Document:

Exhibit 10.1

 

MASTER SERVICES AGREEMENT

 

This
Master Services Agreement (“Agreement”) is made between Advanced
Life Sciences, Inc., an Illinois corporation, which has a place
of business at 1440 Davey Road, Woodridge, Illinois 60517 (hereinafter “Sponsor”), and Quintiles, Inc.,
a North Carolina corporation
having its principal place of business at 5927 South Miami
Boulevard, Morrisville, North Carolina 27560 (hereinafter
“Quintiles”).  When signed by both
parties, this Agreement will set forth the terms and conditions under which
Quintiles agrees to provide certain services to Sponsor as set forth herein.

 

Recitals:

 

A.            Sponsor
is in the business of developing, manufacturing and/or distributing
pharmaceutical products, medical devices and/or biotechnology products.  Quintiles is in the business of providing
clinical trial services, research, and other services for the pharmaceutical,
medical device and biotechnology industries and has made significant, up-front
investments in technologies related to those industries, building on important
inventions and web-based technologies.

 

B.            Sponsor
and Quintiles desire to enter into this Agreement to provide the terms and
conditions upon which Sponsor may engage Quintiles from time-to-time to provide
services for individual studies or projects by executing individual Work Orders
(as defined below) specifying the details of the services and the related terms
and conditions.

 

Agreement:

 

1.0           Scope
of the Agreement; Work Orders; Nature of Services.

 

(a)           Scope
of Agreement.  As a “master” form of
contract, this Agreement allows the parties to contract for multiple projects
through the issuance of multiple Work Orders (as discussed in Section 1(b) below),
without having to re-negotiate the basic terms and conditions contained herein.  This Agreement covers the provision of
services by Quintiles and Quintiles’ corporate affiliates (see Section 18)
and, accordingly, this Agreement represents a vehicle by which Sponsor can
efficiently contract with Quintiles and its corporate affiliates for a broad
range of services.

 

(b)           Work
Orders.  The specific details of each
project under this Agreement (each “Project”) shall be separately negotiated
and specified in writing on terms and in a form acceptable to the parties (each
such writing, a “Work Order”).  A sample
Work Order is attached hereto as Exhibit A.  Each Work Order will include, as appropriate,
the scope of work, time line, and budget and payment schedule. Each Work Order
shall be subject to all of the terms and conditions of this Agreement, in
addition to the specific details set forth in the Work Order.  To the extent any terms or provisions of a
Work Order conflict with the terms and provisions of this Agreement, the terms
and provisions of this Agreement shall control, except to

 

 

the
extent that the applicable Work Order expressly and specifically states an
intent to supersede the Agreement on a specific matter. All Work Orders and
other exhibits hereto shall be deemed to be incorporated herein by reference.

 

(c)           Nature
of Services.  The services covered by
this Agreement may include strategic planning, expert consultation, clinical
trial services, statistical programming and analysis, data processing, data
management, regulatory, clerical, project management, central laboratory
services, medical device services, and other research and development services
requested by Sponsor and agreed to by Quintiles as set forth in the relevant
Work Order (collectively, the “Services”). 
Quintiles and Sponsor, where appropriate, shall cooperate in the
completion of a Transfer of Obligations Form in conjunction with the
relevant Work Order.  Any
responsibilities not specifically transferred in the Transfer of Obligations Form shall
remain the regulatory responsibility of Sponsor.  The Transfer of Obligations Form will be
filed with the Food and Drug Administration (“FDA”) by Sponsor where
appropriate, or as required by law or regulation.

 

2.0           Payment
of Fees and Expenses.  Sponsor will pay Quintiles for fees, expenses
and pass-through costs in accordance with the budget and payment schedule contained
in each Work Order.  Based on the estimated cash flow of the
Project, Sponsor agrees that a prepayment may be needed for Quintiles to
maintain cash neutrality over the term of the Project taking into account the
payment terms agreed to between the parties. 
Unless otherwise agreed in a particular Work Order, the following
shall apply: (a) Quintiles will invoice Sponsor in accordance with the
budget and payment schedule for its fees, and monthly for its expenses and
pass-through costs incurred in performing the Services; and, (b) with the exception of any prepayment or
advances and investigator invoices, which
are due and payable upon receipt, all other invoice payments shall be
made to Quintiles within thirty (30) days of receipt.  Expenses
and pass-through costs will be supported by a summary sheet. For Projects over multiple calendar years,
the budget will include an annualization percentage. If any portion of
an invoice is disputed, then Sponsor shall pay the undisputed amounts as set
forth in the preceding sentence and the parties shall use good faith efforts to
reconcile the disputed amount as soon as practicable.  Sponsor shall pay Quintiles interest in an
amount equal to one percent (1%) per month (or the maximum lesser amount
permitted by law) of all undisputed amounts owing
hereunder and not paid within thirty (30) days of the date of the invoice.

