Exhibit 10
GLOBAL CLINICAL TRIALS AGREEMENT, dated as of August 16, 1999
(this "AGREEMENT"), between SMITHKLINE XXXXXXX PLC, a public
limited company organized under the laws of England ("SB"),
and QUEST DIAGNOSTICS, INCORPORATED, a Delaware corporation
("QUEST") .
WHEREAS, SB and Quest have entered into a Stock and Asset
Purchase Agreement dated as of February 9, 1999 (the "PURCHASE AGREEMENT"),
whereby, among other things, SB has agreed to sell, and Quest has agreed to
purchase, 100% of the outstanding shares of capital stock of SBCL, Inc. and
certain other assets;
WHEREAS, in the Purchase Agreement, SB agreed to contract with
Quest to provide, on an exclusive basis, all of its clinical trials testing
requirements for a period of 10 years, subject to certain exceptions set forth
in this Agreement; and
WHEREAS, it is a condition to the consummation of the
transactions contemplated by the Purchase Agreement that the parties hereto
execute and deliver this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants and
undertakings contained herein, and subject to and on the terms and conditions
herein set forth, the parties hereto agree as follows:
SECTION I. STATEMENT OF WORK
1 For any Study (this term and certain other terms are defined in Section
III(1); Section III(2) identifies the sections of this Agreement in
which capitalized terms used and not defined in Section III(1) are
defined) which SB requests Quest to perform under this Agreement, Quest
shall provide the Services for each Study requested by SB, in each case
pursuant to the terms set forth in this Agreement, including the
Addendum for such Study.
2 For each Study requested by SB, SB and Quest shall execute an addendum
to this Agreement substantially in the form of Exhibit A or in such
other form as may be mutually agreed by SB and Quest (as amended from
time to time, an "ADDENDUM") setting forth, among other things, the
Services to be performed by Quest for such Study, the costs for such
Services, implementation times for such Services, estimated
transportation fees for such Study and the clinical protocol for such
Study. Each Addendum shall apply only to the Study for which it is
executed and shall be valid and binding upon its execution by
authorized representatives of SB and Quest. Any change in the scope of
Services
described in an Addendum which shall have a material effect on the
total laboratory testing costs and/or costs or fees for other Services
specified in such Addendum shall be set forth in a written amendment to
such Addendum executed by authorized representatives of SB and Quest.
3 In providing Services under this Agreement, Quest shall comply with all
applicable governmental laws, rules and regulations, including the
United States Clinical Laboratory Improvements Amendments (CLIA 88),
good clinical laboratory practices, and generally accepted industry
standards for quality assurance and quality control, and shall operate
in accordance with all applicable regulations, standards and
recommendations of the Food and Drug Administration and other relevant
regulatory authorities with respect to the performance of laboratory
testing for clinical trials and related services.
SECTION II. EXCLUSIVITY
1 Subject to this Section II(1) and Sections II(2), XIII (2), XXI, and
XXIV, SB shall exclusively use (and cause the SB Subsidiaries to use)
Quest to conduct any Study for which SB or any SB Subsidiary, in the
ordinary course of its business, would use a clinical laboratory. As of
the date of this Agreement, SB is required to use Quest on an exclusive
basis only in countries included within the North American Territory or
the European Territory. SB and Quest intend to review on an ongoing
basis throughout the Term of this Agreement Quest's ability to provide
Services to SB in countries other than those included within the North
American Territory and the European Territory. Upon the mutual
agreement of SB and Quest, additional countries may be added to the
scope of this Agreement, and if so added, SB shall use Quest to provide
Services to it (and to any SB Subsidiary) for Studies performed in
these additional countries on an exclusive basis, subject to the
limitations set forth in this Section II, and Quest shall provide
Services to SB and any SB Subsidiary for Studies performed in such
additional countries pursuant to the terms of this Agreement.
Similarly, SB and Quest may agree to remove countries included within
the definitions of the North American Territory and the European
Territory from the scope of this Agreement. Upon such mutual agreement
of SB and Quest, SB and any SB Subsidiary shall not be required to use
Quest on an exclusive basis for Studies performed in any countries
removed from the scope of this Agreement.
The exclusivity provisions of this Section II shall also apply to any
Contract Research Organization ("CRO") retained by SB or an SB
Subsidiary, such that for any Studies for which SB or its Subsidiary
uses a CRO, SB or its Subsidiary, as appropriate, shall exclude
laboratory services from its contract with such CRO, and SB or its
Subsidiary shall use Quest to perform the laboratory services for such
Study. In such a situation, Quest shall provide the laboratory services
for such Study and shall provide laboratory results to the CRO and to
SB, as specified in the Addendum for the particular Study. SB shall
have responsibility for oversight of the actions of any CRO retained by
SB or an SB Subsidiary to conduct a Study for which Quest performs
Services under this Agreement.
2 CERTAIN EXCEPTIONS. Notwithstanding the foregoing, the parties hereto
agree that SB shall not be required to use (or to cause the SB
Subsidiaries to use) Quest to conduct:
(i) any Study requiring onsite clinical pharmacology testing under
the direct management of any of SB's or an SB Subsidiary's
clinical pharmacology units currently located at Presbyterian
Medical Center in Philadelphia, Pennsylvania, at SB's
facilities in Harlow, England, and at Adenbrookes Hospital in
Cambridge, England, or of any similar clinical pharmacology
units established during the Term;
(ii) any assay for the DMPK of pharmaceutical compounds; provided,
however, that if any of the testing referred to in (i) or (ii)
is to be performed by a non-SB Subsidiary, such testing shall
be subject to the requirements of this Agreement;
(iii) for any Study which is being conducted as of the date hereof
(or in the case of an SB Subsidiary acquired or formed after
the date hereof, for any Study which is being conducted as of
the date of such acquisition or formation), any laboratory
testing which is conducted as part of that Study by Persons
other than Quest;
(iv) any Phase IV Study in the European Territory in a country
other than the United Kingdom, if such Phase IV Study is
performed by a local clinical laboratory that is not a
competitor of Quest in such country;
(v) any testing in connection with a Study that requires immediate
turn-around time that Quest cannot provide, including
microbiology testing;
(vi) any testing in connection with a Study that is usually
performed by the Investigators participating in a Study;
(vii) any Study funded by a Person, in whole or in part, other than
SB or an SB Affiliate, where use of a laboratory other than
Quest is required by that Person; PROVIDED, HOWEVER, that SB
shall use reasonable commercial efforts to have Quest engaged
to conduct any Studies required in the
course of such research and development and, if so engaged,
such Studies shall be conducted pursuant to the terms of this
Agreement.
(viii) any Study conducted in connection with SB's (or any SB
Affiliate's) research and development activities undertaken
pursuant to any co-development, co-promotion, collaborative
research, licensing or similar agreement with a third party
which is not an Affiliate Controlled by SB (E.G., joint
ventures, partnerships, licensing or co-development contracts)
where use of a laboratory other than Quest is required by that
Person, except for Studies conducted by SB for diaDexus LLC;
PROVIDED, HOWEVER, that SB shall use reasonable commercial
efforts to have Quest engaged to conduct any Studies required
in the course of such research and development and, if so
engaged, such Studies shall be conducted pursuant to the terms
of this Agreement.
3. Notwithstanding the foregoing, Quest shall have the option to decline
to perform any Studies under this Section II that SB or an SB
Subsidiary requests Quest to perform, and should Quest decline to
perform the Study, SB or the SB Subsidiary shall be free to use a
clinical laboratory other than Quest to perform such Study.
SECTION III. DEFINITIONS
1 For purposes of this Agreement:
"AFFILIATE" means, with respect to any Person, any Person which,
directly or indirectly, Controls, is controlled by, or is under common
Control with, the specified Person. An Affiliate, with respect to SB,
shall include the SB Subsidiaries.
"ARCHIVAL SPECIMEN" means a type of specimen which is placed in
long-term storage by Quest, at SB's request, either for a particular
use or for undefined future use.
"CDM" means the Clinical Data Management department of SB and any
successor department.
"CHANGE IN CONTROL" means any event where:
(a) any "person" or "group" (as such terms are used in Section
13(d) and 14(d) of the of the Securities Exchange Act of 1934,
as amended (the "Exchange Act") is or becomes the "beneficial
owner" (as defined in Rules 13d-3 and 13d-5 under the Exchange
Act) of shares representing more than 50% of the combined
voting power of the then outstanding securities entitled to
vote generally in elections of directors of SB (the "Voting
Stock"); or
(b) SB consolidates with or merges into any other corporation, or
conveys, transfers or leases all or substantially all of its
assets (other than to a wholly-owned subsidiary of SB) or any
other corporation merges into SB, and, in the case of any such
transaction, the outstanding common stock of the SB is
reclassified into or exchanged for any other property or
security, unless the shareholders of the SB immediately before
such transaction own, directly or indirectly, immediately
following such transaction, at least a majority of the
combined voting power of such outstanding power of the
outstanding voting securities of the corporation resulting
from, or to which its assets were conveyed, transferred or
leased in connection with, such transaction in substantially
the same proportion as their ownership of the Voting Stock
immediately before such transaction;
"CLW" means a clinical laboratory worksheet, a document substantially
in the form of Exhibit B-1 in the case of any Study in the North
American Territory, and in the form of Exhibit B-2 in the case of any
Study in the European Territory, or in such other form as may be
mutually agreed by SB and Quest. Such document shall be completed by
representatives of both SB and Quest with respect to any Study. The CLW
for any Study is hereby deemed a part of the Addendum for such Study
and all references herein to any Addendum include the CLW, as amended,
executed in connection therewith.
"CONTROL" means, as applied to any Person, the possession, directly or
indirectly, of the power to direct or cause the direction of the
management of that Person, whether through ownership of voting
securities or otherwise.
"DMPK" means distribution, metabolism and pharmokinetics of a
pharmaceutical compound (measurement of the pharmaceutical compound or
its metabolites in body fluid).
"EUROPEAN TERRITORY" means the countries of Austria, Belgium, the Czech
Republic, Denmark, Finland, France, Germany, Holland, Hungary, Iceland,
Ireland, Italy, Lithuania, Luxembourg, Norway, Poland, Portugal,
Slovakia, Sweden, Spain, Switzerland and the United Kingdom.
