optn policies

ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN)

BYLAWS
These Bylaws govern the structure and operation of the Organ Procurement and Transplantation Network (OPTN).
By accepting membership in the OPTN, each Member agrees to comply with all applicable provisions of the
National Organ Transplant Act, as amended, 42 U.S.C. 273 et seq.; OPTN Final Rule, 42 CFR Part 121; these
Bylaws; and OPTN policies as in effect from time to time. The OPTN will conduct ongoing and periodic reviews
and evaluations of each Member OPO and Transplant Hospital for compliance with the OPTN Final Rule and OPTN
policies. All OPTN Members are subject to review and evaluation for compliance with OPTN policies. All such
compliance monitoring is performed using processes and protocols developed by the OPTN Contractor in
accordance with the contract with the Department of Health and Human Services (HHS), Health Resources and
Services Administration (HRSA), to operate the OPTN (OPTN Contract).

ARTICLE I
MEMBERS
1.1

Membership Categories. There shall be five categories of members of the OPTN. These are:
Institutional Members, Medical/Scientific Members, Public Organization Members, Business Members,
and Individual Members. References in these Bylaws to “Members” shall include Institutional Members,
Public Organization Members, Medical/Scientific Members, Business Members, and Individual Members,
except as otherwise noted. By amendment to the Bylaws, the Board of Directors may establish additional
categories of Members so long as they conform to requirements of law and regulations applicable to the
OPTN.

1.2

Institutional Members. An Institutional Member shall be one of the following:
a.

An organization designated as an organ procurement organization by the Secretary of the
Department of Health and Human Services (HHS) under Section 1138(b) of the Social Security
Act or an organization that meets all requirements for such designation, other than OPTN
membership (OPO).

b.

A hospital (i) that aspires to perform organ transplants, as evidenced by submission of an active
application for designated transplant program status for at least one organ type, or in which organ
transplantation is performed, and (ii) that participates in the Medicare or Medicaid programs
(Transplant Hospital).

c.

An independent Histocompatibility laboratory that serves at least one Transplant Hospital that is
active in the field of human organ transplantation within its service area (Histocompatibility
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Laboratory). For purposes of the OPTN Charter and Bylaws, independence from Transplant
Hospital(s) served shall be defined by demonstration of a distinct governing body for the
Histocompatibility Laboratory that is separate and not under the direct or indirect control of the
governing body of any of the Histocompatibility Laboratory’s Transplant Hospitals or of the
governing body of a commonly controlled group of the Histocompatibility Laboratory’s
Transplant Hospitals.
1.3

Medical/Scientific Members. A Medical/Scientific Member shall meet the following criteria:
a.

An established, non-profit organization or institution with at least one year of operating history
that has an interest in the fields of organ donation or transplantation, defined as:
(1)

(2)

1.4

An organization or institution that serves as a medical or scientific membership
organization and includes within its membership professional members who are involved
in organ transplantation, or
An organization or institution that is supported by letters of recommendation for OPTN
membership from at least three other organizations or institutions, each of which meets
the criteria for Institutional Membership listed in Article 1.2 above, Medical/Scientific
Membership listed in Article 1.3(a)(1) above, or Public Organization Membership listed
in Articles 1.4(a)(1) or 1.4(b) below.

Public Organization Members. A Public Organization Member shall meet the following
criteria:
a.

An established, non-profit organization or institution with at least one year of operating history
that has an interest in the fields of organ donation or transplantation, defined as:
(1)

(2)

b.

An organization or institution that engages in organ donation activities or represents or
provides direct support or services to transplant recipients, transplant candidates, or their
families, or
An organization or institution that is supported by letters of recommendation for OPTN
membership from at least three other organizations or institutions, each of which meets
the criteria for Institutional Membership listed in Article 1.2 above, Medical/Scientific
Membership listed in Article 1.3(a)(1) above, or Public Organization Membership listed
in Article 1.4(a)(1) above or Article 1.4(b) below, or

A hospital with at least one year of operating history that participates in the Medicare or Medicaid
programs and has an interest in the fields of organ donation or transplantation, defined by the
referral of at least one potential organ or tissue donor per year for donation.

