MASTER SERVICES AGREEMENT
This
Master Services Agreement ("Agreement") is entered into as of May 17th, 2007
(the "Effective Date") by and between YM Biosciences Inc., a
Canadian corporation with an office at 0000 Xxxxxxx Xxxxx, Xxxx. 11, Suite 400,
Mississauga, Ontario L4W 4Y4 (collectively with its Affiliates hereinafter the
"YMB") and Allphase Clinical
Research Services Inc., having offices at 00 Xxxxxxx Xxxxx, Xxxxxx,
Xxxxxxx, X0X 0X0 (collectively with its Affiliates hereinafter "ALLPHASE"). YMB
and ALLPHASE are referred to singly as "Party" and jointly as "Parties"
throughout this Agreement.
WITNESSETH
WHEREAS, ALLPHASE is a
contract research organization that provides the implementation, management and
monitoring of clinical studies and related services (hereinafter, "Services");
and
WHEREAS, the YMB desires to
obtain Services from ALLPHASE throughout the Term of this Agreement in
accordance with the terms set forth herein and in accordance with a defined
specification and scope of work to be mutually agreed upon by the Parties in
writing (hereinafter the "Work Order") substantially in the form of Attachment A
which is herein incorporated by reference; and,
NOW THEREFORE, for and in
consideration of the mutual covenants and agreements set Forth hereinafter and
for other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, the parties hereto do hereby agree as
follows:
Article
1
DEFINITIONS
For
purposes of this Agreement and the Protocol, each capitalized term shall have
the meaning ascribed to it in this Agreement. Each capitalized tern not defined
in this Agreement shall have the meaning ascribed to that term in the Protocol.
In the event of a discrepancy in the meaning ascribed to a term in the body of
this Agreement and the meaning ascribed to that term in the Protocol, the
definition utilized in the body of this Agreement shall control.
1.1 "Case Report Form" or "CRF" means the record of
pertinent information collected on each subject who participates in the
Study;
1.2 "Cause" means a Defaulting
Party's failure to correct a default or to provide a schedule for correcting a
default which is acceptable to the Non-Defaulting Party, within five (5)
business days after being given notice of default for failure to perform a
material obligation under this agreement.
1.3 "Change Order" means of an
adjustment in fees, timeline, Protocol, performance milestones, budget, payment
schedule, duties, deliverables or matters related to Out of Scope
Services.
1.4 "Clinical Research Associate"
or "CRA" means the
person assigned by ALLPHASE to monitor one or more Study Sites.
1.5 "Clinical Trial Agreement"
means the agreement between YMB and an Investigator that details the respective
rights and obligations of both parties in relation to the Study;
1.6 "Clinical Trial Materials"
means the printed Case Report Forms, CRF monitoring conventions, the Protocol,
the investigational drug brochure, informed consent form, guidelines for use of
the Investigational
Product, and all other materials provided by YMB to conduct the
Study.
1.7 "Closeout Services" means
those services described in Section 10.4 to be performed by ALLPHASE upon
termination of this Agreement.
1.8 "Confidential Information"
means all information relating to the Investigational Product and Study
including but not limited to YMB's business, operations, methods of operating,
customers, affairs, processes, inventions, know-how, research, trade secrets,
personnel, and financial, production, scientific and technical data and
information, whether written, graphic, electronic, digital or oral, as well as
samples and specimens thereof, howsoever or whensoever obtained by ALLPHASE,
whether from YMB or otherwise and whether directly or indirectly and all
clinical data, including Case Report Forms, underlying data and all scientific
and technical information generated as a result of the Study and copies, notes
or summaries prepared with the Confidential Information.
1.9 "Effective Date" means the
effective date of this Agreement as set forth in the initial paragraph of this
Agreement.
1.10 "FDA" means United States Food
and Drug Administration.
1.11
"GCPs" means established
ethical, medical and scientific standards, including without limitation good
clinical practices, including as described in the ICH Guidelines, the
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans and
the Declaration of Helsinki and all applicable regulatory
requirements.
1.12
"GLPs" means good
laboratory practices as established by TPD and the FDA for the commercialization
of pharmaceutical products in Canada and the United States.
1.13
"ICH Guidelines" means
the guidelines of the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use, providing for a
unified standard for Canada, the European Union, Japan and the United States
with respect to the interpretation and application of technical guidelines and
requirements for pharmaceutical product registration.
1.14 "Institutional Review Board"
or "IRB" means the
independent group of professionals designated to ensure that the Study is safe
and effective for human participation and that the Study adheres to the
regulations issued by Health Canada and any other applicable country- specific
laws, regulations or guidelines.
1.15
"Intellectual Property"
means all information, data, works of authorship, discoveries, concepts,
designs, processes, software, algorithms and inventions, whether patentable or
not, including, without limitation, those that could be the subject of patent,
copyright, industrial design, trade secret or other forms of
protection.
1.16 "Investigational New Drug
Application'' or "IND"
means the petition filed by YMB with Health Canada requesting Health
Canada to allow human testing on the Investigational Product.
1.17 "Investigational Product"
means the product (drug, device, or biologic) described in the Protocol
that will be evaluated in this Study.
1.18 "Investigator" means an
individual who actually conducts a clinical investigation, i.e., under whose
immediate direction the Investigational Product is administered or dispensed to,
or used involving a subject, or, in the event of an investigation conducted by a
team of individuals, is the responsible leader of that team.
