Exhibit 4.7
CLINICAL RESEARCH SERVICES AGREEMENT
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THIS CLINICAL RESEARCH SERVICES AGREEMENT ("Agreement") is entered into and
effective as of the date set forth on the signature page hereto by and between
XXXXXXXXXXXXXX.XXX, INC., a Delaware corporation AD and the entity conducting
research trials pursuant to the terms and conditions of this Agreement as set
forth on the signature page hereto ("Affiliate").
DEFINITIONS
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Affiliate: The legal entity executing this Agreement with AD,
including the Medical Director and all medical,
clerical and research personnel employed or under
contract or associated with Affiliate.
Affiliate Site: The individual location(s), including the premises and
facilities, approved by AD for the performance of
clinical research trials by Affiliate under this
Agreement.
Confidential Information, including, but not limited to, trade
Information: secrets concerning the business and affairs of AD or
Affiliate, know-how, processes, inventions and ideas,
past, current and planned research and development,
clinical tests, records, agreements, correspondence,
techniques, procedures, research subject lists, market
studies, business plans, computer software and database
technologies, and information concerning the business
and affairs of AD or Affiliate (which includes
financial information, the names and background of key
personnel, personnel training techniques and
materials), and any other confidential or proprietary
information of AD or Affiliate that is provided to the
other party to this Agreement during the term of this
Agreement and any renewals hereof. Confidential
Information does not include information that AD or
Affiliate, as applicable, demonstrates (a) was, is or
becomes generally available to the public other than as
a result of a disclosure by AD or Affiliate, as
applicable, or their respective representatives, (b)
was, is or becomes available to AD or Affiliate, as
applicable, on a non-confidential basis from a source
other than the other party to this Agreement or its
representatives, which AD or Affiliate, as applicable,
believes, after reasonable inquiry, is not prohibited
from disclosing such portions to it by a contractual,
legal or fiduciary obligation, or (c) was available to
AD or Affiliate, as applicable, on a non-confidential
basis prior to its disclosure to AD or Affiliate, as
applicable, by the other party to this agreement.
FDA: United States Food and Drug Administration.
FDA Form 1572: FDA Form required to be completed by the Principal
Investigator for each clinical research study, whereby
Principal Investigator agrees to conduct clinical
research according to a filed protocol and following
GCPs.
GCPs: Good Clinical Practices; the body of FDA regulations
and guidelines governing the conduct of clinical
research, as set forth in Title 21, Code of
Federal Regulations and any successor thereto or
replacement thereof.
IRB: Institutional Review Board; the legal entity charged
under GCPs with protecting the rights and safety of
clinical study participants.
Medical Director: The person designated by Affiliate as the contact
person with whom AD is authorized and directed to
communicate with respect to conduct of clinical
research trials under this Agreement.
Primary Study The person designated by Affiliate as the contact
Coordinator: person with whom AD is authorized and directed to
communicate with respect to administrative conduct of
clinical research trials under this Agreement.
Principal The investigator, which may be the Medical Director,
Investigator: who executes the Form 1572 for a particular clinical
research study protocol and is principally
responsible for such study.
Interdisciplinary A representative group of Medical Directors selected
Physician Advisory by the affiliates to assist AD in setting standards
Board for admission as an affiliate, maintaining affiliate
quality, furthering strategic growth of the affiliates
and advising AD on protocols and study budgets for the
affiliates.
Sponsor: Pharmaceutical company, device manufacturer,
biotechnology company, contract research organization
or other entity that sponsors clinical research trials.
Sub-Investigators: Additional investigators designated on Form 1572 as
"Sub-Investigators," including Medical Director and
such other professionals as may be designated by
Medical Director or Principal Investigator.
RECITALS
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I. AD will be entering into contracts with Sponsors to provide services
designed to facilitate the completion of Phase II, III and IV human clinical
trials in order to assist Sponsors in meeting their FDA regulatory requirements.
A. AD has developed effective and efficient in-house operating
procedures and policies for, and is experienced in, facilitating clinical
research trials on behalf of Sponsors.
B. Affiliate is experienced in the performance of clinical research
trials.
C. Affiliate desires to become a member of AD's affiliate organization
and to make available its resources and facilities for the performance of such
clinical research trials as may be offered through AD pursuant to the terms and
conditions of this Agreement and any other agreements relating to such trials.
NOW, THEREFORE, in consideration of the mutual promises and covenants
contained herein, the parties agree as follows:
ARTICLE I
OBLIGATIONS OF AD
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1.01 Duties and Obligations. AD assumes the following duties and
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obligations in accordance with the terms and conditions of this Agreement:
(a) Submission to Institutional Review Board. AD will submit to an IRB,
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for the IRB's review and approval, all preliminary information regarding a
proposed study, including, but not limited to, a study protocol, a report on
prior investigations into the particular product, research subject consent forms
and research subject solicitation materials, as well as the curriculum vitae of
the Principal Investigator, Affiliate Site demographics, and Form 1572.