The Board of Directors shall from time to time review these criteria and establish as part of these Bylaws,
Appendix B, additional membership requirements for Institutional Members, Public Organization
Members, and Medical/Scientific Members. Failure to conform with such requirements shall be cause for
any corrective action described in Appendix A of these Bylaws.
1.5

Business Members. A Business Member shall be an established organization or institution with at least
one year of operating history that has an interest in the fields of organ donation or transplantation, defined
as engaging in commercial activities with two or more active Institutional Members.
The Board of Directors shall from time to time review these criteria and establish as part of these Bylaws
additional membership requirements for Business Members. Failure to conform with such requirements
shall be cause for any corrective action described in Appendix A of these Bylaws.

1.6

Individual Members. An Individual Member shall be a person with an interest and/or expertise in the
fields of organ donation or transplantation, defined to include one or more of the following:
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a.

Individuals who have served or are presently serving on the OPTN Board of Directors, or an
OPTN Committee.

b.

Individuals who are themselves or are family members of: a transplant candidate, transplant
recipient, or organ or tissue donor.

c.

Individuals who are presently employed by or are independent contractors with OPOs, Transplant
Hospitals, or Histocompatibility Laboratories.

d.

Individuals who were formerly employed by or were formerly independent contractors with
OPOs, Transplant Hospitals, or Histocompatibility Laboratories and individuals formerly
employed by Federal or State government agencies involved in the field of organ donation and
transplantation, who demonstrate continued active interest in and involvement with the fields of
organ donation or transplantation.

e.

Individuals who otherwise have an active interest in and involvement with the fields of organ
donation or transplantation demonstrated by letters of recommendation for OPTN membership
from at least three persons, each of whom meets the criteria for Individual Membership listed in
Article 1.6 (a, b, c, or d) above.

1.7

Application Process and Requirements/Appeal Protocol. The process and requirements for applying to
be an OPTN Member are set forth in Appendix A of these Bylaws. The protocol for appealing decisions of
the OPTN with respect to membership also are set forth in Appendix A. Members shall be elected by
majority vote of the Directors present at any meeting at which a quorum is present.

1.8

Terms. The term of an Institutional Member shall be indefinite. The term of Public Organization
Members, Medical/Scientific Members, Business Members, and Individual Members shall be two years;
any of these Members may serve for successive terms upon application and approval for such term. Public
Organization Members, Medical/Scientific Members, Business Members, and Individual Members may
resign at any time by written notice to the Executive Director.

1.9

Voting Privileges and Responsibilities. There shall be six classes of voting Members: (i) Transplant
Hospital Members, (ii) OPO Members, (iii) Histocompatibility Laboratory Members, (iv)
Medical/Scientific Members, (v) Public Organization Members, and (vi) Individual Members. OPTN
Members designated “OPTN Members Not in Good Standing” shall not have voting or other OPTN
Member privileges until such designation has been removed; provided, however, that all OPTN Members,
including Members designated “OPTN Members Not in Good Standing” shall be obligated to comply with
OPTN Member responsibilities. Business Members shall not be entitled to voting privileges in OPTN
affairs.
a.

Transplant Hospital Members. Each Transplant Hospital Member shall be entitled to one vote
on OPTN affairs requiring a vote of the Membership; provided, however, that a Transplant
Hospital must have received approval as a designated transplant program for at least one organ
before it is entitled to vote on affairs of the OPTN.

b.

OPO Members. Each OPO Member shall be entitled to one vote on OPTN affairs requiring a
vote of the Membership; provided, however, that an OPO must be independent of the Transplant
Hospital(s) it serves, which may include a single Transplant Hospital, before it is entitled to vote
on affairs of the OPTN. For purposes of the OPTN Charter and Bylaws, independence from
Transplant Hospital(s) served shall be defined by demonstration of a distinct governing body for
the OPO that is separate and not under the direct or indirect control of the governing body of any
of the OPO’s Transplant Hospitals or of the governing body of a commonly controlled group of
the OPO’s Transplant Hospitals.

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c.

