brought to the
attention of the CEO of each Party and such CEO or his/her designee will
negotiate in good faith to define and implement a final resolution. The intent
of this Section 4.6 is to encourage the Parties to work together to resolve any
Dispute without having to rely on arbitration or any other legal proceeding.
However, nothing in this Section 4.6 shall prevent or inhibit either Party to
institute any other action to resolve such Dispute(s).

      

      Article
V

      MONITORING
OF SERVICES, RECORD STORAGE, AND AUDITS

      

      5.1  Monitoring of
Services. AAIPharma will permit YMB USA representative to examine or
audit inspect AAIPharma's premises in pre-announced visits at mutually agreed
upon times and normal business hours during the course of AAIPharma's
performance of Service Documents hereunder. YMB USA may inspect the facilities,
systems and equipment at or with which the work is conducted, and personnel,
procedures, programming, experimental data, including source documents, notes,
schedules, written reports or other work product that pertains to Services and
Results, and quality assurance records.

      

      5.2  Regulatory
Audit.

      

      5.2.1
Each party acknowledges that the other party may respond independently to any
regulatory correspondence or inquiry in which such other party or its affiliates
is named. Each party, however, shall: a) notify the other party promptly of any
FDA or other governmental or regulatory inspection or inquiry concerning any
study or Project of YMB USA in which AAIPharma is providing the Services,
including, but not limited to, inspections of investigational sites or
laboratories; b) forward to the other party copies of any correspondence from
any regulatory or governmental agency relating to such a study or Project,
including, but not limited to, FDA Form 483 notices, and FDA refusal to file,
rejection or warning letters, even if they do not specifically mention the other
party; and, c) obtain the written consent of the other party, which will not
unreasonably be withheld, before referring to the other party or any of its
affiliates in any regulatory correspondence. Where reasonably practicable, each
party will be given the opportunity to have a representative present during a
FDA or regulatory inspection. Each party, however, acknowledges that it may not
direct the manner in which the other party fulfills its obligations to permit
inspection by governmental entities or any other obligations imposed by
Law.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

       

      5.2.2  Each
party agrees that, during an inspection by the FDA or other regulatory authority
concerning any study or Project of YMB USA in which AAIPharma is providing the
Services, it will not disclose information and materials that are not required
to be disclosed to such agency, without the prior consent of the other party.
Such information and materials include, but are not limited to, the following:
a) financial data and pricing data (including, but not limited to, the budget
and payment sections of the Service Documents); b) sales data (other than
shipment data), and; c) personnel data (other than data as to qualification of
technical and professional persons performing functions subject to regulatory
requirements).

      

      5.2.3  If
FDA or other regulatory authority issues a written inspectional observation or
report of the facilities or general laboratory practices, that pertains to or
affects any part of a Services, AAIPharma shall forthwith provide YMB USA with
copy of this written observation along with AAIPharma’s response redacted if
necessary of any confidential information.

      

      5.3  Records. AAIPharma
shall maintain books of account of the Services rendered and the cost and
reimbursable expenses in accordance with generally accepted accounting
principles. AAIPharma shall make available to a third party, as selected by YMB
USA acting reasonably and reasonably accepted to AAIPharma, such books and
records for audit purposes upon the request of YMB USA at mutually agreed upon
times during this Agreement and for a period of two (2) years thereafter. YMB
USA shall be responsible for the costs and expenses of any third party
audit.

      

      5.4  Record
storage.

      

      5.4.1  During
the term of this Agreement, AAIPharma shall maintain all materials and all other
data obtained or generated by AAIPharma in the course of providing the Services
hereunder, including all computerized records and files, in a secure area
reasonably protected from fire, theft and destruction. All computerized records
and files shall be backed up in such a manner and frequency as to reasonably
protect against loss of information from computer viruses or other equipment
failure.

      

      5.4.2  AAIPharma
agrees to notify YMB USA no less than thirty (30) days prior to destruction or
disposal of materials, records and data to enable YMB USA to determine whether
it requires further archival time. In the event YMB USA requires storage of
records and data beyond the minimum storage, AAIPharma agrees to continue to
store the data until the Parties have agreed on storage or transfer of the data
and reports to YMB USA. Time shall be of the essence in respect to coming to an
agreement on further storage.

