XXXX COMPANY

COPYRIGHT LICENSE: M.I.N.I International Neuropsychiatric

Interview For Children and Adolescents 6.0 (10/10/10 version)
and M.I.N.I International Neuropsychiatric Interview For Children
and Adolescents (Parent Version) 6.0 (10/10/10 version)
Dr. David V. Sheehan, as copyright holder of the M.I.N.I International
Neuropsychiatric Interview for Children and Adolescents 6.0 (10/10/10
version) and the M.I.N.I International Neuropsychiatric Interview for
Children and Adolescents (Parent Version) 6.0 (10/10/10 version)
hereinafter referred to as the M.I.N.I KID and the M.I.N.I KID (Parent Version)
hereby grants permission to XXXXXXXX, a pharmaceutical company conducting
international clinical development, to use the M.I.N.I KID and the M.I.N.I KID
(Parent Version) under the following terms and conditions:
Dr. David V. Sheehan, hereby grants permission to XXXXXXXX as Sponsor of
the Clinical Trials defined in Appendix 1 hereinafter, and to XXXXXXXXs Affiliated
Companies and Subcontractors, ONLY for the purpose of implementation of such
research studies defined hereinafter:
-

the right to reproduce in electronic or computer format the M.I.N.I 6

(10/10/10 version) and its existing and future translations and to use it
within its domestic and international clinical trials upon individual request
for each trial;

the right to use the translations of the M.I.N.I 6 (10/10/10 version), in the
languages deemed necessary by copyright holder of the M.I.N.I 6
(10/10/10 version), for each trial as requested, provided that the
translations are acceptable to the copyright holder; MAPI Research
Institute is the exclusive coordinating center to ensure the production of
consistent and conceptually equivalent translations of the M.I.N.I 6
(10/10/10 version) and to provide linguistic validation and certification of
these translations and should be contacted directly for this purpose. MAPI
may charge its own usual fees for this work.
MAPI Research Institute
27 Rue de la Villette
69003 Lyon France
imear@mapi.fr or aboudrot@mapigroup.com
tel: +33 (0)4 72 13 66 67
fax: +33 (0)4 72 13 66 68/ :+33 (0)4 72 13 69 50

the unrestricted right to use all data and results generated from the use of
the M.I.N.I 6 (10/10/10 version) in domestic and international clinical trials.

the right to use the M.I.N.I 6 (10/10/10 version) in rater training.

Such granting of rights to XXXXXXXX, its Affiliated Companies and
Subcontractors to use the M.I.N.I 6 (10/10/10 version) and its final translations,

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as hereinabove provided for, is subject to a charge of $5 per single

administration (based on the number of patients screened at the screening visit
and not per patient number enrolled at the baseline visit), payable in full before
study initiation to:
Medical Outcomes Systems
12740 Gran Bay Parkway, Suite 2400, Jacksonville, FL 32258
Contact: Christopher Gray,
President, Medical Outcomes Systems (cgray@medical-outcomes.com)
The 3-tier pricing model:
a. $10.00 per administration (Initial purchase)
b. $20.00 per administration (Subsequent purchases)
c. $30.00 per administration (Delinquent purchases) - in line with
www.clinicaltrials.gov reporting and publication of study results.
In consideration of this granting of rights, XXXXXXXX, its Affiliated Companies
and Subcontractors undertake to comply with the following conditions:
-

XXXXXXXX, its Affiliated Companies and Subcontractors undertake to

include on any reproduction of the M.I.N.I, Kid 6 used within Clinical Trials
defined hereinafter, a mention redacted as follows:
Copyright 2010 Sheehan DV. All rights reserved.
May be reproduced only with the permission of Dr. David V. Sheehan,
copyright holder.

XXXXXXXX, its Affiliated Companies and Subcontractors undertake to

transmit to Dr. David V. Sheehan a copy of ANY and ALL final
translations of the M.I.N.I 6 (10/10/10 version), in Microsoft Word and/or
PDF format.

In any publication resulting from the use of the M.I.N.I, XXXXXXXX, its
Affiliated Companies and Subcontractors SHALL NOT reproduce any part
of the M.I.N.I 6 (10/10/10 version) or its translations, without the prior
written consent of Dr. David V. Sheehan, copyright holder.

It is hereby agreed that no other right or license on M.I.N.I 6 (10/10/10 version)

shall be granted to XXXXXXXX, its Affiliated Companies and Subcontractors as a
result of this letter and that the rights attached to the M.I.N.I 6 (10/10/10
version) and its translations shall remain the exclusive property of Dr. David V.
Sheehan, copyright holder.
Please indicate your approval of the terms of this letter by returning to
XXXXXXXX the two original copies of this letter enclosed herewith, after they
have been duly initiated and signed by you.
Agreed and accepted:
___________________________________________
Signature of Dr. David V. Sheehan, copyright holder

For XXXXXX and Company

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_______________
Date

XXXX COMPANY

___________________________________________
Signature

_______________
Date

Print Name and Title : XXXXXX

Phone: XXXXXXXXX
E-mail: XXXXXXXXXX
APPENDIX 1
Clinical trials specific to this permission request are defined below.
Permission has been granted to XXXXXXXX, its Affiliated Companies and
Subcontractors to use the M.I.N.I 6 (10/10/10 version), as designated by the
above mentioned terms signed by Dr. David V. Sheehan as copyright holder,
for the following clinical trials ONLY, until further request and permission has
been granted for studies not listed hereinafter:

Product/Compo
und

Will the MINI Kid be done at

the screening visit after the
informed consent form is
signed?
Study Identification
Number

XXXXX

XXXXX

Yes / No

Projected Number to be
randomized to all study
medications at baseline visit
per protocol
XXXX
Projected number who will sign
the informed consent form at
the screening visit (typically
this is a 3:1 or 2:1 ratio to
those expected to be
randomized to study
medications at the baseline
visit). This is the best estimate of
the number of MINI Kids to be done
at the screening visit.
XXXXX

__________________________________________
_________________
Signature of Dr. David V. Sheehan, copyright holder
Date

Non Profit settings:

Individual researchers, clinicians and students working in nonprofit or publicly owned
settings (including universities, nonprofit hospitals, and government institutions) may

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make paper copies of the M.I.N.I. Kid instruments for their own personal clinical and
research use, but not for institutional use.
In these settings the M.I.N.I. Kid instruments may be reproduced in paper format and
in PDF format, but may not be computerized format in these settings without written
permission from Dr. Sheehan. The M.I.N.I Kid may not be posted on any institutions
website. Any use involving financial gain requires a license agreement signed by the
copyright holder and payment of a per use licensing fee.
For Profit settings:
The use of the M.I.N.I. Kid instruments for any for profit use or in any for profit
setting is not free and requires a license agreement signed by the copyright holder
and payment of a per use licensing fee. In for profit settings no part of the M.I.N.I.
Kid instruments may be reproduced or transmitted in any form, or by any means,
electronic or mechanical, including photocopying, or by any information storage or
retrieval system, without written permission from Dr. Sheehan.
The M.I.N.I. Kid instruments may not be computerized without written permission
from Dr. Sheehan.

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