Histocompatibility Laboratory Members. Histocompatibility Laboratories, as a class, shall be
represented by 33 separate Histocompatibility Laboratory Member Electors. Each
Histocompatibility Laboratory Member Elector shall be entitled to one vote on OPTN affairs
requiring a vote of the Membership. Histocompatibility Laboratory Member Electors shall be
elected by and from among the Histocompatibility Laboratory Members as follows:

(i)

Histocompatibility Laboratory Members residing within each of the 11 Regions (as defined in
Article 2.4 of these Bylaws) shall elect two Histocompatibility Laboratory Member Electors from
their respective region. If there are no Histocompatibility Laboratory Members residing within a
Region, then the number of national Histocompatibility Laboratory Member Electors described in
(ii) below shall be increased by two for every such Region without Histocompatibility Laboratory
Members.
(ii)
All Histocompatibility Laboratory Members, collectively, shall elect eleven national
Histocompatibility Laboratory Member Electors or, if there are no Histocompatibility Laboratory
Members residing in one or more regions, as many national Histocompatibility Laboratory
Member Electors as necessary so that there are no more than and no fewer than 33
Histocompatibility Laboratory Member Electors.
(iii)
Any person serving as or designated by the named OPTN Representative for a Histocompatibility
Laboratory Member may serve as a Histocompatibility Laboratory Member Elector upon
nomination for and election to this office. OPTN Representatives for Histocompatibility
Laboratory Members may submit their own names as candidates for Histocompatibility
Laboratory Member Elector, representing Histocompatibility Laboratory Members at the regional
or national level. For the number of Histocompatibility Laboratory Member Electors to be elected
regionally or nationally, those receiving the highest number of votes among eligible candidates
shall be elected.
(iv)
The term of a Histocompatibility Laboratory Member Elector shall be two years.
Histocompatibility Laboratory Member Electors may serve successive terms.
(v)
Nominations and elections for Histocompatibility Laboratory Member Elector shall be conducted
through the Internet using the OPTN web site, www.optn.org, and/or the United States mail.
The number of Histocompatibility Laboratory Member Electors shall be re-evaluated from time to time by
the Board of Directors and increased or decreased as necessary to reflect between approximately 9% and
11% of the then current total number of Institutional Members.
Notwithstanding the foregoing, in the event the total number of Histocompatibility Laboratory Members at
any time at which a vote of the OPTN membership is to take place is equal to or fewer than the then current
number of Histocompatibility Laboratory Member Electors, the process for voting through Member
Electors described above shall be suspended and each such Histocompatibility Laboratory Member shall be
entitled to one vote on any OPTN matter requiring a vote of the Membership.
d.

Medical/Scientific Members. Medical/Scientific Members that provide services and/or are
involved in activities on an interregional or national basis, as a class, shall be represented by 24
separate national Medical/Scientific Member Electors. Each Medical/Scientific Member Elector
shall be entitled to one vote on OPTN affairs requiring a vote of the Membership.
Medical/Scientific Member Electors shall be elected by and from among the Medical/Scientific
Members as follows:

(i)

All Medical/Scientific Members, collectively, shall elect the 24 national Medical/Scientific
Member Electors.
Any person serving as or designated by the named OPTN Representative for a Medical/Scientific
Member may serve as a Medical/Scientific Member Elector upon nomination for and election to
this office. OPTN Representatives for Medical/Scientific Members may submit their own names
as candidates for Medical/Scientific Member Elector, representing Medical/Scientific Members at
the national level. For the number of Medical/Scientific Member Electors to be elected nationally,
those receiving the highest number of votes among eligible candidates shall be elected.
The term of a Medical/Scientific member Elector shall be two years or the remaining OPTN
Membership term of the Medical/Scientific member with whom the Medical/Scientific Member

(ii)

(iii)

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(iv)

Elector is affiliated, whichever is shorter. Medical/Scientific Member Electors may serve
successive terms.
Nominations and elections for Medical/Scientific Member Elector shall be conducted through the
Internet using the OPTN web site, www.optn.org, and/or the United States mail.

The number of Medical/Scientific Member Electors shall be re-evaluated from time to time by the Board of
Directors and increased or decreased as necessary to reflect between approximately 6% and 8% of the then
current total number of Institutional members.
Medical/Scientific Members must provide services and/or be involved in activities on an interregional or
national basis to participate in the election of Medical/Scientific Member Electors.
Notwithstanding the foregoing, in the event the total number of Medical/Scientific Members in good
standing at any time at which a vote of the OPTN membership is to take place is equal to or fewer than the
then current number of Medical/Scientific Member Electors, the process for voting through Member
Electors described above shall be suspended and each such Medical/Scientific Member shall be entitled to
one vote on any OPTN matter requiring a vote of the Membership.
e.