(b) Education and Training. In accordance with guidelines established by
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AD and the Physician Interdisciplinary Advisory Board, AD will assist Affiliate
in developing its capacity to perform AD-contracted clinical research trials
efficiently. Such education and training will include, among other things,
introduction to AD's standards of performance and training in GCPs and will
include training for all principal investigators and study coordinators at AD's
corporate headquarters. Unless AD advises Affiliate otherwise, training and
education will be provided on a tuition-free basis. Affiliate will be
responsible for all travel, lodging and meal costs for Affiliate personnel.
(c) Marketing. AD has implemented a centralized national marketing
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program intended to increase the visibility of the research affiliates. Such
marketing services include direct sales calls, direct mailings, exposure at
industry trade shows and assistance in the preparation of suitable marketing and
advertising materials relating to research subject recruitment.
(d) Research Subject Enrollment. Where appropriate, AD will provide
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assistance in research subject enrollment for clinical research trials,
including identification, documentation to be signed by research subjects,
advertising, and consultation with Affiliate personnel.
(e) Quality Assurance. AD will, at its discretion and in accordance
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with its quality assurance policies and procedures, as in effect from time to
time, provide an annual site qualification review by a consultant or AD employee
to assure continuing site quality. AD will provide assistance upon request to
Affiliate on issues of quality assurance. Depending on the circumstances, the
level of assistance requested and the out-of-pocket costs associated with the
assistance, Affiliate may be required to reimburse AD for services provided.
(f) Collection and Disbursement of Funds. AD will collect the fees
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payable from Sponsors under clinical research trial contracts performed by
Affiliate and will disburse such funds received to Affiliate, less the AD
administrative fee set forth in Section 4.03 hereof.
(g) Budget and Contract Negotiation. AD will be responsible for all
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negotiations relating to clinical research trial budgets and contracts with
Sponsors.
(h) Database Security. AD will be provide Affiliate with access to and
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support an off site hosting facility that will contain an electronic patient
database consisting of information related to clinical trials. The hosting
facility will be in material compliance with the requirements of Health
Insurance Portability and Accountability Act, as it may be amended from time to
time ("HIPAA") and applicable federal and state regulations relating to patient
data security.
(i) SIP Database. AD will provide Affiliate with use of its proprietary
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Site Information Profile (SIP) database as it may be altered or upgraded from
time to time.
(j) Site Branding. AD will provide Affiliate the materials and guidelines
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setting forth the method by which Affiliate shall brand the Affiliate Site as an
"AmericasDoctor Research Site." These materials may include, but not be limited
to, standardized business cards, letterhead, signage, name tags, lapel pins,
voicemail and phone greeting scripts, clinical trial opportunity brochures,
disease awareness flyers, and templates for recruitment advertisements.
(k) Site Web Page Development & Services. AD will develop and provide
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Affiliate with standardized AmericasDoctor Web page template.
ARTICLE II
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OBLIGATIONS OF AFFILIATE
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2.01 Duties and Obligations. Affiliate assumes the following duties and
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obligations in accordance with the terms of this Agreement:
(a) Procedures and Protocols. Affiliate will conduct clinical research
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trials in accordance with AD standard operating procedures and policies
including, but not limited to: (1) confidentiality of clinical research trial
information, (2) ethical handling of clinical research trial opportunities, (3)
development of mutually agreeable budgets, (4) development of expectations for
research subject enrollment for individual clinical research trials, (5)
adherence
to AD's quality control efforts on behalf of Sponsors, (6) conformity in
completing case report forms provided by AD and/or Sponsors and (7) daily
reporting to AD with respect to the status of any clinical research trials or
other matters associated with AD being conducted by Affiliate, including,
without limitation, information with respect to research subject enrollment.
Affiliate will require each of its new Principal Investigators and Study
Coordinators to attend AD's training courses on GCPs and AD policies and
procedure, which training courses shall be provided by AD's corporate
headquarters. Each new Study Coordinator is required to successfully complete
such training courses within 60 days following commencement of their employment
with Affiliate or the date of its execution of this Agreement, whichever is
later, and each new Principal Investigator is required to successfully complete
such training courses within 90 days following commencement of their employment
with Affiliate or the date of execution of this Agreement, whichever is later.
(b) Designation and Approval of Medical Director. Affiliate will
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designate a qualified person to serve as the Medical Director for each Affiliate
Site, subject to AD's review and approval. Affiliate must advise AD of any
proposed change of the Affiliate's Medical Director for an Affiliate Site and
obtain AD's approval of the new person designated. AD may request additional
information regarding the qualifications and background of the Medical Director
as a condition of approval, which approval may be conditioned upon the approval
of the AD and the Physician Interdisciplinary Advisory Board.
(c) Duties of Medical Director. AD will direct clinical research trial
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contract opportunities to the attention of the Medical Director who will have
the authority to bind Affiliate and each of its investigators that has executed
Appendix 1 hereto to the terms of a particular Sponsor study contract. The
Medical Director will have full authority to act on behalf of Affiliate in all
matters relating to the Affiliate's interests in AD. The Medical Director must
ensure that the election to participate in any clinical research trial
opportunity offered by AD to Affiliate is timely made and that all of the terms
and conditions of acceptance are fully performed on a timely basis. The Medical
Director is also responsible for ensuring that AD has all the information
necessary to prepare a Form 1572, and ensuring that each Form 1572 is reviewed,
approved and signed by the Principal Investigator.
