Document:

CONFIDENTIAL

    

    CLINICAL
RESEARCH SERVICES AGREEMENT

    

    BETWEEN

    

    YM
BIOSCIENCES, INC.

    

    AND

    

    PHARM-OLAM
INTERNATIONAL LTD.

    

    YB1002-203Taxotere

     

    
      
        	
                Clinical
      Research Services Agreement

              	 
      
	
                22 February, 2005

              	 
      

      

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    CONFIDENTIAL

    

    TABLE OF
CONTENTS

    

    
      
        
          	
                  RECITALS

                	 
      	
                  4

                
	 
      	 
      	 
      
	
                  1.

                	
                  DEFINITIONS

                	 
      	
                  4

                
	 
      	 
      	 
      	 
      
	
                  2.

                	
                  INTERPRETATION

                	 
      	
                  7

                
	 
      	 
      	 
      	 
      
	
                  3

                	
                  APPOINTMENT
      & RELATIONSHIP OF PARTIES

                	 
      	
                  7

                
	 
      	 
      	 
      	 
      
	
                  4.

                	
                  REPRESENTATIONS
      & WARRANTIES

                	 
      	
                  8

                
	 
      	 
      	 
      	 
      
	
                  5.

                	
                  POI's
      OBLIGATIONS

                	 
      	
                  8

                
	 
      	 
      	 
      	 
      
	
                  6.

                	
                  YM's
      OBLIGATIONS

                	 
      	
                  10

                
	 
      	 
      	 
      	 
      
	
                  7.

                	
                  LIMITATION
      OF LIABILITY

                	 
      	
                  10

                
	 
      	 
      	 
      	 
      
	
                  8.

                	
                  CRO
      COMPENSATION

                	 
      	
                  11

                
	 
      	 
      	 
      	 
      
	
                  9.

                	
                  AUDIT

                	 
      	
                  11

                
	 
      	 
      	 
      	 
      
	
                  10.

                	
                  CLINICAL
      STUDY AGREEMENT NEGOTIATION

                	 
      	
                  12

                
	 
      	 
      	 
      	 
      
	
                  11.

                	
                  INSURANCE

                	 
      	
                  12

                
	 
      	 
      	 
      	 
      
	
                  12.

                	
                  CONFIDENTIALITY

                	 
      	
                  13

                
	 
      	 
      	 
      	 
      
	
                  13.

                	
                  INTELLECTUAL
      PROPERTY

                	 
      	
                  13

                
	 
      	 
      	 
      	 
      
	
                  14.

                	
                  ARBITRATION

                	 
      	
                  14

                
	 
      	 
      	 
      	 
      
	
                  15.

                	
                  NON-SOLICITATION
      OF STAFF

                	 
      	
                  14

                
	 
      	 
      	 
      	 
      
	
                  16.

                	
                  TERM
      & TERMINATION

                	 
      	
                  14

                
	 
      	 
      	 
      	 
      
	
                  17

                	
                  CONSEQUENCES
      OF TERMINATION

                	 
      	
                  16

                
	 
      	 
      	 
      	 
      
	
                  18.

                	
                  REPETITION
      OF THE STUDY

                	 
      	
                  17

                
	 
      	 
      	 
      	 
      
	
                  19.

                	
                  DELAYS

                	 
      	
                  17

                
	 
      	 
      	 
      	 
      
	
                  20.

                	
                  GENERAL
      PROVISIONS

                	 
      	
                  17

                
	 
      	 
      	 
      	 
      
	
                  21.

                	
                  APPLICABLE
      LAW

                	 
      	
                  19

                

        

      

    

    

    
      
        	
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    CONFIDENTIAL

    

    
      
        	
                SCHEDULE
      1 CONTRACT SERVICES COST SCHEDULE

              	 
      
	 
      	 
      
	
                SCHEDULE
      2 PAYMENT SCHEDULE

              	 
      
	 
      	 
      
	
                SCHEDULE
      3 INVESTIGATOR AGREEMENT TEMPLATE

              	 
      

      

    

     

    
      
        	
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    CONFIDENTIAL

    

    AGREEMENT

    

    This
Clinical Research Services Agreement (this Agreement) is made and entered into
effective as of 10 December 2004 (the “Effective Date”), by and between YM
BIOSCIENCES, INC. (hereafter “YM”), a Canadian corporation, with its principal
office at 5045 Orbitor Drive, Building 11, Suite 400, Mississauga, Ontario L4W
4Y4, Canada, and PHARM-OLAM INTERNATIONAL Ltd. (hereafter “POI”), a Texas
limited partnership, with its principal office at 450 N Sam Houston Parkway,
Suite 250, Houston, TX 77060, United States.

     

    RECITALS

    

    WHEREAS,
YM develops, manufactures, or sells pharmaceutical products; and

    

    WHEREAS,
POI is a contract research organization that plans, implements, and manages
clinical trials; and

    

    WHEREAS,
YM desires to engage POI to assist YM in planning, implementing, and managing a
clinical trial on the Investigational Product, as hereafter defined;
and

    

    WHEREAS,
POI is willing to accept such engagement on the terms and conditions set forth
herein;

    

    NOW,
THEREFORE, in consideration of the premises and the mutual covenants and
obligations set forth herein, and for other good and valuable consideration, the
receipt and sufficiency of which are acknowledged, the parties agree as
follows:

    

    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 term 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
“Clinical Laboratory Agreement” means the Agreement between POI and the clinical
laboratory or laboratories that will provide clinical laboratory services for
the Study.

    

    1.3
“Clinical Research Associate” or “CRA” means the person assigned by POI to
monitor one or more Study sites.

    

    
      
        	
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    CONFIDENTIAL

    

    1.4
“Clinical Trial Agreement” means the agreement between POI and an Investigator
that details the respective rights and obligations of both parties in relation
to the Study;

    

    1.5
“Clinical Trial Materials” means the Investigational Product, competitor
substances, the Protocol, the investigational drug brochure, informed consent
form, guidelines for use of the Investigational Product, and all other materials
provided by YM to conduct the Study.

    

    1.6
“Closeout Services” means those services described in Section 17 to be performed
by POI upon termination of this Agreement, or as generally accepted as
GCP.

    

    1.7
“Confidential Information” means any information, whether written or oral,
including all notes, studies, customer lists, forms, business or management
methods, marketing data, fee schedules, or trade secrets of any member of the
POI Group or of YM, as appropriate, disclosed or otherwise made available to one
party by the other party pursuant to this Agreement. Confidential Information
shall also include the terms and provisions of this Agreement and any
transaction or documents executed by the parties pursuant to this Agreement. In
addition, Confidential Information shall include any data, including clinical
study data, or information developed or generated in the course of performance
of this Agreement. Publication of the fact that YM and POI have entered into a
clinical research service agreement, without disclosing the terms and provisions
of this Agreement, shall not be construed as unauthorized disclosure of
Confidential Information.

    

    Confidential
Information does not include any information that (i) is or becomes generally
available to and known by the public, other than as a result of an unauthorized
disclosure directly or indirectly by the receiving party or its affiliates,
advisors, or representatives; (ii) is or becomes available to the receiving
party on a non-confidential basis from a source other than the furnishing party
or its affiliates, advisors, or representatives, provided that such source is
not and was not bound by a confidentiality agreement with or other obligation of
secrecy to the furnishing party of which the receiving party has knowledge at
the time of such disclosure; or (iii) has already been or is hereafter
independently developed by the receiving party by persons not having access to
the Confidential Information of the furnishing party.

    

    1.8 “Data
Safety Monitoring Board” means the group of individuals appointed to monitor
safety issues relating to the Study.

    

    1.9 “CRO
Compensation” means the compensation to be paid by YM to POI as set out in
Schedules 1 and 2.

    

    1.10
“Effective Date” means the effective date of this Agreement as set forth in the
initial paragraph of this Agreement.

    

    1.11
“Food and Drug Administration” or “FDA” means the United States government
agency responsible for ensuring compliance with the Food, Drug, and Cosmetics
Act of 1938.

    

    1.12
“Force Majeure Event” means an event beyond the reasonable control of the
relevant party including, but not limited to, acts of God, a public enemy, or a
civil or military authority; fires or other catastrophes; strikes, lockouts, or
other industrial action taken by the employees of any party or any third party;
delays in transportation; riots; or invasions, wars, or threats of
war.

    

    
      
        	
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    1.13
“Good Clinical Practice” (GCP) means the clinical standards established by the
FDA and counterpart agencies of each country in which the Study will take place,
designed to regulate the activities of YM’s investigators, monitors, and
Institutional Review Boards involved in clinical drug testing.

    

    1.14
“Institutional Review Board/Ethics Committee” or “IRB/EC” 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
the FDA and any other applicable country-specific laws, regulations or
guidelines.

    

    1.15
“Investigational New Drug Application” or “IND” means the petition filed by YM
with the FDA requesting the FDA to allow human testing on the Investigational
Product.

    

    1.16
“Investigational Product” means the product (drug, device, or biologic)
described in the Protocol that will be evaluated in this Study.

    

    1.17
“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.

    

    1.18 “POI
Group” means the following persons and entities, as constituted at the date of
this Agreement or subsequently: (i) POI; and (ii) any person or entity that
directly, or indirectly through one or more intermediaries, controls, is
controlled by, or is under common control with POI.

    

    1.19
“POI's Obligations” means the obligations of POI under this
Agreement.

    

    1.20
“Project Manager” means the manager assigned by POI to be the primary contact
person between POI and YM during the Study.

    

    1.21
“Protocol” means the plan that describes the objectives, study design, and
methodology of the Study entitled, “A
Pharmacokinetic Interaction and Safety and EfficacyPhase II, Open label Study
Evaluating Docetaxel plus Tesmilifene (YMB1002) in Patients with Metastatic
Breast Cancer Suitable for Treatment with Docetaxel”, and any approved
amendments thereto, which is herein incorporated by reference and numbered YMB
1002-203.

    

    1.22
“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.

    

    1.23
“Related Products” means any product (drug, device, or biologic), other than the
Investigational Product, administered or utilized as part of this
Study.

    

    1.24
“Serious Adverse Event” shall take the meaning given this term in the
Protocol.

    

    
      
        	
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    CONFIDENTIAL

    

    1.25
“Services” means the services to be furnished by POI in connection with the
Study as set out in this Agreement including the schedules.

    

    1.26
“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.

    

    1.27
“Study” means the clinical trial of the Investigational Product, the details of
which are set out in the Protocol.

    

    1.28
“Study Documents” means the documents produced by POI in connection with the
Study that are necessary for the production of the final study
report.

    

    1.29
“Term” means the duration of this Agreement as set out in Section
16.

    

    1.30
“YM’s Obligations” means the obligations of YM under this
Agreement.

    

    2.
INTERPRETATION

    

    2.1 Words
of any gender used in this Agreement shall be held and construed to include any
other gender, and words in the singular number shall be held to include the
plural, and the plural to include the singular, unless the context requires
otherwise.

    

    2.2 The
headings of the sections of this Agreement are inserted for convenience only and
in no way define, limit, or prescribe the intent of this Agreement.

    

    2.3
Unless otherwise specified, references in this Agreement to Sections and
Schedules are to the sections of, and schedules to, this Agreement. All
Schedules are deemed to be incorporated into, and form part of, this Agreement,
and the term “Agreement” shall be construed accordingly.

    

    2.4
Unless otherwise specified, any reference to a statute, rule, or regulation
shall be to that statute, rule, or regulation as amended from time to
time.

    

    2.5 If
the terms of this Agreement, including the Schedules, and the Protocol should
conflict, the terms of this Agreement shall control.

    

    3
APPOINTMENT AND RELATIONSHIP OF PARTIES

    

    3.1 YM
hereby engages the services of POI, and POI accepts such engagement, under the
terms and conditions contained in this Agreement.

    

    3.2
During the Term, POI shall at all times be the independent contractor of YM, and
nothing in this Agreement is intended, nor shall be construed, to create between
YM and POI the relationship of principal and agent, employer and employee,
partnership, or joint venture, and the parties shall not represent themselves
otherwise.

    

    
      
        	
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    CONFIDENTIAL

    

    3.3 YM
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 YM’s employees. Likewise, POI 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 the Investigators and POI’s
employees.

    

    3.4 If
the Internal Revenue Service or any other government authority shall, at any
time, question or challenge the independent contractor status of POI, upon
receipt by either party of notice from the Internal Revenue Service or any other
governmental authority, the receiving party shall promptly notify the other
party and afford the other party the opportunity to participate in any
discussion or negotiation with the Internal Revenue Service or other government
authority, regardless as to who initiates such discussions or
negotiations.

    

    4.
REPRESENTATIONS AND WARRANTIES

    

    4.1 POI
warrants to YM that (i) it has the authority to enter into this Agreement; and
(ii) all consents and approvals required for the Study, have been, or will be
obtained prior to initiation of the Study, with the exception of regulatory
approval by Health Canada and the United States Food and Drug Administration,
which will be obtained by YM.

    

    4.2 POI
warrants and represents that it has not been and is not currently an individual,
corporation, partnership, association or entity that has been debarred by the
FDA pursuant to United States regulation 21 U.S.C. §335a (a) or (b) (“Debarred
Person”). POI further warrants and represents that no Debarred Person has
performed or rendered, or will perform or render, any services or assistance
relating to activities taken pursuant to this Agreement. POI further warrants
and represents that it has not been excluded from participation in any Federal
health care program as defined in United States Regulation 42 U.S.C 1320a-7b(f)
(“Excluded Person”). POI further warrants and represents that no Excluded Person
has performed or rendered, or will perform or render, any services or assistance
relating to activities taken pursuant to this Agreement.

    

    4.3 YM
warrants to POI that it has the authority to enter into this
Agreement.

    

    5. POI’S
OBLIGATIONS

    

    In
addition to POI's Obligations set forth in the Schedules, the Protocol and
elsewhere in this Agreement, POI shall have the following
obligations:

    

    5.1
Before commencement of the Study, POI shall assign to the Study a Project
Manager and sufficient personnel, including CRAs, with suitable experience and
training to fulfill POI’s obligations under this Agreement. Any change in the
Project Manager thereafter must be reasonably acceptable to YM. YM may request
that POI remove any personnel, including the Project Manager whom YM deems, in
its sole discretion, to be unfit or otherwise unsatisfactory. POI shall promptly
replace any such personnel with personnel with the necessary skills and
experience to fulfill POI’s Obligations under this agreement.

    

    5.2 POI
shall apply to the Study systems of quality control designed to ensure that the
generation of data, and the recording and reporting of data is in compliance
with the Regulatory Requirements, Good Clinical Practice, the Protocol, and this
Agreement, in that order.

    

    
      
        	
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    CONFIDENTIAL

    

    5.3 POI
shall use its best efforts to perform the Services within the time frames
specified in the Schedules.

    

    5.4 POI
shall be responsible for all the legal and regulatory requirements, including
applicable guidelines, in all countries in which the Study will be conducted,
with the exception of (i) regulatory approval by Health Canada and the United
States Food and Drug Administration to conduct the Study, which will be obtained
by YM, and (ii) adverse event reporting to Health Canada and the United States
Food and Drug Administration which will be done by YM. Such responsibilities of
POI shall include, but are not limited to, the procurement and maintenance of
all consents, approvals, licenses, and operating certificates required to
conduct the Study in the applicable country, including translations, and the
approval of the Protocol and the informed consent forms by an IRB/EC. POI shall
also develop, comply with, and require its agents, employees and contractors 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. POI shall ensure that any institutions and investigational
teams retained to participate in the Study have the necessary staff and other
resources to carry out the Study in accordance with the timelines required by
YM. POI further agrees to ensure that any institutions and investigational teams
retained to participate in the Study have the expertise and experience, and the
necessary licenses, required to perform the Study efficiently and that such
Study shall be performed with care and skill and to the best of their ability
commensurate with such skill and experience and adhering at all times to
applicable laws.

    

    5.5 POI
shall retain all material Study Documents and CRFs until this Agreement has
terminated and all Closeout Services have been performed. All Study Documents
and CRFs will be forwarded to YM after the Study is completed or upon
termination of this Agreement. YM shall be permitted full access to such Study
Documents and CRFs at any time upon written request to POI.

    

    5.6 YM
shall have the right to visit and co-monitor a Study site or inspect and audit
any of the Study Documents and CRFs maintained by POI. All such visits and
inspections must be conducted during normal working hours on regular business
days, unless otherwise agreed. POI shall arrange access to the Study site as
soon as reasonably practicable following notification by YM.

    

    5.7 POI
will provide YM with written status reports in accordance with POI’s
SOPs.

    

    5.8 POI
shall notify YM after becoming aware of a Serious Adverse Event in accordance
with the procedure set out in Schedule 4.

    

    5.9 POI
shall indemnify and save harmless YM, its officers, agents, and employees from
all third party suits, actions, losses, damages, claims, or liability of any
character, types, or description, including without limiting the generality of
the foregoing, all expenses of litigation, court costs, and reasonable attorney’s
fees arising from (i) injury or death to any person, or injury to property,
received or sustained by any person or persons or property, arising out of, or
occasioned by POI (or its agents or employees), in connection with its execution
or performance of services under this Agreement; (ii) any negligent wrongful act
or omission, reckless conduct or willful misconduct of POI, its employees,
agents, directors and officers; or (iii) any deviation by POI from the
terms of the Protocol or this Agreement or requirements or restrictions imposed
by an IRB/EC. The Investigators are not and shall not be deemed the agents of
POI for purposes of this Section 5.9. YM will notify POI of any claim or suit
which may be subject to the provisions of this Section 5.9 as soon as reasonably
practicable after receiving notice of the claim. POI shall have the sole right
to control and settle any such claim or suits, and YM shall make all reasonable
efforts to cooperate (at POI’s expense) as requested by POI in handling any such
claim or suit.

    

    
      
        	
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    6. YM’S
OBLIGATIONS

    

    In
addition to YM’s Obligations set forth in the Schedules and elsewhere in this
Agreement, YM shall have the following obligations:

    

    6.1 YM
shall provide POI, at no expense to POI (i) with all information and
documentation reasonably necessary for POI to perform its duties hereunder,
including but not limited to, all Clinical Trial Materials; and (ii) with all
advice, guidance, and assistance reasonably requested by POI to fulfill its
duties under this Agreement, including the schedules, and the
Protocol.

    

    6.2 YM
shall be responsible for (i) obtaining regulatory approval from Health Canada
and from the United States Food and Drug Administration to conduct the Study in
Canada and in the United States, if necessary; and (ii) reporting adverse events
to Health Canada and to the United States Food and Drug Administration in
conformance with the legal and regulatory requirements.

    

    6.3 YM
shall indemnify and save harmless POI, its officers, agents, and employees from
all third party suits, actions, losses, damages, claims, or liability of any
character, types, or description, including without limiting the generality of
the foregoing, all expenses of litigation, court costs, and reasonable attorneys’
fees for injury or death to any person, or injury to property (collectively,
“Claims”), received or sustained by any person or persons or property, arising
out of, or occasioned by the Investigational Product or the acts or omissions of
YM (or its agents or employees), in connection with the Study or their execution
or performance of this Agreement except to the extent that such Claims arise
from or are caused (i) by POI’s (its agents or employees) execution or
performance of services under this Agreement; (ii) any negligent wrongful act or
omission, reckless conduct or willful misconduct of POI, its employees, agents,
directors and officers; or (iii) any deviation by POI from the terms of the
Protocol or this Agreement or requirements or restrictions imposed by an IRB/EC.
POI will notify YM of any claim or suit which may be subject to the provisions
of this Section 6.2 as soon as reasonably practicable after receiving notice of
the claim. YM shall have the sole right to control and settle any such claims or
suits, and POI shall make all reasonable efforts to cooperate (at YM’s expense)
as requested by YM in handling any such claim or suit.

    

    7.
LIMITATION OF LIABILITY

    

    NOTWITHSTANDING
THE ABOVE, NEITHER PARTY, NOR THEIR AFFILIATES, NOR ANY OF THEIR RESPECTIVE
DIRECTORS, OFFICERS, EMPLOYEES, OR AGENTS SHALL HAVE ANY LIABILITY FOR ANY
SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT
LIMITED TO THE LOSS OF OPPORTUNITY, OR LOSS OF REVENUE OR PROFIT.