Public Organization Members. Public Organization Members that provide services and/or are
involved in activities on an interregional or national basis, as a class, shall be represented by 12
separate Public Organization Member Electors. Each Public Organization Member Elector shall
be entitled to one vote on OPTN affairs requiring a vote of the Membership. Public Organization
Member Electors shall be elected by and from among the Public Organization Members as
follows:

(i)

Public Organization Members residing within each of the 11 Regions (as defined in Article 2.4 of
these Bylaws) shall elect one Public Organization Member Elector from their respective region. If
there are no Public Organization Members residing within a Region, then the number of national
Public Organization Member Electors described in (ii) below shall be increased by one for every
such Region without Public Organization Members.
All Public Organization Members, collectively, shall elect a twelfth national Public Organization
Member Elector or, if there are no Public Organization Members residing in one or more regions,
as many national Public Organization Member Electors as necessary so that there are no more than
and no fewer than 12 Public Organization Member Electors.
Any person serving as or designated by the named OPTN Representative for a Public
Organization Member may serve as a Public Organization Member Elector upon nomination for
and election to this office. OPTN Representatives for Public Organization Members may submit
their own names as candidates for Public Organization Member Elector, representing Public
Organization Members at the regional or national level. For the number of Public Organization
Member Electors to be elected nationally, those receiving the highest number of votes among
eligible candidates shall be elected.
The term of a Public Organization Member Elector shall be two years or the remaining OPTN
Membership term of the Public Organization Member with whom the Public Organization
Member Elector is affiliated, whichever is shorter. Public Organization Member Electors may
serve successive terms.
Nominations and elections for Public Organization Member Elector shall be conducted through
the Internet using the OPTN web site, www.optn.org, and/or the United States mail.

(ii)

(iii)

(iv)

(v)

The number of Public Organization Member Electors shall be re-evaluated from time to time by the Board
of Directors and increased or decreased as necessary to reflect between approximately 3% and 5% of the
then current total number of Institutional Members.
Public Organization Members must provide services and/or be involved in activities on an interregional or
national basis to participate in the election of Public Organization Member Electors.

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Notwithstanding the foregoing, in the event the total number of Public Organization Members at any time
at which a vote of the OPTN membership is to take place is equal to or fewer than the then current number
of Public Organization Member Electors, the process for voting through Member Electors described above
shall be suspended and each such Public Organization Member shall be entitled to one vote on any OPTN
matter requiring a vote of the Membership.
f.

Individual Members. Individual Members, as a class, shall be represented by 12 separate
Individual Member Electors. Each Individual Member Elector shall be entitled to one vote on
OPTN affairs requiring a vote of the Membership. Individual Member Electors shall be elected by
and from among the Individual Members as follows:

(i)

Individual Members residing within each of the 11 Regions (as defined in Article 2.4 of these
Bylaws) shall elect one Individual Member Elector from their respective region. If there are no
Individual Members residing within a Region, then the number of national Individual Member
Electors described in (ii) below shall be increased by one for every such Region without
Individual Members.
All Individual Members, collectively, shall elect a twelfth national Individual Member Elector or,
if there are no Individual Members residing in one or more regions, as many national Individual
Member Electors as necessary so that there are no more than and no fewer than 12 Individual
Member Electors.
With the exception of employees currently employed by or independent contractors currently
working with OPOs, Transplant Hospitals, or Histocompatibility Laboratories, any Individual
Member may serve as an Individual Member Elector upon nomination for and election to this
office. Individual Members may submit their own names as candidates for Individual Member
Elector, representing Individual Members at the regional or national level. For the number of
Individual Member Electors to be elected nationally, those receiving the highest number of votes
among eligible candidates shall be elected.
The term of an Individual Member Elector shall be two years or the remaining OPTN Membership
term of the Individual Member elected to the office of Individual Member Elector, whichever is
shorter. Individual Member Electors may serve successive terms.
Nominations and elections for Individual Member Elector shall be conducted through the Internet
using the OPTN web site, www.optn.org, and/or the United States mail.