      

      Article
VI

      PRIVACY

      

      6.1  In
order to protect the confidentiality of personal information or personal health
information of subjects participating in a Project as defined in the Personal
Information Protection and Electronic Documents Act, Canada or as such
equivalent terms may be defined in the legislation pertaining to privacy of
personal information in a province that has enacted a law governing such
matters, the Parties agree as follows:

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      (i)  to
use personal information or personal health information only as permitted by the
Subject in the consent form or as required or permitted by Law;

      (ii)  to
refrain from publishing Subject personal information or personal health
information in a form that could reasonably enable the Subject's identity to be
ascertained;

      (iii)  to
refrain from obtaining additional personal information or personal health
information from a Subject unless such Subject has provided
consent;

      (iv)  to
be liable for the actions of their respective employees and agents for the
collection, use or disclosure of personal Information or personal health
information and for ensuring compliance with the relevant legislation by such
persons.

      

      6.2  AAIPharma
shall remove all Subject identifying information from any copies of data or
reports prior to providing copies of such to YMB USA. If Subject identifying
information or Subject identifying health information is transferred to YMB USA,
its employees or agents, YMB USA and its employees and agents shall not use or
disclose such information except with the knowledge and consent of the Subject,
as set out in the Subject informed consent form, or as required by law,
regulation or legal process.

      

      ARTICLE
VII

      INTELLECTUAL
PROPERTY

      

      7.1  YMB
USA shall own all documentation, records, raw data, samples and Results
generated by AAIPharma in the performance of each Project under this Agreement
and all Clinical Trial Materials and Test Materials.

      

      7.2  AAIPharma
agrees to promptly disclose any Intellectual Property arising out of Services,
which shall be the property of YMB USA. AAIPharma agrees, and agrees on behalf
of its employees and agents to execute, acknowledge and deliver at YMB USA's
expense and as YMB USA may reasonably request all documents, including
assignment documents, and to perform such other actions to secure, verify or
reflect such ownership or to secure proprietary protection in the name of YMB
USA for such inventions or discoveries at YMB USA's expense and as YMB USA may
reasonably request. YMB USA shall be invoiced from time to time for its use of
AAIPharma’s personnel under this Section 7.2 at AAIPharma’s then current rate.
Payment shall be made as set forth in Section 4.3 herein. YMB USA shall have
full power and authority to file and prosecute patent applications throughout
the world on such inventions or discoveries.

      

      7.3  The
Parties agree that Intellectual Property owned or possessed by each Party prior
to the Effective Date hereof, used in the course of a Project shall remain the
property of such Party. YMB USA acknowledges that AAIPharma may develop methods
of operating, techniques, processes or procedures that are generally applicable
to providing contract clinical trial management services and unrelated to YMB
USA's Confidential Information. Accordingly, nothing in this Agreement shall
preclude AAIPharma from utilizing such general knowledge in providing services
as long as such services do not constitute a breach of Confidentiality under
Article VIII of this Agreement.

      

      7.4  Except
as set forth herein, no Intellectual Property right, title or interest of a
Party is granted to the other Party hereunder.

       

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      ARTICLE
VIII

      CONFIDENTIALITY

      

      8.1
AAIPharma and YMB USA signed a Confidentiality Agreement for the purpose of
determining their interest in pursuing this Agreement. The Parties agree that
the terms of that confidentiality agreement shall apply up to the Effective Date
or this Agreement and shall be superceded by the terms of confidentiality
contained herein on and after the Effective Date. In the event of a conflict
between the terms of that confidentiality agreement and this Agreement, this
Agreement shall prevail.

      

      8.2  AAIPharma
agrees that without the express written consent of the YMB USA, it will not
directly or indirectly, deal with, use, exploit or disclose Confidential
Information of YMB USA to any person or entity for any purpose except as
described or permitted herein or unless and until expressly authorized in
writing to do so by YMB USA.