 

3.0           Term.  This Agreement shall commence on the date it
has been signed by all parties and shall continue for a period of five (5) years
from the date of execution, or until terminated by either party in accordance
with Section 17 below.  The
Agreement will automatically renew each year thereafter for a period of one
year, unless either party notifies the other party in writing at least 30 days
prior to the renewal date that it does not want to renew the Agreement.

 

4.0           Change
Orders.  Any
change in the details of a Work Order or the assumptions upon which the Work
Order is based (including, but not limited to, changes in an agreed starting
date for a Project or suspension of the Project by Sponsor) may require changes
in the budget and/or time lines, and shall require a written amendment to the
Work Order

 

 

(a “Change
Order”).  Each Change Order shall detail
the requested changes to the applicable task, responsibility, duty, budget,
time line or other matter.  The Change
Order will become effective upon the execution of the Change Order by both
parties, and Quintiles will be given a reasonable period of time within which
to implement the changes.  Both parties
agree to act in good faith and promptly when considering a Change Order
requested by the other party.  Without
limiting the foregoing, Sponsor agrees that it will not unreasonably withhold
approval of a Change Order, even if it involves a fixed price contract, if the
proposed changes in budgets or time lines result from, among other appropriate
reasons, forces outside the reasonable control of Quintiles or changes in the
assumptions upon which the initial budget or time lines were based, including,
but not limited to, the assumptions set forth in the budget or timelines.  Quintiles reserves the right to postpone
effecting material changes in the Project’s scope until such time as the
parties agree to and execute the corresponding Change Order.   For any Change Order that affects the scope
of the regulatory obligations that have been transferred to Quintiles,
Quintiles and Sponsor shall execute a corresponding amendment to the Transfer
of Obligations Form.  Sponsor shall file
such amendment where appropriate, or as required by law or regulation.

 

5.0           Confidentiality.  It is understood that during the course of
this Agreement, Quintiles and its employees may be exposed to data and
information that are confidential and proprietary to Sponsor.  All such data and information (hereinafter “Sponsor
Confidential Information”) written or verbal, tangible or intangible, made
available, disclosed, or otherwise made known to Quintiles and its employees as
a result of Services under this Agreement shall be considered confidential and
shall be considered the sole property of Sponsor.  All information regarding Quintiles’
operations, methods, and pricing and all Quintiles’ Property (as defined in Section 6.0
below), disclosed by Quintiles to Sponsor in connection with this Agreement is
proprietary, confidential information belonging to Quintiles (the “Quintiles
Confidential Information”, and together with the Sponsor Confidential
Information, the “Confidential Information”). 
The Confidential Information shall be used by the receiving party and
its employees only for purposes of performing the receiving party’s obligations
hereunder.  Each party agrees that it
will not reveal, publish or otherwise disclose the Confidential Information of
the other party to any third party without the prior written consent of the
disclosing party.  Each party agrees that
it will not disclose the terms of this Agreement or any Work Order to any third
party without the written consent of the other party, which shall not
unreasonably be withheld.  These obligations of
confidentiality and nondisclosure shall remain in effect for a period of ten (10) years
after the completion or termination of the applicable Work Order.

 

The
foregoing obligations shall not apply to Confidential Information to the extent
that it: (a) is or becomes generally available to the public other than as
a result of a disclosure by the receiving party;  (b) becomes available to the receiving
party on a non-confidential basis from a source which is not prohibited from
disclosing such information;  (c) was
developed independently of any disclosure by the disclosing party or was known
to the receiving party prior to its receipt from the disclosing party, as shown
by contemporaneous written evidence; or, (d) is required by law or
regulation to be disclosed.

 

 

6.0           Ownership
and Inventions.  All
data and information generated or derived by Quintiles as the result of
services performed by Quintiles under this Agreement shall be and remain the
exclusive property of Sponsor.  Any
inventions that may evolve from the data and information described above or as
the result of services performed by Quintiles under this Agreement shall belong
to Sponsor and Quintiles agrees to assign its rights in all such inventions
and/or related patents to Sponsor. 
Notwithstanding the foregoing, Sponsor acknowledges that Quintiles
possesses certain inventions, processes, know-how, trade secrets, improvements,
other intellectual properties and other assets, including but not limited to
analytical methods, procedures and techniques, procedure manuals, personnel
data, financial information, computer
technical expertise and software, which have been independently developed by
Quintiles and which relate to its business or operations (collectively “Quintiles’
Property”).  Sponsor and Quintiles agree
that any Quintiles’ Property or improvements thereto which are used, improved,
modified or developed by Quintiles under or during the term of this Agreement
are the sole and exclusive property of Quintiles.