(ii)

(iii)

(iv)

(v)

The number of Individual Member Electors shall be re-evaluated from time to time by the Board of
Directors and increased or decreased as necessary to reflect between approximately 3% and 5% of the then
current total number of Institutional Members.
Notwithstanding the foregoing, in the event the total number of Individual Members at any time at which a
vote of the OPTN membership is to take place is equal to or fewer than the then current number of
Individual Member Electors, the process for voting through Member Electors described above shall be
suspended and each such Individual Member shall be entitled to one vote on any OPTN matter requiring a
vote of the Membership.
Affairs of the OPTN involving a vote of the Membership include, for example, election of the Board of
Directors (see Article II of these Bylaws), election of the Principal Officers (see Article VI of these
Bylaws), and amendment of these Bylaws (see Article X of these Bylaws).
Cumulative voting on affairs of the OPTN is not allowed.
Upon being elected to Membership in the OPTN, each Institutional Member, Medical/Scientific Member
and Public Organization Member shall indicate its acceptance by appointing a representative with authority
to vote and act for the Member in all affairs of the OPTN and an alternate representative who shall have
such authority if the representative is unable to vote or act. Additionally, each Institutional Member,
Medical/Scientific Member and Public Organization Member shall notify the Executive Director in writing
of the name and address of its representative, to whom all notices may be sent, and of its alternate
representative. Upon being elected to Membership in the OPTN, each Business Member shall indicate its
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acceptance by designating in writing the name of a representative and address to which notices may be
sent. Upon his or her election, each Individual Member shall notify the Executive Director in writing of his
or her name and address to which notices may be sent.
A majority of the Transplant Hospital Members, OPO Members, Histocompatibility Laboratory Member
Electors, Medical/Scientific Member Electors, Public Organization Member Electors, and Individual
Member Electors, eligible to vote represented in person or by proxy, shall constitute a quorum for the
transaction of business at any meeting. A vote of a majority of those present and eligible to vote shall be
sufficient to transact any business that might come before the meeting, except where a greater or lesser vote
is provided for in the Bylaws.
1.10

Member Obligations. By accepting membership in the OPTN, each Member agrees to comply with all
applicable provisions of the National Organ Transplant Act, as amended, 42 U.S.C. 273 et seq.; OPTN
Final Rule, 42 CFR Part 121; these Bylaws; and OPTN policies as in effect from time to time. The OPTN
will conduct ongoing and periodic reviews and evaluations of each Member OPO and Transplant Hospital
for compliance with the OPTN Final Rule and OPTN policies. All OPTN Members are subject to review
and evaluation for compliance with OPTN policies. All such compliance monitoring is performed using
processes and protocols developed by the OPTN Contractor in accordance with the OPTN Contract. The
failure of an organ procurement organization Institutional Member, independent Histocompatibility
laboratory Institutional Member, Medical/Scientific Member, Public Organization Member, Business
Member, or Individual Member to qualify as an OPTN Member according to the administrative
requirements under Articles 1.2 – 1.6 of these Bylaws (e.g., an organ procurement organization that ceases
to be designated under Section 1138(b) of the Social Security Act) shall be dealt with in accordance with
Article 1.11 of these Bylaws.

1.11

Removal of Non-Qualifying Members.
a.
Transplant center Institutional Members that fail to qualify as an OPTN Member under Article
1.2(b) shall be treated in accordance with Article II of Appendix B to these Bylaws.
b.
All other OPTN Members who cease to qualify for OPTN membership under Article I of these
Bylaws may be removed as OPTN Members in accordance with the following procedures:
1.
The Member may request removal from OPTN membership by forwarding a written
request therefor to the OPTN, or
2.
Even if the Member does not request removal, the OPTN may notify the Member in
writing that, unless the Member demonstrates that it continues to meet applicable
membership criteria within sixty (60) days of notification, the Member’s OPTN
membership will be terminated.
i.
If, within sixty (60) days of such notification, the Member demonstrates, to the
satisfaction of the OPTN, that the Member continues to meet OPTN
membership requirements, the OPTN shall withdraw its notice of termination.
ii.
If the Member fails to demonstrate that it continues to meet applicable OPTN
membership requirements, its membership in the OPTN will terminate on the
sixtieth (60th) day after notification of termination by the OPTN. The Member
can appeal this decision to the Secretary of HHS. In the event a Member
exercises this right of appeal, the Member shall notify the OPTN Contractor of
this exercise by registered or certified mail, return receipt requested. Pending a
decision on the appeal, the process defined by these procedures shall continue
unless the Secretary directs otherwise. In the event the appeal is denied, the
process shall be further continued or reinitiated, as applicable. Any other
decision on the appeal by the Secretary shall be submitted to the Membership
and Professional Standards Committee or Board of Directors as appropriate for
action consistent with the Secretary’s decision.
c.
Any Member that requests removal from OPTN membership or is otherwise removed from OPTN
membership under this Article 1.11 may later re-apply for membership in accordance with Article
1.7 of these Bylaws.
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1.12