"INVESTIGATOR" means a physician or other clinician who oversees the
conduct of a Study.
"INVESTIGATOR MANUAL" means a document used by the Investigators and
their staffs which provides precise instructions concerning specimen
collection, transport and reporting and includes laboratory
certifications.
"INVESTIGATOR (LAB REQUIREMENT) SUMMARY" means a condensed version of
the Investigator Manual.
"PERSON" means any individual, firm, corporation, partnership, limited
liabilities company, trust, joint venture, governmental entity or other
entity.
"REFERRAL SPECIMEN" means a type of specimen which is sent by Quest to
another laboratory for analysis, with the consent of SB or an SB
Subsidiary.
"RESULT/VIEW(TM)" means the Quest software product for providing near
real-time access to clinical trial laboratory data of laboratory tests
performed by Quest.
"SB CLINICAL STUDY LEADER" means with respect to any Study, the SB
contact identified in the Addendum for such Study as the lead contact
at SB for such Study.
"SB SUBSIDIARY" means (i) any Subsidiary of SB existing as of the date
hereof or formed or acquired by SB during the Term of this Agreement;
PROVIDED, HOWEVER, that the term "SB Subsidiary" shall not include SB
Biologicals unless, and only to the extent, SB elects to have SB
Biologicals conduct any Studies under this Agreement, and (ii) any
Affiliate of SB which SB elects to have Studies conducted under this
Agreement, but only to the extent of such election, in the case of each
clauses (i) and (ii), for so long as such Subsidiary or Affiliate
remains a Subsidiary or Affiliate of SB.
"SB BIOLOGICALS" means SmithKline Xxxxxxx Biologicals S.A., a company
organized under the laws of Belgium.
"QUEST PROTOCOL ADMINISTRATOR" means, with respect to any Study, the
Person appointed by Quest to manage the protocol for such Study. The
protocol administrator will interact on a regular basis with a
designated SB contact. Both the protocol administrator and the SB
contact for any Study shall be identified in each Addendum.
"SERVICES" means laboratory testing, extraction of DNA, specimen
storage for both analyzed and nonanalyzed specimens, specimen
transportation, other distribution of materials or supplies, study
preparation and management, data management (including access to
Result/View(TM) as provided in Section VII(10), management reporting,
technical support, reporting of test results, maintenance of good
laboratory practices and documentation of quality assurance and control
and all other customary services performed, in each case, in connection
with a Study.
"STUDY" means clinical trials or clinical investigations on humans for
a pharmaceutical compound.
"STUDY BLIND" means, with respect to any Study, the confidential
assignment of participants to a treatment group in order to minimize
patient, Investigator and Study sponsor bias.
"SUBSIDIARY" of any Person means another Person, an amount of the
voting securities, other voting ownership or voting partnership
interests of which is sufficient to elect at least 50% or more of its
Board of Directors or other governing body (or, if there are no such
voting interests, 50% or more of the equity interests of which) is
owned by such first Person or by another Subsidiary of such Person.
"3I SHEETS" means a request form sent to all International
Investigators requesting certain site information, including the
location of the Investigator and Co- Investigators, the primary contact
person and his or her telephone and facsimile numbers, the location for
specimen collection and the location to which patient reports should be
sent.
"NORTH AMERICAN TERRITORY" means the United States of America,
including Alaska, Hawaii and Puerto Rico, and Canada and Mexico.
"TERM" means the period of time defined in Section XX(1).
2 The following terms have the meanings set forth in the Sections set
forth below:
Term Section
------------------------------------------
Addendum I(2)
Alerts XI(2)
Annual Minimum XXIV(2)
Change in Control Date XXIV(1)
Clinical Research Organization II(1)
DMPK Specimens IX(8)
Existing SB Compounds XXIV(2)
Indemnified party XXII(3)
Initial Minimum XXIV(2)
Lab Test List XIII(2)
Fee Schedule Discount XV(1)
Fee Schedule XV(1)
Material Breach XXI
Most Favored Nations Pricing XV(1)
Other Client XV(2)(b)
Purchase Agreement Preamble
SB Biologicals II(1)
Successor Company XXIV(1)
Supported Locations VII(10)
Quest Director IV(3)
Quest Internal Systems XVII(2)
Third Party Claim XXII(3)
Voting Stock III
Year 2000 Compliance XVII(1)
SECTION IV. RELATIONSHIP MANAGEMENT
1 Quest shall designate individuals employed by Quest who are approved by
SB to be located at SB's facilities in Upper Providence, Pennsylvania,
Collegeville, Pennsylvania, and Harlow, England, or at such other
locations as may be mutually agreed by SB and Quest, to act as liaison
and relationship managers between Quest and SB's Clinical Research and
Development department.
2 Within thirty days of the date of this Agreement, SB and Quest shall
form an Oversight Team that shall have oversight responsibility for the
parties' performance of their respective obligations under this
Agreement and the relationship between the parties. The Oversight Team
shall be composed of at least two representatives each appointed by
Quest and SB. SB and Quest may elect to include within the Oversight
Team representatives from any CRO routinely used by SB for the
performance of Studies.
3 At a minimum, the Oversight Team shall participate in quarterly
performance and business review meetings, at a location to be mutually
agreed by SB and Quest, to discuss the Quest performance metrics and
measures set forth in Section VIII and any other issues arising under
this Agreement; PROVIDED, HOWEVER, that during the period from the date
of this Agreement through the third anniversary of such date, if
requested by SB, such meetings shall occur monthly. At any time SB
believes that Quest is failing to provide Services pursuant to the
terms of this Agreement, SB may require Quest to participate at a
meeting to discuss such failures at a location to be mutually agreed by
SB and Quest as promptly as practical after SB notifies Quest of the
request to have such meeting. At a minimum, the director of the Quest
clinical trials center (the "QUEST DIRECTOR") shall attend any meetings
required by this Section VI(2). The other attendees of such meetings
shall be mutually agreed by SB and Quest.
SECTION V. REVIEW AND IMPROVEMENT OF SERVICES
1 The parties hereto acknowledge and agree that (i) the pharmaceutical
industry and clinical trials industry frequently undergo change,
including technological advancements in connection with the conduct of
Studies and abilities to communicate the results of the Studies, and
(ii) the parties hereto intend the performance by Quest of Services
under this Agreement to reflect the improvements available as a result
of such changes.
2 SB and Quest shall meet at least one time annually to review the terms
of this Agreement which govern the Services Quest must provide,
including Sections VIII through Section XVI, and to negotiate in good
faith and execute
and deliver amendments to this Agreement providing for quality and
cycle time improvements and other changes in such Services in response
to technological, operational or other advancements or changes. It is
acknowledged and agreed that, among other things, Quest may be required
to invest in new equipment and staff as a result of such amendments.
SECTION VI. CERTAIN PERFORMANCE METRICS AND MEASURES
1 With respect to any Study, Quest shall provide any Services required
pursuant to this Agreement for such Study within the relevant
implementation time specified in Exhibit D, as Exhibit D may be amended
from time to time pursuant to Sections V or XXIII; PROVIDED, HOWEVER,
that, with respect to any Study, to the extent an implementation time
for any Service is expressly set forth in an Addendum, Quest shall
provide such Service for such Study within the implementation time set
forth in such Addendum. In the event Exhibit D is amended, such that
the amendment causes an increase in the costs of Quest's performance of
Services hereunder, Quest and SB shall negotiate an appropriate price
adjustment under this Agreement with respect to the amended item(s)
only.
2 With respect to each Study, Quest shall maintain a system to monitor
and measure its compliance with the performance metrics and measures
set forth in Exhibit D or in the Addendum for such Study and shall
provide SB a monthly written report regarding compliance with such
metrics and measures. Quest shall provide SB with reasonable access to
the data underlying such monthly compliance reports for verification
purposes.
SECTION VII. STUDY PREPARATION PHASE
1 Four weeks before any Study is scheduled to begin, Quest will provide a
cost proposal, based on the final approved protocol for the Study, to
the designated SB Clinical Study Leader (with a copy to the SB Clinical
Development Contract Management Group) in the form of an Addendum. All
anticipated costs must be estimated, including dry ice, travel to
Investigator meetings, translations, reporting costs and storage and
transportation costs. The Addendum also will specify, among other
things, the manner, format and timing of data transmission for such
Study and the sites to be included within the Study. Each of SB and
Quest shall use its reasonable best efforts to agree on the costs for
the Study and to sign the Addendum prior to the Study start date. If SB
makes any subsequent changes to the final approved protocol that impact
the costs of the Study significantly, SB shall bear such additional
costs; provided, however, that
the additional costs are reasonable and are itemized for SB in
reasonable detail. In such a situation, Quest shall incur no additional
costs without the prior approval of SB; provided, however, that Quest
may incur reasonable, additional costs if it is unable promptly to
obtain SB's approval to such additional costs and the nature of the
Study and requirements for timely performance of Services require Quest
immediately to incur such reasonable, additional costs.
2 Prior to the initiation of each Study, SB shall provide Quest with a
copy of all appropriate, approved protocols, amendments and
modifications and other necessary information. Quest will not modify or
change such information without the prior written consent of SB.
3 If the laboratory requirements for a Study involve the extraction of
DNA from a patient's specimen, it is the responsibility of the SB
Clinical Study Leader, as the Study is being set up, to provide the
Quest Protocol Administrator with the master patient informed consent
covering DNA analysis (if not specified in the protocol for such
Study). Quest shall not extract DNA from any specimen unless the
patient informed consent has been signed. Quest will include DNA tubes
in the laboratory test kits.
4 No later than four weeks before the beginning of a Study, a CLW will be
completed by representatives from SB and Quest. No later than two weeks
before the beginning of a Study, Quest will demonstrate to SB its
ability to communicate fluently with Investigators for such Study and,
if necessary, will specify to SB the languages used to communicate with
the Investigators in the relevant CLW. Quest shall ship supplies for
the Investigators in order to arrive at the Investigator sites not
later than one business day prior to the initiation of the Study.