(d) Designation and Role of Principal Investigator. Affiliate will
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designate a qualified licensed physician to serve as the Principal Investigator
for each clinical research trial contract offered to Affiliate, subject to AD's
review and approval. AD recognizes that different persons may need to be
designated to serve as the Principal Investigator for a particular study to meet
Sponsor expectations. Affiliate must advise AD of any proposed change of the
Affiliate's Principal Investigator for a particular study and obtain AD's
approval of the new person designated. AD may request additional information
regarding the qualifications and background of the Principal Investigator as a
condition of approval, which approval may be conditioned upon the approval of AD
and the Physician Interdisciplinary Advisory Board. Each Principal
Investigator must execute Appendix as amended from time to time.
(e) Designation of Sub-Investigators. The Medical Director or Principal
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Investigator may designate qualified licensed physicians to serve as Sub-
Investigators for each clinical research trial contract offered to Affiliate,
subject to AD's review and approval. The Medical Director and/or Principal
Investigator must ensure that any Sub-Investigator(s)
designated for participation in a particular study are listed on the FDA Form
1572 for that study, if so required.
(f) Designation and Role of Primary Study Coordinator. One person at
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each Affiliate Site must be designated to serve as the Primary Study Coordinator
and notice of this designation must be timely given to AD.
(g) On-Site Visitations. Affiliate will permit a consultant or AD
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employee to evaluate the Affiliate's compliance with GCPs and procedures and
policies of AD, the applicable Interdisciplinary Physician Advisory Board
and/or Sponsors through on-site visitations. Regularly scheduled visits will
take place at least annually at mutually convenient times scheduled in advance
with Affiliate. Affiliate will receive a visit report after each visit
iterating issues needing correction, and suggestions for improving performance
of study protocols.
(h) Expansion of Services. Affiliate will demonstrate a willingness to
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expand its research capabilities to fully participate in its therapeutic
specialty and to conform with procedures adopted by AD to ensure the quality
and efficient performance of clinical research trials.
(i) Resources and Facilities. Acceptance by Affiliate of an AD-offered
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clinical research trial contract indicates that Affiliate has available and
agrees to provide the personnel, supplies, facilities and other resources
required to properly perform that clinic research trial at the Affiliate Site.
Affiliate acknowledges that the services it provides hereunder may only be
performed by Affiliate at the Affiliate Site(s) designated herein or as AD may
subsequently approve in writing.
(j) Management Information Systems. Affiliate will use the management
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information system provided by AD for reporting accurate information on clinical
research trials and will institute such reasonable procedures as may be required
to be implemented at the Affiliate Site(s). Affiliate agrees to obtain and
maintain appropriate hardware and software sufficient to perform functions
reasonably required by AD hereunder.
(k) External Contracts. Affiliate will abide by the terms and conditions
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of any contracts with Sponsors, or other service contracts, which affect, either
directly or indirectly, the fulfillment of AD's duties thereunder. Affiliate
agrees that, in negotiating such contracts, AD may identify Affiliate, Medical
Director, Principal Investigator and the Affiliate Site as an entity, person or
research site that has agreed to perform clinical research trials on behalf of
AD, subject to the terms of this Agreement.
(l) Professional Licensure. Affiliate will maintain for each of its
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professional employees and contractors an unrestricted license to practice their
profession in the state(s) in which they practice.
(m) Applicable Standards; Compliance with Laws. Affiliate will, at all
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times during the term of this Agreement, comply with all applicable standards
set forth by law or ordinance or established by the rules and regulations of any
Federal, state or local agency, department, commission, association or other
governing or advisory body having authority to set standards governing the
practice of medicine, the conduct of clinical research trials and the
operation or use of any services or facilities which may be subject to such
regulation, including, but not limited to the FDA regulations applicable to the
performance of clinical research trials, maintenance and use of laboratory or
diagnostic imaging services and facilities and the maintenance of such drug
licenses and certifications as may be necessary in the performance of clinical
research trial studies.
(n) Database Security. Affiliate will fully comply with the requirements
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of HIPAA and all-applicable federal, state or local laws with respect to
securing of patient data. Affiliate may elect to satisfy its obligation under
this paragraph by utilizing AD's hosting facility, at no cost to Affiliate. If
Affiliate elects to satisfy its obligation under this paragraph independently,
any costs incurred shall be borne by Affiliate and Affiliate must provide AD, on
a quarterly basis, with written verification of compliance.