 

7.0           Records and
Materials.  At the completion of the
Services by Quintiles, all materials, information and all other data owned by
Sponsor, regardless of the method of storage or retrieval, shall be delivered to
Sponsor in such form as is then currently in the possession of Quintiles,
subject to the payment obligations set forth in Section 2 herein.   Alternatively, at Sponsor’s written request,
such materials and data may be retained by Quintiles for Sponsor for an agreed-upon time period, or disposed of pursuant to the
written directions of Sponsor.  Sponsor
shall pay the costs associated with any of the above options and shall pay a
to-be-determined fee for storage by Quintiles of records and materials after completion
or termination of the Services. 
Quintiles, however, reserves the right to retain, at its own cost and
subject to the confidentiality provisions herein, copies of all materials that
may be needed to satisfy regulatory
requirements or to resolve disputes regarding the Services.  Nothing in this Agreement shall be construed
to transfer from Sponsor to Quintiles any FDA or regulatory record-keeping
requirements unless such transfer is specifically provided for in the
applicable Transfer of Obligations Form.

 

8.0           Independent
Contractor Relationship.  For the purposes of this Agreement, the
parties hereto are independent contractors and nothing contained in this
Agreement shall be construed to place them in the relationship of partners,
principal and agent, employer/employee or joint venturers.  Neither party shall have the power or right
to bind or obligate the other party, and neither party shall hold itself out as
having such authority. If, however, Sponsor desires to conduct clinical trials
in one or more countries that require a local sponsor or representative, and
Sponsor requests that Quintiles or its affiliates serve as its agent for that
purpose, then Quintiles may serve as Sponsor’s agent for the purpose of
fulfilling local sponsor or representative duties.  Sponsor shall pay Quintiles for such local
representative services at Quintiles’ standard daily rates, unless otherwise
specified in the Work Order.

 

9.0           a)  Regulatory Compliance.
Quintiles agrees that its Services will be conducted in compliance with all
applicable laws, rules and regulations, including but not limited to the
Federal Food, Drug, and Cosmetic Act and the regulations promulgated pursuant

 

 

thereto,
and with the standard of care customary in the contract research organization
industry. Regarding the FDA’s electronic
records and signatures regulation, 21 CFR Part 11 (“Part 11”),
Quintiles has a compliance plan in place as to its applicable database
applications and electronic records systems and it is working diligently to
implement its plan. Quintiles, however, is not responsible for the compliance
or non-compliance of applications or systems used by third parties (including,
but not limited to, investigative sites or third party laboratories), or any Part 11
audits or assessments thereof, unless such applications or systems are owned by
Quintiles.  Quintiles’ standard
operating procedures will be used in performance of the Services, unless
otherwise specifically stated in the Scope of Work. Quintiles certifies that it
has not been debarred under the Generic Drug Enforcement Act and that it will
not knowingly employ any person or entity that has been so debarred to perform
any Services under this Agreement. 
Sponsor represents and certifies that it will not require Quintiles to perform
any assignments or tasks in a manner that would violate any applicable law or
regulation.  Sponsor further represents
that it will cooperate with Quintiles in taking any actions that Quintiles
reasonably believes are necessary to comply with the regulatory obligations
that have been transferred to Quintiles.

 

b)  Inspections and Audits. Each
party acknowledges that the other party may respond independently to any
regulatory correspondence or inquiry in which such party or its affiliates is
named.  Each party, however, shall notify
the other party promptly of any FDA or other governmental or regulatory
inspection or inquiry concerning any study or Project of Sponsor in which
Quintiles is providing Services. During any such inspection or inquiry, the parties
agree to make reasonable efforts to disclose only the information required to
be disclosed.  During the term of this
Agreement, Quintiles will permit Sponsor’s representatives (unless such
representatives are competitors of Quintiles) to examine or
audit the work performed hereunder and the
facilities at which the work is conducted upon reasonable advance notice during
regular business hours to determine that the Project assignment is being
conducted in accordance with the agreed task and that the facilities are
adequate. Sponsor agrees that it shall not disclose to any third party any
information ascertained by Sponsor in connection with any such audit or
examination, except to the extent required by law or regulation.  Sponsor shall reimburse Quintiles for its
time and expenses (including reasonable attorney fees and the costs of
responding to findings) associated with any inspection, audit or investigation
relating to the Services (“Inspection”) instigated by Sponsor or by a
governmental authority, unless such Inspection finds that Quintiles breached
this Agreement or any applicable law or regulation.

 

10.0         Relationship
with Investigators. 
If a particular Work Order obligates Quintiles to contract with
investigators or investigative sites (collectively, “Investigators”) then
Quintiles will use its standard Clinical Trial Agreement (“Global CTA”) form, a
copy of which is attached hereto as Attachment C, along with certain local CTA
forms (“Local CTAs”) that have developed for use in certain countries based on
local requirements with the benefit of local legal advice, which have been
prepared in local language and English language where applicable.  Any applicable Local CTAs will be made
available for inspection by the Sponsor upon request.   If the Global CTA form or a Local CTA is
updated, Quintiles will use its then current Global CTA form (or Local CTA as

 