      

      8.3  AAIPharma
may disclose the Confidential Information only to those employees and agents who
shall have a need to know the Confidential Information for the purpose of a
Project. Each party shall, prior to disclosing the Confidential Information or
portion thereof to such designated employees or agents issue appropriate
instructions to them to satisfy the obligations herein and obtain their written
agreement to receive and use the Confidential Information as confidential and
subject to non-disclosure on the same conditions as contained
herein.

      

      8.4  AAIPharma
shall not reproduce the Confidential Information without the express written
permission of YMB USA, except for such copies as AAIPharma may require pursuant
to this Agreement for internal purposes on a need-to-know basis.

      

      8.5  AAIPHARMA
shall not be liable for disclosure of the Confidential Information or any
portion thereof upon the occurrence of one or more of the following
events:

      

      (i)
information of YMB USA which is now in the public domain or which subsequently
enters the public domain without fault on the part of AAIPharma; or

      (ii)
information which is subsequently lawfully obtained by AAIPharma from a third
party or parties without breach of this Agreement by AAIPharma as shown by
documentation sufficient to establish the third party as a source of the
Confidential Information; or

      (iii)
information of YMB USA which is presently known by AAIPharma from its own
sources where said present knowledge can be demonstrated by written records
sufficient to establish such knowledge; or

      (iv)
information developed by or for AAIPharma independent of disclosure hereunder as
evidenced by AAIPharma's written records; or

      (v)
information of which YMB USA has provided its prior written consent for such
disclosure; or

      (vi)
information which is required to be disclosed by AAIPharma as required by law
pursuant to an appropriate legal order by a court or government agency having
the authority to compel such disclosure; provided that AAIPharma shall notify
YMB USA of the nature of the information to be disclosed notified prior to such
disclosure to enable YMB USA to seek, and where possible, reasonably cooperate
with the YMB USA to provide it with the opportunity to take appropriate legal
action to prevent or safeguard said information.

      

      8.6  The
Parties agree that the disclosure of the Confidential Information does not
oblige YMB USA to give or grant any commercial rights to AAIPharma, other than
as specified herein.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      8.7  The
obligations of confidentiality shall survive the Term or earlier termination of
this Agreement for a period of seven (7) years.

      

      8.8  YMB
USA agrees not to use, or provide to, disclose to, or permit any third party to
use Confidential Information of AAIPharma ("AAIPharma Confidential
Information"), except as set forth in  exceptions (i) through (vi) set
forth in Section 8.5 herein. As used herein, AAIPharma Confidential Information
means information relating to, without limitation, the conduct and financial
aspects of AAIPharma's business, data, trade secrets, know-how, inventions
(whether or not patentable), patent applications, analytical and bioanalytical
methods, manufacturing and clinical research, whether written, electronic,
graphic, or oral, as well as samples and specimens, furnished or disclosed by
either party directly or indirectly, or as the result of a site visit or audit,
to YMB USA.

      

      8.9  Each
Party shall, upon written request of the other Party, return all Confidential
Information and copies thereof or shall destroy such Confidential Information
and copies as directed by a party unless
required to retain certain of the Confidential Information or a copy thereof by
applicable Laws, regulation, or pursuant to this Agreement.

      

      8.10  AAIPharma
and its Affiliates will not publish any articles or make any presentations
relating to the Services or referring to data, information or materials
generated as part of the Services, in whole or in part, without the prior
written consent of YMB USA. Each Party agrees that it shall not use the other
Party's name or disclose any matters relating to the Services provided hereunder
in any advertising, promotion, written articles or communications without the
prior written consent of the other Party.

      

      ARTICLE
IX

      INSURANCE AND
INDEMNIFICATION

      

      9.1  YMB
USA and AAIPharma shall each maintain, at its sale cost and expense, insurance
coverage with a reputable insurer (which shall be either occurrence based or
claims made coverage) in an amount usual and customary for companies engaged in
activities as contemplated by this Agreement. All such insurance shall be in
place before the first patient is enrolled in the Study. Each shall designate
the other party as an additional insured on products and professional liability
policies, and an endorsement shall be made on each such policy prohibiting the
insurer from cancelling the policy for any reason or substantially modifying its
terms without first giving the other party at least thirty (30) days written
notice of its intention to do so.