(o) SIP Database. Affiliate must complete and maintain Site Information
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Profile (SIP) database for the Affiliate Site and all key personnel. Key site
personnel shall include all of Affiliate's Principal Investigators and Study
Coordinators. If Affiliate fails to adequately and accurately complete and
maintain the SIP Database with respect to the Affiliate Site and the key
personnel, AD will, in its sole discretion, assume responsibility for completion
and maintenance of the SIP database for an initial fee of $2,250 (to be paid
within 10 days following AD's notification to Affiliate that it is assuming such
responsibilities) and an annual maintenance fee of $1,000 (to be paid within 20
business days following the end of each calendar year AD will complete and
maintain SIP database for an initial fee of $2,250 and an annual maintenance fee
of $1,000.
(p) Site Branding. Affiliate agrees to brand the Affiliate Site in
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accordance with AD's branding guidelines and by incorporating all of the
following standardized elements provided by AD: business cards, letterhead,
signage, name tags, lapel pins, voice mail and phone greeting templates,
clinical trial opportunity brochures, disease awareness flyers, and recruitment
advertisement template. The development of materials for the Affiliate Site and
the initial branding package delivered by AD will be at no cost to Affiliate.
Affiliate agrees that all Medical Director business cards used for research
purposes will clearly identify the Medical Director as an AmericasDoctor
research physician.
(q) Site Web Page. Affiliate agrees to use AD's standardized Web page
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format for its Web site. If Affiliate does not have a Web site, it agrees to
promptly create a Web site. At Affiliate's election, Affiliate may utilize the
basic standardized template, which will be made available to Affiliate by AD at
no charge.
ARTICLE III
COVENANTS AND CONDITIONS
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3.01 Confidential Information. AD and Affiliate each acknowledges that
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it will have access to, and special knowledge of, certain Confidential
Information of the other party. Affiliate grants to AD the right and authority
to accept Confidential Information from Sponsors on behalf of Affiliate, and
acknowledges that AD may disclose Confidential Information received from
Affiliate to Sponsors for the purpose of assisting Sponsors in site selection.
With regard to the Confidential Information of the other party, AD and
Affiliate each agrees that:
(a) the Confidential Information will, at all times, be and remain the
exclusive property of AD or Affiliate, as applicable;
(b) during the term of this Agreement and any renewals hereof, neither
party will directly or indirectly use for any purpose, copy, disclose to any
third-party or convey to any third-party any Confidential Information of the
other party, except as may be required by or permitted to AD under this
Agreement or as may be required by applicable law; and
(c) at any time following termination of this Agreement by either party
for any reason, neither party will directly or indirectly use for any purpose,
copy, retain or disclose or convey to any third-party any Confidential
Information without the prior written approval of the other party.
3.02 Non-Solicitation of Personnel. During the term of this Agreement and
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for a period of one (1) year following termination of this Agreement, regardless
of the manner in which such termination occurs, neither AD nor Affiliate will
recruit or hire individuals employed by the other party or another Affiliate
during the term of this Agreement without the written consent of the other
party. If Affiliate fails to comply with this Section 3.02, AD will either xxxx
Affiliate for an amount equal to $5,000 per violation or will withhold an amount
equal to $5,000 per violation from amounts owed by AD to Affiliate. If AD fails
to comply with this Section 3.02, Affiliate will xxxx AD for an amount equal to
$5,000 per violation.
3.03 Exclusivity. Except as otherwise approved in advance in writing by
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AD, Affiliate's conduct of clinical research trials will be provided exclusively
through this Agreement, and Affiliate will refrain from entering into a contract
for clinical research trials with any Sponsor independently of AD. This
restriction covers the performance of all clinical research trials, whether
performed directly for a Sponsor or indirectly under subcontract with respect to
any portion of such clinical trial services.
Not withstanding the above, Affiliate may and is encouraged to continue to
solicit and entertain (but not negotiate) clinical research trial contracts with
Sponsors and may participate in the development of the protocols associated with
such clinical research trials, but clinical research trial contracts so obtained
must be placed in the name of or assigned to AD and made subject to the terms of
this Agreement at AD's election, except as may be prohibited by the law
associated with a particular grant or government program. Under no circumstances
is Affiliate authorized to bind AD to any clinical research trial contract
without AD's prior written authorization, counter-signature or subsequent
written ratification. Similarly, Affiliate is not authorized to negotiate or
accept a budget directly with a Sponsor, or to recommend specific Affiliate
Sites to a Sponsor, unless AD has decided not to participate in a study and has
turned the study over to the Affiliate for independent pursuit.
Clinical research trial contract opportunities offered to Affiliate
directly by a Sponsor must be disclosed on a timely basis to AD for review and
determination as to whether such clinical research trial contract opportunity is
(i) consistent with AD's standards of scientific integrity, (ii) on terms
consistent with those generally negotiated by or acceptable to AD, and (iii)
within the range of studies in which AD is presently interested and over which
AD is capable of exercising its management and supervision, and, as a result,
whether AD desires to be
assigned such contract or whether under the circumstances such contract is most
appropriately performed by Affiliate in Affiliate's own name. AD and the
Physician Interdisciplinary Advisory will appoint Medical Directors to assist AD
in evaluating studies and protocols.