1.19 "Laws" means all applicable:
(a) laws, statutes, codes, rules, regulations and Regulatory Requirements; (b)
judgments, orders, decisions, rulings, and words of a regulatory authority; and
(c) pharmaceutical guidelines, policies and standards relating to or having
jurisdiction over a Project.
1.20 "Out of Scope Services" are
changes to a Project or Services that are not specifically provided for in an
executed Work Order.
1.21 "Project Manager" means the
manager assigned by ALLPHASE to be the primary contact person between ALLPHASE
and YMB during the Study.
1.22 "Project" means the Services
described by a Protocol and Work Order, conducted under this
Agreement.
1.23 "Protocol" means the plan that
describes the objectives, study design, and methodology of a Study and any
approved amendments thereto, which is herein incorporated by
reference.
1.24 "Regulatory Requirements"
means those laws, regulations, and professional and ethical standards and
guidelines then in effect in the countries in which the Study is conducted that
apply to the Investigational Product or clinical trials in general and as
specified in the individual Work Order.
1.25 "Results" shall mean all
materials, samples, specimens or compounds, including sub-samples or progeny
thereof, all data, information, reports, slides, or presentations; conclusions
and interpretations created or arising in connection with a
Project.
1.26 "Serious Adverse Event" shall
take the meaning given this term in the Protocol.
1.27 "Services" means the
activities and work provided by ALLPHASE in connection with the Study as set out
in this Agreement.
1.28 "Service Documents" means all
Work Orders or Change Orders executed by both Parties under this
Agreement.
1.29 "Standard Operating
Procedures" or "SOP's" means internal
procedures for the management of a clinical trial designed to ensure that the
trial is carried out in a consistent, controlled, and effective
manner.
1.30
"Study" means the
clinical trial of the Investigational Product, the details of which are set out
in the Schedules.
1.31 "Study Documents" means the
documents produced by ALLPHASE in connection with the Study.
1.32 "Subject" means a human
patient enrolled in the Study.
1.33 "Term" means the duration or
this Agreement as set out in Section 10.1.
1.34 "Test Materials" shall mean
all pharmaceutical compounds, Investigational Product, materials or other
substances provided by YMB to ALLPHASE and administered or utilized as part of
this Study.
1.35 ''TPD'' means Therapeutic
Products Directorate of Health
Canada (or whatever such agency might be called from time to time), or
any successor agency having regulatory jurisdiction over the manufacture,
distribution and sale of drugs in Canada from time to time.
1.36 "Work Order" means a completed
and executed document in the form attached hereto as Appendix A, for a Study and
will include a description of the Project, details of the Services, Protocol,
specifications, deliverables, budget, payment schedule, and timelines, and other
terms agreed to by the Parties.
ARTICLE
II
SCOPE OF
AGREEMENT
2.1 The
purpose of this Agreement is to set forth the terms, conditions and
administrative procedures applicable to Services provided by ALLPHASE to YMB.
The Parties hereby agree that ALLPHASE will provide such Services to YMB, as set
forth in each attached Work Order (which shall be attached hereto and
incorporated herein by reference). This Agreement and the Work Order, attached
as an Appendix, shall collectively constitute the entire agreement for a
Project. To the extent there is any discrepancy between the provisions of this
Agreement and any Work Order, the terms and conditions of this Agreement shall
govern unless otherwise explicitly set forth and mutually agreed upon by the
Parties.
2.2 In
the event ALLPHASE is requested or required to perform Out of Scope Services on
a Project after execution of the Work Order, ALLPHASE will provide YMB with a
written Change Order. The Parties agree to act in good faith when considering a
Change Order requested by the other Party. Any Change Order will be effective
only upon written execution by both Parties, and the Out of Scope Services
agreed to in the Change Order shall be deemed to be Services pursuant to this
Agreement.
2.3 Should
any Laws be amended, and compliance with the new requirements necessitates a
change in the Protocol or Work Order, ALLPHASE will submit a Change Order to YMB
for acceptance prior to making any changes in the Protocol, Work Order or the
Project. ALLPHASE agrees that no changes shall be made without the prior written
approval of YMB. In the event of a conflict in government regulations, ALLPHASE
shall notify YMB to obtain clarification and guidance regarding compliance with
the regulations.
2.4 ALLPHASE
shall at all times be an independent contractor of YMB, and nothing in this
Agreement is intended, nor shall be construed, to create between YMB and
ALLPHASE the relationship of principal and agent, employer and employee,
partnership, or joint venture, and the parties shall not represent themselves
otherwise. ALLPHASE 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
ALLPHASE's employees relative to Services provided under this
Agreement.
ARTICLE
III
PROJECT
IMPLEMENTATION
3.1 Representations of
ALLPHASE.
3.1.1 ALLPHASE
represents and warrants that it has or shall procure and maintain consents,
approvals, licenses and operating certificate as required to perform its
obligations pursuant to this Agreement and in accordance with Regulatory
Requirements.
3.1.2 ALLPHASE
acknowledges, warrants and represents that it and all of the employees and
agents it assigns to perform Services hereunder possess the necessary
qualifications, knowledge, skills, expertise and experience. ALLPHASE shall, at
all times during this Agreement, act in the best interests of YMB.
3.1.3 ALLPHASE
certifies that to the best of its knowledge after investigation and inquiry,
that none of its employees or agents performing or affiliated with a Project or
Work Order is under investigation by a medical licensing board, TPD, a
regulatory authority, or the FDA for debarment action or is presently debarred,
and shall notify YMB immediately upon any inquiry or the commencement of any
proceeding concerning any such person(s). ALLPHASE represents and
warrants that it has not and will not use in any capacity the services of any
person debarred under such law with respect to Services to be performed under
this Agreement.