 

appropriate)
as of the time of the Work Order.  If
Sponsor insists that any CTA form other than the Global CTA and Local CTAs be
used, then Sponsor shall pay all translation costs and additional negotiation
time may be required.  If an Investigator
insists upon any material changes to any provisions that directly affect
Sponsor, then Quintiles shall submit the proposed material change to Sponsor, and
Sponsor shall review, comment on and/or approve such proposed changes within
five (5) working days.  If the
Global CTA form (or Local CTA, where applicable), or any changes approved by
Sponsor, differ from the terms of this Agreement or a Work Order (including,
but not limited to, provisions allowing an Investigator to publish results or
data that Quintiles is prohibited from revealing), then Quintiles shall have no
liability for any such approved provisions or changes.  Unless otherwise stated in the applicable
Work Order, the time incurred by Quintiles in negotiating CTA changes proposed
by sites shall be billed at Quintiles’ Standard Rates. The parties acknowledge
and agree that Investigators shall not be considered the employees, agents, or
subcontractors of Quintiles or Sponsor and that Investigators shall exercise
their own independent medical judgment. 
Quintiles’ responsibilities with respect to Investigators shall be
limited to those responsibilities specifically set forth in this Agreement and
the applicable Work Order.

 

If
Quintiles will be paying Investigators on behalf of Sponsor, the parties will
agree in the applicable Work Orders as to a schedule of amounts to be paid
to Investigators.  Sponsor acknowledges
and agrees Quintiles will only pay Investigators from advances or pre-payments
received from Sponsor for Investigators’ services, and that Quintiles will not
make payments to Investigators prior to receipt of sufficient funds from
Sponsor.  Sponsor acknowledges and agrees
that Quintiles will not be responsible for delays in a study or Project to the
extent that such delays are caused by Sponsor’s failure to make adequate
pre-payment for Investigators’ services. 
Sponsor further acknowledges and agrees that payments for Investigators’
services are pass-through payments to third parties and are separate from
payments for Quintiles’ Services. 
Sponsor agrees that it will not withhold Investigator payments except to
the extent that it has reasonable questions about the services performed by a particular
Investigator.

 

11.0         Third Party Indemnifications and Agreements.  If any investigative sites or any other third
parties, including, but not limited to, Data Safety Monitoring Boards,
independent laboratories, Advisory Boards, or End Point Adjudication Committees
(collectively, “Third Parties”), request an indemnification for loss or damage
caused by the sponsor’s Project , then Sponsor shall provide such
indemnification directly to the Third Party. 
If Sponsor requests Quintiles’ assistance in negotiating the terms of
such indemnities, Quintiles shall provide such negotiation services at its
standard daily rates, unless otherwise agreed in the Work Order.  Quintiles shall not sign such
indemnifications on Sponsor’s behalf unless Sponsor has expressly authorized
Quintiles to act as its agent for such purpose or has given Quintiles a written
power of attorney to sign such indemnifications.  In countries in which local laws or local
ethics committees require that a local company must sign such indemnifications
and Sponsor has no local presence, Quintiles will sign such indemnities only if
the parties have entered into an agreement regarding local representative
duties containing the terms attached hereto as Attachment B, either as a part
of a Work Order or as a separately signed agreement.

 

 

If
Sponsor requests that Quintiles enter into agreements to retain Third Parties
to perform services regarding the Project, such Third Parties shall be
independent contractors and shall not be considered the employees, agents, or
subcontractors of Quintiles or Sponsor. 
Sponsor shall pay Quintiles for its reasonable time and expenses in
negotiating and administering any such Third Party Agreements.

 

12.0         Conflict
of Agreements. 
Quintiles represents to Sponsor that it is not a party to any agreement
which would prevent it from fulfilling its obligations under this Agreement and
that during the term of this Agreement, Quintiles agrees that it will not enter
into any agreement to provide services which would in any way prevent it from
providing the Services contemplated under this Agreement.  Sponsor agrees that it will not enter into an
agreement with a third party that would alter or affect the regulatory
obligations delegated to Quintiles in any study or Project without the written
consent of Quintiles, which will not be unreasonably withheld.

 

13.0         Publication.  Project results may not be published or
referred to, in whole or in part, by Quintiles or its affiliates without the prior
expressed written consent of Sponsor. 
Neither party will use the other party’s name in connection with any
publication or promotion without the other party’s prior, written consent.

 

14.0         Limitation
of Liability.

 

a)             Neither
Quintiles, nor its affiliates, directors,
officers, employees, subcontractors or agents shall have any liability
(including without limitation, contract, negligence and tort liability) for any loss of profits, opportunities or goodwill or any
type of indirect or consequential damages in connection with this Agreement or
any Work Order or the Services performed by Quintiles.

 

b)            In
no event shall the collective, aggregate liability (including without
limitation, contract, negligence and tort liability) of Quintiles or its
affiliates, directors, officers, employees, subcontractors or agents under this
Agreement exceed the amount of fees actually received by Quintiles from Sponsor
under the applicable Work Order.