If AD determines that such a study is outside its interest, Affiliate may
seek from AD a waiver of the exclusivity requirements for such study. If a
waiver is sought, Affiliate must submit a written request for a waiver to the
Director of Medical Affairs. If approved, Affiliate may independently perform
such study. If a waiver is granted by AD, AD will not provide any of the
services to be provided by AD hereunder with respect to such study. These
services include, but are not limited to, contract review, budget negotiation
and regulatory document preparation.
Affiliate acknowledges that all contracts presented to Affiliate by AD
under this Agreement belong to AD and are between AD and any given Sponsor.
Should Affiliate decide not to pursue a clinical research trial contract
opportunity initially offered by AD, Affiliate remains bound by this Agreement
not to subsequently pursue such contract directly with such Sponsor or disclose
to any other party that Sponsor-specific and clinical trial-specific
information.
3.04 Covenant Not to Compete. Affiliate and each of its partners,
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employees, members, officers, directors, affiliates and principal stockholders
(collectively, for purposes of this Section, the "Affiliate") acknowledges that
during the course of its association with AD, AD will expend substantial time,
effort and money to, among other things, market the name and clinical research
practice of Affiliate using contacts established by AD. Affiliate recognizes and
agrees that in express consideration of AD's agreement to promote the services
of Affiliate, Affiliate hereby covenants that it will not join, form or contract
with another enterprise providing services similar in purpose to any part of the
business of AD, for a period of one (1) year following termination of this
Agreement for any reason. Furthermore, if any other entity acquires control of
Affiliate or any substantial part of Affiliate's assets, this covenant not to
compete will bind such third party and restrict such third party from joining,
forming or participating in another such enterprise, provided that nothing
herein will prevent Affiliate from performing clinical research trials
independently with its own employees.
3.05 Right of First Performance. Affiliate will have the first right and
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priority to perform any clinical research trials introduced by Affiliate to AD,
provided Affiliate is qualified to do so, has the present capacity to perform
the requirements thereof on a timely and efficient basis, and is selected by the
Sponsor.
3.06 Right of Refusal. Affiliate has the right to refuse any clinical
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research trial presented to it by AD, and AD does not have the right to commit
Affiliate to the performance of any particular clinical research trial contract
without Affiliate's prior oral commitment. AD has the right to rely upon an oral
commitment by Affiliate to participate in a particular clinical research trial
and Affiliate will confirm such commitment in writing to the extent required by
AD. By offering a clinical research trial contract to Affiliate, AD does not
guarantee that the Affiliate will be selected as a site for that study by the
Sponsor.
3.07 Compliance with Performance Standards. Affiliate's compliance with
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the standards for the performance of clinical research trials established from
time to time by AD is a material condition to this Agreement.
3.08 Publication. Any publication of research results by the Affiliate or
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Affiliate's employees and agents will be subject to prior written approval by
AD, which approval, subject to any restrictions imposed by AD's Sponsors, will
not be unreasonably withheld or delayed. Affiliate also acknowledges that it
may not solicit research subjects pursuant to any public advertisement or other
public communication regarding a particular clinical research trial or for
screening for participation in future clinical research trials that are or may
be performed hereunder without AD's prior written approval of the method and
content of the proposed communication.
3.09 Additional Certifications. Affiliate agrees to execute and deliver
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such additional certifications and/or documentation as may be required by AD
regarding the confidentiality of the arrangement described in this Agreement,
and will obtain such certifications and/or documentation from its affiliates,
employees and agents, including specifically, an acknowledgment of their
individual duties and responsibilities under this Agreement from Affiliate's
Medical Director, Principal Investigator(s) and Primary Study Coordinator.
ARTICLE IV
COMPENSATION
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4.01 Investigative Site Services. AD agrees to pay Affiliate for all
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pre-negotiated- per-research subject costs associated with the institutional,
professional and administrative services provided by Affiliate for every
clinical research trial contract accepted by Affiliate, pursuant to the terms
and conditions set forth in such contract. Each contract will include a budget
and a schedule of all-rental fees, personnel rates, administrative costs, prices
and payment terms. All costs and fees set forth in the schedule will be fixed
and not subject to change during any clinical research trial without the written
approval of AD. In general, Affiliate will be entitled to receive eighty
percent (80%) of the net revenues received by AD from the Sponsor in connection
with the investigative site services provided by Affiliate and AD will be
entitled to receive twenty percent (20%) of these net revenues.
4.02 AD Central Services. In addition to investigative site services
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provided by Affiliates, Sponsors contract with AD for services that are not
related to patient care and case report form data and which are provided by AD
central employees. Such services include, but are not limited to patient
recruitment services, project management services, protocol development and
administrative services. AD is entitled to retain one hundred percent (100%) of
any fees for AD Central Services. If Affiliate personnel provide certain AD
Central Services at the express request of AD, Affiliate will receive
compensation as agreed with AD in advance of delivery of such AD Central
Services.