    

    
      
        	
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      CONFIDENTIAL

    

    

    8. CRO
COMPENSATION

    

    8.1 YM
shall pay POI the amounts set forth in Schedules 1 and 2 for all services
provided and expenses incurred by POI pursuant to this Agreement, according to
the payment schedule set forth in Schedule 2. Amounts due are calculated in
British Pound Sterling or £ or BPS and are converted to US Dollars at the time
of invoicing or payment. All payments to be made in USD or $.

    

    8.2 POI
shall submit invoices to YM upon the completion of each payment milestone event
set forth in Schedule 2. YM shall make full payment of such sums by wire or in
cleared funds to such bank account in the United States as POI may reasonably
specify from time to time, upon receipt of invoice (“Due Date”), without any
deduction, set off or withholding except any tax, duties or governmental charges
which YM is required by law to deduct or withhold. Any amounts which remain
unpaid for thirty (30) days or more after the Due Date shall bear interest at
the rate equal to 10% per annum. Interest shall be computed on the basis of a
365 or 366-day year, as the case may be. If any amounts remain unpaid for sixty
(60) days or more after the Due Date, POI shall have the right to discontinue
all work and services under this Agreement until such amounts are paid in
full.

    

    8.3 If YM
is required by law to make any tax deduction or withholding, YM shall provide
reasonable assistance as requested by POI to assist POI to claim exemption from,
or if that is not possible a credit for, the deduction or withholding under any
applicable double taxation or similar agreement. YM shall also supply POI from
time to time with proper evidence as to the deduction or withholding and payment
over of the tax deducted or withheld.

    

    8.4 YM
shall reimburse POI for all reasonable expenses incurred by POI in its
performance of the Services, including but not limited to, travel expenses
incurred by POI in connection with initiation visits, monitoring visits, and
closeout visits and in connection with attendance at Project Meetings and
Investigators’ Meetings. YM shall also reimburse POI for all couriers, shipping,
regulatory fees, customs, supplies, related drugs, outside or contracted
services, including Investigator payments or grants, and other similar expenses
incurred by POI in its performance of its duties under this Agreement.
Notwithstanding the foregoing, YM shall not be responsible for any costs
described in this Section 8.4 that exceed the amounts budgeted for such expenses
in Schedule 1, without prior written approval being obtained from YM. Any
amounts approved by YM in excess of those specified in Schedule 1, shall be
separately invoiced to YM and YM shall pay these invoices according to the terms
of Paragraph 8.2.

    

    9.
AUDIT

    

    9.1 POI
shall maintain and shall cause to be maintained, complete and accurate books of
account containing all particulars that may be necessary for the purpose of
calculating any fees, expenses or other costs (collectively, the “Service
Costs”) relating to the Services and any deliverables as set out in Schedule 1.
Such books of record shall be kept at its principal place of
business.

    

    9.2 Upon
the written request of YM, POI shall permit YM or its third party independent
auditors to have access during normal business hours, upon ten (10) days’ notice
to POI, to such records, including working papers and supporting documents, of
POI, its independent contractors and agents as may be reasonably necessary to
verify the accuracy of the Service Costs.

    

    
      
        	
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      Research Services Agreement

              	
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    CONFIDENTIAL

    

    9.3 If
any audit reveals any overpayment of Service Costs, POI shall forthwith pay the
amount of the overpayment to YM; provided however, that, in the event that POI
shall not be in agreement with the amount of the overpayment, such matter shall
be resolved pursuant to the provisions of Section 14 herein.

    

    9.4 If
any audit reveals any underpayment of Service Costs, YM shall forthwith pay the
amount of the underpayment to POI, provided however, that, in the event that YM
shall not be in agreement with the amount of the overpayment, such matter shall
be resolved pursuant to the provisions of Section 14 herein.

    

    9.5 Both
parties shall treat all financial information subject to review under this
Section 9 in accordance with the confidentiality provisions of this
Agreement.

    

    9.6 The
costs of conducting any audit hereunder shall be borne by YM unless the audit
reveals an overpayment of Services Costs of greater than 5%. Any such audit fees
not to exceed £15,000 (BPS British Pound Sterlings).

    

    10.
CLINICAL STUDY AGREEMENT NEGOTIATION

    

    Where
possible, POI will endeavor to use the Clinical Study Agreement template
attached at Schedule 3 to this Agreement when entering into agreements with any
investigational teams or sites engaged for the purpose of conducting a clinical
trial on the Investigational Product. POI shall not make any modification to the
Clinical Study Agreement template attached at Schedule 3 or enter into any
clinical study agreement using such modified form of agreement without YM’s
prior written approval. In any case, POI shall not enter into any agreement with
any investigational teams or sites engaged for the purpose of conducting a
clinical trial on the Investigational Product, without YM’s approval of the form
and content of the agreement.

    

    11.
INSURANCE

    

    11.1 YM
and POI shall each maintain, at its sole 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 named insured on all such policies, and an endorsement shall be
made on each such policy prohibiting the insurer from canceling the policy for
any reason or substantially modifying its terms without first giving the other
party at least twenty-eight (28) days written notice of its intention to do
so.

    

    If either
party maintains a claims-made policy and this Agreement expires or terminates
for any reason, then that party shall either continue to maintain the same or
higher coverage with the same insurance carrier for a period of four (4) years
thereafter; or shall purchase “Tail Coverage” effective until the fourth (4th)
anniversary date of the expiration or termination of this Agreement or obtain
and maintain “Prior Acts” coverage equivalent in time and coverage as the “Tail
Coverage” described herein.

    

    
      
        	
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     CONFIDENTIAL

    

    11.2 Upon
request by either party, the other party shall provide evidence of that party’s
compliance with this Section.

    

    12.
CONFIDENTIALITY

    

    12.1
Except as specified in the following Section 12.2, each of the parties agrees
(i) that it shall not disclose any Confidential Information of the other party
to other persons without the express written authorization of the other party;
(ii) that such Confidential Information shall not be used in any way detrimental
to the other party or for any purpose not related to the performance of the
Services or the Study; and (iii) that the parties will keep such Confidential
Information confidential and will ensure that its affiliates and advisors who
have access to such Confidential Information comply with these non-disclosure
obligations.

    

    12.2
Notwithstanding the foregoing, the parties may disclose Confidential Information
to (i) those of its representatives, including, but not limited to the other
party’s legal, financial and accounting advisors, who need to know Confidential
Information for the purpose of conducting this Study, it being understood and
agreed by the parties that such representatives will be informed of the
confidential nature of the Confidential Information, will agree to be bound by
this Section 12, and will be directed by the respective party not to disclose to
any other person any Confidential Information; and (ii) the FDA, an IRB/IEC, or
comparable governmental or professional body with jurisdiction over the Study
provided such disclosure is requested by the respective governmental or
professional body or is required in order to satisfy Section 5.4.

    

    12.3 In
the event that either party determines that it is required by law to disclose
the other party’s Confidential Information, or such disclosure is in response to
a subpoena or a similar legal process, such disclosure shall be permitted
provided that the other party required to make such disclosure promptly notifies
the other party and assists the other party in obtaining a protective order or
other appropriate remedy.

    

    13.
INTELLECTUAL PROPERTY

    

    13.1 POI
acknowledges and agrees that any and all intellectual property rights
(including, but not limited to, inventions, discoveries, improvements and
know-how, whether patentable or not) that may arise or be conceived during, or
are related to, the Study , including without limitation all data generated in
the course of the Study, completed Case Report Forms and all Clinical Trial
Materials (hereinafter the “Intellectual Property”) shall belong solely to YM.
POI shall cooperate with YM, and shall use its best efforts to ensure that any
institutions and investigational teams which participate in the Study, including
their employees and agents, cooperate with YM, in obtaining assignments or other
documents required to transfer to YM all Intellectual Property. In addition, POI
shall use its best efforts to ensure that any institutions and investigational
teams which participate in the Study, including their employees and agents,
cooperate with YM, at YM’s sole expense, in preparing patent applications
relating to the Intellectual Property, where required.

    

    13.2 The
Parties agree that POI has no rights to publish or present, at any time, the
data generated in the course of the Study.

    

    
      
        
          	
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    CONFIDENTIAL

    

    13.3 YM
acknowledges that, as between POI and YM, any and all intellectual property
rights in works authored by POI before the Effective Date of this Agreement and
works authored by POI independent of the Study shall belong to POI.

    

    14.
ARBITRATION

    

    All
disputes, disagreements, controversies, questions or claims arising out of or
relating to this Agreement and all other agreements entered into pursuant to the
terms of this Agreement, including, without limitation, with respect to their
formation, execution, validity, application, interpretation, performance,
breach, termination or enforcement (“Disputes”) shall be determined by
arbitration under the International Commercial Arbitration
Act (Ontario) (the “International Act”), provided that:

    

    14.1 any
hearing in the course of the arbitration shall be held in Toronto,
Ontario;

    

    14.2 the
number of arbitrators shall be one;

    

    14.3 any
award or determination of the arbitrator shall be final and binding on the
parties and there shall be no appeal on any ground, including, for greater
certainty, on the ground of alleged errors of law. For greater certainty,
Article 34 of the International Act shall apply to an arbitration under this
section 14;

    

    14.4
despite Article 26 of the International Act, the arbitrator shall not, without
the written consent of all parties to the arbitration, retain any
expert;

    

    14.5 an
arbitrator may apportion the costs of the arbitration, including the reasonable
fees and disbursements of the parties, between or among the parties in such
manner as the arbitrator considers reasonable, provided that an arbitrator shall
not award costs on a distributive basis;

    

    14.6 all
awards for the payment of money shall include prejudgment and postjudgment
interest in accordance with sections 127 to 130 of the Courts of Justice Act
(Ontario) with necessary modifications; and

    

    14.7 all
matters in relation to the arbitration shall be kept confidential to the full
extent permitted by law, and no individual shall be appointed as an arbitrator
unless he or she agrees in writing to be bound by this dispute resolution
provision.

    

    15.
NON-SOLICITATION OF STAFF

    

    During
the term of this Agreement and for a period of twelve months following its
termination or expiration, YM shall not directly or indirectly (i) solicit or
entice any employee or contractor of POI with whom it comes into contact as a
result of participation in the Study, to become employees of YM or any other
person or entity; or (ii) approach any such employee or contractor for such
purpose or authorize or approve the taking of such action by any other
person.

    

    16. TERM
AND TERMINATION

    

    16.1 This
Agreement shall commence on the Effective Date and, unless terminated pursuant
to this Section 16, shall continue until such time as the Services and Closeout
Services have been completed. This Agreement does not cover any services
required for long-term patient follow up. The parties shall endeavour to enter
into a separate agreement for such services.

    

    
      
        	
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    CONFIDENTIAL

    

    16.2 This
Agreement may be terminated upon the mutual, written consent of both parties.
This Agreement may also be terminated by YM without cause upon thirty (30) days
prior written notice to the other party.

    

    16.3
Either party may immediately terminate this Agreement for cause, upon written
notice to the other party stating the date of termination, pursuant to the
following:

    

    16.3.1
Termination by POI. POI
may terminate this Agreement for cause upon the occurrence of any of the
following events:

    

    (i) YM
fails to maintain the insurance coverage required by Section 11.1;

    

    (ii) The
FDA, IRB/EC, or any regulatory authority with jurisdiction over the Study
suspends or revokes any consent, approval, license, or operating certificate
required to conduct the Study;

    

    (iii) YM
breaches any material provision of this Agreement, other than those specifically
referenced in this Section 16.3.1, and fails to remedy that breach within 30
days after receiving notice of such breach; or

    

    (iv) YM
files a petition for the appointment of a receiver in liquidation or a trustee
with respect to itself or any of its property; or any person other than YM files
a petition for the appointment of a receiver in liquidation or a trustee with
respect to YM in bankruptcy, insolvency, or reorganization, compromise,
adjustment or other relief relating to the relief of debtors, and such
involuntary petition is not vacated or set aside or stayed within 60 days from
YM’s receiving notice of such petition.

    

    16.3.2
Termination by YM: YM
may terminate this Agreement for cause upon the occurrence of any of the
following events:

    

    (i) The
FDA, IRB/EC, or any regulatory authority with jurisdiction over the Study
suspends or revokes any consent, approval, license, or operating certificate
required to conduct the Study;

    

    (ii} The
occurrence of a Serious Adverse Event which causes the study to be terminated
due to safety concerns by the Data Safety Management Board;

    

    (iii) If
POI enters into a Clinical Trial Agreement with an Investigator relating to the
Study, and the Investigator or any member of the Investigator’s staff fails to
possess all qualifications, training, and licenses necessary to perform the
duties and obligations of that individual under that agreement or fails in any
material manner to abide by the provisions of the Regulatory Requirements or
this Agreement; provided, however, that POI may cure any such deficiency by
removing forthwith the affected individual from providing services under this
Agreement;

    

    
      
        	
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    CONFIDENTIAL

    

    (iv) POI
breaches any material provision of this Agreement, other than those specifically
referred to in this Section 16.3.2, and fails to remedy that breach within 30
days after receiving notice of such breach;

    

    (v) POI
files a petition for the appointment of a receiver in liquidation or a trustee
with respect to itself or any of its property; any entity POI controls makes a
-voluntary assignment for the benefit of creditors or files a petition in
bankruptcy or insolvency or for reorganization, compromise, adjustment, or other
relief; or if any person other than POI files a petition for the appointment of
a receiver in liquidation or a trustee with respect to POI or any entity it
controls in bankruptcy, insolvency, or reorganization, compromise, adjustment or
other relief relating to the relief of debtors, and such involuntary petition is
not vacated or set aside or stayed within 60 days from POI’s receiving notice of
the petition; or

    

    (vi) POI
is unable to perform its obligations under this Agreement due to a Force Majeure
Event for a period greater than thirty (30) days.

    

    16.4 In
the event of any change or reinterpretation of a Regulatory Requirement, the
adoption of any new law or regulation, or the initiation of an enforcement
action with response to laws, regulations, or guidelines applicable to this
Agreement, any of which shall affect the legality of this Agreement, the parties
agree to negotiate in good faith to amend this Agreement to comply with the
offended law or regulation. If the parties do not agree to such amendment within
30 days prior to the effective date of the offended law or regulation (or such
earlier time as may be required to comply), then either party may terminate this
Agreement immediately by giving written notice to such effect to the other
party.

    

    17.
CONSEQUENCES OF TERMINATION

    

    17.1 Upon
termination of this Agreement, POI shall immediately provide to YM complete and
up-to-date written records accounting for the full amount of Investigational
Product dispensed, and the amount of unused Investigational Product remaining in
the possession of POI, or the investigational teams or sites participating in
the Study. POI shall, and shall ensure that the investigational teams or sites
participating in the Study, return without delay any unused quantities of the
Investigational Product, including samples, unless YM requests that such
Investigational Product be destroyed, in which case POI shall arrange for such
destruction and provide appropriate proof to YM that such destruction has
occurred.

    

    17.2 The
termination of this Agreement for any reason shall not affect any right or
remedy existing hereunder prior to the effective date of
termination.

    

    17.3 Upon
early termination of this Agreement pursuant to Sections 16.2, 16.3, or 16.4, YM
shall continue to pay POI the amounts set forth in Schedules 1 and 2 for all
services actually provided and expenses actually incurred by POI prior to the
date of termination of this Agreement. Without limiting the foregoing, upon
termination of this Agreement, YM shall, in addition to all CRO Compensation
then due, compensate POI, as specified in Schedules 1 and 2, for all Closeout
Services required to terminate and closeout the Study, including but not limited
to, any activities necessary to satisfy the requirements of any governmental,
regulatory, or professional authority with jurisdiction over the Study. Further,
upon termination of this Agreement by YM prior to the completion of the Study
pursuant to Section 16.2, YM shall pay POI a termination fee that shall equal
10% of the remaining unbilled compensation, if any, pursuant to Section 8.1 and
Schedules 1 and 2 as of the date of termination. This termination fee shall be
paid, in part, to compensate POI for having to reassign its personnel and incur
out-of-pocket expenses not covered by Section 8.1 and Schedules 1 and
2.

    

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    17.4 In
the event that, at the date of termination of this Agreement, the amount already
paid by YM to POI exceeds the total of: (1) the cost for services actually
provided by POI up to the date of termination, (2) expenses actually incurred by
POI up to the date of termination, (3) the cost for the Closeout Services; and
(4) the termination fee according to Section 17.3, if applicable, then the
excess amount shall be immediately refunded to YM.

    

    17.5 In
no event shall the amount payable to POI by YM pursuant to this Agreement exceed
the maximum amounts specified in Schedule 1 or 2, without the prior written
agreement of the Parties.

    

    18.
REPETITION OF THE STUDY

    

    In the
event of a material error by POI as agreed to by POI in the performance of the
Services, POI shall repeat the applicable Services upon YM’s request at no
additional expense to YM.

    

    19.
DELAYS

    

    19.1 YM
may, in its sole discretion, require POI to delay or suspend Services. If (a) YM
requests such a delay due to no fault of POI; and (b) YM requests that POI staff
continue to be assigned to the project during the period of such delay or
suspension; the parties shall negotiate in good faith a monthly maintenance fee
payable by YM during the period that Services are suspended and staff continue
to be assigned. While the monthly maintenance fee is being paid, payments due as
outlined in Schedules 1 and 2 shall continue to be payable. Such delay shall
last no longer than six (6) months, after which time POI shall have the right to
terminate this Agreement.

    

    20.
GENERAL PROVISIONS

    

    20.1 This
Agreement sets forth the entire agreement and understanding among the parties as
to the matters contained therein, and merges and supersedes any prior
discussions, agreements, and understanding of every kind and nature relating
thereto.

    

    20.2 Any
amendment of or modification to this Agreement shall become effective only if it
is in writing and executed by the parties.

    

    20.3 This
Agreement shall be binding upon, and inure to the benefit of, the parties and
their respective legal representatives, trustees, receivers, successors and
permitted assigns.

    

    20.4
Except as otherwise specified in this Agreement or otherwise agreed to by the
parties in writing, all notices, requests, demands, and other communications
provided for in this Agreement shall be in writing in English and shall be
deemed to have been given at the time when personally delivered, or mailed by
registered or certified mail, return receipt requested, to the address of the
other party stated below or to such other address as any such party may have
fixed by notice, provided, however, that any notice of change of address shall
be effective only upon receipt by addressee.

    

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Research Services Agreement

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2005

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      CONFIDENTIAL

       

    

    All
notices to YM shall be addressed to:

    

    David
G.P. Allan

    President
and CEO

    YM
BioSciences Inc.

    5045
Orbitor Drive

    Building
11, Suite 400

    Mississauga,
Ontario L4W4Y4 Canada

    

    If
notices or communications by telephone or facsimile are specifically authorized
in this Agreement or otherwise agreed to by the parties in writing, calls to YM
shall be placed and facsimiles to YM shall be sent to the following
numbers:

    Phone:
(905) 629-9761

    Fax:
(905) 629-4959

    

    All
notices to POI shall be addressed to:

    

    John
Hovre

    Executive
Vice President

    Pharm-Olam
International Ltd.

    450 N Sam
Houston Parkway, Suite 250,

    Houston,
TX 77060

    United
States

     

    If
notices or communications by telephone or facsimile are specifically authorized
in this Agreement or otherwise agreed to by the parties in writing, calls to POI
shall be placed and facsimiles to POI shall be sent to the following
numbers:

    Phone:
(713) 463-8075,

    Fax:
(713) 463-8281

    

    The
parties shall give notice to each other of any change of their address or
telephone, facsimile, or similar number at the earliest possible
opportunity.

    

    20.5 All
agreements of the parties, as well as any rights or benefits accruing to them,
pertaining to a period of time following the termination or expiration of this
Agreement or any of its provisions, including but not limited to Paragraph 5.9,
6.3, and Sections 7 through 15, and 17, shall survive such termination or
expiration hereof and shall not be merged.

    

    20.6 The
waiver by any party of breach or default by any other party shall not operate as
a waiver of a continuing or subsequent breach or default of the same or a
different nature or kind.

    

    20.7 If
any provision of this Agreement or the application of any such provision to any
person or circumstance is held invalid, the remainder of this Agreement and the
application of such provision to other persons or circumstances shall not be
affected unless the invalid provision substantially impairs the benefits of the
remaining provisions of this Agreement.

     

    
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    CONFIDENTIAL

    

    20.8 No
party may assign this Agreement or its rights and duties hereunder, without the
prior written consent of the other party, except that YM may assign this
Agreement to a purchaser or acquirer of substantially all of the business to
which this Agreement relates.