Meetings. The annual meeting of the Members to elect a Board of Directors pursuant to Article 2.1 of
these Bylaws, to elect Principal Officers pursuant to Section 6.1 of these Bylaws and to address such other
matters as may be appropriate shall be held in February or March of each calendar year and may be held in
conjunction with the annual meeting of the Board of Directors. Special meetings of the Members may be
called at any time by the President, Executive Director, or a majority of the Board of Directors, or by
written application of a majority of the Transplant Hospital Members, OPO Members, Histocompatibility
Laboratory Member Electors, Public Organization Member Electors, Medical/Scientific Member Electors,
and Individual Member Electors stating the time, place, and purpose of the meeting. Members attending
meetings shall do so at no cost to the OPTN. Meetings of the OPTN membership typically shall be open to
the public; however, discussions involving confidential matters including, OPTN member admission,
credentialing, monitoring, or disciplinary matters and matters involving individuals’ privacy where
disclosure would constitute a clearly unwarranted invasion of personal privacy, shall be reserved for closed
sessions as appropriate and consistent with the OPTN Contract. Representatives from the Federal
government serving on the Board of Directors, or their designees, shall not be precluded from attending
such closed sessions of OPTN meetings.
Written notice of any regular or special meeting of the Members shall state the date, time, and place of the
meeting and the purpose for which the meeting is called, and shall be mailed to each Member not fewer
than 25 or more than 60 days before the date of the meeting. Giving notice of a meeting of Members to a
Member or Member Elector who is not eligible to vote does not imply that the Member or Member Elector
may vote.

1.13

A written waiver of notice signed at any time by a Member or Member Elector shall be the equivalent of
any notice required herein. A Member or Member Elector who attends a meeting shall be deemed to have
had timely and proper notice of the meeting unless the Member or Member Elector attends for the express
purpose of objecting that the meeting is not lawfully called or convened.
Registration Fees. Institutional Members shall pay an OPTN Patient Registration Fee to be set by the
Board of Directors with approval from the Secretary of HHS for each potential organ recipient listed by
such member institution on the computer system waiting list maintained by the OPTN Contractor. If a
potential recipient is either placed in an inactive status or removed from the waiting list for some reason
other than a transplant and is subsequently placed back on the list in an active status within 90 days, no
additional fee will be due. However, placing a patient back on the list after the 90 day allowance or
maintaining the patient on the list for the purpose of receiving a new transplant generates another
registration fee. Furthermore, potential recipients who are transferred to Transplant Hospitals that are
outside the original local OPO’s waitlist will cause another registration fee to be paid by the receiving
center.
Potential recipients who are listed at multiple Transplant Hospitals will cause a registration fee to be paid
by each hospital.
Members who list patients needing more than a single organ transplant (e.g., kidney and pancreas) will only
be charged one registration fee.

1.14

Expenses Incurred on Behalf of Members. In the event the OPTN Contractor incurs expenses on behalf
of a Member pursuant to providing assistance to that Member by, for example, transporting an organ,
including but not limited to, courier charges, airline, or other transportation charges, such Member shall
reimburse the OPTN Contractor for the expenses incurred.

1.15

Affiliated Organizations. Nothing in this Article I shall require an OPTN Member to become a member
of any organization that is a parent, sponsor, contractor, or affiliated organization of the OPTN, to comply
with bylaws of any such organization, or to assume any corporate duties or obligations of any such
organization.

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