 

15.0         Indemnification.  Sponsor shall indemnify, defend and hold
harmless Quintiles and its affiliates, and its and their directors, officers,
employees and agents (each, a “Quintiles Indemnified Party”), from and against
any and all losses, damages, liabilities, reasonable attorney fees, court
costs, and expenses (collectively “Losses”), joint or several, resulting or
arising from any third-party claims, actions, proceedings, investigations or
litigation relating to or arising from or in connection with this Agreement,
any Work Order, or the Services contemplated herein (including, without
limitation, any Losses arising from or in connection with any study, test,
device, product or potential product to which this Agreement or any Work Order
relates), except to the extent such Losses are determined to have resulted
solely from the negligence or intentional misconduct of the Quintiles
Indemnified Party seeking indemnity hereunder.

 

16.0         Indemnification
Procedure. Quintiles shall give Sponsor prompt notice
of any such claim or lawsuit (including a copy thereof) served upon it and
shall fully cooperate with

 

 

Sponsor
and its legal representatives in the investigation of any matter the subject of
indemnification.  Quintiles shall not
unreasonably withhold its approval of the settlement of any claim, liability,
or action covered by this Indemnification provision.

 

17.0         Termination.  Sponsor or Quintiles may terminate this
Agreement or any Work Order without cause at any time during the term of the
Agreement on sixty (60) day’s prior written notice to Quintiles or Sponsor, as
appropriate.  Either party may terminate
this Agreement or any Work Order for material breach upon thirty (30) days’
written notice specifying the nature of the breach, if such breach has not been
substantially cured within the thirty (30) day period.  During the 30-day cure period for termination
due to breach, each party will continue to perform its obligations under the
Agreement.  If the termination notice is
not due to a breach, or if the cure period has expired without a substantial
cure of the breach, then the parties shall promptly meet to prepare a close-out
schedule, and Quintiles shall cease performing all work not necessary for the
orderly close-out of the Services or required by laws or regulations.   If Quintiles determines, in its sole
discretion, that its continued performance of the Services contemplated by one
or more Work Orders would constitute a potential or actual violation of
regulatory or scientific standards of integrity, then Quintiles may terminate
the applicable Work Order(s) by giving written notice stating the effective
date (which may be less than thirty days from the notice date) of such
termination.  Either party may terminate
this Agreement or any Work Orders immediately upon provision of written notice
if the other party becomes insolvent or files for bankruptcy.  Any written termination notice shall identify
the specific Work Order or Work Orders that are being terminated.

 

If
this Agreement or any Work Order is terminated, Sponsor shall pay Quintiles for
all Services actually performed in accordance with this Agreement and any
applicable Work Order and reimburse Quintiles for all costs and expenses
incurred in performing those Services, including all non-cancelable costs
incurred prior to termination but paid after the termination date. Sponsor
shall pay for all the work actually performed in accordance with this Agreement
and the applicable Work Order, even if the parties’ original payment schedule spreads-out
payments for certain services or defers payments for certain services until the
end of the Study.  If payments are unit
or milestone based, and the Agreement or a Work Order is terminated after costs
have been incurred toward achieving portions of one or more incomplete units or
milestones, Sponsor will pay Quintiles’ standard fees for actual work performed
toward those incomplete units or milestones up to the date of termination, in
addition to paying for completed units or milestones.   Sponsor shall pay for all actual costs,
including time spent by Quintiles personnel (which shall be billed at Quintiles’
standard daily rates in effect as of the date of the termination notice),
incurred to complete activities associated with the termination and close-out
of affected Projects, including the fulfillment of any regulatory
requirements.  In addition, if the
termination is by Sponsor without cause, or by Quintiles for cause, and the
total fees for the Project are greater than one million U.S. dollars in value,
then Sponsor shall pay to Quintiles an amount equal to twenty percent (20%) of
the budget for the remainder of Services that have not yet been performed, to
cover Quintiles’ costs associated with early termination.

 

 

18.0         Relationship
with Affiliates. 
Sponsor agrees that Quintiles may use the services of its corporate
affiliates as subcontractors to
fulfill Quintiles’ obligations under this Agreement or any Work Order.  Quintiles
shall remain responsible for all Services performed by its affiliates, and its
affiliates shall be subject to all of the terms, conditions and rights applicable to Quintiles under
this Agreement or any Work Order. Any affiliate of Quintiles or Sponsor may
enter into a Work Order under this Agreement, and the terms, conditions and
rights in this Agreement shall be incorporated into the Work Order and be
binding on such affiliate.  The term “affiliate”
shall mean all entities controlling, controlled by or under common control with
Quintiles.  The term “control” shall mean
the ability to vote fifty percent (50%) or more of the voting securities of any
entity or otherwise having the ability to influence and direct the polices and
direction of an entity.