      

      9.2  If
either party maintains it claims-made policy and this Agreement expires or
terminates for any reason, then that party shall either: 1) continue to maintain
the same or higher coverage with an insurance carrier for a period of two (2)
years thereafter; or 2) purchase "Tail Coverage" effective until the second
(2nd) anniversary date of the expiration or termination of this Agreement; or
3) obtain
and maintain "Prior Acts" coverage equivalent in time and coverage as the "Tail
Coverage" described herein.

      

      9.3  Upon
request by either party, the other party shall provide evidence of that party's
compliance with this Section 9.1 and/or 9.2.

       

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      9.4  AAIPharma
agrees to defend, indemnify, save and hold harmless YMB USA and its parent,
subsidiaries and affiliates and their respective directors, officers, employees
and agents (the "YMB USA Indemnities") from and against any third party claims,
demands, suits, actions, causes of action, losses, damages, fines and
liabilities, including reasonable legal fees and disbursements (the "Claims")
arising out of or in connection with or attributable to: (a) AAIPharma's wilful
failure to comply with this Agreement, Work Order or Protocol and any amendments
thereto; (b) AAIPharma's gross negligence or willful misconduct in performance
of the Services; (c) violations of applicable Laws, GLPs or GCPs; and/or (d)
AAIPharma's submission of false or incorrect data and information to YMB USA;
except to the extent any of the Claims arise from the gross negligence or wilful
misconduct of YMB USA. AAIPharma agrees to pay the reasonable costs and damages
arising from such Claims, after exhaustion of all reasonable appeals, provided
that YMB USA provides AAIPharma with written notice of the Claims within five
business (5) days of the date YMB USA receives notice of the Claim and YMB USA
provides AAIPharma with reasonable information and assistance required to defend
the Claim. AAIPharma shall have the sale authority to defend and/or settle the
Claim, provided that AAIPharma may not settle a Claim that includes an admission
of liability on the part of YMB USA without YMB USA's prior written
consent.

      

      9.5  YMB
USA agrees to defend, indemnify, save and hold harmless AAIPharma and its
parent, subsidiaries and affiliates and their respective directors, officers,
employees and agents (the "AAIPharma Indemnities") from and against any Claims
arising out of or in connection with or attributable to: (a) the research
(including the ethical review of the Protocol and related materials),
development, manufacture, distribution, use, sale or other disposition of the
Test Materials by YMB USA, or any distributor, collaborator, customer,
sublicense, representative or agent of YMB USA; (b) an infringement of any third
party's patent rights or unauthorized use or misappropriation of its
intellectual property pertaining to the Test Materials; and/or (c) YMB USA's
gross negligence or willful misconduct in connection with this Agreement; (d)
YMB USA’s failure to comply with this Agreement, Work Order or Protocol and any
amendments thereto; or (e) YMB USA’s use of the data or other information
generated as a result of the services; except to the extent of any of the Claims
arise from the gross negligence or wilful misconduct of AAIPharma. YMB USA
agrees to pay the reasonable costs and damages arising from such Claims, after
exhaustion of all reasonable appeals, provided that AAIPharma has given YMB USA
written notice of the Claims within five business (5) days of the date AAIPharma
receives notice of the Claim, and AAIPharma has provided information and
reasonable assistance required to defend the Claim. YMB USA shall have the sole
authority to defend and/or settle the claim, provided that YMB USA may not
settle a claim that includes all admission of liability on the part of AAIPharma
without AAIPharma's prior written consent.

      

      ARTICLE
X

      TERM AND
TERMINATION

      

      10.1  Unless
sooner terminated in a manner herein provided, this Agreement shall commence on
the Effective Date and, unless terminated pursuant to this Article 10 or Clause
2.5, shall continue until such time as the Services and Closeout Services have
been completed for each respective Service Document (hereinafter the "Term").
The Parties may extend this Agreement by written mutual agreement as soon as
reasonably practicable prior to the expiration of the Term.