5. Significant changes made to a Study's protocol or CLW by SB after a
schedule has been determined which necessitate additional programming
time or changing of kit contents by Quest, shall be made at SB's
expense; PROVIDED, HOWEVER, that the additional charges are reasonable
and are itemized for SB in reasonable detail. In such a situation,
Quest shall incur no additional costs without the prior approval of SB;
provided, however, that Quest may incur reasonable, additional costs if
it is unable promptly to obtain SB's approval to such additional costs
and the nature of the Study and requirements for timely performance of
Services require Quest immediately to incur such reasonable, additional
costs.
In the event SB makes any significant changes as described above for
any Study, Quest shall use its reasonable best efforts to ship supplies
for the Investigators in order to arrive at the Investigator sites not
later than one
business day prior to the initiation of the Study at the site. Any
additional shipping charges incurred by Quest to comply with this
obligation shall be the responsibility of SB.
6 Investigator meetings are intended to assist in the orientation of
Investigators and their staff assigned to a Study with respect to the
laboratory procedures contained in the Investigator Manual, and the
performance of other Services as may be required by the relevant CLW.
Quest shall provide a representative at the SB-sponsored Investigator
meeting to review specimen preparation, packaging and transportation
requirements. In the European Territory, Quest shall participate in
Investigator meetings at locations and at times specified by SB upon
two weeks' prior notice. In the North American Territory, Quest shall
participate in Investigator meetings at locations and at times
specified in the relevant CLW.
Upon two weeks' prior notice from SB, and being in receipt of the
clinical protocol contained in the relevant Addendum, Quest will
provide customized presentation materials for the applicable
Investigator meeting.
Upon request by SB, Quest will provide to SB for review and comment in
advance of the Investigator meeting copies of the materials to be
presented at such meeting and will make any factual corrections
requested by SB at no charge to SB.
If Quest is not given two weeks' prior notice, additional reasonable
charges will apply for (i) Quest's preparation of customized meeting
materials and (ii) revisions to customized meeting materials resulting
from changes in SB's protocol or other changes specified by SB to
Quest; PROVIDED, HOWEVER, that the expenses underlying such additional
changes are itemized for SB in reasonable detail.
7 For Services provided in the North American Territory, Quest will
prepare and distribute to each Investigator a protocol-specific
Investigator Manual and Investigator (Lab Requirement) Summary and/or
pictogram. The purpose of the Investigator Manual and Investigator (Lab
Requirement) Summary is to provide the Investigator and the
Investigator's staff with precise instructions concerning specimen
collection, transport and reporting. In the North American Territory,
the Investigator Manual and Investigator (Lab Requirement) Summary
shall be provided in English, Spanish and French.
In the European Territory, Quest will prepare and distribute to each
Investigator a customized Investigator Manual and/or pictogram. The
Investigator Manual and
Investigator (Lab Requirement) Summary is available in English, French,
Spanish, Italian, German and Dutch, and in such additional languages
requested by SB. Upon written request from SB, Quest will translate the
Investigator Manual and/or Investigator (Lab Requirement) Summary into
other languages for an additional charge per language.
For any additional countries that may be added to this Agreement, Quest
will provide the Investigator Manual and/or the Investigator (Lab
Requirement) Summary and/or pictogram in languages as specified in the
Addendum for the particular Study. Quest shall provide such materials
in English, French, Spanish, Italian, German, and Dutch at no
additional charge, and SB and Quest shall negotiate in good faith the
costs of any translations into other languages required by SB.
Quest shall use its reasonable best efforts to provide such additional
translations within two weeks of request.
8 Upon request from SB, Quest will provide telephone in-service training
to staff at clinical study sites at no additional charge to SB. Upon
request and with two weeks' prior notification from SB, Quest will
provide on-site field service training for protocol initiation and/or
ongoing support. Costs associated with this Service (an additional
charge per day plus travel and accommodation expenses) shall be the
responsibility of SB.
Quest will make available, upon SB's request, professional laboratory
consulting services at SB and/or Investigator sites beyond those
consulting services generally provided by Quest in connection with a
Study. Any costs associated with these services shall be agreed to in
advance by Quest and SB.
9. Quest will provide SB with technical support Services, including
provision of data transmission and test codes and remark codes, when
appropriate. Quest, with input from SB, will develop a standard format
for data transmission and will create datasets prior to the initiation
of a Study to transmit records. Quest shall monitor data to ensure
trouble-free transmission to CDM. Quest must confirm to SB that all
data management systems required for any Study are in place or shall be
in place, prior to the commencement of such Study. The costs for any
data programming requested by SB over and above Quest's usual
programming and technical Services provided to SB shall be reimbursed
by SB; provided, however, that Quest shall provide SB with an
itemization of such costs prior to implementing any programming
changes.
10. In addition to the technical support Services set forth in Section
VII(9) above, Quest shall provide SB with access to Result/View(TM) for
all Studies for which
Quest provides Services under this Agreement. Quest hereby provides SB
with a royalty-free, nonexclusive, nontransferable right to use the
Result/View(TM) software to access Quest's database related to the
Studies performed under this Agreement and to download data relating to
Services provided by Quest for any Study performed under this Agreement
and to use any materials or documentation associated with the
Result/View(TM) software. SB shall be free to modify the
Result/View(TM) software for its own use. During the Term of this
Agreement, Quest shall not charge SB with any site license fee for use
of the Result/View(TM) software, regardless of the country or location
in which Result/View(TM) is used, and SB shall not be obligated to make
any payment to Quest for such license fees. In addition, Quest shall
provide training, installation and technical support services for
Result/View(TM). SB shall bear the cost of any training, installation
or technical support services related to Result/View(TM) provided by
Quest. Quest and SB shall work in good faith to determine the
appropriate level of support services to be provided by Quest with
regard to the provision of Result/View(TM) and an appropriate
allocation of costs for such support services.
SECTION VIII. STUDY MANAGEMENT
1. The Quest Protocol Administrator for any Study will interact on a
regular basis with the SB Clinical Study Leader or other designated SB
contact who shall be specified in each Addendum. Quest shall use its
reasonable best efforts to retain such administrator's services for the
length of each Study to which they have been assigned, in order to
maintain the quality and consistency of Services. In addition, Quest
shall provide a qualified back-up to such Protocol Administrator. If
such administrator's responsibilities change during the course of an
Addendum, Quest shall notify the designated SB contact of such change.
Quest shall ensure that the level, quality and continuity of Services
are maintained at the levels required by this Agreement despite any
changes in personnel at Quest.
2 Quest will provide to SB and Investigators a toll-free telephone number
for answering questions related to the Services. Quest shall also
provide to SB and Investigators the names and telephone numbers of
Quest contacts who can answer testing related questions and take orders
for supplies.
3 For Studies in the European Territory, Quest will provide sufficient
personnel to communicate with Investigators and SB personnel in
English, French, Spanish, Italian, German and Dutch, as need be
depending on the language requirements of the country in which the
particular Study is performed. For Studies in both the
North American and European Territories, Quest will provide SB with
access to a staff pathologist or an appropriately qualified Ph.D.- or
M.D.-level staff member.
4 Quest technical support will be provided to interact with SB and any SB
designated SB agent or subcontractor for problem resolution. Quest will
use its reasonable best efforts to resolve any technical errors
promptly upon identification of the problem.
SECTION IX. SPECIMEN TRANSPORT
1 Quest will provide for courier service for shipment of specimens from
an Investigator to Quest, the costs, timing and service provider of
which shall be as mutually agreed by Quest and SB, based upon the
requirements specified in the relevant CLW. In any event, Quest shall
use its reasonable best efforts to provide courier service to
Investigators on weekends or holidays in the event of an unanticipated
patient visit. Quest shall indicate to the SB Clinical Study Leader or
other designated SB contact any limitations on courier service which
would impede proper and/or timely collection and delivery of supplies
or specimens.
2 Quest will provide a tracking system to ensure pick up at Study sites
and delivery to Quest in line with the specifications required and
agreed to by protocol and reflected in the Addendum for a particular
Study. The tracking system shall be that which is currently in place at
SmithKline Xxxxxxx Clinical Laboratories, with such modifications as
Quest may make to the system after the date of this Agreement to
provide specimen pick up Services in both the North American and
European Territories. Such tracking system will be available to SB upon
request. Any requests by SB for tracking of specimens in excess of the
usual tracking system provided by Quest in the North American and
European Territories shall be discussed and agreed to by the parties.
Additional costs, if any, associated with the excess tracking
requirements, will be charged to SB and agreed upon between SB and
Quest.
3 From the point of pick up of specimens from the Investigator by a
courier employed by Quest under any Addendum, all shipping, handling,
storage and disposal of specimens shall be in accordance with any and
all applicable rules and regulations.
4 Quest shall be compensated at reasonable cost for emergency delivery
and/or transportation Services authorized in writing by SB which are
not included in the agreed to price on the applicable Addendum.
5 Quest may be required to provide for shipment of specimens from Quest
to other laboratories or to SB locations as described in the Addendum.
Shipping methods and documentation for clinical sample shipments shall
be in accordance with any and all applicable rules and regulations, and
in compliance with guidelines set forth by the courier service. In
addition, Quest shall be prepared to receive and analyze specimens that
are referred by SB to Quest from other laboratories.
6 If requested by SB, Quest may be required to send Referral Specimens to
other laboratories for analysis. Quest shall be responsible for
obtaining, handling, shipping and reporting Referral Specimens in
accordance with any and all applicable rules and regulations. Quest
will xxxx SB for the cost of testing Referral Specimens (which is the
amount Quest is billed by the referral laboratory) plus a referral
service fee per specimen. This referral service fee includes specimen
transport from the Investigator sites to Quest in the North American
Territory, specimen referral (including specimen tracking and
transport), and results reporting to SB. In the European Territory,
inbound transportation costs will be agreed with SB. Any fee increase
imposed by the referral laboratory will be passed on to SB.
7 Archival Specimens shall be stored and maintained by Quest for the
length of time and under storage conditions as described in the CLW for
the fees described in Section XV(15). Archival Specimens may be shipped
to SB or to others as specified in the relevant CLW or as otherwise
requested by the designated SB contact. Labeling requirements for
Archival Specimens to be returned to SB shall be specified in each CLW.