3.1.4 ALLPHASE
warrants that all Services provided by ALLPHASE and the conduct of this Study
shall comply with the Protocol, YMB's instructions, and according to established
ethical, medical and scientific standards, including without limitation, all
applicable Good Laboratory Practices, Good Clinical Practices, the requirements
of the IRB, and all Laws governing or pertaining to clinical trials and studies,
and any amendments thereto or any successor documents thereof.
3.1.5 ALLPHASE
represents that it has the requisite facilities, equipment and personnel with
the requisite expertise, experience and skill to render the desired Services in
a timely, competent and efficient manner, as specified in the Protocol and/or
Work Order and in accordance with the terms of this Agreement.
3.1.6 Conflict
of Interest. ALLPHASE certifies that:
(a) no
collateral benefit has been offered to it, or its employees or agents, for
participating in this
Agreement
such as promises of gifts, future employment, or travel that is not related to
this
Agreement;
and
(b) the
performance of the work specified in this Agreement does not violate any
other
agreement
ALLPHASE may have with any other party; and
(c) no
gifts or other benefits have been offered to any family members;
and
(d) there
is no conflict of interest between ALLPHASE and any other party that would
inhibit or
affect
the performance of the work specified in this Agreement, and
(e) it
shall promptly inform YMB in writing in the event of any conflict of interest
that arises
during
this Agreement.
3.2 Obligations of
ALLPHASE.
3.2.1 ALLPHASE
shall provide all labour and work required for the performance of the Services,
and agrees to perform such Services within the time limits set forth in the Work
Orders. YMB understands and agrees that completing the Services as set forth in
the Work Order assumes the full cooperation of YMB as well as other necessary
third parties. YMB will not hold ALLPHASE responsible for any occurrences
outside ALLPHASE's control that may delay the completion
of Services. YMB acknowledges that, if YMB materially delays or suspends
performance of the Services, then the personnel and/or resources originally
allocated to the Project may be re-allocated, and ALLPHASE will not be
responsible for delays due to required re-staffing or re-allocation of
resources.
3.2.2 ALLPHASE
shall not engage any third party for any of the Services as set forth in Service
Documents without the prior written consent of YMB. ALLPHASE shall be
responsible for all subcontractors performing any Services hereunder and
ALLPHASE will not be relieved of any of its duties and obligations under this
Agreement in the event a subcontractor performs any Services.
3.2.3 Before
commencement of the Study, ALLPHASE shall assign to the Study a Project Manager
and sufficient personnel, including CRAs, with suitable experience and training
to fulfill ALLPHASE's obligations under this Agreement. Any change in the
Project Manager thereafter must be reasonably acceptable to YMB.
3.2.4 ALLPHASE
shall apply to the Study systems of quality control and SOP's designed to ensure
that, as far as is reasonably practicable, YMB and the Investigators conduct the
Study; generate data; and record and report data, all in compliance with the
Regulatory Requirements, Good Clinical Practice, the Protocol, and this
Agreement, in that order.
3.2.5 ALLPHASE
will review all informed consents, Study related forms and CRFs to ensure their
accuracy and completeness and provide these forms and any other Study data or
samples to YMB in the format and manner requested by YMB. ALPHASE agrees to use
commercia1ly reasonable efforts to resolve any discrepancies or errors in the
informed consents and CRFs and perform audit requirements pertaining to original
case records, laboratory reports and/or other raw data sources underlying the
data recorded on the CRFs, as may be required by YMB or Regulatory
Requirements.
3.2.6 ALLPHASE
shall be responsible, at no cost to YMB, to provide such additional services as
may be necessary to remedy any defects or deficiencies in the Services caused by
the negligent acts or omissions of ALLPHASE or by the failure to materially
perform the Services in accordance with the provisions of this Agreement or a
Work Order.
3.2.7 ALLPHASE
and its personnel shall cooperate with any other contractors or consultants
retained by YMB to undertake related work or programs for the
Project.
3.2.8 ALLPHASE
agrees to manage and review the use of the Test Materials by Study sites to
assure that Test Materials are being used in the manner provided in the Protocol
and in accordance with YMB's instructions, and shall not use the Test Materials
for any other purpose whatsoever. Upon completion of the Project, or at any
other time upon YMB's written request and YMB's expense, ALLPHASE agrees to
promptly return to YMB all Test Materials in its possession, other than those
that ALLPHASE is required to store in accordance with applicable Laws. YMB will
notify ALLPHASE within sixty (60) days after completion of a Project whether the
remaining samples are to be returned to YMB, stored or
destroyed.
3.2.9 ALLPHASE
will provide YMB with written status reports as mutually agreed by the Parties
and as set forth in the applicable Work Order).
3.2.10 ALLPHASE
shall notify YMB by phone immediately after becoming aware of a Serious Adverse
Event and shall submit an initial written report to YMB regarding that Serious
Adverse Event via facsimile within 24 hours after ALLPHASE becomes aware of any
such event.
3.3 Obligations of
YMB.
3.3.1 YMB
shall procure and maintain all consents, approvals, licenses, and operating
certificates required to conduct the Study, including but not limited to, the
approval of the Protocol by TPD. YMB shall also develop, comply with, and
require staff to comply with, policies and procedures designed to assure, at all
times, that such consents, approvals, licenses, and operating certificates
remain in effect throughout the Term.