      

      10.2  This
Agreement and any corresponding Service Document then in effect may be
terminated by either Party as follows:

      

      (i)  by
YMB USA providing at least thirty (30) days written notice to AAIPharma;
or

      (ii)  by
mutual written agreement by the Parties: or

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      (iii)  by
either Party (the "Non-defaulting Party") giving the other Party (the
"Defaulting Party") thirty (30) days written notice of termination for
Cause.

      

      10.3  Either
Party has the right to terminate this Agreement immediately upon written notice
to the other Party and without further liability hereunder, if a Party commits
an act of bankruptcy or if proceedings are taken against it for fraud, or
dishonest or serious misconduct in behaviour.

      

      10.4  In
the event of termination of any Service Document and/or this Agreement for any
reason, AAIPharma agrees to use its commercially reasonable best efforts to
limit any further cost to YMB USA. AAIPharma will cease performing any Services
not necessary for the orderly closeout of the affected Service Document or
fulfillment of Regulatory Requirements and AAIPharma shall instruct its
subcontractors, if any, to do the same. Within thirty (30) days following the
effective date of termination, AAIPharma shall deliver and cause subcontractors,
if any, to deliver all Confidential Information, Clinical Trial Materials, data,
Results, Study Documents, and Test Materials provided by YMB USA or generated
under this Agreement to YMB USA at no additional cost to YMB USA.
Notwithstanding the foregoing, AAIPharma shall retain and keep in custody any
materials or data, original or copy, for the purpose of compliance with
Regulatory Requirements.

      

      10.5  Upon
termination of this Agreement pursuant to Sections 10.2 or 10.3, YMB USA shall
continue to pay AAIPharma the amounts set forth in Service Documents for all
reasonable costs actually incurred or irrevocably obligated for Services
rendered by AAIPharma through to the effective date of termination and for the
Closeout Services furnished by AAIPharma after the termination of this
Agreement, provided that in no event will the amount owed to AAIPharma exceed
the maximum amounts specified in the Service Documents.

      

      ARTICLE
XI

      CORRESPONDENCE: AND
NOTICE

      

      11.1  Any
and all notices required or permitted to be given hereunder by either Party
hereunder shall be in writing and shall be deemed given on the date received if
delivered personally or received by facsimile transmission before 4:00 pm on a
business day in the jurisdiction of the recipient and otherwise on the next
business day:

      

      
        	
                If
      to YMB USA:

              	
                YM
      BioSciences USA Inc.

              
	 
      	
                701
      Lee Road, Suite 200

              
	 
      	
                Wayne,
      PA 19087

              
	 
      	
                Attn.
      Gary Floyd

              
	 
      	
                Phone:
      (610)-560-0600

              
	 
      	
                Fax:
      (610)-560-0700

              
	 
      	 
      
	
                If
      to AAIPharma:

              	
                AAIPharma
      Inc.

              
	 
      	
                2320
      Scientific Park Drive

              
	 
      	
                Wilmington,
      North Carolina 28405

              
	 
      	 
      
	 
      	
                Attn:
      Legal Department, North American Operations

              
	 
      	
                Phone:
      (910) 254-7000

              
	 
      	
                Fax:
      (910) 815-6067

              

      

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      11.2 All
communications and notices related to a Service Document shall be addressed to
the appropriate individual for each Party as set forth in such Service
Document.

      

      ARTICLE
XII

      MISCELLANEOUS

      

      12.1  Waiver. No waiver by
any Party hereto of any condition, or of the breach of any provision, term,
covenant, representation, or warranty contained in this Agreement or a Service
Document, whether by conduct or otherwise, in anyone or more instances, shall be
deemed to be or construed as a further or continuing waiver of any such
condition or of the breach of any other provision, term, covenant,
representation or warranty of this Agreement or Service Document.