 

19.0         Cooperation;
Sponsor Delays; Disclosure of Hazards.
Sponsor shall forward to Quintiles in a timely manner all documents, materials
and information in Sponsor’s possession or control necessary for Quintiles to
conduct the Services.  Quintiles shall
not be liable to Sponsor nor be deemed to have breached this Agreement for
errors, delays or other consequences arising from Sponsor’s failure to timely
provide documents, materials or information or to otherwise cooperate with
Quintiles in order for Quintiles to timely and properly perform its
obligations, and any such failure by Sponsor shall automatically extend any
timelines affected by a time period reasonably commensurate to take into
account such failure, unless Sponsor agrees in writing to pay any additional
costs that would be required to meet the original timeline.  If Sponsor delays a project from its agreed
starting date or suspends performance of the project then either: a) Sponsor
will pay the standard daily rate of the Quintiles’ personnel assigned to the
project, based on the percentage of their time allocated to the project, for
the period of the delay, in order to keep the current team members; or, b)
Quintiles may re-allocate the personnel at its discretion, and Sponsor will pay
the costs of re-training new personnel. In addition, Sponsor will pay all
non-cancelable costs and expenses incurred by Quintiles due to the delay and
will adjust all timelines to reflect additional time required due to the
delay.  Sponsor shall provide Quintiles
with all information available to it regarding known or potential hazards
associated with the use of any substances supplied to Quintiles by Sponsor, and
Sponsor shall comply with all current legislation and regulations concerning
the shipment of substances by the land, sea or air.

 

20.0         Force
Majeure.  In the
event either party shall be delayed or hindered in or prevented from the
performance of any act required hereunder by reasons of strike, lockouts, labor
troubles, inability to procure materials or services, failure of power or
restrictive government or judicial orders, or decrees, riots, insurrection,
war, Acts of God, inclement weather or other reason or cause beyond that party’s
control, then performance of such act (except for the payment of money owed)
shall be excused for the period of such delay.

 

21.0         Notices
and Deliveries. 
Any notice 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 by a 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:

 

 

	
  If to Quintiles:

  	
  If to Sponsor:

  
	
   

  	
   

  
	
  Quintiles, Inc.

  	
  Advanced Life
  Sciences, Inc.

  
	
  5927 South Miami
  Boulevard

  	
  1440 Davey Road

  
	
  Morrisville,
  North Carolina 27560

  	
  Woodridge, IL
  60517

  
	
  Attention: Elena
  M. Mestre

  	
  Attn: Legal
  Department

  

 

With a
copy to:

 

Quintiles
Transnational Legal Department

P.O. Box
13979

Research
Triangle Park, North Carolina

27709-3979

Attention:
John Russell

 

If
Sponsor delivers, ships, or mails materials or documents to Quintiles, or
requests that Quintiles deliver, ship, or mail materials or documents to
Sponsor or to third parties, then the expense and risk of loss for such
deliveries, shipments, or mailings shall be borne by Sponsor.  Quintiles disclaims any liability for the
actions or omissions of third-party delivery services or carriers.  All information transmitted by Quintiles
pursuant to this Agreement will be sent by the standard transmission method
selected by Quintiles (telephone, facsimile, mail, personal delivery or
email).  Sponsor hereby consents and
authorizes Quintiles to send facsimiles relating to the Services, or relating
to potential future services, to any office of Sponsor or Sponsor’s affiliates.

 

22.0         Insurance.  During the term of this Agreement to cover its
obligations hereunder, each party shall maintain insurance coverage as follows:
1) (a) Professional Liability for Quintiles in an amount of at least
US$5,000,000.00; (b) Clinical Trials and/or Product Liability for Sponsor
in an amount of at least US$5,000,000.00; and 2) General Liability in amounts
of at least US$3,000,000.00.  All
insurance amounts may be obtained by full, individual primary policy amount; a
primary amount of less than minimum requirement enhanced by a blanket excess
umbrella policy; or a combination of either. Each party shall provide the other
party with a certificate of insurance upon request. The insured shall provide
the other party with at least thirty (30) days prior written notice of any
material change, cancellation or expiration of the above-required insurance.

 

23.0         Foreign Currency Exchange. The currency to be used for
invoice and payment shall be the currency stated in the Budget or Table
attached to the applicable Work Order (the “Contracted Currency”). If Quintiles
incurs pass-through costs in a currency other than the Contracted Currency,
then Sponsor shall reimburse Quintiles for Quintiles’ actual costs in the
Contracted Currency based on the Oanda foreign currency exchange rate
(Oanda.com) for the applicable currencies on the last business day of the month
in which such pass-through costs are submitted.  If a currency
referenced within the Budget is replaced by the Euro or otherwise ceases to
become legal tender, the applicable replacement currency will be substituted
for such currency for purposes of this provision at an established conversion
rate.  For Work Orders that involve the
performance of Services by Quintiles or its affiliates in any countries that
use currencies other than the

 

 

Contracted Currency, and
the fees for such Services will exceed $500,000, then a currency exchange
provision shall be included in the Work Order.