3.3.2 YMB
shall provide ALLPHASE, at no expense to ALLPHASE (i) with all information and
documentation reasonably necessary for ALLPHASE to perform its duties hereunder,
including but not limited to; (ii) all Clinical Trial Materials; and (iii) with
all advice, guidance, and assistance reasonably requested by ALLPHASE to fulfill
its duties under this Agreement.
3.3.3 YMB
will provide ALLPHASE with sufficient amounts of Test Materials to perform the
Services. Prior to or concurrent with delivery of Test Materials, YMB will
provide information pertaining to stability, proper storage, safety and other
characteristics and requirements of the Test Materials. YMB will be solely
responsible for providing ALLPHASE with the Test Materials in a manner that
complies with applicable laws, including but not limited to regulatory permits
or licenses to ship or test the Test Materials and/or labelling
requirements.
3.3.4 YMB
shall have the right to visit and co-monitor a Study site or inspect and audit
any of the Study Documents maintained by ALLPHASE consistent with Laws
regulating the review of study data and information. All such visits and
inspections must be conducted during normal working hours on regular business
days with reasonable written notice and at mutually agreed upon times, unless
otherwise agreed. ALLPHASE shall arrange access to the Study site as soon as
reasonably practicable following notification by YMB.
ARTICLE
IV
PAYMENT FOR SERVICES
RENDERED
4.1 YMB
agrees to pay to ALLPHASE for Services provided, and all expenses incurred by
ALLPHASE pursuant to this Agreement and properly executed Service
Documents.
4.2 YMB
shall reimburse ALLPHASE for all reasonable airfare, hotel, and other travel
expenses incurred by ALLPHASE in its performance of the Services, including but
not limited to, expenses incurred by ALLPHASE in connection with site selection
visits, initiation visits, monitoring visits, and closeout visits and in
connection with attendance at Project Meetings and Investigators' Meetings. YMB
shall also reimburse ALLPHASE for all photocopying, courier, and other similar
expenses incurred by ALLPHASE in its performance of its duties under this
Agreement. Original receipts will not accompany pass-through invoices. All
original and pass-through receipts will be housed at ALLPHASE and will be
available for YMB's audit upon request. In the case where ALLPHASE anticipates
that travel expenses described in this Paragraph 4.2 may exceed the amount
budgeted for such expenses in Service Documents, ALLPHASE shall be responsible
for (i) notifying YMB that the travel expenses exceed the budget, and (ii)
receiving prior written approval from YMB prior to incurring any such excess
travel expenses. Any amounts approved by YMB in excess of those specified in
Service Documents, shall be separately invoiced to YMB and YMB shall pay these
invoices according to the terms of Paragraph 4.3 and 4.4 below.
4.3 Unless
otherwise agreed by the Parties in writing, ALLPHASE shall provide to YMB one or
more appropriate invoices on a calendar month basis for Services rendered as set
forth in the respective Service Documents. Invoices are due and payable net
thirty (30) days of receipt, unless YMB notifies ALLPHASE of any disputes with
the invoiced amounts. All payments to ALLPHASE shall be made in U.S. dollars
unless otherwise agreed upon in writing by the parties. Invoice balances not
remitted within thirty (30) days of YMB's receipt of each invoice shall be
subject to a one and one-half percent (1.5%) per month interest charge. Should
any part of the invoice be in dispute, the YMB shall pay the balance of the
undisputed amount according to the terms and conditions described herein while
said dispute is being resolved.
4.4 All
payment will be made payable to ALLPHASE Clinical Research Inc. and reference
GST # 88554 4213 RT0001. Payments shall be sent to the following
address:
Attn.
Accounts Receivable
Allphase
Clinical Research Inc.
00
Xxxxxxx Xxxxx
Xxxxxx,
XX, X0X 0X0
4.5 If
advances or other payments by YMB exceed the amount owed for work actually
performed under the Protocol and Service Documents, ALLPHASE agrees to return
the excess balance to YMB within thirty (30) days of the effective date of
termination or completion of Closeout Services by ALLPHASE.
4.6 In
the event of a dispute regarding payment or the performance of Services pursuant
to this Agreement or a Service Document (each, a “Dispute”),the Parties shall
endeavour to negotiate in good faith an agreeable solution. If after ten (l0)
business days following receipt of a Party's written notification of a Dispute
such Dispute has not been resolved, the Dispute shall be brought to the
attention of the CEO of each Party and such CEO or his/her designee will
negotiate in good faith to define and implement a final resolution. The intent
of this Section 4.6 is to encourage the Parties to work together to resolve any
Dispute without having to rely on arbitration or any other legal proceeding.
However, nothing in this Section 4.6 shall prevent or inhibit either Party to
institute any other action to resolve such Dispute(s).
Article
V
MONITORING
OF SERVICES, RECORD STORAGE, AND AUDITS
5.1 Monitoring of
Services. ALLPHASE will permit YMB representative to examine or audit
inspect ALLPHASE's premises in pre-announced visits at mutually agreed upon
times and normal business hours during the course of ALLPHASE's performance of
Service Documents hereunder. YMB may inspect the facilities, systems and
equipment at or with which the work is conducted, and personnel, procedures,
programming, experimental data, including source documents, notes, schedules,
written reports or other work product that pertains to Services and Results, and
quality assurance records.
5.2 Regulatory
Audit.