8 If requested by SB, Quest will be required to send any DMPK specimens
received by Quest in extended storage to other laboratories for
analysis ("DMPK SPECIMENS"). Quest will be responsible for handling and
shipping DMPK Specimens. Quest will xxxx SB for the cost of storage as
detailed in Exhibit A. This storage fee includes specimen transport
from the Investigator sites to Quest in the North American Territory,
except where non-Quest transport is used. In the European Territory,
inbound transportation costs will be charged to SB. DMPK specimens
shipped to Quest designated for extended storage shall be stored and
maintained by Quest for the length of time and under storage conditions
as described in the relevant CLW.
SECTION X. RESULT REPORTS
1 Quest shall complete test assays upon specimens received from
Investigators and shall compile patient demographic data which
accompanied such
specimens. Results of test assays and patient demographic data will be
reported to Investigators and SB with the data specified, by the method
and with the frequency of transmission and turnaround as set forth in
the relevant CLW, or as otherwise requested by SB. Examples of standard
reports are available to SB upon request. Additional reports requested
by SB, which require fields of data not specified in the original CLW,
will be provided at an additional reasonable charge to SB.
2 Upon request and as directed by SB, Quest will implement any or all of
the following report format and flagging options: (i) delta flags; (ii)
blinded results; (iii) clinical significance summary; (iv) quick trend
summary; (v) toxicity grading; and (vi) report header and footer text,
and any additional format and flagging options requested by SB. If SB
requests a format or flagging which requires significant customization
of Quest's standard report format and flagging options, SB and Quest
shall negotiate in good faith an additional reasonable charge to SB for
such request.
3 The following Service options apply to report delivery to the
Investigators and SB:
WITHIN THE NORTH AMERICAN TERRITORY: One hard copy result report will
be delivered via Quest courier per visit. As an alternative, upon
request from SB, Quest will distribute to the Investigators one result
report transmitted via facsimile plus one hard copy report delivered
via Quest courier, per visit, or in such alternate reporting fashion as
requested by an Investigator (e.g., electronic reporting). SB and Quest
shall negotiate in good faith the costs of any alternate reporting
fashion requested by SB.
FROM THE NORTH AMERICAN TERRITORY TO A DESTINATION OUTSIDE THE NORTH
AMERICAN TERRITORY: One result report will be transmitted via facsimile
plus one hard copy report will be sent via standard postal service per
visit for countries other than the North American Territory.
FROM THE UNITED KINGDOM TO A DESTINATION WITHIN THE EUROPEAN TERRITORY:
One result report will be transmitted via facsimile plus one hard copy
report will be sent via standard postal service per visit.
OTHER: SB may request overnight express report delivery, or multiple
modes of delivery, at an additional charge for any of the reports
described above. The parties hereto acknowledge and agree that as
improved technology becomes reasonably available, Quest will make
available "real-time" communication or other electronic communication
between and among Quest, SB and the Investigators.
SECTION XI. DATA MANAGEMENT REQUIREMENTS
1 Quest shall perform edit checks on patient demographic data on the day
that the sample is received. If Quest detects errors or omissions,
including an invalid Study number, an invalid Investigator number, an
invalid Investigator site number, an invalid patient number, an
improper visit sequencing, or patient demographics that changed from a
previous visit, then Quest shall contact the Investigators by telephone
(or other mutually acceptable method of communication) for resolution.
A record of all such changes shall be maintained by Quest. If Quest is
unable to contact the Investigators or has been unable to reach a
resolution within five business days (or within two business days if
after the last patient visit), then Quest shall notify the designated
SB contact.
2 Quest shall telephone the Investigators to notify them of lab assay
values which must be made known immediately to the Investigator (and
any medical monitors designated in the Addendum) for proper patient
care and which are defined in the relevant CLW (hereinafter "ALERTS").
In addition, Quest shall immediately provide notification to the
Investigator and medical monitor of lab assay values which would
exclude the patient from the Study and which are defined in each
clinical protocol if requested in the relevant CLW. Quest shall notify
Investigator sites within one working day (limited to Monday through
Friday) of the completion of testing, or as specified in the CLW. If
Quest is unable to reach the Investigator after Quest has made a
minimum of two attempts, Quest shall promptly notify the SB Clinical
Study Leader, medical monitor or other designated SB contact. All
Alerts shall be automatically flagged on the hard copy laboratory
report.
3 Quest shall provide to SB a support service for queries or resolving
errors related to Quest, with such queries or errors to be resolved
within three days (or within 24 hours if after the last patient visit).
Quest also shall provide guidance for any general lab questions and
shall ensure the complete resolution of all data issues at the
completion of the Study (ensuring satisfactory completion of the
relevant Study). Quest shall track all queries raised in each Study.
4. Quest will retain all patient records and test results from any Study
for five years following the termination of each Study or for such
longer period as specified in the Addendum for a Study or as required
by applicable laws or regulations. Quest shall maintain all specimens
from a Study following the termination of the Study for the period
specified in the Addendum for a Study or for such longer period of time
as required by applicable law or regulations. Upon SB's request, Quest
shall return any specimens or data from a Study to SB, at an additional
charge to be agreed upon by SB and Quest. SB and Quest shall agree on
long-
term specimen retention and specimen destruction on a Study by Study
basis. Quest shall comply with all data and specimen retention methods
established by relevant regulatory authorities. SB shall advise Quest
in writing of data or specimen retention requirements in excess of
these standards, and Quest will use its reasonable best efforts to
accommodate SB's requirements. Additional reasonable charges may apply
to any deviations to data and specimen retention standards specified
herein. Archived data may be maintained on microfiche or electronic
record, provided that a back-up exists and a hard copy can be obtained
from it if required.
SECTION XII. MANAGEMENT REPORTING
Quest will provide, upon request from SB, any or all of the following management
reports generated from Studies under this Agreement: (i) new activity report,
(ii) study status report, (iii) patient visit history report, (iv) patient trend
analysis, (v) trend analysis, (vi) tracking report, (vii) toxicity grade report,
and/or (viii) selected abnormal report, and any other standard reporting entries
as they become available. Quest will make such reports available as frequently
as SB specifies, and such reports shall be incorporated into the Result/View(TM)
format if requested by SB. Distribution will be by standard postal service or
electronically, at SB's option. An additional charge may apply for customization
or deviations to Quest's standard Study management reports and methods of
distribution.
SECTION XIII. LABORATORY METHODOLOGY
1 Quest shall not subcontract tests to any third party or send our
Referral Specimens without the prior written approval of SB. Quest
shall require any subcontractor approved by SB to enter into written
agreements requiring such subcontractor to perform the Services for
which it is the subcontractor pursuant to the terms of this Agreement,
including the terms of the confidentiality provisions in Section XVIII
and the Year 2000 compliance in Section XVII. Quest shall be
responsible for ensuring that (i) all subcontracted tests are correctly
validated and (ii) each subcontractor's sites have passed appropriate
quality audits conducted by third parties hereto within the previous 12
months. If SB approves Quest's use of a subcontractor, SB shall pay the
costs of any testing performed by such third party, as charged by the
third party to Quest.
2 On or prior to the date hereof, Quest has provided to SB a current list
of all laboratory tests Quest is capable of conducting as updated from
time to time, (the "LAB TEST LIST") and a summary of Quest's laboratory
methodology for such tests. Quest shall update such list and such
summaries at least every six
months. If a Study requires a laboratory test not currently included on
the Lab Test List, or if the existing methodology used by Quest for a
particular test on the Lab Test List is not acceptable to SB, and, in
either situation, such test is a significant part of the Study, SB and
Quest shall discuss Quest's ability to validate and perform any new
test or to change test methodology for the Study prior to its
initiation. SB shall use reasonable efforts to notify Quest at a
sufficiently early stage, no less than 12 weeks prior to the Study
initiation, to allow full validation and setup of desired tests. If,
after discussions with Quest, SB determines i) that Quest will not be
able to develop and validate a test in a fashion satisfactory to SB and
in sufficient time prior to the initiation of the Study and suitable
arrangements cannot be made for Quest to use a subcontractor to perform
the test or ii) that the methodology used by Quest for such test is not
acceptable to SB, including Study critical assays, then,
notwithstanding anything else to the contrary in this Agreement, SB
shall not be obligated pursuant to Section II to use (and to cause the
SB Subsidiaries to use) Quest to conduct such Study. SB and Quest shall
negotiate in good faith when determining Quest's ability to validate a
new test or to agree on test methodology. If SB elects pursuant to this
Section to use another laboratory to perform a Study, SB may not use
any laboratory to conduct the Study unless such laboratory also is
required to conduct the relevant laboratory test or use the relevant
methodology which, in each case, was the basis for SB (or an SB
Subsidiary) not using Quest to conduct a Study pursuant to this Section
XII(2).
3 From time to time, Quest may determine it necessary to change existing
methodology and/or reference ranges as a result of modifications in the
type of reagents and/or methodologies or the discontinuance of
materials and/or supplies to support existing equipment. To the extent
practicable, Quest shall notify SB of any such change not less than
thirty days before such change is implemented, together with an
assessment of the potential impact on either validation of assays or
changes in normal ranges for tests. Quest shall not change any
methodology and/or reference ranges during the course of a Study
without the prior written consent of SB. Upon request from SB, Quest
shall provide SB with any and all method comparison data.
4. Quest shall investigate any trends identified during quality control of
its laboratory testing. Quest shall notify SB of such trends and
provide an explanation to SB regarding these trends.
SECTION XIV. LABORATORY EQUIPMENT
1 Quest will ensure at all times that its computer equipment is in good,
working condition and that it has made reasonable provision for backup
equipment to avoid delays in the analysis of SB's specimens.
2 Quest will ensure that any changes in equipment being used in Studies
that will require revalidation of assays or that may have an impact on
normal ranges of tests will be communicated to SB in a timely fashion.
Quest will make no change in laboratory equipment during the course of
a Study that would require revalidation of assays, without the prior
written approval of SB. Quest shall notify SB if a failure in its
equipment causes changes in test results.
4 Quest shall ensure that the reagents and equipment used in performing
any Service hereunder, at all times, are in compliance with the reagent
and equipment standards set forth by applicable regulatory authority's
standards for such equipment and reagents.