    

    20.9 The
provisions of this Agreement shall be self-executing and shall not require
further agreement by the parties except as may otherwise be specifically
provided in this Agreement; provided, however, that, at the request of a party,
the other party shall execute such additional instruments and perform such
additional acts as may be reasonably necessary to effectuate this
Agreement.

    

    20.10
This Agreement may be executed in counterpart originals, with each counterpart
to be deemed an original, but all counterparts together shall constitute a
single instrument.

    

    20.11 In
the event that performance by a party of any of its obligations under the terms
of this Agreement shall be interrupted or delayed by a Force Majeure Event, that
party shall be excused from such performance for the same amount of time as such
occurrence shall have lasted or such period of time as is reasonably necessary
after such occurrence abates for the effects thereof to have
dissipated.

    

    21.
APPLICABLE LAW

    

    This
Agreement shall be governed by and be construed under the laws of Ontario,
Canada without giving effect to its choice-of-law rules, and exclusive venue of
any action or other proceeding that may be brought or arise out of, in
connection with, or by reason of this Agreement shall be in Ontario,
Canada.

    

    IN
WITNESS WHEREOF, this Agreement is executed by the parties hereto and is
effective as of the day and year first above written.

    

    
      
        
          
            
              	 	
                      YM
      BIOSCIENCES, INC.:

                    	 
      	 
      	 
      
	 	 
      	 
      	 
      	 
      
	 	
                      By:

                    	
                      /s/
      David G.P. Allan

                    	 
      	
                      Date: 8/12/05

                    	 
      
	 	
                      David
      G.P. Allan, its President and CEO

                    	 
      	 
      	 
      
	 	 
      	 
      	 
      	 
      
	 	
                      PHARM-OLAM
      INTERNATIONAL LTD.:

                    	 
      	 
      	 
      
	 	 
      	 
      	 
      	 
      
	 	
                      By:

                    	
                      /s/
      John Hovre

                    	 
      	
                      Date:
      2/22/05

                    	 
      
	 	
                      John
      Hovre, Executive Vice-President

                    	 
      	 
      	 
      

            

          

        

      

    

     

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                MASTER

              	
                Schedule
      3

              

      

    

    

    INVESTIGATOR
AGREEMENT

    

    This
Agreement is entered into as of the date on the signature page, between
Pharm-Olam International, Ltd., YM BioSciences Inc. and undersigned
parties:

    

    
      
        	 
      	
                Pharm-Olam
      International, Ltd

              	 
      	
                Name
      of Investigator

              
	 
      	 
      	
                Investigator:

              	 
      
	 
      	 
      	 
      	 
      
	 
      	
                450
      N Sam Houston Parkway, Ste 250

              	 
      	 
      
	
                Address:

              	
                Houston,
      TX

              	
                Institution:

              	
                Name
      of clinic/hospital

              
	 
      	
                77060
      USA

              	 
      	 
      
	 
      	 
      	 
      	 
      
	 
      	 
      	
                Address:

              	 
      
	 
      	 
      	 
      	
                Clinic
      address

              
	 
      	 
      	 
      	 
      
	
                Tel
      No:

              	
                (713)
      463-8075

              	
                Tel
      No:

              	
                (  
      )

              
	
                Fax
      No:

              	
                (713)
      463-8281

              	
                Fax
      No:

              	
                (  
      )

              
	 
      	 
      	 
      	 
      
	 
      	
                YM
      BioSciences Inc.

              	 
      	 
      
	 
      	
                David
      G.P. Allan, President & CEO

              	 
      	 
      
	
                Address:

              	
                5045
      Orbitor Drive

              	 
      	 
      
	 
      	
                Building
      11, Suite 400

              	 
      	 
      
	 
      	
                Mississauga,
      Ontario

              	 
      	 
      
	 
      	
                Canada

              	 
      	 
      
	 
      	
                L4W
      4Y4

              	 
      	 
      
	
                Tel
      No:

              	
                905.629.9761

              	 
      	 
      
	
                Fax
      No:

              	
                905.629.4959

              	 
      	 
      

      

    

    

    Pharm-Olam
International, Ltd. (hereafter referred to as “POI”) and YM BioSciences Inc.
(hereafter referred to as “YM”) desire PHYSICIAN NAME (hereafter
referred to as “the investigator”) to conduct the following clinical trial: ‘A
Pharmacokinetic Interaction Phase I, Open Label, Single Centre Study Evaluating
the Plasma Pharmacokinetics of Taxotere Alone and in Combination with YMB1002 in
Patients with Advanced Metastatic Breast Cancer or Other Advanced Cancer
Suitable for Treatment with Taxotere’ sponsored by YM. POI is a contract research
organization retained by YM for this
study.

    

    The study
is planned to start in JANUARY
2005 all patients should be enrolled by MARCH 2005. These dates are
based on the current time-frame specified by YM.

    

    The
investigator agrees to the following:

    

    1. Scope of
work

    

    The study
will be performed and directed by the investigator and his/her co-workers, under
his/her immediate supervision, according to the final, signed protocol and this
agreement. The investigator possesses the required skill, experience and
knowledge, staff and access to patients, to conduct the study. The investigator
shall: 1) provide an acceptable facility throughout the clinical trial: 2)
maintain adequate and confidential records of patients identification, clinical
observations, laboratory tests, study drug receipts and disposition: 3) complete
Case Report Forms (CRFs): and 4) deliver all unused drug supplies, all CRFs,
Serious Adverse Event reports and any other study related information to POI, YM or regulatory agencies, as
requested and in a timely manner.

    

    
      
        	
                Date
      of template: 21 December 2004

              	
                Page
      1 of 6

              	
                Date
      of Agreement:

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      
        	
                MASTER

              	
                Schedule
      3

              

      

    

    

    The
investigator shall conduct the study to conform with local law and regulations,
institutional regulations, and according to the Declaration of Helsinki (2000
Edinburgh Scotland amendment) and applying consistently Principles of Good
Clinical Practice (GCP) as required by the ICH-CPMP Guidelines
(1996).

    

    The
investigator will not concurrently conduct any study that may conflict with or
negatively impact upon the goals of this study.

    

    The
investigator represents and warrants that he and the staff which will be
involved in this study have the necessary licenses and qualifications to conduct
the study.

    

    2. Regulatory
responsibilities

    

    The
investigator will obtain a signed Letter of Approval for the study and for the
Informed Consent Form from the appropriate Independent Ethics Committee prior
(IEC) to the study start and provide POI with a copy of the
approval documentation. The investigator will also provide a list of the
Committee members at the time when approval was given and their
titles/occupation/positions. The investigator will provide POI with the copy of any
direct correspondence with Ethics Committee and/or Regulatory Bodies concerning
the review and approval of study documentation. The investigator shall ensure
that written informed consent is obtained from each patient prior to enrolment
in the study. In order to support continuous review of the study by the IEC, the
investigator will periodically update the committee on trial progress, including
patient recruitment, safety issues, new information, etc. In addition, the
investigator will submit for review by the IEC any amendments to the study
documentation, which may impact upon patient rights, safety and/or
well-being.

    

    3. Clinical
data

    

    All
information entered into the Case Report Forms should reflect the patient’s true
condition. The investigator shall review all CRFs and check the data against all
pertinent information in the patients clinical records for accuracy and
completeness of information, legibility of entries, correct any erroneous data,
record use of concomitant drugs, report adverse events, concurrent illnesses and
document reasons for any missing visits or examinations.

    

    All study
related data and information will be the property of YM and may be freely utilized
by YM.

    

    4. Adverse
experiences

    

    The
investigator agrees to notify POI and/or YM within a maximum
of 24 hours (whenever possible immediately by telephone or fax) of any serious
(fatal, life threatening, requiring or prolonging hospitalisation, resulting in
persistent or significant disability, representing a significant hazard, a
congenital anomaly, or other medically important condition) and/or unexpected
adverse events. An SAE form with all available information should be submitted
within 24 hours to YM
and POI. Details should
be also noted on the appropriate form in the CRF, followed up and investigated
further when necessary. All events should be followed-up until resolution and
any new information should be promptly submitted to YM and POI on a follow-up SAE form.
The investigator should also notify the local Ethics Committee, within the time
frame specified by the Ethics Committee.

    

    5. Monitoring and data
verification

    

    According
to ICH-GCP guidelines, data entered on to the CRF have to be monitored and
verified against source documents for completeness, accuracy and consistency.
For complying with these regulations the POI study monitor will require
access to CRFs, patients clinical notes and other relevant patient information.
The investigator agrees to allow direct access to hospital records, etc., for
the purpose of Source Document Verification (SDV) by the POI study monitor. The
investigator also agrees to provide any missing information in the CRFs, correct
any data errors and complete
hospital records, for 100% consistency with data entered into the CRFs.
Hospital records should be completed before CRFs.

    

    
      
        	
                Date
      of template: 21 December 2004

              	
                Page
      2 of 6

              	
                Date
      of Agreement:

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      
        	
                MASTER

              	
                Schedule
      3

              

      

    

    

    6. Audit and
inspection

    

    The
investigator will permit access to the facilities and provide patient data and
all study related information for the purpose of the Quality Assurance audit by
POI or YM personnel (or
their delegates) or to Regulatory Authorities representatives for the purpose of
inspection within usual working hours.

    

    7. Retention of the
documents

    

    The
investigator agrees to retain all study related documentation in secure, fire
retardant storage, for at least 2 years after the last approval of a marketing
application (and there are no pending or contemplated applications), or at least
2 years after clinical development of the medication has been terminated. If
local regulations require a longer period of retention, then these will take
precedence. YM will
inform the investigator when retention of trial documents is no longer
required.

    

    8.
Confidentiality

    

    The
investigator agrees that he/she and all his/her co-workers involved, will treat
all information related to the study as confidential to YM. Such information will be
kept in confidence and not used except in connection with the study and will not
be disclosed, without prior written consent of YM, to any third party other
than those who have a need for such information in conjunction with the approval
or conduct of the study. The information will remain confidential for 10 years
following study completion.

    

    9.
Publications

    

    All
clinical studies carried out by YM will be published wherever
possible. Any proposed publication or presentation by the investigator is
subject to the written approval by YM in advance. A copy of the
proposed publication will be sent to YM at least 30 days before the
intended date of submission/presentation for YM reference and comment. The
investigator agrees to comply with any amendments deletions or comments made by
YM , including delay or
non-publication of the article, if requested. YM will be included as
co-author of any publication or presentation. The obligations described in this
Section 9 shall survive the expiration or earlier termination of this
Agreement.

    

    10. Amendments and
Addenda

    

    This
agreement should not be amended or modified except in writing signed by POI.

    

    11.
Invention

    

    YM shall solely own all
intellectual property (including but not limited to, patentable and
non-patentable inventions, discoveries, improvements and know-how) made or
conceived in the course of or as a result of the study. The Investigator is
obliged to disclose any inventions or discoveries as a result of the study to
YM. The Investigator
hereby assigns and agrees to assign to YM all right, title and
interest in any such intellectual property and agrees to cooperate with YM, at YM’s expense, in preparing,
filing and executing patent applications and any and all other documents to
secure YM’s intellectual
property rights and to obtain, maintain, and enforce all worldwide rights in any
such intellectual property. Investigator shall promptly turn over to YM any and all records
relating to all such intellectual property and shall cause his/her co-workers
and staff involved in the study to comply with the terms and conditions of this
Section 11. The obligations described in this Section 11 shall survive the
expiration or earlier termination of this Agreement.

    

    
      
        	
                Date
      of template: 21 December 2004

              	
                Page
      3 of 6

              	
                Date
      of Agreement:

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      
        	
                MASTER

              	
                Schedule
      3

              

      

    

    

    12.
Termination

    

    YM reserves the right to
terminate the study prematurely for reasonable causes at a single centre or the
entire study for all centers at any time, which effectively would also terminate
their contract with POI.
If this situation should arise, POI reserves the right to
terminate this Investigator’s agreement. In this event, payments will be made on
pro-rata basis, for work done prior to termination of the agreement. The
Investigator may also terminate this agreement by giving POI 30 days notice if he/she
is no longer able to perform the study only for reasons beyond his/her control.
POI may terminate this
agreement if the investigator fails to comply with their obligations,
responsibilities and the terms and conditions of this Agreement and the
Protocol.

    

    If this
study is terminated prematurely, the investigator agrees to furnish to POI all
CRFs completed and/or partially completed up to the date of termination of the
study, as well as all other study related materials including, but not limited
to study drug.

    

    POI reserves the right to
instruct the Investigator not to enroll any patients into the study, in which
case payments will be made according to the payment structure in section 14 for
time already spent on the study.

    

    POI also reserves the right to
instruct the investigator to enroll fewer patients than the number agreed at the
time of the signature of this Investigator’s agreement, in which eventually the
payment due to the Investigator will be made on a pro-rata basis.

    

    13. Liability and
indemnification

    

    The
investigator acknowledges that he is acting as an independent contractor and not
as an employee of POI.

    

    YM shall indemnify the
investigator in accordance with the letter of indemnification. YM shall have no
indemnification, obligation or liability and the investigator shall indemnify,
defend and hold YM and
POI and their employees
and contractors harmless against any loss, claim, demand, costs and expenses, or
damage resulting from:

    

    
      	
              a.

            	
              Failure of the investigator or
      his co-workers to adhere to the protocol or agreed amendments or written
      recommendations and instructions relative to the administration of the
      study drug.

            

    

    
      	
              b.

            	
              Failure of investigator or his
      co-workers to comply with local law or regulations applicable to the
      performance of its obligations under this
  agreement.

            

    

    
      	
              c.

            	
              Negligent act or omission or
      willful misconduct.

            

    

    

    14.
Payments

    

    POI will pay $4,650.00 for each completed and evaluable
patient. An evaluable patient is defined as follows:

    

    a.
patients fulfill all selection criteria

    b.
there are no protocol violations

    c.
all examinations are conducted according to the study schedule

    d.
CRFs are completed accurately and only in
English

    

    Up to
30 eligible patients
will be DOSED in the
study by the study site.

    

    
      
        	
                Date
      of template: 21 December 2004

              	
                Page
      4 of 6

              	
                Date
      of Agreement:

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      
        	
                MASTER

              	
                Schedule
      3

              

      

    

    

    POI AND YM will pay according
to the schedule below:

    

    
      
        
          
            
              
                	
                        VISIT
      NO

                      	 
      	
                        AMOUNT US$

                      	 
      
	
                        BASELINE

                      	 
      	 
      	
                        300

                      	 
      
	
                        COURSE
      1

                      	 
      	 
      	
                        250

                      	 
      
	
                        ICU
      Unit day for PK sampling

                        (9-10
      samples/24h)

                      	 
      	 
      	
                        550

                      	 
      
	
                        Day
      2 PK sampling

                      	 
      	 
      	
                        150

                      	 
      
	
                        Day
      3 PK sampling

                      	 
      	 
      	
                        150

                      	 
      
	
                        COURSE
      2

                      	 
      	 
      	
                        300

                      	 
      
	
                        ICU
      Unit day for PK sampling
(9-10 samples/24h)

                      	 
      	 
      	
                        550

                      	 
      
	
                        Day
      2 PK sampling

                      	 
      	 
      	
                        150

                      	 
      
	
                        Day
      3 PK sampling

                      	 
      	 
      	
                        150

                      	 
      
	
                        COURSE
      3

                      	 
      	 
      	
                        300

                      	 
      
	
                        COURSE
      4

                      	 
      	 
      	
                        300

                      	 
      
	
                        COURSE
      5

                      	 
      	 
      	
                        350

                      	 
      
	
                        COURSE
      6

                      	 
      	 
      	
                        350

                      	 
      
	
                        COURSE
      7

                      	 
      	 
      	
                        350

                      	 
      
	
                        FUp
      Day l6O

                      	 
      	 
      	
                        250

                      	 
      
	
                        FUp
      Day 190

                      	 
      	 
      	
                        200

                      	 
      
	
                        TOTAL

                      	 
      	 
      	
                        4650

                      	 
      

              

            

          

        

      

    

    

    For
patients who withdraw/are withdrawn from the study, every effort should be made
to ensure the patient is assessed at the time of withdrawal and a final
termination visit is performed. The investigator will be responsible for the
payment of any local taxation (if applicable).

    

    Payments
will be made quarterly according to monitored visits.

    

    Study
Products:

    All study
products (DPPE, taxotere, doxorubicin, epirubicin, cyclophosphamide) will be
provided or fully reimbursed by the sponsor.

    

    Diagnostics:

    Study-specific
diagnostics will be reimbursed to the investigator site upon receipt of
quarterly invoices for the following procedures and conditions:

    
      	
               
      

            	
              ·

            	
              The diagnostics tests/procedures
      were required by the protocol,
and

            

    

    
      	
               
      

            	
              ·

            	
              Are not routinely included in the
      standard of care assessments for non-study patients at this site,
      and

            

    

    
      	
               
      

            	
              ·

            	
              Are not covered by the subject’s
      health insurance or other health benefits payments to the site,
      and

            

    

    
      	
               
      

            	
              ·

            	
              Do not exceed the below maximum
      amounts per procedure.

            

    

    

    
      
        
          
            
              	
                      Maximum Reimbursement

                      for Diagnostics

                    	 
      	
                      US$

                    	 
      
	
                      CT
      Scan or Abdominal US

                    	 
      	
                      $     

                    	
                      300

                    	 
      
	
                      Bone
      scan

                    	 
      	
                      $

                    	
                      100

                    	 
      
	
                      MUGA
      scan

                    	 
      	
                      $

                    	
                      125

                    	 
      

            

          

        

      

    

    

    15.
Counterparts

     

    This
Agreement may be signed by facsimile and in counterparts and each of such
counterparts will constitute an original document and such counterparts, taken
together, will constitute one and the same document.

    

    
      
        	
                Date
      of template: 21 December 2004

              	
                Page
      5 of 6

              	
                Date
      of Agreement:

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      
        	
                MASTER

              	
                Schedule
      3

              

      

    

    

    To
demonstrate the full agreement with this document the investigator should sign
below and write his/her
initials in the right hand bottom corner of each page, then return the
signed copy to POI. The
original should be retained for the investigator’s record

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    	 
      	
                                            The
      Investigator

                                          	 
      	
                                            An
      authorised signatory of

                                            Pharm-Olam
      International, Ltd

                                          
	 
      	 
      	 
      	 
      	 
      
	
                                            Name:

                                          	 
      	 
      	
                                            Name:

                                          	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                            Signature:

                                          	 
      	 
      	
                                            Signature:

                                          	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                            Date:

                                          	 
      	 
      	
                                            Date:

                                          	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                            An
      authorised signatory of

                                            YM
      BioSciences Inc.

                                          	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                            Name:

                                          	 
      	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                            Signature

                                          	 
      	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                            Date:

                                          	
                                              

                                          	 
      	 
      	 
      

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    

    17. Payment
procedures:

    

    
      
        
          
            
              
                
                  	
                          —

                        	
                          transfer
      to specified bank account

                        
	
                          —

                        	
                          other
      (please specify or discuss with POI
monitor)

                        
	 
      	 
      
	 
      	 
      
	 
      	 
      
	 
      	 
      

                

              

            

          

        

      

    

     

    
      
        
          
            
              
                
                  
                    
                      	
                              Bank:

                            	 
      
	 
      	 
      
	
                              Address
      of the Bank:

                            	 
      
	 
      	 
      
	
                              Account
      No:

                            	 
      

                    

                  

                

              

            

          

        

      

    

    

    
      
        	
                Date
      of template: 21 December 2004

              	
                Page
      6 of 6

              	
                Date
      of Agreement:

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    SCHEDULE
2

    

    Pharm-Olam
International

    Payment
Schedule

    Study:
Taxotere PK YMB Study YB1002-203

    Number
of Patients: 30 Randomised

    Countries: Serbia (2 sites)

    Date: 25th January 2005

       

      
        

      

    

    

    Total
Contracted Services

    
      
        
          
            
              
                
                  
                    	 
      	 	
                            £114,333

                          	 	 	
                            $217,232

                          	 
	 
      	 	 	 	 	 	 	 	 
	
                            1 20% due
    now

                          	 	 	22,867.00	 	 	 	43,446.00	 
	
                            2
      Monthly Jan 05

                          	 	 	10,163.00	 	 	 	19,310.00	 
	
                            3
      Monthly Feb 05

                          	 	 	10,163.00	 	 	 	19,310.00	 
	
                            4
      Monthly Mar 05

                          	 	 	10,163.00	 	 	 	19,310.00	 
	
                            5
      Monthly Apr 05

                          	 	 	10,163.00	 	 	 	19,310.00	 
	
                            6
      Monthly May 05

                          	 	 	10,163.00	 	 	 	19,310.00	 
	
                            7
      Monthly Jun 05

                          	 	 	10,163.00	 	 	 	19,310.00	 
	 
      	 	 	 	 	 	 	 	 
	
                            8
      Final Payment: To be paid when YM Bioscience, Inc. recieves the final
      report and all appropriate documents.