5.2.1
Each party acknowledges that the other party may respond independently to any
regulatory correspondence or inquiry in which such other party or its affiliates
is named. Each party, however, shall: a) notify the other party promptly of any
FDA or other governmental or regulatory inspection or inquiry concerning any
study or Project of YMB in which ALLPHASE is providing the Services, including,
but not limited to, inspections of investigational sites or laboratories; b)
forward to the other party copies of any correspondence from any regulatory or
governmental agency relating to such a study or Project, including, but not
limited to, FDA Form 483 notices, and FDA refusal to file, rejection or warning
letters, even if they do not specifically mention the other party; and, c)
obtain the written consent of the other party, which will not unreasonably be
withheld, before referring to the other party or any of its affiliates in any
regulatory correspondence. Where reasonably practicable, each party will be
given the opportunity to have a representative present during a FDA or
regulatory inspection. Each party, however, acknowledges that it may not direct
the manner in which the other party fulfills its obligations to permit
inspection by governmental entities or any other obligations imposed by
Law.
5.2.2 Each
party agrees that, during an inspection by the FDA or other regulatory authority
concerning any study or Project of YMB in which ALLPHASE is providing the
Services, it will not disclose information and materials that are not required
to be disclosed to such agency, without the prior consent of the other party.
Such information and materials include, but are not limited to, the following:
a) financial data and pricing data (including, but not limited to, the budget
and payment sections of the Service Documents); b) sales data (other than
shipment data), and; c) personnel data (other than data as to qualification of
technical and professional persons performing functions subject to regulatory
requirements).
5.2.3 If
FDA or other regulatory authority issues a written inspectional observation or
report of the facilities or general laboratory practices, that pertains to or
affects any part of a Services, ALLPHASE shall forthwith provide YMB with copy
of this written observation along with ALLPHASE’s response.
5.3 Records. ALLPHASE
shall maintain books of account of the Services rendered and the cost and
reimbursable expenses in accordance with generally accepted accounting
principles. ALLPHASE shall make available to a third party, as selected by YMB
acting reasonably, such books and records for audit purposes upon the request of
YMB at reasonable times during this Agreement and for a period of two (2) years
thereafter. YMB shall be responsible for the costs and expenses of any third
party audit.
5.4 Record
storage.
5.4.1 During
the term of this Agreement, ALLPHASE shall maintain all materials and all other
data obtained or generated by ALLPHASE in the course of providing the Services
hereunder, including all computerized records and files, in a secure area
reasonably protected from fire, theft and destruction. All computerized records
and files shall be backed up in such a manner and frequency as to reasonably
protect against loss of information from computer viruses or other equipment
failure.
5.4.2 ALLPHASE
agrees to notify YMB no less than thirty (30) days prior to destruction or
disposal of materials, records and data to enable YMB to determine whether it
requires further archival time. In the event YMB requires storage of records and
data beyond the minimum storage, ALLPHASE agrees to continue to store the data
until the Parties have agreed on storage or transfer of the data and reports to
YMB. Time shall be of the essence in respect to coming to an agreement on
further storage.
Article
VI
PRIVACY
6.1 In
order to protect the confidentiality of personal information or personal health
information of subjects participating in a Project as defined in the Personal
Information Protection and Electronic Documents Act, Canada or as such
equivalent terms may be defined in the legislation pertaining to privacy of
personal information in a province that has enacted a law governing such
matters, the Parties agree as follows:
(i) to
use personal information or personal health information only as permitted by the
Subject in the consent form or as required or permitted by Law;
(ii) to
refrain from publishing Subject personal information or personal health
information in a form that could reasonably enable the Subject's identity to be
ascertained;
(iii) to
refrain from obtaining additional personal information or personal health
information from a Subject unless such Subject has provided
consent;
(iv) to
be liable for the actions of their respective employees and agents for the
collection, use or disclosure of personal Information or personal health
information and for ensuring compliance with the relevant legislation by such
persons.
6.2 ALLPHASE
shall remove all Subject identifying information from any copies of data or
reports prior to providing copies of such to YMB. If Subject identifying
information or Subject identifying health information is transferred to YMB, its
employees or agents, YMB and its employees and agents shall not use or disclose
such information except with the knowledge and consent of the Subject, as set
out in the Subject informed consent form, or as required by law, regulation or
legal process.
ARTICLE
VII
INTELLECTUAL
PROPERTY
7.1 YMB
shall own all documentation, records, raw data, samples and Results generated by
ALLPHASE in the performance of each Project under this Agreement and all
Clinical Trial Materials and Test Materials.
7.2 ALLPHASE
agrees to promptly disclose any Intellectual Property arising out of Services,
which shall be the property of YMB. ALLPHASE agrees, and agrees on behalf of its
employees and agents to execute, acknowledge and deliver at YMB's expense and as
YMB may reasonably request all documents, including assignment documents, and to
perform such other actions to secure, verify or reflect such ownership or to
secure proprietary protection in the name of YMB for such inventions or
discoveries at YMB's expense and as YMB may reasonably request. YMB shall have
full power and authority to file and prosecute patent applications throughout
the world on such inventions or discoveries.
7.3 The
Parties agree that Intellectual Property owned or possessed by each Party prior
to the Effective Date hereof, used in the course of a Project shall remain the
property of such Party. YMB acknowledges that ALLPHASE may develop methods of
operating, techniques, processes or procedures that are generally applicable to
providing contract clinical trial management services and unrelated to YMB's
Confidential Information. Accordingly, nothing in this Agreement shall preclude
ALLPHASE from utilizing such general knowledge in providing services as long as
such services do not constitute a breach of Confidentiality under Article VIII
of this Agreement.