SECTION XV. COMPENSATION
1 For laboratory testing Services provided under this Agreement, Quest
shall provide any such laboratory testing Service to SB or an SB
Subsidiary, as specified in each Addendum, at the lower of:
(i) the then lowest price (measured by percent of discount from
Quest's published fee schedule for clinical trials testing
(the "Fee Schedule") (the "Fee Schedule Discount") for such
Service or group of Services being charged by Quest to any
other client in the North American Territory (with respect to
Services to be provided in the North American Territory) or in
the European Territory (with respect to Services to be
provided in the European Territory) (the "Most Favored Nations
Pricing") and
(ii) the price for such Service calculated using a Fee Schedule
Discount off the then applicable Fee Schedule for such Service
or group of Services being charged by Quest to any other
client in the North American Territory (with respect to
Services to be provided in the North American Territory) or in
the European Territory (with respect to Services to be
provided in the European Territory), equal to (a) 32% with
respect to laboratory testing Services performed in the North
American Territory or (b) 20% with respect to laboratory
testing Services performed in the European Territory.
The discount set forth in this Section XV(I) shall apply only to
Studies that SB initiates after the date of this Agreement.
Additionally, the Most Favored Nations Pricing shall be determined on a
test by test basis, such that if Quest provides a 40% discount to a
client for a particular laboratory test in a study, Quest must provide
the same discount to SB for the same test in any Study conducted by SB
or an SB Subsidiary after the date that Quest provided such lower price
to another client, subject to Section XV 2(b) below. Any Service or
group of Services other than a laboratory testing Service shall be
provided to SB or the SB Subsidiaries at a price equal to or less than
the price for such Service or group of Services charged to any other
client of Quest in the North American Territory or in the European
Territory, as the case may be.
2 a) For purposes of calculating, pursuant to Section XV (1), prices
subject to a Fee Schedule Discount, (i) the Fee Schedule for the most
frequently ordered laboratory testing Services performed in 1999 shall
be as set forth in Exhibits C-1 and C-2 attached hereto along with the
discounted price to be charged to SB and (ii) the prices for laboratory
testing Services performed after 1999 shall be as agreed to between SB
and Quest pursuant to Section XV(3). All laboratory testing Services
requested by SB at any time for which fees are not specified in the
Addendum shall be billed in accordance with Quest's then current Fee
Schedule, including the applicable discount, unless otherwise agreed to
by the parties.
b) For purposes of calculating the Most Favored Nations Pricing
pursuant to Section XV(1) during the Term of this Agreement, Quest
shall include all discounts and reductions in price provided to any
client in the North American and European Territories during the prior
twelve-month period (or such lesser period of time if prior to July 30,
2000), excluding any discounts and reductions in price provided by
Quest or SmithKline Xxxxxxx Clinical Laboratories at any time prior to
Quest's acquisition of SmithKline Xxxxxxx Clinical Laboratories. On a
quarterly basis, Quest shall notify SB if any of the pricing offered to
other clients in either the North America or the European Territory is
lower than pricing provided to SB in such Territories in accordance
with this Section XV. If Quest has provided more favorable pricing to a
client other than SB in contravention of this Section XV(1) (the "Other
Client"), SB shall be entitled to receive such Most Favored Nations
Pricing for any test in any Study conducted by SB or an SB Subsidiary
after the date Quest provides such lower price to the Other Client. SB
shall be entitled to receive such Most Favored Nations Pricing only for
the period that Quest extends such pricing to the Other Client. SB
shall have the right to audit Quest's records related to pricing
provided to other clients in accordance with Section XVI for purposes
of ensuring Quest's compliance with this Section XV.
3 On December 1 of each year, Quest shall submit to SB's World Wide
Medical Director a list of the new clinical trials testing prices for
the twelve-month period beginning January 1 of the subsequent year. The
total increase in the new clinical trials testing prices from the prior
year shall equal and not exceed i) in the North American Territory, the
increase in the overall Consumer Price Index for the United States and
(ii) in the European Territory, the increase in the overall Consumer
Price Index for the United Kingdom, in each case during the twelve
month period ending September 30. The limitation on price increases set
forth in this Section XV(3) shall not apply to non-testing charges, or
to changes in test prices resulting from changes in methodology or
equipment; PROVIDED SB is notified in writing of such increases and
approves of them in writing in advance of implementation.
4 If any Study is revised after such Study's materials have been approved
in writing, SB agrees to pay Quest for Services rendered and actual
documented costs incurred in the revision of previously approved Study
materials.
5 If the initiation or conduct of the applicable Study is delayed by SB's
direct actions for more than two months such that specimen collection/
transport supplies and/or specialized testing reagents expire, SB
agrees to pay Quest for Services rendered and actual and documented
costs incurred to replace expired supplies and/or specialized testing
reagents. Quest will provide documentation reasonably evidencing the
replacement of such expired supplies or specialized testing reagents.
6 Quest shall be compensated for supplies properly sent to the
Investigators which were not used due to patient drop-out or
cancellation or termination of any Addendum. Quest will provide
documentation reasonably evidencing the delivery of such supplies.
7 Upon written request from SB, Quest, for an additional charge per
language translation, will translate the Investigator Manual and/or
Summary into languages other than English and Spanish for the U.S. and
English, Spanish, French, Italian, German and Dutch for the European
Territory.
8 Upon request and with two weeks' prior notification from SB, Quest will
provide on-site field service training for protocol initiation and/or
ongoing support. Costs associated with this service (additional
reasonable charge per day plus travel and accommodation expenses) shall
be borne by SB.
9 SB is responsible for the cost of travel and accommodation for Quest's
representatives at Investigator meetings to the extent SB has approved
their
attendance, provided that expenses are incurred in accordance with SB's
travel policy, a copy of which has been provided to Quest.
10 Quest will make available, upon SB's request, professional laboratory
consulting services at SB and/or Investigator sites. Any costs
associated with these services shall be agreed to in advance by Quest
and SB.
11 Inbound transportation will be charged from the Investigator site to
Quest laboratories for actual commercial carrier costs plus a 10%
administrative fee. Outbound transportation of starter kits,
resupplies, dry ice and reports from Quest laboratories to the
Investigator sites will be charged at actual commercial carrier costs
plus a 10% administrative fee. Actual charges for transportation costs
will be reviewed annually, beginning at March 30, 2000 and if necessary
will be renegotiated.
12 In the event that the actual costs to Quest of courier services for (i)
specimen transport, (ii) supply shipment, or (iii) result reporting,
increases at any time during the term of a Study, whether because of an
increase in the fees charged by Quest's proprietary or commercial
courier, an increase in the cost of packaging materials used to ship
specimens, or a mandatory change in applicable regulations, Quest shall
have the right to increase the courier fees quoted herein to the same
extent as the actual increase in the invoiced cost of courier services.
13 Quest shall be compensated at reasonable cost for emergency delivery
and/or transportation Services authorized by SB which are not included
in fees noted in the relevant Addendum.
14 If, at any time, SB chooses to change the level of service provided by
the courier and that change is accompanied by an increase in the fee to
Quest, Quest reserves the right to pass that increase on to SB;
provided, however, that Quest shall make no change that decreases the
level of courier service provided without the consent of SB.
15 Quest will charge SB an annual fee for each Archival Specimen stored on
behalf of SB. The 1999 fees for North American Territory and European
storage are as stated in Exhibit A. Quest will inform SB in writing by
December 1 of each year of the fees for such storage the proposed fees
to be in effect for the subsequent year beginning January 1, if
different than the then-existing prices, and Quest and SB will
negotiate in good faith to agree on such fees as promptly as
practicable after such notification.
16 Quest shall promptly invoice SB for all testing Services provided
hereunder on a monthly basis. All invoices submitted by Quest to SB
shall identify the Services rendered by Study, Investigator's name,
patient designation, tests and testing date. All payments due Quest for
Services provided shall be made to Quest within 30 days of SB's receipt
of an invoice including the above information for Services provided in
the North American Territory and within 45 days of SB's receipt of an
invoice including the above information for Services provided in the
European Territory. SB shall not be required to make payment to Quest
on any invoice unless the invoice contains all information specified
herein.
SECTION XVI. AUDITS, INSURANCE AND PERSONNEL CHANGES
1 FINANCIAL AUDITS. During the Term of this Agreement, and until two
years after its expiration or termination, SB may direct the audit of
any financial records of Quest relating to Services provided under this
Agreement, or any Addenda hereunder. Such records may include invoice
records, invoices from third parties hereto, contracts with third
parties hereto and payments relating to any Studies hereunder. To the
extent that such records are not separable from other customer records
or SB is auditing compliance with the compensation terms of Section XV,
Quest shall give reasonable access to Quest's records to such
independent auditor selected by SB and reasonably agreeable to Quest,
who shall audit the records pertaining to the Addenda, and may disclose
the results of the audit only to the extent that it relates to any
Study hereunder, or to this Agreement. In no event shall other customer
information be disclosed to SB except as a blind basis with respect to
pricing.
2 QUALITY AUDITS. SB, at reasonable times and upon reasonable advance
notice, may, at its sole cost and expense, visit Quest's testing
facilities to conduct quality assurance audits of Quest's facilities
and the procedures implemented for any Study. At its option, SB may
elect to use a third party to conduct such audit. SB or its agent must
sign Quest's standard Confidentiality Agreement at the time of its
visit to Quest's testing facilities. Quest will maintain adequate
records so as to allow SB or its agent to conduct and audit testing
Services relative to Studies as well as Quest's tracking and
measurement of performance metrics for each Study. Quest also shall
maintain records demonstrating the training and qualifications of its
employees. SB shall advise Quest in writing of any special or unusual
record keeping needs for any Study, and Quest will use its reasonable
best efforts to accommodate SB's requirements. Additional charges will
apply for any requirements in excess of Quest's usual record keeping
process; PROVIDED, HOWEVER, that Quest must itemize such charges for SB
in reasonable detail. Quest agrees to maintain such records in
confidence in accordance with applicable laws, rules and regulations.
SB shall notify Quest of any serious
quality deficiencies identified in any SB audit or SB sponsored audit,
and Quest shall have three months from the date of such notification to
remedy such deficiencies. In the event that Quest does not remedy such
deficiencies within such three-month period, SB shall engage a
reputable and experienced third party to audit Quest. If such new audit
confirms the results of SB's or its agent's initial audit, Quest's
failure to remedy such deficiencies shall be deemed to constitute a
Material Breach under this Agreement for purposes of Section XXI.