                          	 	 	30,487.00	 	 	 	57,926.00	 
	 
      	 	 	 	 	 	 	 	 
	
                            Total
      Payments

                          	 	 	114,332.00	 	 	 	217,232.00	 

                  

                

              

            

          

        

      

    

    

    
      
        	 
      	
                Page
      1 of 1

              	
                CONFIDENTIAL

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    SCHEDULE
1

    

    Pharm-Olam
International

    Clinical
Services Cost

    Study:
Taxotere PK YMB Study YB1002-203

    Number
of Patients: 30 Randomised

    Countries: Serbia (2
sites)

    Date:
25th January 2005

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              	 
      	 	 
      	 	
                                                      Number of Hours per task per position

                                                    	 	 	 	 	 	 	 	 	 	 
	
                                                      Task

                                                    	 	
                                                      Position

                                                    	 	
                                                      Admin

                                                    	 	 	
                                                      CRA

                                                    	 	 	
                                                      PM

                                                    	 	 	
                                                      OA Auditor

                                                    	 	 	 	 	 	 	 	 	 	 
	
                                                      No.

                                                    	 	
                                                      Hourly Rate

                                                    	 	
                                                      £26

                                                    	 	 	
                                                      £50

                                                    	 	 	
                                                      £66

                                                    	 	 	
                                                      £81

                                                    	 	 	
                                                      Cost (£)

                                                    	 	 	
                                                      Cost (US$)

                                                    	 	 	
                                                      Assumptions

                                                    	 
	
                                                      1.

                                                    	 	
                                                      Selection
      of Investigators

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	
                                                      Investigator
      Identification

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      Using
      same sites as Doxirubicin study

                                                    	 
	 
      	 	
                                                      Approval
      of Sites

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      “

                                                    	 
	 
      	 	
                                                      Assemble
      pre-study documents and distribute to sites

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      “

                                                    	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                      2.

                                                    	 	
                                                      Documentation

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	
                                                      Protocol
      Review

                                                    	 	 	 	 	 	 	 	 	 	 	12	 	 	 	4	 	 	£	1,116	 	 	$	2,120	 	 	
                                                      12
      hrs PM and 4 hrs QA to review final protocol

                                                    	 
	 
      	 	
                                                      CRF
      Review

                                                    	 	 	 	 	 	 	 	 	 	 	16	 	 	 	 	 	 	£	1,056	 	 	$	2,006	 	 	
                                                      16
      hrs for PM to comment on design before finalisation

                                                    	 
	 
      	 	
                                                      Generation
      of master PIL/ICF

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      Assume
      not required

                                                    	 
	 
      	 	
                                                      PK
      Protocol development

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      None

                                                    	 
	 
      	 	
                                                      Translations

                                                    	 	 	 	 	 	 	0	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      (see
      translation table for assumptions and breakdown)

                                                    	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                      3.

                                                    	 	
                                                      Site
      Selection Visits

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	
                                                      Site
      Visits

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      Using
      same sites as Doxirubicin study

                                                    	 
	 
      	 	
                                                      Approval
      of Sites by PM

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      0.5
      hr PM per site

                                                    	 
	 
      	 	
                                                      Selection
      of Central Laboratory

                                                    	 	 	 	 	 	 	 	 	 	
                                                      NA

                                                    	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      Assume
      not needed

                                                    	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                      4.

                                                    	 	
                                                      Regulatory
      & EC Approval

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	
                                                      Regulatory
      Submissions

                                                    	 	 	4	 	 	 	16	 	 	 	 	 	 	 	 	 	 	£	904	 	 	$	1,718	 	 	
                                                      8
      hrs CRA per site and 4 hrs admin to collate documents

                                                    	 
	 
      	 	
                                                      Ethics
      Submissions

                                                    	 	 	2	 	 	 	16	 	 	 	 	 	 	 	 	 	 	£	852	 	 	$	1,619	 	 	
                                                      8
      hrs CRA per site. 2 hrs admin per site

                                                    	 
	 
      	 	
                                                      Obtain
      Import/Export License

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      Not
      needed

                                                    	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                      5.

                                                    	 	
                                                      Study
      Preparation

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	
                                                      Monitoring
      Guidelines

                                                    	 	 	 	 	 	 	 	 	 	 	4	 	 	 	 	 	 	£	264	 	 	$	502	 	 	
                                                      4
      hrs for PM to modify and final

                                                    	 
	 
      	 	
                                                      Investigator/Hospital
      Contracts

                                                    	 	 	 	 	 	 	8	 	 	 	8	 	 	 	 	 	 	£	928	 	 	$	1,763	 	 	
                                                      4
      hrs per site for PM write + 4 hrs CRA per site to
      negotiate/distribute

                                                    	 
	 
      	 	
                                                      Local
      Insurance

                                                    	 	 	 	 	 	 	16	 	 	 	 	 	 	 	 	 	 	£	800	 	 	$	1,520	 	 	
                                                      16
      hrs to obtain

                                                    	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                      6.

                                                    	 	
                                                      Sponsor
      Meetings & teleconferences

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	
                                                      Bi-weekly
      teleconferences with CRA, PM & research secretary

                                                    	 	 	9	 	 	 	9	 	 	 	9	 	 	 	 	 	 	£	1,278	 	 	$	2,428	 	 	
                                                      On
      average 0.5 hrs bi-weekly teleconference for 9 months

                                                    	 
	 
      	 	
                                                      Kick-off
      Meeting

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      Assume
      not required

                                                    	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                      7.

                                                    	 	
                                                      Monitor
      Training

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	
                                                      CRA
      training preparation

                                                    	 	 	 	 	 	 	 	 	 	 	8	 	 	 	 	 	 	£	528	 	 	$	1,003	 	 	
                                                      8
      hrs (PM) to prepare presentation

                                                    	 
	 
      	 	
                                                      CRA
      training attendance

                                                    	 	 	6	 	 	 	6	 	 	 	6	 	 	 	 	 	 	£	852	 	 	$	1,619	 	 	
                                                      6
      hrs

                                                    	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                                      8.

                                                    	 	
                                                      Investigator
      Meetings

                                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	
                                                      Investigator
      Meeting preparation

                                                    	 	 	0	 	 	 	0	 	 	 	0	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      No
      Investigator Meeting

                                                    	 
	 
      	 	
                                                      Investigator
      Meeting attendance

                                                    	 	 	0	 	 	 	0	 	 	 	0	 	 	 	 	 	 	£	0	 	 	$	0	 	 	
                                                      N/A

                                                    	 

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    

    
      
        	 
      	
                Page
      1 of 6

              	
                CONFIDENTIAL

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    SCHEDULE
1

     

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        	 
      	 	 
      	 	
                                                Number of Hours per task per position

                                              	 	 	 	 	 	 	 	 
      	 
	
                                                Task

                                              	 	
                                                Position

                                              	 	
                                                Admin

                                              	 	 	
                                                CRA

                                              	 	 	
                                                PM

                                              	 	 	
                                                OA Auditor

                                              	 	 	 	 	 	 	 	 
      	 
	
                                                No.

                                              	 	
                                                Hourly Rate

                                              	 	
                                                £26

                                              	 	 	
                                                £50

                                              	 	 	
                                                £66

                                              	 	 	
                                                £81

                                              	 	 	
                                                Cost (£)

                                              	 	 	
                                                Cost (US$)

                                              	 	
                                                Assumptions

                                              	 
	
                                                9.

                                              	 	
                                                Site
      Initiation Visits

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	
                                                Site
      Visits

                                              	 	 	 	 	 	 	23	 	 	 	 	 	 	 	 	 	 	£	1,150	 	 	$	2,185	 	
                                                1
      local site – 9 hrs to include 2 hrs preparation, 4 hr visit, 1 hr travel
      and 2 hrs for report writing and related administration

                                                1
      provincial site – 14 hrs to include 2 hrs preparation, 4 hr visit, 6 hrs
      travel and 2 hrs for report writing and related
    administration

                                              	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                10.

                                              	 	
                                                Monitoring

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	
                                                Routine
      monitoring Visits

                                              	 	 	 	 	 	 	248	 	 	 	 	 	 	 	 	 	 	£	12,400	 	 	$	23,560	 	
                                                8
      monitoring visits per site: (once every 3 weeks during recruitment and PK
      sampling period: over 4 months = 6) and once every 6 weeks over the next 3
      months = 2; 1 local site – 13 hrs to include 2 hrs preparation, 8 hr
      visit, 1 hr travel and 2 hrs for report writing and related
      administration

                                                1
      provincial site – 18 hrs to include 2 hrs preparation, 8 hr visit, 6 hrs
      travel and 2 hrs for report writing and related
    administration

                                              	 
	 
      	 	
                                                Internal
      monitoring

                                              	 	 	 	 	 	 	72	 	 	 	 	 	 	 	 	 	 	£	3,600	 	 	$	6,840	 	
                                                1 hr
      per week per site for 9 months – CRF tracking and status
      update

                                              	 
	 
      	 	
                                                Tel.
      Contacts/Correspondence

                                              	 	 	 	 	 	 	18	 	 	 	 	 	 	 	 	 	 	£	900	 	 	$	1,710	 	
                                                0.5
      hr bi-weekly per site for 9 months (duration of the study)

                                              	 
	 
      	 	
                                                Query
      Management

                                              	 	 	 	 	 	 	60	 	 	 	 	 	 	 	 	 	 	£	3,000	 	 	$	5,700	 	
                                                Assume
      8 queries per patient 0.25 hrs per query for CRA to answer

                                              	 
	 
      	 	
                                                SAE
      reporting to Sponsor

                                              	 	 	 	 	 	 	60	 	 	 	 	 	 	 	 	 	 	£	3,000	 	 	$	5,700	 	
                                                2
      hrs per SAE (assume 1 SAE/patient)

                                              	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                11.

                                              	 	
                                                Medical
      Safety

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	
                                                SAE
      reporting to Regulatory

                                              	 	 	 	 	 	 	30	 	 	 	 	 	 	 	 	 	 	£	1,500	 	 	$	2,850	 	
                                                Assume
      1 hr per SAE

                                              	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                12.

                                              	 	
                                                Project
      Management

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	
                                                Set-up
      & Maintenance, Project Coordination, Sponsor Contact, Project
      Tracking, Investigator fee payments

                                              	 	 	 	 	 	 	 	 	 	 	343	 	 	 	 	 	 	£	22,638	 	 	$	43,012	 	
                                                12
      hrs per week for the first 2 months then 8 hrs per week for the remaining
      7 months

                                              	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                13.

                                              	 	
                                                Quality
      Assurance/Audits

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	24	 	 	£	1,944	 	 	$	3,694	 	
                                                Assume
      1 site audit

                                                24
      hours each to include:

                                                4
      hours preparation, 8 hours return International travel, 8 hours at site
      and 4 hours report writing.

                                              	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                14.

                                              	 	
                                                Sponsor
      Audits

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	 	 	 	
                                                None
      assumed for now

                                              	 
	
                                                15.

                                              	 	
                                                Site
      Close-Out

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	
                                                Site
      Visits

                                              	 	 	 	 	 	 	23	 	 	 	 	 	 	 	 	 	 	£	1,150	 	 	$	2,185	 	
                                                Same
      assumptions as initiation visits

                                              	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                16.

                                              	 	
                                                Study
      Follow Up

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	0	 	 	$	0	 	
                                                Costs
      included in Close-Out Visits

                                              	 
	
                                                17.

                                              	 	
                                                Administration

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	
                                                Study
      File set up

                                              	 	 	18	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	468	 	 	$	889	 	
                                                3
      hrs per file, 6 files (4/site, 1/country & 1 master)

                                              	 
	 
      	 	 
      	 	 	46	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	1,196	 	 	$	2,272	 	
                                                2
      hrs/week for the first 2 months, then 1 hr/week for the remaining 7
      months

                                              	 
	 
      	 	 
      	 	 	6	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	156	 	 	$	296	 	
                                                Payments
      to investigators – assume 2 payments per site. 1 hour per payment Research
      Secretary and 0.5 hours per payment Finance Admin

                                              	 
	
                                                18.

                                              	 	
                                                PK
      Sampling

                                              	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	 
      	 	 	 	 	 	 	32	 	 	 	 	 	 	 	 	 	 	£	1,600	 	 	$	3,040	 	
                                                Time
      for handling, tracking and shipping.

                                              	 

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    
      
        	 
      	
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      2 of 6

              	
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    SCHEDULE
1

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            	 
      	 	 
      	 	
                                                    Number of Hours per task per position

                                                  	 	 	 	 	 	 	 	 
      	 
	
                                                    Task

                                                  	 	
                                                    Position

                                                  	 	
                                                    Admin

                                                  	 	 	
                                                    CRA

                                                  	 	 	
                                                    PM

                                                  	 	 	
                                                    OA Auditor

                                                  	 	 	 	 	 	 	 	 
      	 
	
                                                    No.

                                                  	 	
                                                    Hourly Rate

                                                  	 	
                                                    £26

                                                  	 	 	
                                                    £50

                                                  	 	 	
                                                    £66

                                                  	 	 	
                                                    £81

                                                  	 	 	
                                                    Cost (£)

                                                  	 	 	
                                                    Cost (US$)

                                                  	 	
                                                    Assumptions

                                                  	 
	
                                                    19.

                                                  	 	
                                                    Data
      Management: Stats and Randomisation

                                                  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	51,053	 	 	$	97,000	 	
                                                    To
      include data management, statistical analysis and report writing (draft
      & final).

                                                  	 
	
                                                    20.

                                                  	 	
                                                    Passthroughs

                                                  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
                                                    See
      passthrough table

                                                  	 
	 
      	 	
                                                    Calculation
      based on £1 = $1.9

                                                  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	£	144,333	 	 	$	217,232	 	 
      	 

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    

    Subject
to exchange rate fluctuations and marked to British Pound.

    

    
      
        	 
      	
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      3 of 6

              	
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    SCHEDULE
1

    

    Pharm-Olam
International

    Pass
Through Costs

    Study:
Taxotere PK YMB Study YB1002-203

    Number
of Patients: 30 Randomised

    Countries: Serbia (2
sites)

    Date:
25th January 2005 

       

      
        

      

    

     

    
      
        
          
            
              
                
                  
                    	
                            Note: The below costs are estimates only

                          
	
                            Item

                          	 	
                            Cost (£)

                          	 	 	
                            Cost ($)

                          	 	
                            Note

                          
	
                            Fixed
      charge for Paper, photocopying, faxes, telephone, mobile telephone, Study
      Files

                          	 	£	8,003	 	 	$	15,206	 	
                            To
      be charged on a monthly basis based on 12 months @ £667 per
      month

                          
	
                            Purchase
      of Drug Taxotere

                          	 	£	157,895	 	 	$	300,000	 	
                            Average
      $10,000 per patient. (assumes 20pts @ 2 cycles & 10 pts @ 7
      cycles)

                          
	
                            Auditor
      Travel

                          	 	£	684	 	 	$	1,300	 	
                            Assume
      1 site audit – Approx. $1,300/audit for travel, meals and
      accommodation

                          
	
                            Monitor
      travel including meals (selection, initiation, monitoring and close out
      visits)

                          	 	£	2,321	 	 	$	4,410	 	
                            26
      visits per site in total x $63 per visit = $882

                            Note:
      This is an approximate fee. Mileage will be charged @ $0.65 per
      mile.

                          
	
                            CRF
      Printing

                          	 	£	947	 	 	$	1,800	 	
                            40
      CRF’s @ $45/CRF

                          
	
                            Regulatory
      and Ethics

                          	 	£	900	 	 	$	1,620	 	
                            Regs.
      -£200 GBP; Provincial Site Ethics £700 GBP

                          
	
                            Local
      Insurance certificates

                          	 	£	5,789	 	 	$	11,000	 	
                            Approximately
      $11,000 for 500,000 Euros coverage

                          
	
                            PK
      specialist consultancy for Protocol finalization

                          	 	£	0	 	 	 	 	 	
                            None

                          
	
                            Investigator
      fees to include labs, etc*

                          	 	£	53,263	 	 	$	101,200	 	
                            For
      pts completing 2 cycles = $2,140 + $525 labs = $2,665, For Pts completing
      all 7 cycles = $3,740 + $1,050 labs = $4,790 Assume 20 pts 2 cycles &
      10 pts 7 cycles

                          
	
                            Bank
      charges for Investigator fees payment

                          	 	£	133	 	 	$	240	 	
                            Assume
      $60 per payment (total of 4 payments)

                          
	
                            Total

                          	 	£	229,936	 	 	$	436,776	 	
                            £1
      =
$1.9

                          

                  

                

              

            

          

        

      

    

    

    The
following are INCLUDED in the fixed charge (based on the
net service value and to be amended if the service costs alter): Paper,
photocopying, faxes, telephone, mobile telephone, Study Files

    

    The
following Non-Fixed
costs will be charged extra (see above table for details) and will be subject to
a 5% handling charge with an accompanying receipt; Couriers, Printing,
Teleconference, Travel (flights or per km mileage), Meals, Accommodation,
Regulatory and Ethics fees, Investigator fees)

    
       

      
        

      

    
      
        	 
      	
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    SCHEDULE
1

     

    Pharm-Olam
International

    Translation
Times

    Study:
Taxotere PK YMB Study YB1002-203

    Number
of Patients: 30 Randomised

    Countries: Serbia
(2 sites)

    Date:
25th January 2005 

       

      
        

      

    

     

    Note:
This is an assumption and depends on the final number of pages to be
translated

    

    
      
        
          	
                  Document

                	 
      	
                  Assumptions

                	 
      	
                  Number of Hours

                
	
                  Patient
      information sheet

                	 
      	
                  8
      hours per country

                	 
      	 
      
	
                  Consent
      form

                	 
      	
                  4
      hours per country

                	 
      	 
      
	
                  Drug
      labels

                	 
      	
                  NA (assume not needed)

                	 
      	
                  NA

                
	
                  EC
      aspproval letter

                	 
      	
                  4
      hours per site

                	 
      	 
      
	
                  Import
      licence and regulatory approval letter

                	 
      	
                  8
      hours per country

                	 
      	 
      
	
                  Insurance
      certificate

                	 
      	
                  4
      hours per country

                	 
      	 
      
	
                  Hospital/Investigator
      Contract

                	 
      	
                  8
      hours per site

                	 
      	 
      
	
                  Total

                	 
      	 
      	 
      	
                  0

                

        

      

    

    

    N.B.
These translation times are an estimate, a more accurate costing can be provided
after a review of the full study documentation. If you require local language
correspondence ( e.g. to/from Regulatory Authorities, EC’s and investigators) to
be translated this will be charged at £75 per page.

    

    
      
        	 
      	
                Page 5
      of 6

              	
                CONFIDENTIAL

              

      

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    SCHEDULE
1

    

    Pharm-Olam
International

    Timelines

    Study:
Taxotere PK YMB Study YB1002-203

    Number
of Patients: 30 Randomised

    Countries:
Serbia (2 sites)

    Date:
25th January 2005 

       

      
        

      

    

     

    
      
        
          
            	
                    Start
      Date

                  	
                    December
      1, 2004

                  	 
	
                    First
      patient in (FPI)

                  	
                    February
      1, 2005

                  	 
	 
      	 
      	 
	
                    Last
      patient in (LPI)

                  	
                    May
      31, 2005

                  	 
	 
      	 
      	 
	
                    Last
      patient out

                  	
                    October
      30, 2005

                  	 
	 
      	 
      	 
	
                    Close
      out

                  	
                    December
      31, 2005

                  	 

          

        

      

    

    

    
      
        	 
      	
                Page 6
      of 6

              	
                CONFIDENTIALYM
BIOSCIENCES INC.