      

      12.2  Severability.
Whenever possible, it is the intention of the Parties that each provision of
this Agreement and related documents shall be interpreted so as to be effective
and valid under applicable Laws. In the event any provision of this Agreement,
or a Work Order or Change Order is prohibited by or invalid under applicable
Laws, such provision shall be ineffective only to the extent of such prohibition
or invalidity without invalidating the remainder of such provision or the
remaining provisions of this Agreement or such related document.

      

      12.3  Cooperation. Each
Party will execute and deliver all such instruments and perform all such other
acts as the other Party may reasonably request to carry out the transactions
contemplated by this Agreement.

      

      12.4  Force Majeure. No
Party shall be in default hereunder by reason of its delay in the performance of
or failure to perform any of its obligations hereunder if such delay or failure
is caused by strikes, acts of God or the public enemy, terrorism or threats of
terrorism, riots, incendiaries, weather, interference by civil or military
authorities, compliance with governmental laws, rules, and regulations, delays
in transit or delivery, or any fault beyond its control or without its fault or
negligence.

      

      12.5  Headings. All
headings herein are for convenience only and shall not be construed as a
limitation or the scope of the particular sections to which they
refer.

      

      12.6  Entire Agreement
Modification. This Agreement, together with the Work Orders, Change
Orders if any, and Protocols, constitute the entire agreement and understanding
between the Parties, superseding any and all previous statements, negotiations,
documents agreements and understandings, whether oral or written. No
modification or waiver of the provisions of this Agreement shall be valid or
binding on either Party unless in writing and signed by both Parties. This
Agreement and any Protocol or Work Order executed pursuant to this Agreement
shall not be waived, released, discharged, changed or modified in any manner
except by an instrument signed by the authorized representatives of each
Parties, which instrument shall make specific reference to this Agreement or the
applicable Protocol or Work Order and shall clearly state the plan or intention
to modify same.

      

      12.7  Assignment - Neither
AAIPharma nor YMB USA shall assign its rights under this Agreement without the
prior written consent of the other Party, such consent not to be unreasonably
withheld; provided, however, the Parties
may transfer or assign its rights and obligations under this Agreement to a
successor to all or substantially all of its business or assets relating to this
Agreement whether by sale, merger, operation of law or otherwise. Subject to the
restrictions on transfers, assignments and encumbrances set forth herein, this
Agreement shall inure to the benefit of and be binding upon the undersigned
Parties and their respective legal successors.

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      12.8  Surviving Provisions
- The Parties agree that the following provisions will survive the Agreement;
the definitions contained herein to the extent such definitions pertain to terms
in surviving provisions, Articles IV, VII, VIII, XI, XII in their entirety and
Sections 3.1, 3.2.8, 3.3, 5.3, 5.4, 9.4, 9.5.

      

      12.9  French/English
Language - The parties to this Agreement have agreed that this Agreement
and all related documents shall be drafted in the English language only. Les
parties ont convenu que cette convention ainsi que tout document y afférent
soient rédigés en anglais seulement.

      

      IN WITNESS WHEREOF, the
Parties have caused this Agreement to be executed by their duly

      authorized
officers.

      

      
        	
                AAIPHARMA
      INC.

              	
                YM
      BIOSCIENCES USA INC.

              
	
                By:

              	
                By:

              
	
                Name:
      Ludo J. Reynders

              	
                Name:
      David Allan

              
	
                Title:
      President and CEO

              	
                Title:
      Chairman and CEO

              
	
                Date:
      August 28, 2007

              	
                Date:
      August 28, 2007

              

      

       

      
        
           

        

        
           

          
            

          

        

        
           

        

      

      

      Attachment
A

      

      Sample
Work Order

      Date
__________

      

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

      

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

      

      Attachment
I      Final Protocol dated ___ 200_

      

      Attachment
II    Final Scope of Work dated ___ 200_, including the
description of Services to be provided and timeline

      

      Attachment
III   Costs and Payment Terms for the Final Scope of
Work

      

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

      

      ACKNOWLEDGED,
ACCEPTED AND AGREE TO:

      

      
        	
                AAIPharma
      Inc.

              	
                Date

              
	 
      	 
      
	
                YM
      BioSciences USA Inc.

              	
                Date

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