3 OTHER. Quest shall provide SB with copies of (i) any audits (other than
financial or tax audits) conducted by any regulatory authority, which
audit uncovers significant deficiencies in the quality of Services
provided by Quest to SB or an SB Subsidiary, and (ii) any written
communication by any regulatory authority alleging a failure to comply
with any applicable law or regulation, including any 483 notices
received by Quest from the United States Food and Drug Administration.
4 INSURANCE. Quest agrees to keep and maintain in full force and effect
professional liability and/or comprehensive liability insurance or self
insurance that covers liability arising in connection with the Services
performed under this Agreement with minimum coverage of $2,000,000 for
each occurrence or claim and $30,000,000 in the aggregate annually.
Upon the signing of this Agreement and annually thereafter, Quest
agrees to furnish SB with a current and valid certificate of insurance
or self-insurance evidencing the extent of professional and/or
comprehensive liability coverage.
5 PERSONNEL. To ensure the continuing quality of its Services, Quest
shall notify SB of any changes in key personnel of Quest's clinical
trials business, including any change in the Quest Director or the
liaisons to SB facilities. In addition, Quest shall immediately notify
SB of any change in the Protocol Administrator for a Study.
SECTION XVII. YEAR 2000 COMPLIANCE
Quest hereby represents and warrants that Quest's ability to performs its
obligations or the Services under this Agreement before, during and after the
Year 2000 will not be affected by issues related to Year 2000 compliance. "Year
2000 compliance" requires that the design and performance specifications of the
relevant item shall include: date and century recognition, calculations that
accommodate same century and multi-century formulas and date values, and date
data interface values that reflect the century. In addition to any other rights
and remedies available to SB under this Agreement, Quest's obligation and SB's
remedy for any breach of this warranty shall be for Quest to take all reasonable
steps, including necessary repairs or replacement, to
minimize the impact of the breach on the continuity and quality of performance
of Services to SB and its Affiliates.
Quest shall afford SB at least equal priority with Quest's other preferred
customers in maintaining the continuity and quality of performance of Services,
and shall make diligent and timely efforts to cure any breach of this warranty.
SECTION XVIII. CONFIDENTIALITY AND OWNERSHIP OF SPECIMENS AND DATA
1 During the performance of this Agreement, SB may provide to Quest or
Quest may generate data, test results, Studies, and other information
regarding the drug under Study, or regarding the protocols or other
information relating to research programs being conducted by SB. Quest
understands that SB considers such information to be confidential.
Quest will not use such confidential information except for the purpose
of conducting the Study for SB and will maintain the information in
confidence to the extent that it is not already known to the public and
for such time as it remains unknown to the public. Quest may disclose
such information to only those employees, agents, contractors and
consultants who are reasonably necessary to carry out the terms of this
Agreement and shall take reasonable measures to ensure that such
employees, agents, contractors and consultants maintain the
confidentiality of this information. Quest may disclose such
confidential information to any other laboratory to whom Quest refers
testing as agreed by to by Quest and SB, provided that any such
laboratory shall be obligated in writing to maintain the
confidentiality of such information to the same extent as Quest
hereunder.
2 During the performance of this Agreement, Quest may provide to SB
information regarding Quest's standard operating procedures, processes,
testing procedures, pricing and other information relating to the
clinical trials testing business conducted by Quest. SB understands
that Quest considers such information to be confidential. SB will not
use such confidential information except for the purpose of conducting
its Study and will maintain the information in confidence to the extent
it is not already known to the public and such information remains
unknown to the public. SB may disclose such confidential information to
only those employees, agents, contractors and consultants who are
reasonably necessary to carry out the terms of this Agreement and shall
take reasonable measures to ensure that such employees, agents,
contractors and consultants maintain the confidentiality of this
information.
3 To the extent confidential information is already known to the public
or becomes known to the public from any source other than the party
bound hereunder by this obligation of confidentiality, there shall be
no obligation of confidentiality. The
obligation of confidentiality as set forth in this paragraph shall
survive for ten years following the termination of this Agreement. Upon
termination of this Agreement, all documents containing confidential
information shall be returned to the party who disclosed the
confidential information within sixty days of a written request.
4 All right, title, and interest in and to any specimens obtained by SB
during the course of any Study and any data generated from any Study,
whether by SB or its Affiliates, an Investigator, subcontractor or
other Person or by Quest in the course of providing Services pursuant
to this Agreement are the proprietary rights of SB and its Affiliates,
and all ownership rights in such specimens and data shall remain with
SB and its Affiliates. Nothing herein or in any Addendum shall grant or
be deemed to grant to Quest any rights in such property of SB or its
Affiliates. Quest acknowledges and agrees that it shall have no claim
to any specimens or data obtained by SB or its Affiliates or generated
on its behalf by Quest or any Investigator, subcontractor, agent or
Person during the course of any Study. Upon request of SB, Quest shall
return all specimens and data to SB; PROVIDED, HOWEVER, that Quest may
retain copies of any data necessary to satisfy applicable regulatory
requirements.
SECTION XIX. CANCELATION
In the event that a Study is canceled by SB after Quest has been authorized to
render start-up Services, including (i) the purchase of specialized testing
reagents and/or supplies, (ii) preparation and/or distribution of specimen
collection/transport supplies, or (iii) protocol administration and/or data
management Services, Quest, at its sole option, may charge SB, and SB agrees to
reimburse Quest, for actual Services rendered and actual costs incurred in the
set-up of the Study in each case, upon receipt by SB of reasonable documentation
evidencing such Services and such costs.
SECTION XX. TERM AND OBLIGATIONS SURVIVING TERMINATION
1 The Term of this Agreement shall commence on the date hereof and shall
end on the earlier to occur of (i) the tenth anniversary of the date
hereof and (ii) the date this Agreement is otherwise terminated
pursuant to its terms.
2 If this Agreement is terminated, this Agreement shall become void and
of no further force or effect, except that (i) the obligations set
forth in this Agreement (including in the Addenda) with respect to any
Study which has not been completed at the time of such termination and
(ii) the obligations set forth in Sections XV, XVI, XVIII, XX and XXII
shall, in each case, survive such
termination, unless otherwise separately terminated or canceled in
writing by SB and Quest; PROVIDED, HOWEVER, that in the event that this
Agreement is terminated by SB as a result of a Material Breach, SB may
elect, in its sole discretion, also to terminate any Study which has
not been completed at the time of such termination with no further
obligation to Quest except for liabilities accrued but unpaid at the
time of such termination.
SECTION XXI. MATERIAL BREACH
1 A "MATERIAL BREACH" by Quest of this Agreement means any of the
following:
1.1 Any failure to provide Services with respect to any Study pursuant
to the terms of this Agreement which failure results (or, if after SB
becomes aware of such failure, without the use of substantial resources
of SB not initially planned or budgeted and not reimbursed by Quest
would have caused) a substantial delay, which delay is caused solely by
the failure of Quest to provide Services under this Agreement, in any
of
(a) the initiation or completion of the conduct of a Study
that is pivotal to SB or an SB Subsidiary; provided, however,
that SB shall advise Quest at the quarterly Oversight Team
meetings of the Studies which it deems to be pivotal;
(b) the completion of the reporting of the laboratory results
of such Study or of a clinical Study report or other
regulatory submission for such Study;
(c) the acceptance by the relevant regulatory authority of the
results of such Study, clinical Study report or regulatory
submission for such Study; or
(d) the completion of the regulatory review process (E.G.,
such failure results in additional for-cause audits or
regulatory questions related to laboratory issues);
1.2 Any failure to satisfy, in any material respect, the U.S. Clinical
Laboratory Improvements Amendments (CLIA 88), or good clinical
laboratory practices or generally accepted industry standards for
quality assurance and quality control, including the standards set
forth in the United States Federal Food, Drug and Cosmetics Act or
promulgated by the College of American Pathologists, or any failure by
Quest promptly to remedy any deficiencies uncovered in any audit by the
FDA or equivalent European regulatory authority which jeopardizes
Quest's license to operate a clinical laboratory;
1.3 Repeated and continued failure to provide Services pursuant to the
terms of this Agreement which failures are not promptly resolved after
notice from SB, including, without limitation:
a) repeated and continued failures to satisfy in any material
respect the requirements of this Agreement with respect to
data management and reporting of test results;
b) repeated and continued failure to satisfy the standards or
requirements for Study preparation, management or conduct in
this Agreement (E.G., the timely and accurate provision of
supplies and materials and maintaining the Study Blind);
c) the failure, with respect to 5% of Studies within any 12
month period, to provide 90% of the testing sites for any such
Studies with the supplies required for such Study in the
implementation time specified in this Agreement for such
Studies;
d) any error in, or repeated and continued failure in quality
of, Services provided by Quest under this Agreement which
causes Investigators for any Study to withdraw their
participation in any Study;
1.4 Any Material Breach that occurs pursuant to Section XVI(2); and
1.5 Any other material breach by Quest of the terms of this Agreement.
2 A "MATERIAL BREACH" by SB means any material breach by SB of the terms
of this Agreement.
3 REMEDIES FOR MATERIAL BREACH.
3.1 REMEDIES. In the event of a Material Breach under Sections XXI
(1.2) through XXI (1.5), provided Quest has failed to cure the breach
(if curable) within the cure period set forth below in Section XXI (4),
or in the event of a Material Breach by Quest pursuant to Section XXI
(1.1), SB may terminate this Agreement immediately or, in its sole
discretion, terminate only its obligation in Section II to exclusively
use Quest without terminating the entire Agreement, or terminate in the
geographic area where the Material Breach occurred; HOWEVER, that to
the extent that a Material Breach relates solely to Services of Quest
in the European Territory, SB may only terminate this Agreement with
respect to Studies in the European Territory or, in its sole
discretion, terminate only all its obligations in Section II to
exclusively use Quest in the European Territory;
PROVIDED, HOWEVER, that if, upon the occurrence of a Material Breach,
SB elects, in its sole discretion, to terminate only its obligations in
Section II to exclusively use Quest (whether with respect to the North
American Territory and/or the European Territory) without terminating
the entire Agreement, to the extent SB continues to use Quest to
conduct any Studies in the North American Territory or the European
Territory, as the case may be, after such termination, such Studies
shall be conducted pursuant to the terms set forth in this Agreement.