    

    WORK
ORDER

    

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

    Nimotuzumab
400 mg Weekly plus

    Irinotecan
(Cohort 1) and Nimotuzumab

    400
mg Every 2 weeks plus Irinotecan

    (Cohort
2) in Patients with Irinotecan-

    Refractory
Metastatic Colorectal Cancer

    

    April 2,
2007

     

    

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

    

    Table
of Contents

     

    
      

    

    

    
      
        	
                1.
      Proposal Details

              	
                3

              
	
                2.
      Corporate Summary

              	
                4

              
	
                Features
      & Benefits

              	
                4

              
	
                Team
      & Location

              	
                5

              
	
                Technology

              	
                5

              
	
                Standards

              	
                5

              
	
                Corporate
      & Clinical Organizational Chart

              	
                7

              
	
                Services

              	
                8

              
	
                Project
      Management

              	
                8

              
	
                Regulatory
      Affairs

              	
                8

              
	
                Clinical
      Monitoring

              	
                8

              
	
                Operational
      Support

              	
                9

              
	
                Medical
      Writing

              	
                9

              
	
                Quality
      Assurance

              	
                10

              
	
                Data
      Management

              	
                10

              
	
                Training

              	
                11

              
	
                Clinical
      Supply Logistics

              	
                11

              
	
                Affiliate
      Services

              	
                11

              
	
                3.
      Therapeutic Experience

              	
                12

              
	
                4.
      ProjectTeam

              	
                14

              
	
                Project
      Oversight

              	
                14

              
	
                Project
      Management

              	
                15

              
	
                Clinical
      Research Associates

              	
                15

              
	
                Clinical
      Operations Associates

              	
                16

              
	
                Quality
      Assurance

              	
                16

              
	
                5.
      Project Summary

              	
                17

              
	
                Project
      Timelines

              	
                21

              
	
                Roles
      and Rates

              	
                21

              
	
                Project
      Details

              	
                22

              
	
                6.
      Estimate

              	
                36

              
	
                7.
      Pass-Through Cost Estimate

              	
                38

              
	
                8.
      Payment Schedule and Terms

              	
                40

              
	
                9.
      Standard Practices

              	
                40

              
	
                10.
      Client Signatures

              	
                41

              
	
                11.
      Letter of Intent

              	
                42

              

      

    

    

    CONFIDENTIAL

      
        

        
          
             

          

          
            Page 2 of
42

            
              

            

          

          
             

          

        

      

    

    

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

    

    1.
Proposal Details 

       

      
        

      

    

    

    
      
        	
                Title:

              	
                A
      Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly plus
      Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks plus Irinotecan
      (Cohort 2) in Patients with Irinotecan-Refractory Metastatic Colorectal
      Cancer

              
	 
      	 
      
	
                Protocol
      #:

              	
                YMB1000-015

              
	 
      	 
      
	
                Customer:

              	
                YM
      BioSciences Inc.

              
	 
      	 
      
	
                MSA#:

              	
                YMBO7-MSA-30APR2007-
      1.0

              
	 
      	 
      
	
                Proposal
      No.:

              	
                YMBO7-WOI-29MAR2007-2.3

              
	 
      	 
      
	
                Customer
      Reference:

              	
                YMBO7-WO1

              
	 
      	 
      
	
                Confidentiality:

              	
                Restricted –
      Commercial Copyright and Reproduction

              
	 
      	 
      
	 
      	
                This
      proposal is submitted by Allphase Clinical Research Inc. in response to
      the invitation issued by Ms. Nancy Cohen, Project Manager at YM
      BioSciences Inc. dated 28FEB2007, with revisions requested on 12 & 30
      MAR; 01 APR2007. It may not be used for any other purposes, reproduced in
      whole or in part, nor passed to any organization or person without the
      specific permission in writing of the President, Allphase Clinical
      Research Services Inc.

              
	 
      	 
      
	
                Proposal
      Date:

              	
                02APR2007

              
	 
      	 
      
	
                Version:

              	
                1.0

              
	 
      	 
      
	
                Validity:

              	
                90
      days

              
	 
      	 
      
	
                CRO
      Address:

              	
                Allphase
      Clinical Research Services Inc.

              
	 
      	
                19
      Camelot Drive

              
	 
      	
                Ottawa,
      ON Canada K2G 5W6

              
	 
      	
                P:
      (613) 228-1990

              
	 
      	
                F:
      (613) 228-8493

              
	 
      	
                C:
      (613) 291-2362

              
	 
      	
                Email:
      jsmith@allphaseclinical.com

              

      

    

     

    
      
        
          	
                  Approved
      by:

                	 
      	 
      	 
      	 
      
	 
      	 
      	
                  /s/ Jeff Smith

                	 
      	
                  22 May 2007

                
	 
      	 
      	
                  Jeff
      Smith

                	 
      	
                  Date

                
	 
      	 
      	
                  President

                	 
      	 
      

        

      

    

    

    CONFIDENTIAL

      
        

      

    

    
      
         

      

      
        Page 3 of
42

        
          

        

      

      
         

      

    

    

    
      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

    

    

    2.
Corporate Summary 

       

      
        

      

    

    

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

    

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

    

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

    

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

    

    Features
& Benefits

    

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

    

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

    
      	
               
      

            	
              t

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

            

    

    
      	
               
      

            	
              t

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

            

    

    
      	
               
      

            	
              t

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

            

    

    
      	
               
      

            	
              t

            	
              A personable, team-focused
      approach; and

            

    

    
      	
               
      

            	
              t

            	
              Innovative, time-saving
      technologies.

            

    

    

    CONFIDENTIAL

      
        

        
          
             

          

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

    

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

    

    Team
& Location

    

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

    

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

    

    Technology

    

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

    

    Standards

    

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

    
      	
               
      

            	
              t

            	
              Standard Operating Procedures and
      policies;

            

    

    
      	
               
      

            	
              t

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

            

    

    
      	
               
      

            	
              t

            	
              Access-controlled
      facility;

            

    

    
      	
               
      

            	
              t

            	
              Access-controlled and
      independently alarmed clinical supply
  room;

            

    

    

    CONFIDENTIAL

      
        

      

    

    
      
         

      

      
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              t

            	
              Access-controlled Trial Master
      File room;

            

    

    
      	
               
      

            	
              t

            	
              Access-controlled secure server
      room;

            

    

    
      	
               
      

            	
              t

            	
              Appropriate data storage and
      redundancy systems;

            

    

    
      	
               
      

            	
              t

            	
              Robust anti-virus and firewall
      security;

            

    

    
      	
               
      

            	
              t

            	
              128-bit VPN
      encryption;

            

    

    
      	
               
      

            	
              t

            	
              VoIP communications
      system;

            

    

    
      	
               
      

            	
              t

            	
              Teleconferencing capability;
      and

            

    

    
      	
               
      

            	
              t

            	
              Proprietary data/document
      processing systems.

            

    

    

    CONFIDENTIAL

      
        

      

    

    
      
         

      

      
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    Corporate & Clinical
Organizational Chart (currently 45 employees)

     

    

    CONFIDENTIAL

      
        

        
          
             

          

          
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    Services

    

    Project
Management

    

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

    
      	
               
      

            	
              t

            	
              IND/CTA
      maintenance;

            

    

    
      	
               
      

            	
              t

            	
              Collaborative interaction with
      regulatory authorities and
IRBs;

            

    

    
      	
               
      

            	
              t

            	
              Investigator site selection and
      feasibility assessments;

            

    

    
      	
               
      

            	
              t

            	
              Regulatory document package
      design (site level);

            

    

    
      	
               
      

            	
              t

            	
              Contract and budget preparation,
      negotiation, and
administration;

            

    

    
      	
               
      

            	
              t

            	
              Investigator meeting organization
      and site training;

            

    

    
      	
               
      

            	
              t

            	
              CRA resourcing, mentoring, and
      co-monitoring support;

            

    

    
      	
               
      

            	
              t

            	
              Monitoring report
      review;

            

    

    
      	
               
      

            	
              t

            	
              SAE reporting
      coordination;

            

    

    
      	
               
      

            	
              t

            	
              Coordination of site/ vendor/
      client communications; and

            

    

    
      	
               
      

            	
              t

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

            

    

    

    Regulatory
Affairs

    

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

    

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

    
      	
               
      

            	
              t

            	
              Investigational New Drug
      Applications (INDs);

            

    

    
      	
               
      

            	
              t

            	
              New Drug Applications
      (NDAs);

            

    

    
      	
               
      

            	
              t

            	
              Abbreviated New Drug Applications
      (NDAs);

            

    

    
      	
               
      

            	
              t

            	
              Biologic License Applications
      (BLAs);

            

    

    
      	
               
      

            	
              t

            	
              New Drug Submissions
      (NDSs);

            

    

    
      	
               
      

            	
              t

            	
              Abbreviated New Drug Submissions
      (ANDSs);

            

    

    
      	
               
      

            	
              t

            	
              Clinical Trial Applications
      (CTAs).

            

    

    

    Clinical
Monitoring

    

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

    
      	
               
      

            	
              t

            	
              Site initiation, routine
      monitoring, and close-out;

            

    

    
      	
               
      

            	
              t

            	
              Site personnel training,
      mentoring, and guidance;

            

    

    
      	
               
      

            	
              t

            	
              Assessing protocol compliance and
      data integrity;

            

    

    

    CONFIDENTIAL

      
        

        
          
             

          

          
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      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
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              t

            	
              Regulatory document
      review;

            

    

    
      	
               
      

            	
              t

            	
              Pharmacy training and drug
      accountability; and

            

    

    
      	
               
      

            	
              t

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

            

    

    

    Operational
Support

    

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

    

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

    

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

    

    Medical
Writing

    

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

    

    
      	
               
      

            	
              t

            	
              Phase I-IV study
      protocols;

            

    

    
      	
               
      

            	
              t

            	
              Investigational drug
      brochures;

            

    

    
      	
               
      

            	
              t

            	
              Informed consent
      forms;

            

    

    
      	
               
      

            	
              t

            	
              Case report form and diary card
      design;

            

    

    
      	
               
      

            	
              t

            	
              Clinical study reports and safety
      narratives;

            

    

    
      	
               
      

            	
              t

            	
              Presentation posters and
      PowerPoint Presentations;

            

    

    
      	
               
      

            	
              t

            	
              Technical briefs;
      and

            

    

    
      	
               
      

            	
              t

            	
              Training
      manuals.

            

    

     

    CONFIDENTIAL

      
        

      

    

    
      
         

      

      
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    Quality
Assurance

    

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

    
      	
               
      

            	
              t

            	
              Evaluation and auditing of GCP
      quality processes:

            

    

    
      	
               
      

            	
              o

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

            

    

    
      	
               
      

            	
              o

            	
              Clinical investigator site
      audits;

            

    

    
      	
               
      

            	
              o

            	
              Clinical data management process
      audits;

            

    

    
      	
               
      

            	
              o

            	
              Clinical study report and
      regulatory submission document
audits;

            

    

    
      	
               
      

            	
              o

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

            

    

    
      	
               
      

            	
              t

            	
              Standard Operating Procedure
      (SOP) and policies
development:

            

    

    
      	
               
      

            	
              o

            	
              Clinical research SOP gap
      analyses and needs
assessment;

            

    

    
      	
               
      

            	
              o

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

            

    

    
      	
               
      

            	
              o

            	
              Collaborative design and writing
      of customized SOPs and
policies.

            

    

    

    Data
Management

    

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

    
      	
               
      

            	
              t

            	
              CRF and database
      design;

            

    

    
      	
               
      

            	
              t

            	
              AE and medical coding and
      reporting;

            

    

    
      	
               
      

            	
              t

            	
              Clinical trial safety database/
      reconciliation;

            

    

    
      	
               
      

            	
              t

            	
              Lab data
      import;

            

    

    
      	
               
      

            	
              t

            	
              Single and double data
      entry;

            

    

    
      	
               
      

            	
              t

            	
              Query
      generation;

            

    

    
      	
               
      

            	
              t

            	
              Data validation, storage and
      archiving; and

            

    

    
      	
               
      

            	
              t

            	
              Biostatistics.

            

    

    

    CONFIDENTIAL

      
        

      

    

    
      
         

      

      
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    Training

    

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

    

    Clinical
Supply Logistics

    

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

    

    Affiliate
Services

    

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

    
      	
               
      

            	
              t

            	
              Statistical
      Analysis;

            

    

    
      	
               
      

            	
              t

            	
              Medical
      Monitoring;

            

    

    
      	
               
      

            	
              t

            	
              DSMB.

            

    

    

    Our
Team is Your Team

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

    

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

     

    CONFIDENTIAL

      
        

      

    

    
      
         

      

      
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    3.
Therapeutic Experience

    

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

    

    
      
        	
                Therapeutic Area

              	 
      	
                # of studies

              	 
      	
                Indications

              
	
                Allergy/ Respiratory

              	 
      	
                7

              	 
      	
                Asthma

                Chronic
      Obstructive Pulmonary Disease

                Perennial
      Allergic Rhinitis

                Seasonal
      Allergic Rhinitis

              
	
                Cardiovascular

              	 
      	
                9

              	 
      	
                Atrial
      Fibrillation

                Deep
      Vein Thrombosis

                Intermittent
      Claudication

                Pulmonary
      Embolism

              
	
                CNS

              	 
      	
                6

              	 
      	
                Amyotrophic
      Lateral Sclerosis

                Alzheimer’s
      Disease

                Depression

                Multiple
      Sclerosis

                Smoking
      Cessation

              
	
                Endocrinology

              	 
      	
                5

              	 
      	
                Diabetes

                Dyslipidemia

              
	
                Infectious
      Disease

              	 
      	
                6

              	 
      	
                Hepatitis

                HIV

              
	
                Oncology

              	 
      	
                8

              	 
      	
                Brain

                Breast

                Head
      and Neck

                Ovarian

                Renal
      Cell Carcinoma

                Small
      Cell Lung

              
	
                Other

              	 
      	
                8

              	 
      	
                Alpha-1
      Antitrypsin Deficiency

                Chronic
      Idiopathic Urticaria

                Immunodeficiency

                Primary
      Immune Deficiency

                Rabies

              
	
                TOTAL

              	 
      	
                49

              	 
      	 
      

      

    

     

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    Oncology
Experience

    

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

    

    
      
        
          	
                  Therapeutic Area

                	 
      	
                  Phase

                	 
      	
                  # of Sites

                	 
      	
                  # of Subjects

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Small
      Cell Lung Cancer

                	 
      	
                  I/Il

                	 
      	
                  5

                	 
      	
                  48

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Advanced
      Breast Cancer

                	 
      	
                  II

                	 
      	
                  5

                	 
      	
                  30

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Metastatic
      Renal Cell Carcinoma

                	 
      	
                  II

                	 
      	
                  1

                	 
      	
                  5

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Metastatic
      Breast Cancer

                	 
      	
                  II

                	 
      	
                  4

                	 
      	
                  37

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Squamous
      Cell Carcinoma

                	 
      	
                  II

                	 
      	
                  6

                	 
      	
                  20

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Squamous
      Cell Carcinoma

                	 
      	
                  II

                	 
      	
                  6

                	 
      	
                  10

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Pediatric
      Brain Tumors

                	 
      	
                  I

                	 
      	
                  1

                	 
      	
                   19

                
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                  Ovarian
      Cancer

                	 
      	
                  II

                	 
      	
                  7

                	 
      	
                  40

                

        

      

    

     

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                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

     

    4.
Project Team 

       

      
        

      

    

    

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

    

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

    

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

    

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

    

    Project
Oversight

    

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

    

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

     

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                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

     

    Project
Management

    

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

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

    

    
      
        
          
            
              	
                      # of

                      Studies

                    	 
      	
                      Phase

                    	 
      	
                      Indication

                    
	
                      2

                    	 
      	
                      III

                    	 
      	
                      Metastatic
      Colorectal

                    
	
                      1

                    	 
      	
                      II/III

                    	 
      	
                      Ovarian
      Cancer

                    
	
                      3

                    	 
      	
                      III

                    	 
      	
                      Cervical
      Dystonia

                    
	
                      1

                    	 
      	
                      I

                    	 
      	
                      Hemifacial
      Spasm

                    
	
                      I

                    	 
      	
                      III

                    	 
      	
                      International
      Melanoma

                    
	
                      1

                    	 
      	
                      III

                    	 
      	
                      AML

                    

            

          

        

      

    

     

    Her
therapeutic experience includes the following areas:

    

    
      
        	
                Therapy Area

              	 
      	
                Indication

              
	
                Hematology

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

              
	
                Infectious
      Diseases

              	 
      	
                Antiviral
      research: HIV

              
	
                Oncology

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

              
	
                Neurological

              	 
      	
                Alzheimer’s
      Disease, Cervical Dystonia

              

      

    

     

    Clinical
Research Associates

    

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

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

    

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

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

     

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                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

     

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

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

     

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

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

     

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

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

     

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

     

    Clinical
Operations Associates

     

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

     

    Quality
Assurance

     

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

     

    CONFIDENTIAL

      
        

      

    

    
      
         

      

      
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                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      5.
Project Summary

       

      
        
          

        

      Based on
the information received to date and the noted assumptions, the following
summary of tasks has been identified for outsourcing:

      

      
        
          
            	
                    Protocol

                  	 
      	 
      
	
                    Drug

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

                  
	
                    Indication

                  	 
      	
                    Metastatic
      Colorectal Cancer

                  
	
                    Phase

                  	 
      	
                    II

                  
	
                    Title

                  	 
      	
                    A
      Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly plus
      Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks plus Irinotecan
      (Cohort 2) in Patients with Irinotecan-Refractory Metastatic Colorectal
      Cancer

                  
	
                    Short
      Title

                  	 
      	
                    Nimotuzumab
      plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal
      Cancer

                  
	
                    Objectives

                  	 
      	
                    Primary:

                    To
      evaluate whether the combination of Irinotecan and nimotuzumab will result
      in a lower incidence of Grade 2 or greater acneform rash or infusion
      reaction, allergic reaction or anaphylactoid reaction AEs in patients with
      irinotecan-refractory metastatic colorectal cancer.

                  
	 
      	 
      	
                    Secondary:

                    •
      To evaluate whether the combination of irinotecan and one of the 2
      different dosing schedules of nimotuzumab will result in an objective
      response rate (ORR) in patients with irinotecan-refractory metastatic
      colorectal cancer.

                  
	 
      	 
      	
                    •
      To compare progression-free survival (PFS), defined as time from date of
      randomization until date of disease progression (clinical or radiological)
      or death due to any cause, in each nimotuzumab
  arm;

                  

          

        

      

       

      CONFIDENTIAL

      
        

      

      
        
          
          

        

        
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                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

      

      
        
          
            	 
      	 
      	 	
                    •
      To compare the rate and duration of Stable Disease (SD) in each treatment
      arm;

                  
	 
      	 
      	 	
                    •
      To compare the time to disease progression (TTP) in each treatment
      arm;

                  
	 
      	 
      	 	
                    •
      To compare ORR in patients who are identified as having “primary”
      irinotecan resistance according to stratification criteria at the time of
      randomization in each treatment arm;

                  
	 
      	 
      	 	
                    •
      To compare overall survival in each tx arm;

                  
	 
      	 
      	 	
                    •
      To compare the overall safety and toxicity profiles of 2 dose regimens of
      nimotuzumab plus irinotecan;

                  
	 
      	 
      	 	
                    •
      To compare incidence of symptomatic rash, defined as any rash or pain in
      each treatment arm,

                  
	 
      	 
      	 	
                    •
      To define the biologically effective dose of

                  
	 
      	 
      	 	
                    nimotuzumab
      based on ORR and safety data

                  
	 
      	 
      	 	
                    which
      can serve as a reference for future studies.