4.03 Performance Bonuses. AD may from time to time attempt to negotiate
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contracts with Sponsors that specifically provide for the payment of a bonus
directly to Affiliate for exceeding a specified quota or meeting any other bonus
criterion. If Affiliate earns an enrollment bonus which results directly from
AD services, including, but not limited to, patient recruitment services and
project management service. AD shall deliver the bonus to Affiliate and an
administrative fee shall be charged. If AD negotiates a contract with a sponsors
that
specifically provide for payment of a performance bonus directly to Affiliate
for exceeding a specified quota or meeting any other bonus criterion and AD is
not and had not provided any services in connection therewith, including, but
not limited to, patient recruitment and project management. The bonus will be
delivered by AD to Affiliate without charge for an administrative fee. If AD
negotiates a bonus with regard to AD's services, Affiliate will not receive any
portion of such bonus.
4.04 Right to Invest in AD Shares. Unless otherwise restricted by law or
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otherwise, and subject to the terms and conditions of any applicable offering,
Affiliate will be required to purchase a minimum number of shares of AD directly
from AD under such common stock offering as may then be in effect and may be
entitled to purchase additional shares of stock in such offering or a subsequent
offering. Nothing in this Section 4.04 shall require AD to make available to
Affiliate a common stock offering.
4.05 Payment Procedures. All fees for clinical research trial services
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provided by Affiliate hereunder would be paid to Affiliate by AD and under no
circumstances will such fee-for-service payments or supplemental payments are
made directly to Affiliate. To the extent that it becomes necessary for the
Sponsor to make the fees payable to Affiliate, Affiliate hereby appoints and
authorizes AD to act as Affiliate's billing and collection agent for such
payments, and to deposit such payments in AD's account subject to the terms
hereof. If any Sponsor contract requires the refund of any advance payments for
services that Affiliate has failed or been unable to perform for any reason, AD
will have the right, if such fees are not refunded by Affiliate, to offset such
amount against any other fees due from AD to Affiliate and to take such other
action as may be appropriate to recover the amount of any such refund and the
cost related to collecting such amount.
4.06 Billing. AD specifically prohibits Affiliate from billing, and
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Affiliate hereby agrees not to xxxx, a third party payor or a study research
subject for any services covered by a clinical research trial budget and
contract, unless expressly authorized to do so under the terms of the clinical
research trial contract. AD and Affiliate will take all necessary measures to
assure that no "double-billing" occurs either by intent or oversight.
ARTICLE V
INSURANCE AND INDEMNIFICATION
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5.01 Insurance.
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(a) Affiliate will provide, at its sole cost and expense, throughout the
term of this Agreement, (i) a policy of commercial general liability insurance
in a minimum aggregate amount of Three Million Dollars ($3,000,000) covering
Affiliate and each Affiliate Site (such amount subject to increase in order to
reflect then current industry practices), and (ii) professional liability
insurance covering each professional authorized to provide professional services
in connection with a clinical research trial pursuant to this Agreement with a
licensed insurance company admitted to do business in the Affiliate state in an
amount usual and customary for a medical practice in Affiliate's particular
medical specialty in Affiliate's state, as reported to and approved by AD or
the Interdisciplinary Physician Advisory Board, but in no event shall such
professional liability coverage be less than One Million Dollars ($1,000,000)
per
occurrence. Upon termination of this Agreement, Affiliate must ensure that
"tail" coverage is provided for the services provided under this Agreement for a
minimum of five (5) years.
(b) Affiliate must provide, or cause its insurance carrier(s) to provide,
to AD a minimum of thirty (30) days' prior written notice of any cancellation,
modification or amendment of any policy of insurance required under this
Article. Affiliate must, from time to time on the reasonable request of AD,
furnish to AD written evidence that the policies of insurance required by this
Agreement are in full force and effect, and are valid and existing in accordance
with the provisions of this Agreement.
5.02 Indemnification.
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(a) Sponsor: AD will pursue contracts with Sponsors who provide
--------
indemnification for adverse outcome(s) that may occur in an enrolled
research subject as a result of the performance of the Sponsor's
protocol, provided that the conditions specified by the Sponsor are
complied with; such conditions generally require that (1) such
research subject has given prior written informed consent to
participate in the IRB-approved protocol, (2) the Affiliate has
treated such research subject in full compliance with such protocol,
and (3) Affiliate has complied with the terms of the particular
Sponsor protocol in reporting any adverse events to the Sponsor, and
thereafter treated the research subject in accordance with the
standards of care indicated. Any such indemnification will be subject
to the specific indemnification conditions for a particular clinical
research trial, which conditions will be available upon written
request to AD. This indemnification will generally be available to
Affiliate, all research subjects enrolled in an AD-provided clinical
trial being conducted by Affiliate, the Principal Investigator, any
Sub-Investigators and all personnel employed by Affiliate involved
with the performance of such IRB-approved clinical research trial.
ARTICLE VI
TERM AND TERMINATION
--------------------
6.01 Term Unless sooner terminated as provided herein, the initial
----
term of this Agreement will be for a period of three (3) years, commencing on
the date first set forth above (the "Initial Term") Unless sooner terminated as
provided herein, the Initial Term will be automatically extended for two
additional terms of three (3) years each unless one party gives written notice
to the other party of its intent not to renew at least one hundred twenty (120)
days prior to the end of the initial term or any renewal term hereof.