7.4 Except
as set forth herein, no Intellectual Property right, title or interest of a
Party is granted to the other Party hereunder.
ARTICLE
VIII
CONFIDENTIALITY
8.1
ALLPHASE and YMB signed a Confidentiality Agreement for the purpose of
determining their interest in pursuing this Agreement. The Parties agree that
the terms of that confidentiality agreement shall apply up to the Effective Date
or this Agreement and shall be superceded by the terms of confidentiality
contained herein on and after the Effective Date. In the event of a conflict
between the terms of that confidentiality agreement and this Agreement, this
Agreement shall prevail.
8.2 ALLPHASE
agrees that without the express written consent of the YMB, it will not directly
or indirectly, deal with, use, exploit or disclose Confidential Information of
YMB to any person or entity for any purpose except as described or permitted
herein or unless and until expressly authorized in writing to do so by
YMB.
8.3 ALLPHASE
shall not disclose any Confidential Information to any subsidiaries, affiliates
and/or scientific consultants without the prior written consent of
YMB.
8.4 ALLPHASE
may disclose the Confidential Information only to those employees and agents who
shall have a need to know the Confidential Information for the purpose of a
Project. Each party shall, prior to disclosing the Confidential Information or
portion thereof to such designated employees or agents issue appropriate
instructions to them to satisfy the obligations herein and obtain their written
agreement to receive and use the Confidential Information as confidential and
subject to non-disclosure on the same conditions as contained
herein.
8.5 ALLPHASE
shall not reproduce the Confidential Information without the express written
permission of YMB, except for such copies as ALLPHASE may require pursuant to
this Agreement for internal purposes on a need-to-know basis.
8.6 ALLPHASE
shall not be liable for disclosure of the Confidential Information or any
portion thereof upon the occurrence of one or more of the following
events:
(i)
information of YMB which is now in the public domain or which subsequently
enters the public domain without fault on the part of ALLPHASE; or
(ii) the
Confidential Information of YMB or any portion thereof is subsequently lawfully
obtained by ALLPHASE from a third party or parties without breach of this
Agreement by ALLPHASE as shown by documentation sufficient to establish the
third party as a source of the Confidential Information; or
(iii)
information of YMB which is presently known by ALL-PHASE from its own sources
where said present knowledge can be demonstrated by written records sufficient
to establish such knowledge; or
(iv)
information developed by or for ALLPHASE independent of disclosure hereunder as
evidenced by ALLPHASE's written records; or
(v) YMB
has provided its prior written consent for such disclosure; or
(vi)
information which is required to be disclosed by ALLPHASE as required by law
pursuant to an appropriate legal order by a court or government agency having
the authority to compel such disclosure; provided that ALLPHASE shall notify YMB
of the nature of the information to be disclosed notified prior to such
disclosure to enable YMB to seek, and where possible, reasonably cooperate with
the YMB to provide it with the opportunity to take appropriate legal action to
prevent or safeguard said information.
8.7 The
Parties agree that the disclosure of the Confidential Information does not
oblige YMB to give or grant any commercial rights to ALLPHASE, other than as
specified herein.
8.8 The
obligations of confidentiality shall survive the Term or earlier termination of
this Agreement for a period of seven (7) years.
8.9 YMB
agrees not to use, or provide to, disclose to, or permit any third party to use
Confidential Information of ALLPHASE ("ALLPHASE Confidential Information"),
except as set forth in exceptions (i) through (vi) set forth in
Section 8.6 herein. As used herein, ALLPHASE Confidential Information means
information relating to, without limitation, the conduct and financial aspects
of ALLPHASE 's business, data, trade secrets, know-how, inventions (whether or
not patentable), patent applications, analytical and bioanalytical methods,
manufacturing and clinical research, whether written, electronic, graphic, or
oral, as well as samples and specimens, furnished or disclosed by either party
directly or indirectly, or as the result of a site visit or audit, to
YMB.
8.10 Each
Party shall, upon written request of the other Party, return all Confidential
Information and copies thereof or shall destroy such Confidential Information
and copies as directed by a party unless
required to retain certain of the Confidential Information or a copy thereof by
applicable Laws, regulation, or pursuant to this Agreement.
8.11 ALLPHASE
and its Affiliates will not publish any articles or make any presentations
relating to the Services or referring to data, information or materials
generated as part of the Services, in whole or in part, without the prior
written consent of YMB. Each Party agrees that it shall not use the other
Party's name or disclose any matters relating to the Services provided hereunder
in any advertising, promotion, written articles or communications without the
prior written consent of the other Party.
ARTICLE
IX
INSURANCE AND
INDEMNIFICATION
9.1 YMB
and ALLPHASE shall each maintain, at its sale cost and expense, insurance
coverage with a reputable insurer (which shall be either occurrence based or
claims made coverage) in an amount usual and customary for companies engaged in
activities as contemplated by this Agreement. All such insurance shall be in
place before the first patient is enrolled in the Study. Each shall designate
the other party as an additional named insured on all such policies, where
possible. The Parties will endeavour to advise the other Party in writing within
twenty-eight (28) days of its intention to cancel the policy.