                  
	
                    Sites

                  	 
      	 	 
      
	
                    No.
      of Investigator Meetings

                  	
                    1

                  	 	 
      
	
                    Investigator
      Meeting Location

                  	 
      	 	
                    TBD

                  
	
                    Number
      of Treatment Groups

                  	
                    2

                  	 	 
      
	
                    Local
      of Central IRB

                  	 
      	 	
                    Local

                  
	
                    Number
      of Sites

                  	
                    11

                  	 	 
      
	
                    Location
      of sites

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

                  
	
                    Number
      of Site Selection Visits

                  	
                    0

                  	 	 
      
	
                    Number
      of Initiation Visits

                  	
                    11

                  	 	 
      
	
                    Est.
      # of Monitoring hrs/ SF CRF

                  	
                    0.5

                  	 	
                    assuming
      minimal data review & collection

                  
	
                    Est.
      # of Monitoring hrs/ Completed CRF

                  	
                    16

                  	 	
                    Based
      on 60 CRF pages per patient. Also includes: query resolution (monitoring
      & DM generated); drug accountability; proportional share of regulatory
      reconciliation

                  
	
                    Estimated
      Number of Monitoring Hour

                  	
                     1605 

                  	 	 
      
	
                    Estimated
      Number of Monitoring Days

                  	
                    229

                  	 	
                    7
      hour monitoring day (1hr for site administration)

                  
	
                    Estimated
      Number of Visits per Site

                  	
                    21

                  	 	
                    assumes
      1 day visit

                  
	
                    Estimated
      Monitoring Frequency

                  	
                    6

                  	 	
                    every
      6 weeks (1 day visits)

                  
	
                    Estimated
      Number of Monitors

                  	
                    3

                  	 	
                    Workload
      estimated at 1.3 FTE. 3 CRAs regionally distributed will save travel
      costs.

                  
	
                    Estimated
      Number of Close-out Visits

                  	
                    11

                  	 	 
      
	
                    Estimated
      Number of Ad-Hoc Visits

                  	
                    4

                  	 	
                    PM
      visits to YMB (approx every 6 months)

                  
	
                    Estimated
      Number of Co-Visits by PM

                  	
                    3

                  	 	 
      

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
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                  MSA#:

                	
                  YMB07-MSA-30APR2007-l.0

                	
                  WO
      Version Code:

                	
                  YMB07-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

      

      
        
          
            	
                    Subjects

                  	 
      	 	 
      
	
                    Number
      of Subjects Screened

                  	
                    110

                  	 	 
      
	
                    Number
      of Subjects Randomized

                  	
                    100

                  	 	 
      
	
                    Enrolment
      Period

                  	
                    78

                  	 	
                    weeks
      (FPFV 06/2007 to LPFV 12/2008)

                  
	
                    Duration
      of Each Subject

                  	
                    26

                  	 	
                    weeks
      (Scr; 26 wk Tx)

                  
	
                    Follow
      Up of Each Subject

                  	
                    26

                  	 	
                    Weeks(26
      wk FU)

                  
	
                    Total
      Study Duration (all subjects - active)

                  	
                    104

                  	 	
                    weeks
      (FPFV 06/2007 to LPLV (active period) 06/2009)

                  
	
                    Total
      Study Duration (all subjects)

                  	
                    130

                  	 	
                    weeks
      (30 mo)

                  
	
                    Total
      Study Duration (PM) Active Period

                  	
                    104

                  	 	
                    weeks

                  
	
                    Total
      Study Duration (PM) Follow-Up Period

                  	
                    26

                  	 	
                    weeks

                  
	
                    Total
      Study Duration (PM)

                  	
                    138

                  	 	
                    weeks
      (total study duration + 8 weeks F/U)

                  
	
                    Estimated
      # PM hours/week (active period)

                  	
                    11

                  	 	
                    hours
      (1hr/wk/site)

                  
	
                    Estimated
      # PM hours/week (F/U period)

                  	
                    5.5

                  	 	
                    hours
      (0.5hr/wk/site)

                  
	
                    Estimated
      Number of SAE

                  	
                    100

                  	 	 
      
	
                    Medical
      Writing

                  	 
      	 	 
      
	
                    Number
      of Medical Reports

                  	
                    1

                  	 	 
      
	
                    SOP

                  	 
      	 	 
      
	
                    SOPs
      to be used

                  	 
      	 	
                    YM
      BioSciences

                  
	
                    Forms

                  	 
      	 	
                    YM
      BioSciences

                  
	
                    Data
      Management

                  	 
      	 	 
      
	
                    Allphase
      DM

                  	 
      	 	
                    paper
      CRF

                  
	
                    Quality
      Assurance

                  	 
      	 	 
      
	
                    Site
      Audits

                  	
                    4

                  	 	 
      
	
                    Vendor
      Audits

                  	
                    2

                  	 	
                    Central
      lab for PK samples & Radiology Lab

                  
	
                    QA
      Audit of Clinical Database

                  	
                    0

                  	 	 
      
	
                    QA
      Audit of Clinical Study Report

                  	
                    0

                  	 	 
      
	
                    QA
      Audit of Study File

                  	
                    0

                  	 	 
      
	
                    Vendors

                  	 
      	 	 
      
	
                    Number
      of Laboratories

                  	 
      	 	
                    Local
      & Central (PK)

                  
	
                    Investigational
      Product Distributor

                  	 
      	 	
                    YM
      BioSciences

                  
	
                    Radiology
      Review

                  	
                    120

                  	 	
                    based
      on 20% responders and 6 images/patient

                  
	
                    Services
      Requested

                  	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    Regulatory

                  
	 
      	 
      	 	
                    CTA
      prep, submission and maintenance

                  
	 
      	 
      	 	
                    Project
      Management

                  

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
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                  MSA#:

                	
                  YMB07-MSA-30APR2007-l.0

                	
                  WO
      Version Code:

                	
                  YMB07-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            	 
      	
                    N/A

                  	 	
                    Site
      Contract Negotiation and Payment Facilitation

                  
	 
      	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    Regulatory
      Document Collection

                  
	 
      	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    ICF
      Preparation & Translation

                  
	 
      	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    IRB
      preparations and submissions - central

                  
	 
      	 
      	 	
                    IRB;
      or assistance with the submissions if

                  
	 
      	 
      	 	
                    local
      IRB.

                  
	 
      	 
      	 	 
      
	 
      	
                    N/A

                  	 	
                    Site
      Identification

                  
	 
      	 
      	 	
                    Multi-site
      Management

                  
	 
      	 
      	 	
                    CRA
      Management

                  
	 
      	 
      	 	
                    Teleconference
      and Project Updates

                  
	 
      	 
      	 	
                    Vendor
      Management (if applicable)

                  
	 
      	 
      	 	
                    General
      Administration

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Investigator
      Meeting

                  
	 
      	 
      	 	
                    Planning
      & Execution

                  
	 
      	 
      	 	
                    Presentations

                  
	 
      	 
      	 	
                    Travel
      Arrangements for Attendees

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Clinical
      Monitoring

                  
	 
      	
                    N/A

                  	 	
                    Pre-Study
      Visits

                  
	 
      	 
      	 	
                    Site
      Initiation

                  
	 
      	 
      	 	
                    Interim
      Monitoring & site management

                  
	 
      	 
      	 	
                    Site
      Close Out

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Safety

                  
	 
      	 
      	 	
                    Safety
      Database

                  
	 
      	 
      	 	
                    CIOMS/
      MedWatch report prep

                  
	 
      	 
      	 	
                    SAE
      alert reporting to authorities

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Data
      Management/Biostatistics

                  
	 
      	 
      	 	
                    CRF
      Design & build

                  
	 
      	 
      	 	
                    DM
      System Set Up (include edit checks)

                  
	 
      	 
      	 	
                    Data
      Validation and Review CRFs

                  
	 
      	 
      	 	
                    Data
      Query

                  
	 
      	 
      	 	
                    Coding
      AE & Medications

                  
	 
      	 
      	 	
                    Interim
      Analysis Plan

                  
	 
      	 
      	 	
                    Final
      Analysis Plan

                  

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
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                  MSA#:

                	
                  YMB07-MSA-30APR2007-l.0

                	
                  WO
      Version Code:

                	
                  YMB07-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            	 
      	 
      	 	
                    Medical
      Monitoring

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Radiology
      Review

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Medical
      Writing

                  
	 
      	 
      	 	
                    Draft
      & Final Clinical Study Report

                  
	 
      	 
      	 	 
      
	 
      	 
      	 	
                    Quality
      Assurance

                  
	 
      	 
      	 	
                    GCP
      Investigator/Site/ Vendor Audit

                  
	 
      	
                    N/A

                  	 	
                    QA
      Audit of Clinical Database

                  
	 
      	
                    N/A

                  	 	
                    QA
      Audit of Clinical Study
Report

                  

          

        

      

      

      Project
Timelines

       

      
        
          
            
              	
                      Activity

                    	 
      	
                      Date of Completion

                    
	
                      Contract
      or LOI executed

                    	 
      	
                      Apr-07

                    
	
                      Investigator
      Meeting

                    	 
      	
                      Apr-Jun-07

                    
	
                      First
      patient enrolled

                    	 
      	
                      Jun-07

                    
	
                      25%
      subjects enrolled

                    	 
      	
                      Nov-07

                    
	
                      50%
      subjects enrolled

                    	 
      	
                      Mar-07

                    
	
                      75%
      subjects enrolled

                    	 
      	
                      Aug-08

                    
	
                      Enrolment
      completed

                    	 
      	
                      Dec-08

                    
	
                      Last
      patient/ last visit (active period)

                    	 
      	
                      Jun-09

                    
	
                      Database
      Lock

                    	 
      	
                      Aug-09

                    
	
                      Final
      close out visit

                    	 
      	
                      Oct-09

                    

            

          

        

      

      

      Roles
and Rates

       

      
        
          
            
              	
                      Allphase Role

                    	  	
                      Allphase Resource

                    	  	
                      Hourly Rate

                    	 
	
                      DE

                    	 
      	
                      Data
      Entry Personnel

                    	 
      	$	
                      65

                    	 
	
                      COA

                    	 
      	
                      Clinical
      Operations Associate

                    	 
      	$	
                      75

                    	 
	
                      CRA

                    	 
      	
                      Clinical
      Research Associate

                    	 
      	$	
                      90

                    	 
	
                      DM

                    	 
      	
                      Data
      Manager

                    	 
      	$	
                      100

                    	 
	
                      MW

                    	 
      	
                      Medical
      Writing

                    	 
      	$	
                      100

                    	 
	
                      PM

                    	 
      	
                      Project
      Manager

                    	 
      	$	
                      100

                    	 
	
                      RA

                    	 
      	
                      Regulatory
      Affairs

                    	 
      	$	
                      100

                    	 
	
                      DS

                    	 
      	
                      Drug
      Safety

                    	 
      	$	
                      100

                    	 
	
                      QA

                    	 
      	
                      Quality
      Assurance Auditor

                    	 
      	$	
                      100

                    	 
	
                      BlO

                    	 
      	
                      Biostatistician

                    	 
      	$	
                      120

                    	 
	
                      ACE

                    	 
      	
                      Trainer

                    	 
      	$	
                      150

                    	 
	
                      MM

                    	 
      	
                      Medical
      Monitor

                    	 
      	$	
                      350

                    	 

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
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                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      Project
Details

      
        
          
            	
                    x

                  	 
      	
                    Full
      Responsibility

                  
	
                    (x)

                  	 
      	
                    Partial
      Responsibility/ Input/ Advice

                  
	
                    ADM

                  	 
      	
                    Data
      Management

                  

          

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Pre-Study
      Activities

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Project
      Feasibility study

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Protocol
      Development 

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Synopsis

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Draft

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review

                                      	 	
                                        x

                                      	 	
                                        (x)

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Final

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Protocol
      Amendments

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Draft

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review

                                      	 	
                                        x

                                      	 	
                                        (x)

                                      	 	 
      	 	4	 	1	 	4	 	
                                        PM

                                      	 
	
                                        Final

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Compilation
      & update IB

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Draft

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Final

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Paper
      CRF Preparation

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Draft

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Final

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Printing

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CRF
      Design (CA3)

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CRF
      Design - Draft (17 unique forms, 60

                                        CRF
      pages/pt) - template provided by YMB

                                      	 	 	 	
                                        x

                                      	 	 
      	 	40	 	1	 	40	 	
                                        PM

                                      	 
	
                                        CRF
      Draft Review & Revisions

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        CRA

                                      	 
	
                                        Edit
      Check Development

                                      	 	 	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Review
      & Finalize Programmed Edit Checks

                                      	 	 	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Final
      Review and Final Revisions to CRF

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        PM

                                      	 
	
                                        CRF
      Completion Guidelines (revisions incl)

                                      	 	 	 	
                                        x

                                      	 	 
      	 	36	 	1	 	36	 	
                                        PM

                                      	 
	
                                        CRF
      Completion Guidelines - review

                                      	 	 	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        CRA

                                      	 
	
                                        CRF
      printing logistics and QC

                                      	 	 	 	
                                        x

                                      	 	 
      	 	4	 	1	 	4	 	
                                        PM

                                      	 
	
                                        Project
      Plan

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        SOPs
      assignment documentation

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	3	 	1	 	3	 	
                                        PM

                                      	 
	
                                        Responsibility
      assignment

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	3	 	1	 	3	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	24	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	130	 	
                                        PM

                                      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 22
of 42

            
              

            

          

          
            
            

          

        

      

       

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Submissions
      to FDA

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        US
      agent

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        amendment
      & maintenance

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CTA
      - Health Canada

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Canadian
      Agent

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      & Submission

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	
                                        Clarifax
      response

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	
                                        Review
      of Approval NOL & follow-up

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	
                                        Submission
      of CTSI forms to TPD

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	
                                        amendment
      & maintenance

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        RA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	0	 	
                                        RA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Vendors

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        ID
      & contracting lab

                                      	 	 	 	
                                        x

                                      	 	 
      	 	12	 	1	 	12	 	
                                        PM

                                      	 
	
                                        ID
      & contracting Radiology Review

                                      	 	 	 	
                                        x

                                      	 	 
      	 	12	 	1	 	12	 	
                                        PM

                                      	 
	
                                        Vendor
      Assessment

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Provide
      sites with manual

                                      	 	
                                        n/a

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Payment
      administration & tracking

                                      	 	 	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	32	 	
                                        PM

                                      	 
	
                                        Investigator’s
      Meeting

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Identify
      location and conduct preliminary investigation of costs;
      reservations

                                      	 	
                                        x

                                      	 	
                                        (x)

                                      	 	 
      	 	8	 	1	 	8	 	
                                        COA

                                      	 
	
                                        Organize
      travel & hotel for study team

                                      	 	 	 	
                                        x

                                      	 	 
      	 	14	 	1	 	14	 	
                                        COA

                                      	 
	
                                        Plan
      and organize IM

                                      	 	 	 	
                                        x

                                      	 	 
      	 	24	 	1	 	24	 	
                                        PM

                                      	 
	
                                        Prepare
      agenda

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	3	 	1	 	3	 	
                                        PM

                                      	 
	
                                        Prepare
      presentations

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Design
      Investigator Meeting materials

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Prepare
      Investigator Meeting materials

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	
                                        Prepare
      welcome letters, name tags, meeting materials

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	12	 	1	 	12	 	
                                        COA

                                      	 
	
                                        Ensure
      vendor/sponsor presentations are organized and appropriate

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Attendance
      and presentations at Investigator meeting

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 	 	 	 	 	 	 
      	 
	 
      	 	
                                         

                                      	 	 	 	 
      	 	 	 	 	 	 	 	
                                          

                                      	 
	
                                        PM
      prep

                                      	 	 	 	 	 	 
      	 	2	 	1	 	2	 	
                                        PM

                                      	 
	
                                        PM
      travel

                                      	 	 	 	 	 	 
      	 	16	 	1	 	16	 	
                                        PM

                                      	 
	
                                        PM
      presentation & attendance

                                      	 	 	 	 	 	 
      	 	16	 	1	 	16	 	
                                        PM

                                      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 23
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        CRA
      prep

                                      	 	 	 	 
      	 	 
      	 	2	 	3	 	6	 	
                                        CRA

                                      	 
	
                                        CRA
      travel

                                      	 	 	 	 
      	 	 
      	 	16	 	3	 	48	 	
                                        CRA

                                      	 
	
                                        CRA
      attendance

                                      	 	 	 	 
      	 	 
      	 	16	 	3	 	48	 	
                                        CRA

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        ACE
      Trainer prep

                                      	 	 	 	 
      	 	 
      	 	2	 	0	 	0	 	
                                        ACE

                                      	 
	
                                        ACE
      Trainer travel

                                      	 	 	 	 
      	 	 
      	 	16	 	0	 	0	 	
                                        ACE

                                      	 
	
                                        ACE
      Trainer presentation & attendance

                                      	 	 	 	 
      	 	 
      	 	8	 	0	 	0	 	
                                        ACE

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        COA
      prep

                                      	 	 	 	 
      	 	 
      	 	2	 	1	 	2	 	
                                        COA

                                      	 
	
                                        COA
      travel

                                      	 	 	 	 
      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	
                                        COA
      attendance

                                      	 	 	 	 
      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        DM
      prep

                                      	 	 	 	 
      	 	 
      	 	2	 	0	 	0	 	
                                        DM

                                      	 
	
                                        DM
      travel

                                      	 	 	 	 
      	 	 
      	 	16	 	0	 	0	 	
                                        DM

                                      	 
	
                                        DM
      presentation & attendance

                                      	 	 	 	 
      	 	 
      	 	8	 	0	 	0	 	
                                        DM

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        MM
      prep

                                      	 	 	 	 
      	 	 
      	 	2	 	1	 	2	 	
                                        MM

                                      	 
	
                                        MM
      travel

                                      	 	 	 	 
      	 	 
      	 	16	 	1	 	16	 	
                                        MM

                                      	 
	
                                        MM
      presentation & attendance

                                      	 	 	 	 
      	 	 
      	 	8	 	1	 	8	 	
                                        MM

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total
      - PM

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	85	 	
                                        PM

                                      	 
	
                                        Sub-Total
      - CRA

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	102	 	
                                        CRA

                                      	 
	
                                        Sub-Total
      - ACE

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	0	 	
                                        ACE

                                      	 
	
                                        Sub-Total
      - COA

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	84	 	
                                        COA

                                      	 
	
                                        Sub-Total
      - DM

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	0	 	
                                        DM

                                      	 
	
                                        Sub-Total
      - MM

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	26	 	
                                        MM

                                      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ethics

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of ICF template (PIPEDA)

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	16	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Customization
      of ICF (PIPEDA)

                                      	 	
                                        n/a

                                      	 	 
      	 	 
      	 	8	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Preparation
      of other subject materials

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	12	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Assist
      sites with submissions

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	3	 	0	 	0	 	
                                        PM

                                      	 
	
                                        IRB
      approval review & action if needed

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	2	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Translation
      of ICF & materials

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	6	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Subsequent
      ICF revisions (amendments)

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	8	 	0	 	0	 	
                                        PM

                                      	 
	
                                        IND
      Safety alert reporting to sites

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	2	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Annaul
      re-approval documentation

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	4	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Study/
      site closure documentation

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	4	 	0	 	0	 	
                                        PM

                                      	 
	
                                        IRB
      payment facilitation

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	1	 	0	 	0	 	
                                        PM

                                      	 
	
                                        IRB
      payment

                                      	 	
                                        x

                                      	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 
      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 
      	 	 
      	 	 	 	 	 	0	 	
                                        PM

                                      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 24
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        CRA

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Site
      Selection Visits

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Contact
      sites and confirm date for visit

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Send
      confirmation letter

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Interview
      PI and site staff regarding experience

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      project requirements and expectations

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Tour
      facility and assess site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prepare
      report and make recommendation of site suitability

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	0	 	0	 	
                                        CRA

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	8	 	0	 	0	 	
                                        CRA

                                      	 
	
                                        On-Site

                                      	 	 	 	 	 	 
      	 	3	 	0	 	0	 	
                                        CRA

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	4	 	0	 	0	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	0	 	
                                        CRA

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Site
      Initiation Visit

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Contact
      sites and confirm date for visit and provide an agenda

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Send
      confirmation letter

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Complete
      Monitors’ Sign-In Log

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      regulatory documentation

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      Study protocol and CRF including:

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Inclusion
      /exclusion criteria

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Efficacy
      parameters and measurement

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Study
      schedule

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Complete/evaluable
      patient definitions

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Study
      medication procedures

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Lab
      requirements

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CRF
      completion instructions

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      adverse event reporting, including:

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Definition
      of AEs and SAEs.

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Requirements
      for documentation collection

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Proper
      procedures for reporting SAEs to Sponsor and REB.