6.02 Termination Without Cause. Either party may terminate this agreement
-------------------------
for any reason following one hundred and twenty (120) days' prior written notice
to the other party
6.03 Termination for Cause. This Agreement may be terminated for "cause"
---------------------
upon the occurrence of any of the following:
(a) Immediately upon Affiliate's loss of any license required to operate
the Affiliate Site for the conduct of clinical research trials;
(b) Immediately upon failure by Affiliate to comply with the GCPs or to
maintain AD's standards of quality and scientific integrity, including
specifically, any falsification or intentional mislabeling of data or research
subject screening information;
(c) Immediately upon failure by Affiliate to maintain a duly approved
Medical Director, Principal Investigator and/or Primary Study Coordinator for
the conduct of clinical research trials performed hereunder; and
(d) Immediately upon Affiliate's debarment from clinical research
participation by local, state, or Federal authorities.
6.04 Effect of Termination. Any study in progress at the time of
---------------------
termination of this Agreement, may, at the sole discretion and option of AD, be
continued to its completion upon the terms and conditions otherwise set forth
herein, or discontinued immediately upon termination of this Agreement. To the
extent AD obtains a related payment from the applicable Sponsor, Affiliate will
be paid for work performed up to the time of termination following proper
completion of Sponsor-directed procedures, tests and case report forms, as
specified in the clinical research trial protocol. If this Agreement is
terminated for any reason, all of the covenants and conditions of Article III of
this Agreement will survive such termination.
ARTICLE VII
RECORDS
-------
7.01 Retention of Records. Affiliate agrees to maintain all records
--------------------
associated with any given clinical research trial in a separate, reasonable and
retrievable location for a period of not less than two (2) years following the
completion of the clinical research trial, or for such longer period as required
by the contract therefor or by FDA regulations. All such records will remain the
property of Affiliate, but will be available to AD to the extent specified in
Section 7.02.
7.02 Medical Records. Affiliate agrees to allow AD and its duly
---------------
authorized representatives to inspect, audit and duplicate any and all data and
other records referred to in Section 7.01, including records maintained on
research subjects pursuant to this Agreement. Such inspection, audit and
duplication will be allowed upon reasonable notice during regular business
hours. Subject to all applicable privacy and confidentiality requirements,
medical records of Affiliate will be made available to AD and the Research
Network Governing Board and their duly authorized representatives upon
reasonable request in order to allow for quality assurance review and
credentialling, as may be applicable.
ARTICLE VIII
INDEPENDENT CONTRACTOR
----------------------
8.01 Independent Contractor. In the performance of the duties and
----------------------
obligations required of each party under this Agreement, it is mutually
understood and agreed that the parties are not forming nor will they function
hereunder as employer-employee or joint ventures or partners of each other, and
that AD and Affiliate are at all times hereunder acting and performing as
independent contractors as to each other.
ARTICLE IX
MISCELLANEOUS PROVISIONS
------------------------
9.01 Complete Agreement. This Agreement constitutes the entire agreement
------------------
between the parties with respect to the subject matter hereof, and may be
amended only in writing signed by the parties. This Agreement supersedes any
prior clinical research services agreement between the parties.
9.02 Scope of the Agreement. This Agreement covers all clinical research
----------------------
trial contracts negotiated after Affiliate/L/F acceptance of this Agreement, and
any contracts AD and Affiliate negotiated in good faith in anticipation of
formalization of this Agreement.
9.03 Governing Law. This Agreement will be construed in accordance with
-------------
the internal laws of the State of Illinois without regard to the principles of
conflicts thereof.
9.04 Headings. The headings in this Agreement are for reference purposes
--------
only and are not intended to have any substantive effect upon the Agreement.
9.05 Notice. Any notice required to be given by one party to the other
------
party must be personally delivered or sent via certified mail, return receipt
requested (or sent by a nationally recognized overnight courier such as Federal
Express or UPS), or dispatched by electronic facsimile transmission (with
receipt thereof confirmed) to the following address, unless otherwise directed
in writing:
Affiliate: Name, address and facsimile number of Affiliate as provided
on the signature page hereof.
AD: XXXXXXXXXXXXXX.XXX, INC.
0000 Xxx-Xxxxx Xxxxxxx, Xxxxx 000
Xxxxxx, Xxxxxxxx 00000
Attention: President, Research Services
Facsimile: (000) 000-0000
9.06 Dispute Resolution.
------------------
(a) Any dispute arising out of or relating to this Agreement will be
settled by arbitration. The following rules apply to arbitration: (i) the then
current CPR Non-Administered Arbitration Rules (adopted by the CPR Institute for
Dispute Resolution) will govern, and the United States Federal Arbitration Act,
9 U.S.C.(S) 1-16, will also govern to the extent consistent; (ii) there will be
one independent arbitrator selected in accordance with the CPR Non-Administered
Arbitration Rules; (iii) the place of arbitration will be Chicago, Illinois;
(iv) the arbitrator shall not be empowered to award damages in excess of
compensatory damages, and each party hereby irrevocably waives any right to
recover such damages; (v) as a primary goal of this Section 9.06 is to conclude
disputes in a speedy manner at substantially less cost to the parties than
litigation, the arbitrator is therefore to conduct the proceedings in a speedy
and expeditious manner, each party is limited to presenting two days of evidence
including up to
three live witnesses, and the arbitrator shall issue an award within seven days
after the last hearing date; and (vi) the arbitrator's decision will be final
and binding and judgment upon the award rendered by the arbitrator may be
entered by any court having jurisdiction.
(b) Each party must bear its own costs of resolving any dispute under
this Agreement and AD and Affiliate each hereby severally agree to pay 50% of
the costs of any arbitrator engaged.
(c) Each party is required to continue to perform its obligations under
this Agreement pending final resolution of any dispute arising out of or related
to this Agreement, unless it would be impossible to do so or impracticable under
the circumstances.
9.07 Attorneys' Fees. In the event of legal action arising from, or
---------------
related to, the terms of this Agreement, the prevailing party may recover all of
his, her or its actual attorneys' fees and costs incurred in connection with the
action, unless the applicable tribunal hearing the matter specifically finds
that the fees were grossly unreasonable in amount.
9.08 Severability. If any provision of this Agreement is rendered invalid
------------
or unenforceable for any reason, the remainder of the provisions of this
Agreement will remain in full force and effect. However, if the removal of any
particular provision materially alters the obligations of either party hereto,
the party so affected has the right to terminate this Agreement immediately.
9.09 Waiver of Breach. Waiver of a breach of any provision of this
----------------
Agreement is not a waiver of any other breach of either the same or any
different provision.
9.10 Assignment. The rights, duties and obligations of Affiliate under
----------
this Agreement may not be assigned by Affiliate without the prior written
consent of AD, which consent may be withheld, in AD's sole discretion, subject
to the proposed assignee meeting all of AD's credentialling requirements and the
proposed assignee's ability to competently and efficiently perform clinical
research trials on behalf of AD. Notwithstanding the foregoing, Affiliate may
assign all of its rights and obligations hereunder to a conduit entity, such as
a limited liability company, limited liability partnership or sub-chapter S
corporation, into which Affiliate has reorganized; provided, however, that such
-------- -------
reorganization does not substantially change the nature of Affiliate's business
or the underlying ownership thereof. AD may assign all or any part of its rights
hereunder to any affiliate of AD or to any acquirer of AD or all or any
substantial portion of the assets of AD.
9.11 Counterparts. This Agreement may be executed by counterparts.
------------
9.12 Survival. Any provision of this Agreement that by its terms is to
--------
survive the termination of this Agreement will continue in full force and effect
in accordance with its terms following termination of this Agreement for any
reason.
[Remainder of Page Intentionally Left Blank]
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
last date written below.
XXXXXXXXXXXXXX.XXX, INC. a AFFILIATE:
Delaware corporation
____________________________________
By: ____________________________ Name of Entity Conducting Trials
Signature
By: ________________________________
________________________________ Signature
Print Name
____________________________________
Its: ___________________________ Print Name
Title
Its: _______________________________
Date: __________________________ Title
Date: ______________________________
Affiliate Site:
____________________________________
Address
____________________________________
City, State, Zip
____________________________________
Telephone Number
____________________________________
Facsimile Number
____________________________________
Medical Director:
____________________________________
Name of Affiliate's Designee (Print)
____________________________________
Signature
Primary Study Coordinator:
____________________________________
Name of Affiliate's Designee (Print)
APPENDIX I
INVESTIGATOR AUTHORIZATION OF AFFILIATE
---------------------------------------
The undersigned Principal Investigators hereby authorize _____________
___________________________________________________________________________
_______________ to represent them, and their legal entity indicated beneath
their names below (if any), in contractual obligations to and through AD. Every
Principal Investigator proposed by Affiliate is subject to approval by AD for
participation in any Research Network, and every Principal Investigator that is
not an owner or employee of Affiliate will be required to execute a Principal
Investigator Agreement in such form as may then be approved by AD. This
authorization gives Affiliate the authority to file an application on behalf of
the Principal Investigators for the approval of the Principal Investigator's
participation in a Therapeutic Specialty and of the Principal Investigator
Agreement with the AD Affiliate, where applicable. Furthermore, this
authorization gives Affiliate the authority to bind the undersigned to the
Affiliate's Agreement with AD and through AD to contracts with Sponsors, as well
as to divulge information relevant to the undersigned's research experience,
practice demographics, and scientific and medical expertise.
(1) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(2) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(3) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(4) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(5) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(6) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(7) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(8) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(9) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
(10) _____________________________________________
Print Name
______________________________________ ______________________
Signature Date
___________________________________________________________________
Name of Legal Entity, if any