Notwithstanding the foregoing, if SB elects to terminate its
obligations to exclusively use Quest in the event of a Material Breach,
SB and Quest shall renegotiate the compensation provided by SB for
Services provided under this Agreement.
3.2 ADDITIONAL REMEDIES FOR MATERIAL BREACH. If there is a Material
Breach by either party under this Agreement, which breach is not cured
pursuant to Section XXI (4), the non-breaching party shall be entitled
to any and all remedies available at law and equity or under this
Agreement, including, without limitation, injunctive relief against the
breaching party to require it to comply with its obligations under this
Agreement.
4 CURE PERIODS RELATED TO BREACH. For any Material Breach by SB and any
Material Breach by Quest pursuant to Sections XXI (1.2) through (1.5),
the non-breaching party shall provide notice to the breaching party of
the Material Breach, with 30 days to cure such breach. If the Material
Breach is cured during the 30 day period (or if not curable within a 30
day period, the breaching party has commenced the cure and continues to
diligently work, meeting mutually agreed to milestones, to cure the
breach), the notice of breach will be deemed withdrawn. Any Material
Breach by Quest pursuant to Section XXI (1.1) shall not be subject to
the cure period specified herein and, upon the occurrence of such
Material Breach, SB may immediately terminate this Agreement or
exercise its rights as provided in Section XXI (3) above.
5. FORBEARANCE IN DECLARING MATERIAL BREACH. SB agrees that it shall not
terminate this Agreement in the event of a Material Breach (i) for the
three month period commencing on the date of this Agreement or (ii) for
the six-month period commencing on the date of this Agreement if such
breach is the result of Quest's repeated and continued failure to
comply with the Performance Metrics and Measurements set forth in
Exhibit D. Notwithstanding the foregoing, SB may notify Quest of a
Material Breach during such three-month or six-month period, including
any failure to comply with the Performance Metrics and Measurements set
forth in Exhibit D, and Quest shall use its best efforts to remedy any
breaches and failures in the quality of Services provided to SB or an
SB Subsidiary during such three- month or six-month period.
SECTION XXII. INDEMNIFICATION
1 INDEMNIFICATION BY QUEST. Quest agrees to defend, indemnify and hold
harmless SB, its Affiliates, and their respective officers, directors,
employees, stockholders, agents and representatives from claims,
demands, costs, expenses (including reasonable attorney's fees) and
liabilities or losses (collectively, "LOSSES") which may be asserted
against or incurred by SB, its Affiliates, and their respective
officers, directors, employees, stockholders, agents and
representatives, caused or alleged to be caused by Quest, or its
respective Affiliates, officers, directors, employees, agents or
representatives in providing Services under the terms of the Agreement;
PROVIDED, HOWEVER, that Quest shall have no liability under this
Section XXII(1) to the extent such Loss arises solely as a result of
any negligent, improper or illegal act or failure to act on the part of
SB, its Affiliates or their respective officers, directors, employees,
stockholders, agents, or representatives.
2 INDEMNIFICATION BY SB. SB agrees to defend, indemnify and hold harmless
Quest, its respective Affiliates, officers, directors, employees,
stockholders, agents and representatives from any and all Losses which
may be asserted against Quest, its respective Affiliates, officers,
directors, employees, stockholders, agents and representatives which
result from or arise out of (i) the manufacture, distribution, sale or
use in any manner of the pharmaceutical compound being tested by Quest,
or (ii) the conduct of clinical trials by SB, its Affiliates, or their
respective officers, directors, employees, agents or representatives;
PROVIDED, HOWEVER, that SB shall not have any liability under this
Section XXII(2) to the extent such Loss arises solely as a result of
any negligent, improper or illegal act or failure to act on the part of
Quest, or its respective Affiliates, officers, directors, employees,
stockholders, agents, or representatives.
3 LIMITATIONS ON QUEST'S LIABILITY. Notwithstanding Sections XXII (1),
the liability of Quest under this Agreement shall be no greater than:
(i) in the case where Quest's breach has not rendered a Study
invalid, a reduction in the total contract price for the Study
in an amount equal to the difference between (a) the total
contract price for the Study and (b) the value of the work
properly performed; and
(ii) in the case where Quest's breach renders a Study invalid, a
refund of the total contract price paid by SB or an SB
Subsidiary to Quest, plus the difference in such contract
price and any additional, commercially reasonable amounts that
SB or an SB Subsidiary must incur to have the
Study performed over; provided, however, that any Study that
SB shall have performed over shall be performed using similar
standards that were required by SB or an SB Subsidiary of
Quest initially for the Study. In such a situation where
Quest's breach renders a Study invalid, SB or the SB
Subsidiary shall have the option to have Quest re-perform the
Study at no additional expense to SB or the SB Subsidiary or,
alternatively, to have a clinical laboratory other than Quest
perform the Study. If SB or the SB Subsidiary elects to have
another laboratory perform the Study, SB and the SB Subsidiary
shall be released from the obligations under Section II to use
Quest on an exclusive basis, but only for the particular Study
that was invalidated by Quest's breach.
UNDER NO CIRCUMSTANCES SHALL SB BE ENTITILED TO, NOR SHALL QUEST BE
RESPONSIBLE FOR, ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL
DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS) ARISING AS A
RESULT OF OR IN CONNECTION WITH QUEST'S DEFAULT OR BREACH OF ITS
OBLIGATIONS UNDER THIS AGREEMENT OR ANY GIVEN STUDY, OR ANY DOCUMENTS
RELATED THERETO.
4. LIMITATION ON SB'S LIABILITY. Notwithstanding Section XXII (2), should
SB terminate this Agreement as a result of the repeated and continued
failure of Quest to provide Services in accordance with the generally
accepted quality standards in the clinical trials laboratory testing
industry, which failure does not rise to the level of a Material Breach
under section XXI (1), the liability of SB under this Agreement,
including any liability for incidental, indirect, consequential or
special damages, including, without limitation, lost profits of Quest,
shall be no greater than $ 30 million.
5 PROCEDURES RELATING TO INDEMNIFICATION OF THIRD PARTY CLAIMS. In order
for a party (the "INDEMNIFIED PARTY") to be entitled to any
indemnification provided for under this Agreement in respect of,
arising out of or involving a claim or demand made by any Person
against the indemnified party (a "THIRD PARTY CLAIM"), such indemnified
party must notify the indemnifying party in writing, and in reasonable
detail, of the Third Party Claim within 15 business days after receipt
by such indemnified party of written notice of the Third Party Claim;
PROVIDED, HOWEVER, that failure to give such notification shall not
affect the indemnification provided hereunder except to the extent the
indemnifying party shall have been actually prejudiced as a result of
such failure (except that the indemnifying party shall not be liable
for any expenses incurred during the period in which the indemnified
party failed to give such notice). Thereafter, the indemnified party
shall deliver to the indemnifying party, within five business days
after the indemnified party's
receipt thereof, copies of all notices and documents (including court
papers) received by the indemnified party relating to the Third Party
Claim.
If a Third Party Claim is made against an indemnified party, the
indemnifying party shall be entitled to participate in the defense
thereof and, if it so chooses and acknowledges its obligation to
indemnify the indemnified party therefor, to assume the defense thereof
with counsel selected by the indemnifying party; PROVIDED that such
counsel is not reasonably objected to by the indemnified party. Should
the indemnifying party so elect to assume the defense of a Third Party
Claim, the indemnifying party shall not be liable to the indemnified
party for legal expenses subsequently incurred by the indemnified party
in connection with the defense thereof. If the indemnifying party
assumes such defense, the indemnified party shall have the right to
participate in the defense thereof and to employ counsel, at its own
expense, separate from the counsel employed by the indemnifying party,
it being understood that the indemnifying party shall control such
defense. The indemnifying party shall be liable for the fees and
expenses of counsel employed by the indemnified party for any period
during which the indemnifying party has failed to assume the defense
thereof (other than during the period prior to the time the indemnified
party shall have given notice of the Third Party Claim as provided
above).
If the indemnifying party so elects to assume the defense of any Third
Party Claim, all of the indemnified parties shall cooperate with the
indemnifying party in the defense or prosecution thereof. Such
cooperation shall include the retention and (upon the indemnifying
party's request) the provision to the indemnifying party of records and
information which are reasonably relevant to such Third Party Claim,
and making employees available on a mutually convenient basis to
provide additional information and explanation of any material provided
hereunder. Whether or not the indemnifying party shall have assumed the
defense of a Third Party Claim, the indemnified party shall not admit
any liability with respect to, or settle, compromise or discharge, such
Third Party Claim without the indemnifying party's prior written
consent (which consent shall not be unreasonably withheld). If the
indemnifying party shall have assumed the defense of a Third Party
Claim, the indemnified party shall agree to any settlement, compromise
or discharge of a Third Party Claim which the indemnifying party may
recommend and which by its terms obligates the indemnifying party to
pay the full amount of the liability in connection with such Third
Party Claim, which releases the indemnifying party completely in
connection with such Third Party Claim.
The indemnification required by this Section XXII shall be made by
periodic payments of the amount thereof during the course of the
investigation or defense, as and when bills are received or loss,
liability, claim, damage or
expense is incurred. All claims under this Section XXII other than
Third Party Claims shall be governed by Section XXII(6).
6 PROCEDURES RELATING TO OTHER CLAIMS. In the event any indemnified party
should have a claim against any indemnifying party under this Section
XXII that does not involve a Third Party Claim being asserted against
or sought to be collected from such indemnified party, the indemnified
party shall deliver notice of such claim with reasonable promptness to
the indemnifying party. The failure by any indemnified party to so
notify the indemnifying party shall not relieve the indemnifying party
from any liability which it may have to such indemnified party under
this Section XXII, except to the extent that the indemnifying party
demonstrates that it has been materially prejudiced by such failure. If
the indemnifying party does not notify the indemnified party within 30
calendar days following its receipt of such notice that the
indemnifying party disputes its liability to the indemnified party
under this Section XXII, such claim specified by the indemnified party
in such notice shall be conclusively deemed a liability of the
indemnifying party under this Section XXII and the indemnifying party
shall pay the amount of such liability to the indemnified party on
demand or, in the case of any notice in which the amount of the claim
(or any portion thereof) is estimated, on such later date when the
amount of such claim (or such portion thereof) becomes finally
determined. If the indemnifying party has timely disputed its liability
with respect to such claim, as provided above, the indemnifying party
and the indemnified party shall proceed in good faith to negotiate a
resolution of such dispute and, if not resolved through negotiations,
such dispute shall be resolved by litigation in an appropriate court of
competent jurisdiction.
