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Contract Policy & Procedures



The purpose of this policy is to ensure a consistent procedure

through which ___________________ will negotiate and enter into
agreements with third-parties and to provide guidance to employees
on the standards of conduct that govern our relationships with and
engagement of third-parties. This policy protects _______________ by
bringing consistency to the contracting process and ensuring that
_______________ is aware at all times of the terms of its agreements with
___________________ must have written agreements in place with
all third-parties with which it does business. These agreements must
be fair and reasonable and the appropriate departments must be given
an opportunity to comment on and propose revisions to the terms of an
agreement within the scope of that departments expertise.
_______________________ must also maintain original hard copies of all
agreements in a centralized location and have the ability to track and
audit compliance with the terms of its third-party agreements.


This policy applies to any agreement between ___________________

and any third-party, including, but not limited to, non-disclosure
agreements, sales and purchasing contracts and orders, leases, clinical
contracts, consulting agreements, distribution agreements, license
agreements, employment agreement, board of director agreements,
and vendor agreements. This policy applies regardless of whether the
agreement being used is ________________ agreement or a third-partys


Employee Includes all employees and officers of _______________

worldwide, as well as any third-party who is or may be authorized by
__________________ to represent or act on behalf of ____________________.

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The term employee may include contractors, distributors, agents, and

independent representatives.
Agreement Any arrangement or understanding of any kind
establishing any relationship or creating any obligation(s) between
_____________________ and any other individual or entity. The term
agreement includes not only the original agreement, but also any
revisions or amendments to, or extensions of, the agreement.
Third-Party Any individual or entity other than _________________.

A. Communicating Need for Agreement

All agreements must be memorialized in a formal written

agreement. ______________ cannot do business with a third-party based
on an oral agreement or informal agreement (e.g., verbal
conversations, email exchanges, letters, etc.).
Any ________________ employee who becomes aware of the need
for an agreement between ______________ and a third-party is required
Communicate the need for the agreement to Corporate
Compliance as soon as possible once the need becomes
Communicate to Corporate Compliance as soon as possible
all relevant information, including the name and contact
information of the third-party, the name and contact
information of the individual responsible for the agreement
on the third-partys behalf, the general nature or scope of
the agreement, any information regarding the
_________________ departments that may be affected by the
agreement, and a copy of any agreement provided by the
B. Reviewing the Agreement
Within 3 business days, after receipt of the information
above, Corporate Compliance will select the appropriate
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__________________ agreement or review any agreement

provided by the third-party.
Corporate Compliance will determine the department(s)
that may be affected by the agreement and solicit input
from the appropriate manager, director, or executive of
each such department. Corporate Compliance will also
determine if the agreement should be reviewed by outside
legal counsel.
Corporate Compliance will respond as soon as possible, and
always in a timely manner, to any questions posed by any
employee asked to review an agreement on behalf of his or
her department.
Each employee asked to review an agreement on behalf of
his or her department will provide to Corporate Compliance,
as soon as possible, any comments, suggestions, or
proposed revisions to the agreement. Corporate Compliance
will request additional information, if necessary.
A single contact person will be selected to communicate
with the third-party regarding the agreement.
Corporate Compliance will incorporate the appropriate
revisions into the agreement and send the revised
agreement either to the third-party directly or to the
designated _________________ contact person for the
The review procedure above also applies to revisions to an
agreement proposed by the third-party. Proposed revisions
will be communicated to the appropriate department for
comment, and Corporate Compliance will respond
appropriately after receiving the necessary input.
C. Finalizing the Agreement
Corporate Compliance will have the agreement executed, in
accordance with applicable law, by the appropriate

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_________________ employee and will transmit the agreement

to the third-party and/or the appropriate employee(s).
Agreements may only be executed on behalf of
_______________ as specified below.
o Financial Approval Limit: All agreements with a
financial commitment exceeding $50,000,
whether one-time or in the aggregate, must be
approved by the board of directors. All such
agreements must be sent to the Chief Financial
Officer, who will obtain board approval, prior to
o Generally, agreements may be executed by those with
the title of Vice-President or above. However,
agreements may only be executed within the limits of
the financial approval authority of the individual
signing the agreement.
o Clinical agreements may be executed by the VicePresident of Clinical Affairs or the Chief Financial
o Lease or rental agreements may be executed by the
Chief Financial Officer.
o Employment agreements may be executed by the
Chief Financial Officer or the Chief Executive Officer.
o Distribution agreements must be approved by the
Chief Financial Officer and then executed by the
appropriate Vice-President.
o Licensing agreements may only be executed by the
Chief Executive Officer.
Corporate Compliance will ensure that the agreement is
executed by both _________________ and the third-party and
will maintain the fully executed agreement.

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The Corporate Compliance Department is responsible for

overseeing this policy. Corporate Compliance is responsible for
reviewing any proposed agreement, soliciting feedback from the
appropriate departments, incorporating any requested revisions into
the agreement, and communicating with the other party to the
Any employee desiring or needing to enter into an agreement
with a third-party is responsible for ensuring that the need for the
agreement and all relevant information is communicated to Corporate
Compliance as early as possible after the need for the agreement is
The employee in each department from whom input is sought
regarding an agreement is responsible for reviewing the agreement
and providing the appropriate feedback to Corporate Compliance in a
timely manner.





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