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Follow-up
      requirements

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      Investigational Brochure

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      communication channels

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      requirements for source documentation

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        IRB/site
      responsibilities

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 25
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  	
                                          List of Tasks

                                        	 	
                                          YM

                                        	 	
                                          Allphase

                                        	 	
                                          ADM

                                        	 	
                                          Task

                                          Hours

                                        	 	
                                          Units

                                        	 	
                                          Total

                                          Hours

                                        	 	
                                          Resp

                                        	 
	
                                          Review
      monitoring schedule

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      study site documentation

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Train
      study coordinators

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      PI contract and payment schedule

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Prepare
      study initiation visit report

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Send
      site SIV report and ackg. form

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Prep

                                        	 	 
      	 	 	 	 
      	 	2	 	1	 	2	 	
                                          CRA

                                        	 
	
                                          Travel

                                        	 	 
      	 	 	 	 
      	 	8	 	1	 	8	 	
                                          CRA

                                        	 
	
                                          On-Site

                                        	 	 
      	 	 	 	 
      	 	5	 	1	 	5	 	
                                          CRA

                                        	 
	
                                          Admin

                                        	 	 
      	 	 	 	 
      	 	4	 	1	 	4	 	
                                          CRA

                                        	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Sub-Total/site

                                        	 	 
      	 	 	 	 
      	 	19	 	1	 	19	 	
                                          CRA

                                        	 
	
                                          Total

                                        	 	 
      	 	 	 	 
      	 	19	 	11	 	209	 	
                                          CRA

                                        	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Interim
      Monitoring

                                        	 	 
      	 	
                                          x

                                        	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Send
      confirmation letter

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Complete
      Monitors’ Sign-In Log

                                        	 	 
      	 	
                                           

                                        	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Verify
      proper Informed Consent procedures

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Monitor
      in accordance with protocol/ICH/GCP

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          100%
      source document verification vs. CRF

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

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

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      study-related regulatory documents

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      monitoring & discrepancy report queries

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Source
      verify data clarification/ correction forms

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      of laboratory data

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Review
      and verify SAEs (100% SDV)

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Verify
      study drug inventory and storage

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

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Maintain
      protocol violation list

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Monitoring
      of other variables as specified

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Prepare
      monitoring visit reports following each monitoring visit

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Provide
      monitoring follow-up reports to sites following each visit

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Regular
      contacts with sites & TC reports

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          Ongoing
      training of site personnel

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                          CRF
      and query management

                                        	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 26
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        CRA

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	6	 	1	 	6	 	
                                        CRA

                                      	 
	
                                        On-Site

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        CRA

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	5	 	1	 	5	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	20	 	1	 	20	 	
                                        CRA

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	20	 	229	 	4580	 	
                                        CRA

                                      	 
	 
      	 	 	 	
                                         

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Close
      Out Visit

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        COV
      within 6 weeks post data base lock

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Contact
      potential sites, confirm date for visit

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Send
      confirmation letter

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Complete
      Monitors’ Sign-In Log

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ensure
      site regulatory documentation is complete and accessible for future
      audits

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ensure
      that the investigator is aware of his/her responsibilities

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

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prepare
      COV report following visit

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Provide
      follow-up report to sites

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Follow-up
      with sites to resolve open issues

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        CRA

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        CRA

                                      	 
	
                                        On-Site

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        CRA

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	5	 	1	 	5	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	22	 	1	 	22	 	
                                        CRA

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	22	 	11	 	242	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CRA
      Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	5031	 	
                                        CRA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Overall
      Project Management

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        In-house
      study management

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Selection
      - US sites

                                      	 	
                                        N/A

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Selection
      - CDN site

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Identification
      & contracting of vendors

                                      	 	
                                        N/A

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Feasibility
      form admin (incl. initial contact)

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Confidential
      Discl. Agreement - template

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CDA
      Approval

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CTRA
      template

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CTRA
      template approval

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        CTRA
      negotiation

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 27
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        	
                                                List of Tasks

                                              	 	
                                                YM

                                              	 	
                                                Allphase

                                              	 	
                                                ADM

                                              	 	
                                                Task

                                                Hours

                                              	 	
                                                Units

                                              	 	
                                                Total

                                                Hours

                                              	 	
                                                Resp

                                              	 
	
                                                CTRA
      - site sign off

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Preparation
      of initial project specific reg pkg

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Review
      received reg docs:

                                              	 	
                                                x

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                site
      - 1572

                                              	 	 	 	
                                                 

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                site
      - QIU

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                REBA

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                CTSI

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Consent
      to Use Personal Data

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Protocol
      signature page

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                IB
      distribution to sites

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Financial
      Disclosure

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                CV

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                biosketch

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                MD
      qualification

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                lab
      ref ranges & license

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Internal
      monthly project team meetings

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Site
      level management

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Regular
      status reports for client

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Liaise
      bi-weekly with sponsor

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                TMF
      Set-up & Maintenance

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Track
      CRF completion & queries and manage deficiencies

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Site
      budget set-up

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Payment
      calculation

                                              	 	 	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Payment
      tracking

                                              	 	
                                                x

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Payment
      issuance

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                 Preparation
      of Project Plan

                                              	 	
                                                (x)

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Preparation
      of Monitoring Plan

                                              	 	
                                                (x)

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Prep.
      of initiation Visit Booklet

                                              	 	
                                                (x)

                                              	 	
                                                x

                                              	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                  

                                              	 	 	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Prep.
      of Study specific forms

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	
                                                PM

                                              	 
	
                                                Prep.
      study specific tracking tools

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                CRF
      Transmittal Logs

                                              	 	
                                                x

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

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Drug
      Accountability Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Individual
      Subject Drug logs

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Drug
      Return & Reconciliation Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Clinical
      Re-Supplies Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Drug
      Receipt Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 
	
                                                Release
      of IP (RIP) Form

                                              	 	
                                                x

                                              	 	 	 	 
      	 	 
      	 	 
      	 	 
      	 	 
      	 

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        

      

      
        
          
          

        

        
          Page 28
of 42

          
            

          

        

        
          
          

        

      

       

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List
      of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Destruction
      of IP (DIP) Form

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                         Study
      specific tracking tools

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Investigational
      Product (IP) and other Clinical Study Supplies

                                      	 	
                                        x

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

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Identification
      of Drug Distribution Vendor

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Comparator
      Procurement

                                      	 	
                                        N/A

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of written instructions for handling and storage of IP

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Request
      for import/export approvals for IP

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of custom clearance(s)

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Storage
      of IP

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Development/maintenance
      Randomization System/Codes

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        DM

                                      	 
	
                                        Request
      for authorization to release IP to sites

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Authorization
      to distribute drug

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Packaging/labeling
      of Clinical Supplies

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Distribution
      of Clinical Study Supplies to sites

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Tracking
      of IP

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        PM

                                      	 
	
                                        Tracking
      of Clinical Study Supplies

                                      	 	
                                        x

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        PM

                                      	 
	
                                        Organization
      of return of unused Clinical Study Supplies

                                      	 	
                                         

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        CRA

                                      	 
	
                                        Organization
      of destruction of unused Clinical Study Supplies

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Study
      Completion/Study Termination

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Notification
      to national/local authorities of study termination

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Final
      recon of TMF

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	
                                        PM

                                      	 
	
                                        Archiving
      of Sponsor’s TMF

                                      	 	
                                        x

                                      	 	
                                         

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

                                        Active
      Period

                                      	 	 	 	
                                        x

                                      	 	 
      	 	11	 	104	 	1144	 	
                                        PM

                                      	 
	 
      	 	 	 	
                                         

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

                                        Follow-Up
      Period

                                      	 	 	 	
                                        x

                                      	 	 
      	 	5.5	 	26	 	143	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ex-house
      Project Management

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Site
      Selection Visits

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	2	 	0	 	0	 	
                                        PM

                                      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 29
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	14	 	0	 	0	 	
                                        PM

                                      	 
	
                                        On-Site

                                      	 	
                                         

                                      	 	
                                         

                                      	 	
                                          

                                      	 	3	 	0	 	0	 	
                                        PM

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	5	 	0	 	0	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	0	 	
                                        PM

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Co-Initiation/Monitoring/COV

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        PM

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        On-Site
      (average)

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	18	 	
                                        PM

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	18	 	3	 	54	 	
                                        PM

                                      	 
	 
      	 	 	 	
                                         

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ad
      hoc meetings (4 trips)

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 	 	 	 	 
      	 	1	 	1	 	1	 	
                                        PM

                                      	 
	
                                        Travel

                                      	 	 	 	 	 	 
      	 	6	 	1	 	6	 	
                                        PM

                                      	 
	
                                        On-Site
      (average)

                                      	 	 	 	 	 	 
      	 	8	 	1	 	8	 	
                                        PM

                                      	 
	
                                        Admin

                                      	 	 	 	 	 	 
      	 	3	 	1	 	8	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Sub-Total/site

                                      	 	 	 	 	 	 
      	 	 	 	 	 	18	 	
                                        PM

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	18	 	4	 	72	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	1413	 	
                                        PM

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Administration
      - COA

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Assemble
      site reg. packages

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Courier
      packages to sites

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Receive,
      log, scan & file initial reg docs

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Follow-up
      on reg doc errors & omissions

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Courier
      - second round

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

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

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Assemble
      PI Site Files (ISF) for TMF

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Courier
      site ISF to PI

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        Assemble
      TMF

                                      	 	 	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	
                                        Assemble
      In-House site File (IHF) for TMF

                                      	 	 	 	
                                        x

                                      	 	 
      	 	3	 	11	 	33	 	
                                        COA

                                      	 
	
                                        CRF
      related admin

                                      	 	
                                         

                                      	 	
                                        x

                                      	 	 
      	 	16	 	1	 	16	 	
                                        COA

                                      	 
	
                                        CDA
      - send to sites; review; send to Client

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 
	
                                        CTRA
      - send to sites; review; send to Client

                                      	 	
                                        x

                                      	 	 	 	 
      	 	0	 	0	 	0	 	
                                        COA

                                      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 30
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        COA
      Pre-Study Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	65	 	
                                        COA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        General
      Admin

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Post
      tracking tools to web for client

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Assist
      with IRB/ reg. authority submissions

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Ongoing
      regulatory doc. tracking/ scanning

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Trial
      Master File maintenance

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Contact
      sites for enrolment updates

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        High
      level site support

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Assist
      with query resolution

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        TC
      minutes

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Return
      of Sponsor’s TMF

                                      	 	 	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        COA
      General Admin (Active) Total

                                      	 	 	 	 	 	 
      	 	5	 	104	 	520	 	
                                        COA

                                      	 
	
                                        COA
      General Admin (Follow-up) Total

                                      	 	 	 	 	 	 
      	 	3	 	34	 	102	 	
                                        COA

                                      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	622	 	
                                        COA

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Allphase
      Center of Excellence (ACE) Training

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Site
      level GCP/ICH CRF training

                                      	 	 	 	
                                        n/a

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Source
      documentation

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Drug
      accountability

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        DM
      insight for reducing queries

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        ACE
      Trainer prep

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        ACE

                                      	 
	
                                        ACE
      Trainer travel

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        ACE

                                      	 
	
                                        ACE
      Trainer attendance

                                      	 	 	 	 	 	 
      	 	0	 	0	 	0	 	
                                        ACE

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	0	 	
                                        ACE

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Medical
      Writing

                                      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      of therapeutic area/medication

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      of protocol/related study documents

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Integration
      of tables/statistical analysis plan

                                      	 	
                                        x

                                      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of draft report #1

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	60	 	1	 	60	 	
                                        MW

                                      	 
	
                                        Preparation
      of draft report #2

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	40	 	1	 	40	 	
                                        MW

                                      	 
	
                                        Preparation
      of draft report #3

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	30	 	1	 	30	 	
                                        MW

                                      	 
	
                                        Preparation
      of final report

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	30	 	1	 	30	 	
                                        MW

                                      	 
	 
      	 	 	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 	 	 	 	 
      	 	 	 	 	 	160	 	
                                        MW

                                      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      CONFIDENTIAL 

      
        

      

      
        
          
          

        

        
          Page 31
of 42

          
            

          

        

        
          
          

        

      

       

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                	
                                        List of Tasks

                                      	 	
                                        YM

                                      	 	
                                        Allphase

                                      	 	
                                        ADM

                                      	 	
                                        Task

                                        Hours

                                      	 	
                                        Units

                                      	 	
                                        Total

                                        Hours

                                      	 	
                                        Resp

                                      	 
	
                                        Quality
      Assurance

                                      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Familiarization
      with client SOPs (if applicable)

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Familiarization
      with protocol

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Inspection
      of site regulatory files

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      and assessment of site SOPs

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Random
      sampling of source and CRF data

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Discussion
      with site personnel re: processes and findings.

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Inspection
      of client TMF regulatory files

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Review
      of vendor facilities, SOPs, processes

                                      	 	 
      	 	
                                        N/A

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Discussion
      with vendor personnel re: processes and findings.

                                      	 	 
      	 	
                                        N/A

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Preparation
      of audit report

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Follow-up
      of resolutions

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Vendor
      Audits

                                      	 	 
      	 	
                                        N/A

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 
      	 	 	 	 
      	 	6	 	 	 	 	 	 
      	 
	
                                        Travel

                                      	 	 
      	 	 	 	 
      	 	6	 	 	 	 	 	 
      	 
	
                                        On-Site

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        Report
      Writing

                                      	 	 
      	 	 	 	 
      	 	6	 	 	 	 	 	 
      	 
	
                                        Sub-Total

                                      	 	 
      	 	 	 	 
      	 	26	 	2	 	52	 	
                                        QA

                                      	 
	
                                        Site Audits (ü(n+1))

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        Travel

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        On-Site

                                      	 	 
      	 	 	 	 
      	 	16	 	 	 	 	 	 
      	 
	
                                        Report
      Writing

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        Sub-Total

                                      	 	 
      	 	 	 	 
      	 	40	 	4	 	160	 	
                                        QA

                                      	 
	
                                        TMF
      Audit

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Prep

                                      	 	 
      	 	
                                         

                                      	 	 
      	 	2	 	 	 	 	 	 
      	 
	
                                        Travel

                                      	 	 
      	 	 	 	 
      	 	0	 	 	 	 	 	 
      	 
	
                                        On-Site

                                      	 	 
      	 	 	 	 
      	 	16	 	 	 	 	 	 
      	 
	
                                        Report
      Writing

                                      	 	 
      	 	 	 	 
      	 	8	 	 	 	 	 	 
      	 
	
                                        Sub-Total

                                      	 	 
      	 	 	 	 
      	 	26	 	0	 	0	 	
                                        QA

                                      	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Total

                                      	 	 
      	 	 	 	 
      	 	 	 	 	 	212	 	
                                        QA

                                      	 
	 
      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Safety

                                      	 	 
      	 	 	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Overall
      Medical Oversight

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	 	 	 	 	 	 	 
      	 
	
                                        Manage
      site questions

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	0.5	 	110	 	55	 	
                                        MM

                                      	 
	
                                        review
      patient eligibility

                                      	 	 
      	 	
                                        x

                                      	 	 
      	 	0.5	 	110	 	55	 	
                                        MM

                                      	 
	
                                        Protocol
      deviation decision making and management (as required)

                                      	 	
                                        (x)

                                      	 	
                                        x

                                      	 	 
      	 	0.75	 	100	 	75	 	
                                        MM

                                      	 

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

      

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 32
of 42

            
              

            

          

          
            
            

          

        

         

      

      
        
          	
                  MSA#:

                	
                  YMBO7-MSA-30APR2007-1.0

                	
                  WO
      Version Code:

                	
                  YMBO7-WO1-29MAR2007-2.3

                
	
                  Version
      Date:

                	
                  02APR2007

                	
                  Work
      Order #:

                	
                  01

                

        

      

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      	
                                              List of Tasks

                                            	 	
                                              YM

                                            	 	
                                              Allphase

                                            	 	
                                              ADM

                                            	 	
                                              Task

                                              Hours

                                            	 	
                                              Units

                                            	 	
                                              Total

                                              Hours

                                            	 	
                                              Resp

                                            	 
	
                                              SAE
      Trend Analysis

                                            	 	 	 	
                                              x

                                            	 	 	 	8	 	2	 	16	 	
                                              MM

                                            	 
	
                                              Protocol
      deviation processing and tracking

                                            	 	 	 	
                                              x

                                            	 	 	 	0.75	 	100	 	75	 	
                                              PM

                                            	 
	
                                              AE/SAE
      Database Setup

                                            	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              AE/SAE
      Coding and Reporting

                                            	 	 	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	
                                              DM

                                            	 
	
                                              Medications
      Coding

                                            	 	 	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	
                                              DM

                                            	 
	
                                              SAE
      Collection, Processing & Reporting

                                            	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              SAE
      report receipt, processing & follow-up

                                            	 	 	 	
                                              x

                                            	 	 	 	1	 	100	 	100	 	
                                              DS

                                            	 
	
                                              Submit
      Alert Reports to Reg. Agencies/ IRB/ Sponsor

                                            	 	 	 	
                                              x

                                            	 	 	 	0.75	 	100	 	75	 	
                                              DS

                                            	 
	
                                              Submit
      SAE Reports to Sites

                                            	 	 	 	
                                              x

                                            	 	 	 	0.75	 	100	 	75	 	
                                              PM

                                            	 
	
                                              SAE
      Evaluation

                                            	 	 	 	
                                              x

                                            	 	 	 	0.5	 	100	 	50	 	
                                              MM

                                            	 
	
                                              24/7
      phone coverage (2hrs/wk)

                                            	 	 	 	
                                              x

                                            	 	 	 	2	 	130	 	260	 	
                                              MM

                                            	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	150	 	
                                              PM

                                            	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	175	 	
                                              DS

                                            	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	511	 	
                                              MM

                                            	 
	
                                              Radiology
      Review

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Provider:
      TBD

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Database
      Development

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Image
      Receipt and Processing

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Image
      Review

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Data
      Transfer Files

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Program
      Management

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              DSMB

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Formation
      and Management

                                            	 	 	 	
                                              N/A

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

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Organize
      & Conduct DSMB meetings

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Interact
      with sponsor regarding conclusions

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              implement
      next steps.

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Charter
      & SOPs

                                            	 	 	 	
                                              N/A

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

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Administration

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Distribute
      meeting materials (Send Safety Data)

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Prepare
      minutes

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              MD
      Participation & Evaluation

                                            	 	 	 	
                                              N/A

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Total

                                            	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	0	 	
                                              PM

                                            	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	0	 	
                                              COA

                                            	 
	
                                              Sub-Total

                                            	 	 	 	 	 	 	 	 	 	 	 	0	 	
                                              MM

                                            	 

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

      

      CONFIDENTIAL

      
        
          

        

        
          
            
            

          

          
            Page 33
of 42

            
              

            

          

          
            
            

          

        

         

      

    

     

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                	
                                                        List of Tasks

                                                      	 	
                                                        YM

                                                      	 	
                                                        Allphase

                                                      	 	
                                                        ADM

                                                      	 	
                                                        Task

                                                        Hours

                                                      	 	
                                                        Units

                                                      	 	
                                                        Total

                                                        Hours

                                                      	 	
                                                        Resp

                                                      	 
	
                                                        Data
      Management

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Data
      Management Plan

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Project
      specific DM standards & SOPs

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	16	 	1	 	16	 	
                                                        DM

                                                      	 
	
                                                        Preparation
      of Data Management Plan

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        Database
      Design

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        DB
      definition

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	4	 	1	 	4	 	
                                                        DM

                                                      	 
	
                                                        DB
      security

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	4	 	1	 	4	 	
                                                        DM

                                                      	 
	
                                                        CRF
      review

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	8	 	1	 	8	 	
                                                        DM

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

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	40	 	1	 	40	 	
                                                        DM

                                                      	 
	
                                                        Define
      & code edit checks

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	24	 	1	 	24	 	
                                                        DM

                                                      	 
	
                                                        Finalize
      data entry screens, edit checks, validation

                                                      	 	 
      	 	 	 	 	 	16	 	1	 	16	 	
                                                        DM

                                                      	 
	
                                                        Data
      Validation Plan

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 
      	 
	
                                                        Initial
      programming & query wording

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        Testing
      and locking DVP (sign off)

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	4	 	1	 	4	 	
                                                        DM

                                                      	 
	
                                                        Periodic
      re-testing

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        CRF
      Completion Guidelines

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	
                                                        PM

                                                      	 
	
                                                        CRF
      Completion Guidelines review

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	
                                                        CRA

                                                      	 
	
                                                        Site
      training

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	
                                                        CRA

                                                      	 
	
                                                        Data
      Entry and Cleaning

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Double
      Data Entry of all paper CRF data

                                                        (60
      CRF pages/pt)

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	0.1	 	6000	 	600	 	
                                                        DE

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

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	1	 	100	 	100	 	
                                                        DM

                                                      	 
	
                                                        Administration
      of DCFs

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	1	 	100	 	100	 	
                                                        COA

                                                      	 
	
                                                        Closing
      of DCFs

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	1	 	100	 	100	 	
                                                        DE

                                                      	 
	
                                                        Medical/Science
      Review

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Clinical
      Review

                                                      	 	 
      	 	 	 	 	 	0.5	 	100	 	50	 	
                                                        MM

                                                      	 
	
                                                        AE/SAE
      Database Setup

                                                      	 	
                                                        (x)

                                                      	 	 	 	
                                                        x

                                                      	 	16	 	1	 	16	 	
                                                        DM

                                                      	 
	
                                                        SAE
      Reconciliation

                                                      	 	 
      	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Reconciliation
      based on central SAE DB vs. study DB

                                                      	 	 
      	 	 	 	 	 	16	 	1	 	16	 	
                                                        DM

                                                      	 
	
                                                        Medical
      Coding

                                                      	 	 
      	 	 	 	
                                                        x

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

                                                      	 	 
      	 	 	 	 	 	0.06	 	200	 	12	 	
                                                        DM

                                                      	 
	
                                                        Coding
      of Con Meds (WHODRUG)

                                                      	 	 
      	 	 	 	 	 	0.06	 	200	 	12	 	
                                                        DM

                                                      	 
	
                                                        Data
      Validation & Management

                                                      	 	 
      	 	 	 	
                                                        x

                                                      	 	 	 	 	 	 	 	 
      	 
	
                                                        Periodic
      validation of CRF data

                                                      	 	 
      	 	 	 	 	 	8	 	1	 	8	 	
                                                        DM

                                                      	 
	
                                                        Flexible
      query routing

                                                      	 	 
      	 	 	 	 	 	0.1	 	100	 	10	 	
                                                        DM

                                                      	 
	
                                                        Accommodating
      3rd party queries

                                                      	 	 
      	 	 	 	 	 	0.1	 	50	 	5	 	
                                                        DM

                                                      	 
	
                                                        Central
      Lab DB imports

                                                      	 	 
      	 	
                                                        n/a

                                                      	 	 	 	 	 	 	 	 	 	 
      	 
	
                                                        Reconcile
      Clinical End-Point & CRF

                                                        Database

                                                      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 

                                              

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    

    CONFIDENTIAL 

    
      

    

    
      
         

      

      
        Page 34
of 42

        
          

        

      

      
         

      

    

     

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

     

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      	
                                              List of Tasks

                                            	 	
                                              YM

                                            	 	
                                              Allphase

                                            	 	
                                              ADM

                                            	 	
                                              Task

                                              Hours

                                            	 	
                                              Units

                                            	 	
                                              Total

                                              Hours

                                            	 	
                                              Resp

                                            	 
	
                                              Preparation
      of the Interim Analysis Plan

                                            	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Preparation
      of the Final Analysis Plan

                                            	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Biostats
      & Programming for Interim and Final Analysis

                                            	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              DB
      lock & audit

                                            	 	 
      	 	 	 	
                                              x

                                            	 	 	 	 	 	 	 	 
      	 
	
                                              Interim
      & final DB locks with assoc.

                                              documentation

                                            	 	 
      	 	 	 	 	 	24	 	1	 	24	 	
                                              DM

                                            	 
	
                                              08
      documentation & release

                                            	 	 
      	 	 	 	 	 	8	 	1	 	8	 	
                                              DM

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

                                            	 	 
      	 	 	 	 	 	4	 	1	 	4	 	
                                              DM

                                            	 
	
                                              Randomization
      Services

                                            	 	 
      	 	
                                              x

                                            	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Sample-Size
      Justification and Calculation,

                                            	 	 
      	 	 	 	 	 	6	 	0	 	0	 	
                                              BIO

                                            	 
	
                                              Randomization
      Codes - Specification and programming of the randomization
      lists

                                            	 	 
      	 	 	 	 	 	8	 	0	 	0	 	
                                              BIO

                                            	 
	
                                              24/7
      Un-blinding of Patients for 30 months

                                            	 	 
      	 	 	 	 	 	
                                              as
      needed

                                            	 	 	 	 	 	
                                              DM

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

                                            	 	 
      	 	 	 	 	 	3	 	0	 	0	 	
                                              DM

                                            	 
	
                                              Set-up
      (Annual Licenses) and Maintenance

                                            	 	 
      	 	 	 	
                                              x

                                            	 	3	 	11	 	33	 	
                                              DM

                                            	 
	
                                              Associated
      Project Management

                                            	 	 
      	 	 	 	
                                              x

                                            	 	2	 	11	 	22	 	
                                              DM

                                            	 
	
                                              Project
      Close-Out & Archiving of database

                                            	 	 
      	 	 	 	
                                              x

                                            	 	24	 	1	 	24	 	
                                              DM

                                            	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	401	 	
                                              DM

                                            	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	700	 	
                                              DE

                                            	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	100	 	
                                              COA

                                            	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	50	 	
                                              MM

                                            	 
	
                                              Sub-Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	0	 	
                                              BIO

                                            	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Biostatistical
      Services

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

                                            	 	 
      	 	
                                              x

                                            	 	 	 	40	 	1	 	40	 	
                                              BIO

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

                                            	 	 
      	 	
                                              x

                                            	 	 	 	152	 	1	 	152	 	
                                              BIO

                                            	 
	
                                              Statistical
      Report (optional)

                                            	 	 
      	 	
                                              x

                                            	 	 	 	30	 	1	 	30	 	
                                              BIO

                                            	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Interim
      Analysis (Limited)

                                            	 	 
      	 	
                                              x

                                            	 	 	 	24	 	1	 	24	 	
                                              BIO

                                            	 
	 
      	 	 
      	 	 	 	 	 	 	 	 	 	 	 	 
      	 
	
                                              Total

                                            	 	 
      	 	 	 	 	 	 	 	 	 	246	 	
                                              BIO

                                            	 

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    

    CONFIDENTIAL 

    
      

    

    
      
         

      

      
        Page 35
of 42

        
          

        

      

      
         

      

    

    

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

    

    6.
Estimate

     

    
      

    

     

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

     

    
      
        
          
            	
                    Service

                  	 	
                    Approx. #

                    hours

                  	 	 	
                    Hourly Rate

                    (CDN)

                  	 	 	
                    TOTALS

                  	 
	
                    Project
      Management (PM)

                  	 	 	 	 	 	 	 	 	 
	
                    Pre-Study
      Activities

                  	 	 	130	 	 	$	100	 	 	$	13,000	 
	
                    Vendors
      Selection

                  	 	 	32	 	 	$	100	 	 	$	3,200	 
	
                    Investigator’s
      Meeting

                  	 	 	85	 	 	$	100	 	 	$	8,500	 
	
                    Ethics

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

                  	 	 	54	 	 	$	100	 	 	$	5,400	 
	
                    Ad
      hoc meetings

                  	 	 	72	 	 	$	100	 	 	$	7,200	 
	
                    Safety
      - SAE

                  	 	 	150	 	 	$	100	 	 	$	15,000	 
	
                    Safety
      - DSMB

                  	 	 	0	 	 	$	100	 	 	$	0	 
	
                    General

                  	 	 	1287	 	 	$	100	 	 	$	128,700	 
	
                    Sub
      Total

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

                  	 	 	 	 	 	 	 	 	 	 	 	 
	
                    Health
      Canada Submission

                  	 	 	0	 	 	$	100	 	 	$	0	 
	
                    Sub
      Total

                  	 	 	0	 	 	$	100	 	 	$	0	 
	
                    Clinical
      Monitoring (CRA)

                  	 	 	 	 	 	 	 	 	 	 	 	 
	
                    Pre-Study
      Activities

                  	 	 	24	 	 	$	90	 	 	$	2,160	 
	
                    Investigator’s
      Meeting

                  	 	 	102	 	 	$	90	 	 	$	9,180	 
	
                    Site
      Selection Visits

                  	 	 	0	 	 	$	90	 	 	$	0	 
	
                    Initiation
      Visit

                  	 	 	209	 	 	$	90	 	 	$	18,810	 
	
                    Interim
      Monitoring

                  	 	 	4580	 	 	$	90	 	 	$	412,200	 
	
                    Close-Out
      Visit

                  	 	 	242	 	 	$	90	 	 	$	21,780	 
	
                    Sub
      Total

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

                  	 	 	 	 	 	 	 	 	 	 	 	 
	
                    Pre-Study
      Activities

                  	 	 	65	 	 	$	75	 	 	$	4,875	 
	
                    Investigator’s
      Meeting

                  	 	 	84	 	 	$	75	 	 	$	6,300	 
	
                    DSMB

                  	 	 	0	 	 	$	75	 	 	$	0	 
	
                    General

                  	 	 	622	 	 	$	75	 	 	$	46,650	 
	
                    Data
      Management

                  	 	 	100	 	 	$	75	 	 	$	7,500	 
	
                    Sub
      Total

                  	 	 	871	 	 	$	75	 	 	 	65,325	 

          

        

      

    

    

    CONFIDENTIAL

    
      

    

    
      
         

      

      
        Page 36
of 42

        
          

        

      

      
         

      

    

     

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              	
                                      Service

                                    	 	
                                      Approx. #

                                      Hours

                                    	 	 	
                                      Hourly Rate

                                      (CDN)

                                    	 	 	
                                      TOTALS

                                    	 
	
                                      Training
      (ACE)

                                    	 	 	 	 	 	 	 	 	 
	
                                      Investigator’s
      Meeting

                                    	 	 	0	 	 	$	150	 	 	$	0	 
	
                                      Site
      Training

                                    	 	 	0	 	 	$	150	 	 	$	0	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Quality
      Assurance (QA)

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Vendor
      Audits

                                    	 	 	52	 	 	$	100	 	 	$	5,200	 
	
                                      Site
      Audits

                                    	 	 	160	 	 	$	100	 	 	$	16,000	 
	
                                      TMF
      Audit

                                    	 	 	0	 	 	$	100	 	 	$	0	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Drug
      Safety – Management

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Drug
      Safety

                                    	 	 	175	 	 	$	100	 	 	$	17,500	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Drug
      Safety - Medical

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Investigator’s
      Meeting

                                    	 	 	26	 	 	$	350	 	 	$	9,100	 
	
                                      Medical
      Monitoring

                                    	 	 	511	 	 	$	350	 	 	$	178,850	 
	
                                      DSMB

                                    	 	 	0	 	 	$	350	 	 	$	0	 
	
                                      Data
      Management

                                    	 	 	50	 	 	$	350	 	 	$	17,500	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Medical
      Writing

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Professional
      Services

                                    	 	 	160	 	 	$	100	 	 	$	16,000	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Data
      Management

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Investigator’s
      Meeting

                                    	 	 	0	 	 	$	100	 	 	$	0	 
	
                                      Double
      Data Entry

                                    	 	 	700	 	 	$	65	 	 	$	45,500	 
	
                                      Professional
      Services

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

                                    	 	
                                      11 sites

                                    	 	 	$	2,300	 	 	$	75,900	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Biostatistician

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Data
      Management

                                    	 	 	0	 	 	$	120	 	 	$	0	 
	
                                      Professional
      Services

                                    	 	 	246	 	 	$	120	 	 	$	29,520	 
	
                                      [Illegible]

                                    	 	
                                      [Illegible]

                                    	 	 	 	[*	]	 	 	[*	]
	
                                      Radiology
      Review

                                    	 	 	 	 	 	
                                      unconfirmed

                                    	 	 	$	161,292	 
	
                                      Radiology
      Review

                                    	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Total
      Project Services Fees

                                    	 	 	$	1,322,917	 

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    

    CONFIDENTIAL 

    
      

    

    
      
         

      

      
        Page 37
of 42

        
          

        

      

      
         

      

    

    

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

    

    7.
Pass-Through Cost Estimate

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          	 
      	 	 
      	 
      	
                                  TOTALS

                                	 
      
	
                                  Pass-Through Expenses

                                	 	
                                            

                                	 
      	
                                  Unit Cost

                                	 
      	
                                  #

                                  Units

                                	 
      	
                                  Total Cost

                                	 
      
	
                                  Monitor
      Travel Expenses (incl. $0.44/km)

                                	 	
                                  per
      trip

                                	 
      	 
      	
                                  250.00

                                	 
      	
                                  229.00

                                	 
      	$	
                                  57,250

                                	 
      
	
                                  Monitor
      Meal Expenses

                                	 	
                                  per
      day

                                	 
      	 
      	
                                  30.00

                                	 
      	
                                  229.00

                                	 
      	$	
                                  6,870

                                	 
      
	
                                  Monitor
      Overnight Expenses (i.e. hotel)

                                	 	
                                  30%

                                	 
      	 
      	
                                  165.00

                                	 
      	
                                  69.00

                                	 
      	$	
                                  11,385

                                	 
      
	
                                  Monitor
      Meal Expenses (overnight)

                                	 	
                                  per
      day

                                	 
      	 
      	
                                  60.00

                                	 
      	
                                  69.00

                                	 
      	$	
                                  4,140

                                	 
      
	
                                  Quality
      Assurance / Site Audit Travel

                                	 	
                                  per
      trip

                                	 
      	 
      	
                                  300.00

                                	 
      	
                                  6.00

                                	 
      	$	
                                  1,800

                                	 
      
	
                                  Allphase
      & Client Meeting Expenses

                                	 	
                                  per
      person

                                	 
      	 
      	
                                  800.00

                                	 
      	
                                  4.00

                                	 
      	$	
                                  3,200

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

                                	 	
                                  per
      month

                                	 
      	 
      	
                                  400.00

                                	 
      	
                                  26.00

                                	 
      	$	
                                  10,400

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

                                	 	
                                  per
      month

                                	 
      	 
      	
                                  200.00

                                	 
      	
                                  6.50

                                	 
      	$	
                                  1,300

                                	 
      
	
                                  Teleconferences

                                	 	
                                  per
      conf.

                                	 
      	 
      	
                                  40.00

                                	 
      	
                                  69.00

                                	 
      	$	
                                  2,760

                                	 
      
	
                                  Mailing

                                	 	
                                  per
      letter

                                	 
      	 
      	
                                  1.50

                                	 
      	
                                  251.00

                                	 
      	$	
                                  377

                                	 
      
	
                                  Courier

                                	 	
                                  per
      package

                                	 
      	 
      	
                                  20.00

                                	 
      	
                                  138.00

                                	 
      	$	
                                  2,760

                                	 
      
	
                                  Newsletters

                                	 	
                                  per
      newsletter

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Regulatory
      Binders

                                	 	
                                  per
      site

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Study
      Reference Binders

                                	 	
                                  per
      site

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Investigator
      Grants

                                	 	
                                  per
      patient

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Ethics
      Committee / IRB Fees

                                	 	
                                  per
      site

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Insurance

                                	 	
                                  per
      site

                                	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                  Sub-Total

                                	 	 
      	 
      	 
      	 
      	 
      	 
      	 
      	$	
                                  102,242

                                	 
      
	
                                  Investigator’s
      Meeting

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

                                	 	
                                  per
      person

                                	 
      	 
      	
                                  1,706.00

                                	 
      	
                                  22

                                	 
      	$	
                                  37,532

                                	 
      
	
                                  Investigator
      Meeting Airfare - sponsor staff (all economy)

                                	 	
                                  per
      person

                                	 
      	 
      	
                                  1,341.00

                                	 
      	
                                  9

                                	 
      	$	
                                  12,069

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

                                	 	
                                  per
      person

                                	 
      	 
      	
                                  900.00

                                	 
      	
                                  22

                                	 
      	$	
                                  19,800

                                	 
      

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    CONFIDENTIAL

    
      

    

    
      
         

      

      
        Page 38
of 42

        
          

        

      

      
         

      

    

    

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

     

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

                                          	 	
                                            per
      person

                                          	 	 	900.00	 	9	 	$	8,100	 
	
                                            Transportation
      and meals

                                          	 	
                                            per
      person

                                          	 	 	600.00	 	31	 	$	18,600	 
	
                                            Sub-Total

                                          	 	 	 	 	 	 	 	 	$	96,101	 
	 
      	 	 	 	 	 	 	 	 	 	 	 
	
                                            Vendors
      (non-affiliated)

                                          	 	 	 	 	 	 	 	 	 	 	 
	
                                            Translations

                                          	 	
                                            ICF

                                          	 	 	
                                            unsourced

                                          	 	 	 	$	4,500	 
	
                                            Central
      Laboratory Service (PK Lab)

                                          	 	
                                            per
      patient

                                          	 	 	
                                            unsourced

                                          	 	 	 	
                                            unk

                                          	 
	
                                            IVRS
      Vendor

                                          	 	
                                            N/A

                                          	 	 	 	 	 	 	 	 	 
	
                                            Drug
      Distribution Vendor

                                          	 	
                                            N/A

                                          	 	 	 	 	 	 	 	 	 
	
                                            Sub-Total

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

                                          	 	 	 	 	 	 	 	 	$	202,843	 
	 
      	 	 	 	 	 	 	 	 	 	 	 
	
                                            Total
      Project (CDN)

                                          	 	 	 	 	 	 	 	 	$	1,525,760	 

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    CONFIDENTIAL 

    
      

    

    
      
         

      

      
        Page 39
of 42

        
          

        

      

      
         

      

    

    

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

    

    8.
Payment Schedule and Terms 

     

    
      

    

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

     

    
      
        	
                o

              	
                Monthly labour invoices to be
      issued by the 15th of the following
      month

              

      

    

    
      	
              o

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

            

    

    
      	
              o

            	
              Applicable taxes on labor will be
      indicated on invoice.

            

    

    
      	
              o

            	
              Payment terms are 30 days from
      receipt of monthly invoice.

            

    

    
      	
              o

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

            

    

    
      	
              o

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

            

    

    
      	
              o

            	
              Retainer based payment schedule
      is also available if
preferred.

            

    

    

    9.
Standard Practices

     

    
      

    

     

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

    

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

    

    Allphase
Clinical Research is an insured and incorporated company.

     

    CONFIDENTIAL 

    
      

    

    
      
         

      

      
        Page 40
of 42

        
          

        

      

      
         

      

    

     

    
      
        	
                MSA#:

              	
                YMBO7-MSA-30APR2007-1.0

              	
                WO
      Version Code:

              	
                YMBO7-WO1-29MAR2007-2.3

              
	
                Version
      Date:

              	
                02APR2007

              	
                Work
      Order #:

              	
                01

              

      

    

    

    10.
Client Signatures

     

    
      

    

     

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

    

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

    

    Agreed
and accepted

    

    
      
        	
                YM
      BioSciences Inc.

              	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                Signature:

              	
                [ILLEGIBLE]

              	 
      	
                Signature:

              	
                [ILLEGIBLE]

              
	 
      	 
      	 
      	 
      	 
      
	
                Date:

              	
                May
      16/07

              	 
      	
                Date:

              	
                22
      May 2007

              
	 
      	 
      	 
      	 
      	 
      
	
                Name/Title: 

              	
                CHAIR
      & CEO

              	 
      	
                Name/Title: 

              	
                Jeff
      Smith/President

              
	 
      	 
      	 
      	 
      	 
      
	
                I have the authority to bind the
      corporation.  

              	 
      	
                I
      have the authority to bind the
corporation.

              

      

    

    

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

    

    CONFIDENTIAL 

    
      

    

    
      
         

      

      
        Page 41
of 42

        
          

        

      

      
         

      

    

     

    
      
        
          
            	
                    MSA#:

                  	
                    YMBO7-MSA-30APR2007-1.0

                  	
                    WO
      Version Code:

                  	
                    YMBO7-WO1-29MAR2007-2.3

                  
	
                    Version
      Date:

                  	
                    02APR2007

                  	
                    Work
      Order #:

                  	
                    01

                  

          

        

      

    

    

    11.
Letter of Intent

     

    
      

    

     

    CONFIDENTIAL

    
      

    

    
      
         

      

      
        Page 42
of 42

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00169-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00169-of-00352.parquet"}]]