SECTION XXIII. ASSIGNABILITY AND AMENDMENTS
1 This Agreement and the rights and obligations hereunder shall not be
assignable in whole or in part by any party without the prior written
consent of the other parties hereto (such consent not to be
unreasonably withheld or delayed); PROVIDED, HOWEVER, that (i) subject
to clause (ii) below, any party may assign its rights and obligations,
in whole or in part, to an Affiliate of such party which (a) is
Controlled by such party and (b) agrees in writing to be bound by the
terms of this Agreement (including clause (ii) below); provided,
however, that if SB assigns this Agreement to an Affiliate, the
Agreement will continue to be applicable to SB and the SB Subsidiaries,
and (ii) upon such assignee ceasing to be an Affiliate of such party or
an Affiliate Controlled by such party, such rights and obligations must
be assigned back to such party or to another permitted assignee of such
party and, in any event, the parties hereto agree that the original
assignment shall have no further force and effect. Any transaction or
series of transactions by which Quest or any of its respective
Affiliates transfers,
directly or indirectly, responsibility for, control of, or ownership
of, the operations of Quest's clinical trials business, or other
business division or Quest Affiliate providing Services pursuant to
this Agreement, to a third party, including through a management
contract, a sale of assets, a business combination, liquidation,
dissolution, merger or other transaction, shall constitute an
assignment requiring SB's prior written consent (such consent not to be
unreasonably withheld or delayed). Should SB withhold its consent to
any transfer by Quest described above, and Quest elects to continue
with such transfer, SB shall have the right to immediately terminate
this Agreement. Any attempted assignment in violation of this Section
XXIII shall be void.
2 No amendment, modification or waiver of this Agreement shall be
effective unless it shall be in writing and signed by all the parties
hereto.
SECTION XXIV. CHANGE IN CONTROL OF SB
1. In the event of a Change in Control of SB, the successor company to SB
as a result of such Change in Control (the "Successor Company") shall
be required to conduct Studies under this Agreement for any
pharmaceutical compound which immediately prior to the date of such
Change in Control (the "Change of Control Date") (i) SB or any SB
Subsidiary owns or has interests in, or (ii) is in development by SB or
any SB Subsidiary (the "Existing SB Compounds"), in each case to the
extent such Studies are required by the terms of Section II; provided,
however, that, in any event, the Successor Company shall be required to
continue to conduct Studies under this Agreement such that on an annual
basis the revenues paid to Quest are at or above the Annual Minimum, as
defined below in Section XXIV(2). One month following each anniversary
following the Change of Control Date, Quest will xxxx SB, and SB shall
pay to Quest the Annual Minimum, less the revenues actually billed by
Quest and paid by SB in the twelve months prior to such anniversary.
2. The "Annual Minimum" for a twelve-month period shall be defined and
determined as follows:
(i) an amount equal to the average of the revenues actually paid
by SB to Quest in the three years preceding the Change of
Control Date for Services under this Agreement (or, in the
event that the Change of Control Date is less than three years
after the date hereof, the intercompany transfers between SB
and SmithKline Xxxxxxx Clinical Laboratories, Inc. for such
services shall be deemed to be revenues)(the "Initial
Minimum"); plus
(ii) for the first twelve month period, an increase of 10% over the
Initial Minimum; or
(iii) for subsequent twelve month periods, an increase of 10% over
the calculated prior Annual Minimum.
3. For the avoidance of doubt and notwithstanding the foregoing, in the
event of a Change in Control of SB, no Successor Company or any Person
which otherwise becomes an Affiliate of SB as a result of such Change
in Control shall be required to conduct any Studies under this
Agreement except with respect to Existing SB Compounds.
SECTION XXV. GOVERNING LAW
This Agreement shall be construed, interpreted and enforced under the laws of
the State of Delaware, regardless of the laws that might otherwise govern under
applicable principles of conflicts of laws thereof.
SECTION XXVI. INTERPRETATION
1 The headings contained in this Agreement, in any Exhibit hereto, in any
Addendum executed pursuant to this Agreement and in the table of
contents to this Agreement are for reference purposes only and shall
not affect in any way the meaning or interpretation of this Agreement.
All Exhibits annexed hereto or referred to herein and all Addenda
executed pursuant to this Agreement are hereby incorporated in and made
a part of this Agreement as if set forth in full herein (E.G., any
requirement for Quest to perform Services for any Study "pursuant to
the terms set forth in this Agreement," is a requirement to perform
such Services as set forth in the terms included in all Sections of
this Agreement, in the relevant Addendum (including the relevant CLW)
and in any Exhibit or Schedule to this Agreement). Any capitalized
terms used in any Exhibit or Addendum but not otherwise defined
therein, shall have the meanings set forth in this Agreement.
2 The definitions of the terms herein shall apply equally to the singular
and plural forms of the terms defined. Whenever the context may
require, any pronoun shall include the corresponding masculine,
feminine and neuter forms. The words "include", "includes" and
"including" shall be deemed to be followed by the phrase "without
limitation". The word "will" shall be construed to have the same
meaning and effect as the word "shall". Unless the context requires
otherwise (A) any definition of or reference to any agreement,
instrument or other document herein shall be construed as referring to
such agreement, instrument or other document as from time to time
amended, supplemented or otherwise
modified (subject to any restrictions on such amendments, supplements
or modifications set forth herein), (B) any reference herein to any
Person shall be construed to include the Person's successors and
permitted assigns, (C) the words "herein", "hereof" and "hereunder",
and words of similar import, shall be construed to refer to this
Agreement in its entirety and not to any particular provision hereof,
and (D) all references herein to paragraphs, Sections, Exhibits, or
Addenda shall be construed to refer to paragraphs, Sections, Exhibits,
Schedules and Addenda of this Agreement.
3 All references to Quest's laboratory in the United Kingdom are hereby
deemed to be references to any replacement laboratory Quest may
establish in the future.
SECTION XXVII. ENFORCEMENT
1 Each party irrevocably submits to the exclusive jurisdiction of (i) any
Federal court located in the State of New Jersey and (ii) any New
Jersey state court, for the purposes of any suit, action or other
proceeding arising out of this Agreement or any transaction
contemplated hereby. Each party agrees to commence any action, suit or
proceeding relating hereto either in a Federal Court located in the
State of New Jersey or in a New Jersey state court. Each party further
agrees that service of any process, summons, notice or document by U.S.
registered mail to such party's address as listed in Section XXVIII
shall constitute effective service of process for any action, suit or
proceeding in New Jersey with respect to any matters to which it has
submitted to jurisdiction in this Section XXVII. Each party irrevocably
and unconditionally waives any objection to the laying of venue of any
action, suit or proceeding arising out of this Agreement or the
transactions contemplated hereby in (i) any Federal court located in
the State of New Jersey or (ii) any New Jersey state court, and hereby
further irrevocably and unconditionally waives and agrees not to plead
or claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient forum.
2 Each party hereby waives to the fullest extent permitted by applicable
law, any right it may have to a trial by jury in respect to any
litigation directly or indirectly arising out of, under or in
connection with this Agreement or any transaction contemplated hereby.
Each party (i) certifies that no representative, agent or attorney of
any other party has represented, expressly or otherwise, that such
other party would not, in the event of litigation, seeks to enforce
that foregoing waiver and (ii) acknowledges that it and the other
parties hereto have been induced to enter into this Agreement by, among
other things, the mutual waivers and certifications in this Section
XXVII.
SECTION XXVIII. NOTICES
All notices permitted or required to be given under the terms of this Agreement
shall be deemed to have been given when sent by telex or facsimile followed by
letter to the respective addresses of each party as indicated as set forth below
(or any new addresses with which as either party may provide the other party in
writing from time to time):
If to Quest: Quest Diagnostics Incorporated
Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
Attn: Vice President of Sales
With a required copy to:
Quest Diagnostics Incorporated
Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
Attn: General Counsel
000-000-0000
000-000-0000 (fax)
If to SB: SmithKline Xxxxxxx Pharmaceuticals
Research and Development
000 Xxxxxxxxx Xxxx, XX0000
Xxxx xx Xxxxxxx, XX 00000
Attn: Xxxxxxx Xxxxxxxx, M.D.
Senior Vice President and Director
Clinical Research and Development
and
SmithKline Xxxxxxx Pharmaceuticals
Research and Development
New Frontiers Science Park
The Pinnacles
Harlow, Essex CM 19 5AW
U.K.
Attn: Xxxxx Waltham, Ph.D.
Director
Clinical Development Contract Management
With a required copy to:
SmithKline Xxxxxxx Corporation
Corporate Law Department
One Franklin Plaza
000 X. 00xx Xxxxxx
Xxxxxxxxxxxx, XX 00000
Attn: General Counsel-U.S.
000-000-0000
000-000-0000 (fax)
SECTION XXIX. TERMINATION OF EXISTING AGREEMENT
SB shall terminate the Global Service Level Agreement for Clinical Trials
Laboratory Testing and Services dated January 8, 1999, such that upon the date
of this Agreement, this Agreement shall constitute the entire agreement between
Quest and SB regarding the subject matter hereof.
[Signatures continue on next page]
IN WITNESS WHEREOF, SB and Quest have duly executed this
Global Clinical Trials Agreement on the first day above written.
SMITHKLINE XXXXXXX PLC
By /s/ Xxxxxx X. Xxxxxx
---------------------------------
Name: Xxxxxx X. Xxxxxx
Title: Authorized Signatory
By
---------------------------------
Name:
Title:
QUEST DIAGNOSTICS INCORPORATED
By /s/ Xxxxxxx X. Xxxxxxx
---------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Chief Executive Officer
By
---------------------------------
Name:
Title:
