Confidential Treatment
Exhibit 10.1
PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECRETARY OF THE COMMISSION PURSUANT TO REGISTRANT’S
APPLICATION OBJECTING TO DISCLOSURE AND REQUESTING CONFIDENTIAL
TREATMENT UNDER RULE 24b-2. THE OMITTED PORTIONS HAVE BEEN MARKED
WITH BRACKETS.
EXCLUSIVE MARKETING AGREEMENT
This Exclusive Marketing Agreement
(this “ Agreement ”) is made this 27th day of
November, 2007, by and between Covance Inc., a Delaware corporation
(“ Parent ”), and eResearchTechnology, Inc., a
Delaware corporation (“ eRT ”).
WHEREAS, eRT is engaged in the
provision of the Services (as hereinafter defined); and
WHEREAS, eRT and Parent desire to
enter into an agreement relating to the joint marketing of the
Services, the potential referral of other business between Parent
and its subsidiaries (collectively, “ Covance ”)
and eRT, non-competition and the other matters referred to
herein.
NOW THEREFORE, for and in
consideration of the mutual promises contained herein, and other
good and valuable consideration, the receipt and legal sufficiency
of which is hereby acknowledged by the parties, the parties agree
as follows:
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Definitions . |
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As used in this Agreement, the following terms, whether used in
the singular or the plural, shall have the following respective
meanings: |
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1.1 |
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“Affiliate” shall mean any Person,
from to time, which directly or indirectly through one or more
intermediaries either controls, or is controlled by or is under
common control with, the Person specified. |
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1.2 |
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“Audit” shall mean an audit of the
Services, in the case of eRT, and an audit of any services provided
by Covance, in the case of Covance. |
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1.3 |
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“Backlog” means each written Contract
identified on Section 3.4(g) of the Disclosure Schedule of
that certain Share Purchase Agreement by and among eRT, Parent,
Covance Central Laboratory Services Limited Partnership and the
Company dated as of the date hereof. For the avoidance of doubt,
the “Backlog” does not include any Contracts entered
into after September 30, 2007; provided, that, only Revenues
received after the effective date of this Agreement may be deemed
Relevant Revenues. |
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1.4 |
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“Business” shall mean eRT’s
ongoing efforts to sell the Services, but shall not include any
other business activities engaged in by eRT from time to time. |
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1.5 |
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“Claims” shall have the meaning
specified in Section 5. |
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1.6 |
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“Company” shall mean Covance Cardiac
Safety Services Inc., a Pennsylvania corporation. |
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1.7 |
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“Confidential Information” shall have
the meaning specified in Section 7. |
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1.8 |
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“Covance Relationship Manager” shall
mean the individual appointed by Covance from time to time pursuant
to Section 2.3.1. The initial Covance Relationship Manager
shall be identified on Schedule 2.3.1 to this Agreement. |
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1.9 |
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“Covance Sales Manager” shall mean
the individual appointed by Covance from time to time pursuant to
Section 2.3.2. The initial Covance Sales Manager shall be
identified on Schedule 2.3.2 to this Agreement. |
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1.10 |
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“Critical Finding” shall mean, with
respect to any Party, a finding made in an audit report, based on
the results of an Audit, with respect to Services, in the case of
eRT, and any services provided by Covance, in the case of Covance,
prepared by the other Party, its Affiliates or any third party
which is characterized as critical, and which (i) identifies
any deficiency of such Party posing a threat to patient safety,
(ii) is reasonably likely to result in materially adverse
regulatory action by any Governmental Authority with respect to
such Party, (iii) is reasonably likely to invalidate the
acceptability of any Study involving the Services, in the case of
eRT, or any services provided by Covance with respect to such
Study, in the case of Covance, to any Customer or to any
Governmental Authority; provided, however, that neither
Covance nor any Person shall be permitted to characterize as
critical, for purposes of the definition of “Critical
Finding,” (a) any conduct of the business of the Company
after the effective date of this Agreement, relating to a study set
forth in the Backlog, that eRT reasonably believes to be consistent
with the manner the Company conducted its business before the
effective date of this Agreement, including, for the sake of
clarity, conduct of the Company after the effective date of this
Agreement consistent with the finding of any regulatory audit
before the effective date of this Agreement or (b) any finding
with respect to Services provided by the Company, unless such
finding represents a meaningful and material degradation that
occurred after the effective date of this Agreement. |
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1.11 |
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“Cure Period Expiration Date” shall
have the meaning specified in Section 8.1.1. |
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1.12 |
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“Customer” shall mean any customer or
prospective customer of Covance or its Affiliates. |
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1.13 |
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" Damages Cap ” shall have the meaning
specified in Section 6.2. |
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1.14 |
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“Documented Lead” shall mean any lead
or other information, based on a request by a Customer, for
Services that is communicated in writing by Covance to eRT that
subsequently results in verifiable Relevant Revenues to eRT, other
than leads or other information known to eRT at the time of such
communication as demonstrated by eRT’s prior written records.
eRT shall be deemed to have knowledge of any lead or other
information concerning any opportunity known to a member of its
sales force as demonstrated by eRT’s prior written records.
For purposes of tracking Documented Leads, the Relationship
Managers will meet weekly (or as otherwise determined by the
Parties) to review a list of trials and other potential sources of
leads, and will maintain a process for identifying and tracking
Documented Leads. |
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1.15 |
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“eRT Excluded Customer” shall mean
the Persons identified on Schedule 1.15. |
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1.16 |
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“eRT Relationship Manager” shall mean
the individual appointed by eRT from time to time pursuant to
Section 2.4.1. The initial eRT Relationship Manager shall be
identified on Schedule 2.4.1 to this Agreement. |
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1.17 |
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“Exclusivity Period” shall have the
meaning specified in Section 3.7. |
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1.18 |
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“FDA” shall mean the United States
Food and Drug Administration. |
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1.19 |
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“Governmental Authority” shall mean
any governmental department, commission, board, bureau, agency,
court or other instrumentality of the United States or any other
country, including but not limited to federal, state, district,
territory, possession or commonwealth thereof, as well as any
entity with the authority to grant or issue licenses or permits
necessary to competently perform the Services. |
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1.20 |
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“Implementation Plan” shall have the
meaning specified in Section 3.4. |
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1.21 |
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“Independent Third-Party Auditor”
shall mean an auditor, not an Affiliate of either of the Parties,
and experienced in quality assurance and other audits related to
the provision of services in clinical trials, appointed by Covance
for the purposes set forth in Section 8.1.1 of this Agreement
and approved by eRT in its reasonable discretion; provided,
however, that in the event that eRT does not, in its reasonable
discretion, approve any auditor chosen by Covance for the purposes
set forth in Section 8.1.1, then, within thirty (30) days
following the date that Covance originally designated such
potential auditor, each of Covance and eRT shall request that their
independent public accountants engage a mutually acceptable auditor
to act as the Parties auditor with respect to Section 8.1.1.
The findings of any Independent Third-Party Auditor designated
pursuant to this Agreement shall be final, binding and conclusive
on the Parties. |
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1.22 |
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“Joint Bid” shall mean any response
to request for proposal, bid or other offer of services by Covance
which includes, subject to Section 3.1, Services to be
provided by eRT. |
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1.23 |
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“Losses” shall have the meaning
specified in Section 5. |
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1.24 |
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“Party” shall mean eRT or
Covance. |
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1.25 |
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“Person” shall mean an individual, a
corporation, a limited liability company, a partnership (including
without limitation a joint venture), an unincorporated association,
a trust or any other entity or organization, including but not
limited to a government or political subdivision or any agency or
instrumentality thereof. |
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1.26 |
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“Potential Termination Event” shall
mean the occurrence and continuation beyond any available cure
period of any event, circumstance or condition set forth in Section
8.1 or 8.1.1. |
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1.27 |
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“Relationship Managers” shall mean
the eRT Relationship Manager and the Covance Relationship
Manager. |
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1.28 |
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“Relevant Revenues” shall mean
Revenues when and to the extent received by eRT or the fair value
of other compensation received by eRT resulting from Documented
Leads from Covance or Joint Bids, as reduced by sales taxes, value
added taxes or other similar taxes, and excluding all pass-through
charges; provided, however, that Relevant Revenues shall
exclude amounts received by eRT on account of Backlog. To the
extent that the customer identified on Schedule 1.28 (the
“ Schedule 1.28 Customer ”) enters into a
written and legally binding contract with respect to the study and
for a dollar amount within thirty-three percent (33%) of, or more
than, the dollar value of Services (identified on
Schedule 1.28 with such study), and eRT recognizes any ECG
Revenues under such contract, on or before May 31, 2008 (the
“ Contract Date ”), “Relevant
Revenues” shall be deemed to include Revenues received by eRT
in accordance with the definition of “Relevant
Revenues” on or after the date hereof, and eRT shall pay to
Covance, on or before April June 30, 2008, any referral fees
then owed to Covance on account of such Relevant Revenues received
by eRT between and including the date hereof and on and including
December 31, 2007. In the event that the Schedule 1.28
Customer does not enter into a written and legally binding contract
on or before the Contract Date, “Relevant Revenues”
shall be deemed to include Revenues received by eRT in accordance
with the definition of “Relevant Revenues” after
December 31, 2007. |
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1.29 |
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“Revenues” means revenues received or
the fair value of other compensation received, as reduced by sales
taxes, value added taxes or other similar taxes, and excluding all
pass-through charges, as such is in accordance with GAAP applied
consistently with prior periods. |
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1.30 |
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“Services” shall mean centralized
electrocardiogram, Holter monitoring, diagnostic services and other
similar centralized diagnostic services, in each case to the extent
involving, in whole or in part, the measurement and/or
interpretation of human electrophysiological or other cardiac
signals as applicable in the conduct of clinical trials (including
“for fee” cardiologist, protocol design, |
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statistical, and reporting consultation services used
specifically in the business of eRT as currently conducted), and
any technical or other innovations to any of the foregoing, such as
web-based data access. Services shall not include any
non-centralized diagnostic services performed by any Clinical
Research Unit as part of routine safety patient monitoring.
However, notwithstanding the limitation contained in the
immediately preceding sentence, in all cases, without limitation,
Thorough QT/QTc electrocardiology trials (TQT as defined by FDA ICH
E14 Guidance) and intensive as well as routine electrocardiogram
trials will be included in Services. |
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1.31 |
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“Study” shall mean any clinical trial
or study, as expanded, contracted or otherwise modified from time
to time. |
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1.32 |
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“Subcontracting Agreement” shall have
the meaning specified in Section 3.3. |
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1.33 |
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“Term” shall have the meaning
specified in Section 8. |
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1.34 |
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“$” shall mean United States
dollars. |
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1.35 |
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“Work Order” shall have the meaning
specified in Section 3.3. |
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Marketing of
Services . |
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2.1 |
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Marketing of eRT Services . |
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2.1.1 |
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During the Term, Covance agrees, and shall cause its
Affiliates, to (i) use eRT for all Services provided or
otherwise used by Covance and any of its Affiliates and
(ii) recommend eRT as the exclusive provider of Services to
Customers, and market, and cooperate with eRT in the marketing of,
eRT’s Services to Customers, as described in the
Implementation Plan. |
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2.1.2 |
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Covance’s and its Affiliates’ marketing obligations
pursuant to Section 2.1.1 shall not apply (i) to any
Study for any Customer in which case such Customer has informed
Covance that such Customer will not use eRT to provide Services for
such Study (and, in such case, Covance shall provide to eRT
(a) notice that any Customer has so informed Covance, which
notice shall identify the Customer, the Study and the reason why
the Customer stated it will not work with eRT, to the extent of
information available to the Covance Relationship Manager, unless
and only to the extent that disclosure of the foregoing information
is prohibited by provisions of a written confidentiality agreement
to which Covance is bound and was entered into before the time such
Customer so informs Covance, and (b) any Customer feedback
regarding such Customer’s decision to the extent information
regarding such feedback is available to the Covance Relationship
Manager), or (ii) following any Potential Termination
Event. |
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2.2.1 |
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Covance agrees that during the Term, neither Covance nor any
Affiliate of Covance shall perform any Services, or recommend to
any Customer any Person, other than eRT, as a provider of Services,
except (i) with the prior written consent of eRT,
(ii) following any Potential Termination Event, or
(iii) under circumstances in which, pursuant to the provisions
of Section 2.1.2, Covance’s and its Affiliates’
marketing obligations under Section 2.1.1 do not apply. |
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2.2.2 |
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Nothing contained in this Agreement shall prevent Covance (or
any Affiliate thereof) from (i) owning up to five percent (5%)
of the outstanding voting stock of a publicly traded corporation or
(ii) subject to the provisions of the side letter of even date
herewith between eRT and Covance, acquiring any Person whose
principal line of business is not the provision of the
Services. |
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2.3 |
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Covenants of Covance . During the Term, Covance
shall: |
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2.3.1 |
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Appoint the Covance Relationship Manager, who shall be an
employee of Covance with qualifications sufficient to meet the
existing needs of the position as Covance may deem appropriate in
its reasonable discretion, as relationship manager responsible for
managing Covance’s relationship with eRT under this Agreement
and facilitating the completion of tasks set forth in the
Implementation Plan. |
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2.3.2 |
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Appoint the Covance Sales Manager, who shall be (i) a
full-time, fully dedicated employee of Covance,
(ii) knowledgeable in the sale of the Services and other
cardiac safety services and (iii) suitable, in the reasonable
discretion of Covance, for interaction with (a) other
employees of Covance and its Affiliates responsible, directly and
indirectly, for the performance by Covance of its obligations under
this Agreement and (b) Customers in a manner expected, in the
reasonable discretion of Covance, to enable the Covance Sales
Manager to promote successfully to such employees and Customers the
availability and value proposition for Services able to be provided
by eRT. eRT shall pay to Covance a sum equal to fifty percent (50%)
of the salary and benefits paid to such Covance Sales Manager which
salary shall be mutually agreed upon annually by Covance and eRT.
Such payment shall be made on a quarterly basis and shall be
remitted by eRT within thirty (30) days after the end of each
calendar quarter. |
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2.3.3 |
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Comply with and perform in all material respects
Covance’s obligations set forth in the Implementation
Plan. |
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2.3.4 |
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Cause the attendance at meetings either in-person or via
teleconference with eRT’s chief executive officer and/or
chief financial officer and the eRT Relationship Manager of at
least three of the following individuals: (i) the president of
late-stage development of Covance, (ii) the senior financial
officer responsible for the late-stage development unit of Covance,
(iii) the senior executive responsible for the Phase I unit
(or, in case of any individual identified by clause (i),
(ii) or (iii) of this Section 2.3.4, any other senior
executive of Covance with similar responsibilities), (iv) the
Covance Relationship Manager and (v) the Covance Sales
Manager. Covance and eRT acknowledge that they shall make good
faith reasonable efforts to (i) hold such meetings once during
each calendar quarter during the Term, and shall be of sufficient
duration and (ii) prepare adequately to enable productive
discussion at such meetings of matters incident to the performance
by the Parties of their respective obligations under this
Agreement. |
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2.4 |
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Covenants of eRT . During the Term, eRT shall: |
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2.4.1 |
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Appoint the eRT Relationship Manager, who shall be an employee
of eRT with qualifications sufficient to meet the existing needs of
the position as eRT may deem appropriate in its reasonable
discretion, as relationship manager responsible for managing
eRT’s relationship with Covance under this Agreement and
facilitating the completion of tasks set forth in the
Implementation Plan. |
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2.4.2 |
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Respond promptly to any request for proposal or other
communication from Covance pursuant to this Agreement or the
Implementation Plan; |
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2.4.3 |
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Keep proper books and records sufficient to demonstrate the
basis for the calculation of amounts payable to Covance hereunder,
and permit representatives of Covance, upon reasonable prior notice
during normal business hours, to visit its facilities and any
pending projects, examine and make copies of books and records and
to discuss the information contained therein (or such other
information as may be relevant to the calculation of amounts
payable to Covance hereunder) with eRT’s officers and
employees; |
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2.4.4 |
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Permit representatives of Covance or its Affiliates, upon
reasonable prior notice during normal business hours, to have
access to and inspect eRT’s facilities, to inspect, audit and
make extracts from its books, records and files, and to meet with
eRT officers, employees and representatives for the purpose of
conducting quality assurance audits, including with respect to
(i) the provision of the Services, (ii) compliance with
regulations of any Governmental Authority and
(iii) satisfaction of eRT’s other obligations under this
Agreement; |
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2.4.5 |
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In the event that corrective action is required to address any
issues identified by Covance or its Affiliates in connection with
any audit pursuant to Section 2.4.4, eRT will respond
promptly, but no longer than fifteen (15) business days
following notification of such issues, with a plan reasonably
calculated to provide such corrective action, and will implement
such plan on a reasonable timetable as set forth therein; |
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2.4.6 |
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Notify Covance promptly of any material complaints received
from Customers for which eRT is providing Services related to the
provision of Services to such Customers; |
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2.4.7 |
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Inform the Covance Relationship Manager (or any other Covance
employee appointed by Covance to receive such information) of any
new Services offered by eRT from time to time, in order that
Covance may inform those of its representatives dealing with
Customers that such Services are available; |
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2.4.8 |
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Notify Covance promptly and, in any event, within seven (7)
business days of the occurrence of any event, notice or condition
which would i |
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