 

24.0         Data Protection.  Quintiles and Sponsor agree to comply with all
applicable privacy laws and regulations. 
If the Project will involve the collection or processing of personal
data (as defined by applicable data protection legislation) within the European
Economic Area (“EEA”), then Sponsor shall serve as the controller of such data,
as defined by the European Union (“EU”) Data Protection Directive (the “Directive”),
and Quintiles shall act only under the instructions of the Sponsor in regard to
personal data.  If Sponsor is not based
in the EEA, but personal data will be gathered or processed in the EEA, Sponsor
must appoint an EEA company to act as its local representative for data
protection purposes in order to comply with the Directive, and such designation
is attached hereto and incorporated by reference.  If Sponsor does not have an affiliate in the
EEA and requests that a Quintiles affiliate in the EEA serve as its local
representative, then the parties shall negotiate a fee for such representative
duties and shall enter into a Data Transfer Agreement between the parties
containing the Standard Contractual Clauses set forth by the EU Commission
Decision of 15 June 2001 (Decision 2001/497/EC) before Quintiles will
assume any such representative duties. 
If Sponsor is not based in the EEA, Quintiles will not export any
personal data from the EEA unless Sponsor has appointed a local representative.

 

25.0         Binding Agreement and  Assignment.
This Agreement shall be binding upon and inure to the benefit of Sponsor and
Quintiles and their respective successors and permitted assigns.  Except as stated above in Section 18,
neither party may assign any of its rights or obligations under this Agreement
to any party without the express, written consent of the other party.

 

26.0         Choice of Law, Waiver and Enforceability. This Agreement
shall be construed, governed, interpreted, and applied in accordance with the
laws of the State of North Carolina, exclusive of its conflicts of law
provisions. The failure to enforce any right or provision herein shall not
constitute a waiver of that right or provision. 
Any waiver of a breach of a provision shall not constitute a waiver of
any subsequent breach of that provision. 
If any provisions herein are found to be unenforceable on the grounds
that they are overly broad or in conflict with applicable laws, it is the
intent of the parties that such provisions be replaced, reformed or narrowed so
that their original business purpose can be accomplished to the extent
permitted by law, and that the remaining provisions shall not in any way be
affected or impaired thereby.

 

27.0         Survival.  The rights
and obligations of Sponsor and Quintiles, which by intent or meaning have validity
beyond such termination (including, but not limited to, rights with respect to
inventions, confidentiality, discoveries and improvements, indemnification and
liability limitations) shall survive the termination of this Agreement or any
Work Order.

 

28.0         Arbitration.  Any
controversy or claim arising out of or relating to this Agreement or the breach
thereof shall be settled by arbitration administered by the American
Arbitration Association (“AAA”) under its Commercial Arbitration Rules, and
judgment on the award rendered by the arbitrator shall be binding and may be
entered in any court having

 

 

jurisdiction
thereof.  Such arbitration shall be filed
and conducted at the office of the AAA closest to the Quintiles office having
responsibility for the Project, and shall be conducted in English by one
arbitrator mutually acceptable to the parties selected in accordance with AAA
Rules. The arbitrator shall not have the power to award any punitive damages or
any damages excluded by this Agreement.

 

29.0         Entire Agreement, Headings and Modification. This Agreement,
together with the applicable Work Orders, contains the entire understandings of
the parties with respect to the subject matter herein, and supersedes all
previous agreements (oral and written), negotiations and discussions. The
descriptive headings of the sections of this Agreement are inserted for
convenience only and shall not control or affect the meaning or construction of
any provision hereof.  Any modifications
to the provisions herein must be in writing and signed by the parties.

 

IN
WITNESS WHEREOF, this Agreement has been executed by the parties hereto through
their duly authorized officers.

 

 

ACKNOWLEDGED, ACCEPTED AND AGREED TO:

 

 

	
  Quintiles, Inc.

  	
   

  	
  Advanced
  Life Sciences, Inc.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Elena Mestre

  	
   

  	
  By:

  	
  /s/ Michael T.
  Flavin

  	
   

  
	
   

  	
  (signature)

  	
   

  	
   

  	
  (signature)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Print Name:

  	
  Elena M. Mestre

  	
   

  	
  Print Name:
  Michael T. Flavin, Ph.D.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Vice President

  	
   

  	
  Title: Chief
  Executive Officer

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Date: November 17,
  2005

  	
   

  	
  Date: November 21,
  2005

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  FEDERAL ID # 56-1323952Exhibit 10.2

 

AUTHORIZATION TO PROCEED WITH:  PROTOCOL CL05-001

 

This Authorization to Proceed Agreement (“Agreement”) is between
Advanced Life Sciences, Inc., an Illinois corporation located at 1440
Davey Road, Woodridge, IL 60517 (“Customer”) and Quintiles, Inc. located
at 5927 South Miami Blvd, Morrisville, NC 27560(“Quintiles”).  The parties agree that, while the parties are
attempting to negotiate a comprehensive agreement regarding the
above-referenced project (the “Project”), Quintiles shall commence, or continue
performing, the following activities relating to the Project (the “Services”):

 

Start-up
Planning, Initial Clinical and Project Management

Case
Report Form design and printing

Regulatory
Document Review and Approval

Site
Selection/Initiation Visits

Investigator
Contract Negotiations and Advanced Payments

Biostatistics
review of randomization

Enroll
Subjects

Shipment
of Study Drugs

 