9.2 If
either party maintains it claims-made policy and this Agreement expires or
terminates for any reason, then that party shall either: 1) continue to maintain
the same or higher coverage with an insurance carrier for a period of two (2)
years thereafter; or 2) purchase "Tail Coverage" effective until the second
(2nd) anniversary date of the expiration or termination of this Agreement; or
3) obtain
and maintain "Prior Acts" coverage equivalent in time and coverage as the "Tail
Coverage" described herein.
9.3 Upon
request by either party, the other party shall provide evidence of that party's
compliance with this Section 9.1 and/or 9.2.
9.4 ALLPHASE
agrees to defend, indemnify, save and hold harmless YMB and its parent,
subsidiaries and affiliates and their respective directors, officers, employees
and agents (the "YMB Indemnities") from and against any third party claims,
demands, suits, actions, causes of action, losses, damages, fines and
liabilities, including reasonable legal fees and disbursements (the "Claims")
arising out of or in connection with or attributable to: (a) ALLPHASE's wilful
failure to comply with this Agreement, Work Order or Protocol and any amendments
thereto; (b) ALLPHASE's gross negligence or willful misconduct in performance of
the Services; (c) violations of applicable Laws, GLPs or GCPs; and/or (d)
ALLPHASE's submission of false or incorrect data and information to YMB; except
to the extent any of the Claims arise from the gross negligence or wilful
misconduct of YMB. ALLPHASE agrees to pay the reasonable costs and damages
arising from such Claims, after exhaustion of all reasonable appeals, provided
that YMB provides ALLPHASE with written notice of the Claims within five
business (5) days of the date YMB receives notice of the Claim and YMB provides
ALLPHASE with reasonable information and assistance required to defend the
Claim. ALLPHASE shall have the sale authority to defend and/or settle the Claim,
provided that ALLPHASE may not settle a Claim that includes an admission of
liability on the part of YMB without YMB's prior written consent.
9.5 YMB
agrees to defend, indemnify, save and hold harmless ALLPHASE and its parent,
subsidiaries and affiliates and their respective directors, officers, employees
and agents (the "ALLPHASE Indemnities") from and against any Claims arising out
of or in connection with or attributable to: (a) the research (including the
ethical review of the Protocol and related materials), development, manufacture,
distribution, use, sale or other disposition of the Test Materials by YMB, or
any distributor, collaborator, customer, sublicense, representative or agent of
YMB; (b) an infringement of any third party's patent rights or unauthorized use
or misappropriation of its intellectual property pertaining to the Test
Materials; and/or (c) YMB's gross negligence or willful misconduct in connection
with this Agreement YMB agrees to pay the reasonable costs and damages arising
from such Claims, after exhaustion of all reasonable appeals, provided that
ALLPHASE has given YMB written notice of the Claims within five business (5)
days of the date ALLPHASE receives notice of the Claim, and ALLPHASE has
provided information and reasonable assistance required to defend the Claim. YMB
shall have the sole authority to defend and/or settle the claim, provided that
YMB may not settle a claim that includes all admission of liability on the part
of ALLPHASE without ALLPHASE's prior written consent.
ARTICLE
X
TERM AND
TERMINATION
10.1 Unless
sooner terminated in a manner herein provided, this Agreement shall commence on
the Effective Date and, unless terminated pursuant to this Article 10, shall
continue until such time as the Services and Closeout Services have been
completed for each respective Service Document (hereinafter the "Term"). The
Parties may extend this Agreement by written mutual agreement as soon as
reasonably practicable prior to the expiration of the Term.
10.2 This
Agreement and any corresponding Service Document then in effect may be
terminated by either Party as follows:
(i) by
YMB providing at least thirty (30) days written notice to ALLPHASE;
or
(ii) by
mutual written agreement by the Parties: or
(iii) by
either Party (the "Non-defaulting Party") giving the other Party (the
"Defaulting Party") thirty (30) days written notice of termination for Cause
where the defaulting Party has failed to correct the default or provide a
schedule acceptable to the other Party within five (5) business days of being
given notice of the default.
10.3 Either
Party has the right to terminate this Agreement immediately upon written notice
to the other Party and without further liability hereunder, if a Party commits
an act of bankruptcy or if proceedings are taken against it for fraud, or
dishonest or serious misconduct in behaviour.
10.4 In
the event of termination of any Service Document and/or this Agreement for any
reason, ALLPHASE agrees to use its commercially reasonable best efforts to limit
any further cost to YMB. ALLPHASE will cease performing any Services not
necessary for the orderly closeout of the affected Service Document or
fulfillment of Regulatory Requirements and ALLPHASE shall instruct its
subcontractors, if any, to do the same. Within thirty (30) days following the
effective date of termination, ALLPHASE shall deliver and cause subcontractors,
if any, to deliver all Confidential Information, Clinical Trial Materials, data,
Results, Study Documents, and Test Materials provided by YMB or generated under
this Agreement to YMB at no additional cost to YMB. Notwithstanding the
foregoing, ALPHASE shall retain and keep in custody any materials or data,
original or copy, for the purpose of compliance with Regulatory
Requirements.
10.5 Upon
termination of this Agreement pursuant to Sections 10.2 or 10.3, YMB shall
continue to pay ALLPHASE the amounts set forth in Service Documents for all
reasonable costs actually incurred or irrevocably obligated for Services
rendered by ALLPHASE through to the effective date of termination and for the
Closeout Services furnished by ALLPHASE after the termination of this Agreement,
provided that in no event will the amount owed to ALLPHASE exceed the maximum
amounts specified in the Service Documents.
ARTICLE
XI
CORRESPONDENCE: AND
NOTICE
11.1 Any
and all notices required or permitted to be given hereunder by either Party
hereunder shall be in writing and shall be deemed given on the date received if
delivered personally or received by facsimile transmission before 4:00 pm on a
business day in the jurisdiction of the recipient and otherwise on the next
business day, or by reputable overnight delivery service, or three (3) days
after the date postmarked if sent by registered or certified mail. return
receipt requested, postage prepaid to the following addresses:
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If
to YMB:
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0000
Xxxxxxx Xxxxx, Xxxxxxxx 00, Xxxxx 000
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Xxxxxxxxxxx,
Xxxxxxx
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Xxxxxx L4W
4Y4
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Attn.
Xxxxx Xxxxx
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Phone:
(000) 000-0000
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Fax:
(000) 000-0000
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If
to ALLPHASE:
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Allphase
Clinical Research Inc.
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00
Xxxxxxx Xxxxx
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Xxxxxx,
Xxxxxxx
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X0X
0X0
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Attn.
Xxxx Xxxxx
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Phone:
(000) 000-0000
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Fax:
(000) 000-0000
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11.2 All
communications and notices related to a Service Document shall be addressed to
the appropriate individual for each Party as set forth in such Service
Document.
ARTICLE
XII
MISCELLANEOUS
12.1 Waiver. No waiver by
any Party hereto of any condition, or of the breach of any provision, term,
covenant, representation, or warranty contained in this Agreement or a Service
Document, whether by conduct or otherwise, in anyone or more instances, shall be
deemed to be or construed as a further or continuing waiver of any such
condition or of the breach of any other provision, term, covenant,
representation or warranty of this Agreement or Service Document.
12.2 Severability.
Whenever possible, it is the intention of the Parties that each provision of
this Agreement and related documents shall be interpreted so as to be effective
and valid under applicable Laws. In the event any provision of this Agreement,
or a Work Order or Change Order is prohibited by or invalid under applicable
Laws, such provision shall be ineffective only to the extent of such prohibition
or invalidity without invalidating the remainder of such provision or the
remaining provisions of this Agreement or such related document.
12.3 Cooperation. Each
Party will execute and deliver all such instruments and perform all such other
acts as the other Party may reasonably request to carry out the transactions
contemplated by this Agreement.
12.4 The
Parties agree that during the Term of this Agreement and for a period of six (6)
months thereafter, neither Party shall directly nor indirectly solicit for
employment, or otherwise retain, employees of the other Party whom the Parties
have met as a result of the performance of services under this
Agreement.
12.5 Force Majeure. No
Party shall be in default hereunder by reason of its delay in the performance of
or failure to perform any of its obligations hereunder if such delay or failure
is caused by strikes, acts of God or the public enemy, terrorism or threats of
terrorism, riots, incendiaries, weather, interference by civil or military
authorities, compliance with governmental laws, rules, and regulations, delays
in transit or delivery, or any fault beyond its control or without its fault or
negligence.
12.6 Headings. All
headings herein are for convenience only and shall not be construed as a
limitation or the scope of the particular sections to which they
refer.
12.7 Entire Agreement
Modification. This Agreement, together with the Work Orders, Change
Orders if any, and Protocols, constitute the entire agreement and understanding
between the Parties, superseding any and all previous statements, negotiations,
documents agreements and understandings, whether oral or written. No
modification or waiver of the provisions of this Agreement shall be valid or
binding on either Party unless in writing and signed by both Parties. This
Agreement and any Protocol or Work Order executed pursuant to this Agreement
shall not be waived, released, discharged, changed or modified in any manner
except by an instrument signed by the authorized representatives of each
Parties, which instrument shall make specific reference to this Agreement or the
applicable Protocol or Work Order and shall clearly state the plan or intention
to modify same.
12.8 Assignment - Neither
ALLPHASE nor YMB shall assign its rights under this Agreement without the prior
written consent of the other Party, such consent not to be unreasonably
withheld; provided, however, the Parties
may transfer or assign its rights and obligations under this Agreement to a
successor to all or substantially all of its business or assets relating to this
Agreement whether by sale, merger, operation of law or otherwise. Subject to the
restrictions on transfers, assignments and encumbrances set forth herein, this
Agreement shall inure to the benefit of and be binding upon the undersigned
Parties and their respective legal successors.
12.9 Surviving Provisions
- The Parties agree that the following provisions will survive the Agreement;
the definitions contained herein to the extent such definitions pertain to terms
in surviving provisions, Articles VII, VII, XI, XII in their entirety and
Sections 3.1, 3.2.8, 5.3, 5.4, 9.4, 9.5.
12.10 Governing Law - This
Agreement shall be governed by and construed in accordance with the laws of the
Province of Ontario without regard to any conflicts of law provisions. The
Parties agree that the exclusive place of jurisdiction for any suit will be in
the courts of the Province of Ontario.
12.11 French/English
Language - The parties to this Agreement have agreed that this Agreement
and all related documents shall be drafted in the English language only. Les
parties ont convenu que cette convention ainsi que tout document y afférent
soient rédigés en anglais seulement.
IN WITNESS WHEREOF, the
Parties have caused this Agreement to be executed by their duly authorized
officers.
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ALLPHASE
CLINICAL RESEARCH INC.
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By:
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By:
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Name:
Xxxx Xxxxx
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Name:
Xxxxx Xxxxx
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Title:
President
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Title:
Chairman and CEO
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Date:
22 MAY 2007
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Date:
16 MAY 2007
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