The Services will be carried out pursuant to the terms and conditions
of the Master Services Agreement dated November 21, 2005 between
Customer and Quintiles, which are incorporated by reference herein.  Customer shall pay Quintiles at Quintiles’
Standard Daily Rates (a copy of which is attached hereto) for Quintiles’ actual
time expended on the Services and shall reimburse Quintiles for all costs and
expenses Quintiles reasonably incurs in performing the Services, within thirty
days of receipt of an itemized invoice.  Quintiles’
costs and expenses will be supported by a summary sheet. If the parties enter
into a Work Order regarding the Project, all monies paid under this Agreement
will be applied toward, and reconciled with, the payments specified in the Work
Order. Quintiles may provide such additional preliminary Services as Customer
may request and Quintiles may agree in writing to perform.  Normally, Quintiles would not perform such
activities as executing investigator agreements, shipping drugs, or enrolling
or monitoring patients without a fully executed work order; however, in light
of the unique circumstances pertaining to this Project, Quintiles will proceed
with these activities upon execution of this Authorization to Proceed.  All regulatory obligations shall remain
Customer’s responsibility.  Customer may
terminate this Agreement upon thirty days’ written notice for any reason.
Quintiles may terminate this Agreement upon thirty days’ written notice if: a)
Customer breaches this Agreement; b) a final Work Order is not executed within
four months of the date of this Agreement; or, c) the Services performed under
this Agreement exceed $600,000 in total fees and costs without execution of a
final Work Order.

 

Upon execution of this Agreement, Customer agrees to pay Quintiles an
advance of $90,000, which shall be credited to
Customer on the final invoice. If this Agreement is terminated prior to
execution of a final Work Order, then any unearned portion of this advance will
be refunded, less a thirty-percent retention to offset the costs of
reallocating project staff.  If any
additional money is due under the terms of this Agreement, Customer shall pay
Quintiles the money owed within thirty days of receipt of an itemized invoice.

 

ACCEPTED AND AGREED TO AS OF THE DATE LAST
SIGNED BELOW:

 

	
  Quintiles, Inc.

  	
  Advanced Life Sciences, Inc.

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Elena Mestre

  	
   

  	
  By:

  	
  /s/ Michael T. Flavin

  	
   

  
	
   

  	
  (signature)

  	
   

  	
   

  	
  (signature)

  	
   

  
	
  Print Name:

  	
  Elena M. Mestre

  	
  Print Name: Michael T. Flavin, Ph.D.

  	
   

  
	
  Title:

  	
  Vice President

  	
  Title: Chief Executive Officer

  	
   

  
	
  Date: November 17, 2005

  	
  Date: November 21, 2005

  
								

 

1

 

	
  Date:

  	
  Date:

  

 

2005 Quintiles Americas CRO Services Group
Standard Rate Schedule

 

	
  Category

  	
   

  	
  2005

  Hourly

  Rate

  	
   

  	
  2005

  Daily

  Rate

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Executive Medical & Technical
  Consultation, Senior Statistical Consultation

  	
   

  	
  366

  	
   

  	
  2,928

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Executive Project Management, Senior
  Regulatory, Senior Medical, Senior Management, Medical Mgmt &
  Monitoring

  	
   

  	
  296

  	
   

  	
  2,368

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Safety Review/Analysis

  	
   

  	
  266

  	
   

  	
  2,128

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Senior Project Management, Statistical
  Design, Senior Statistical Planning and Analysis, Quality Assurance, Senior
  Scientists, Regulatory Consultation, Senior Management

  	
   

  	
  236

  	
   

  	
  1,888

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Management, Scientist

  	
   

  	
  196

  	
   

  	
  1,568

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Project Management, Monitoring
  Management, Site Selection, Statistical Interpretation, Senior Statistical
  Analysis, Regulatory Support

  	
   

  	
  168

  	
   

  	
  1,344

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Senior Clinical Monitoring, Statistical
  Analysis, Statistical and Medical Writing , Regulatory Documentation
  Preparation

  	
   

  	
  142

  	
   

  	
  1,136

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical Monitoring, In-house Monitoring,
  Statistical Programming, Technical Writing, Biostatistics Quality Control,
  Data Management, Medical Coding

  	
   

  	
  116

  	
   

  	
  928

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data Support

  	
   

  	
  102

  	
   

  	
  816

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical Services Support, Medical
  Writing Support

  	
   

  	
  85

  	
   

  	
  680

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  IVRS Support

  	
   

  	
  78

  	
   

  	
  624

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data Processing, Administrative Support

  	
   

  	
  64

  	
   

  	
  512

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Call Center Support

  	
   

  	
  59

  	
   

  	
  472

  	
   

  

 

Confidential

 

Executive Consulting rates may exceed those listed
above.

 

Billing rates are subject to change on January 1
of each calendar year, and the new rates will apply thereafter.

 

2

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