Mini International Neuropsychiatric Interview

COPYRIGHT LICENSE: for use in paper or pdf format of either the Standard orof the Psychotic Disorders versions of the

Mini International Neuropsychiatric Interview –

The M.I.N.I. 7.0.2 for DSM-5, (8/8/16 version).

Dr. David V. Sheehan, as “copyright holder” of the “Mini International Neuropsychiatric Interview - The M.I.N.I. 7.0.2 (8/8/16version)” hereinafter referred to as the “M.I.N.I.” hereby grants permission to XXXXXXXX, a pharmaceutical company conducting international clinical drug development or a clinical research organization or a healthcare provider, to use the M.I.N.I. under the following terms and conditions:

Dr. David V. Sheehan, hereby grants permission to XXXXXXXX as sponsor of the clinical trials / clinical research organization / provider of healthcare, defined in Appendix 1 hereinafter, and to XXXXXXXX’s affiliated companies and subcontractors / clinical care setting, ONLY for the purpose of implementation of such research studies / provision of care, defined hereinafter:

-the right to reproduce in paper format and in pdf format, but not in electronic or computer format the M.I.N.I. 7.0.2 (8/8/16version) and its existing and future translations and to use it within its domestic and international clinical trials / your clinical care setting, upon individual request for each trial and number of uses in each trial;

-the right to use the translations of the M.I.N.I. 7.0.2(8/8/16 version),in the languages approved by the copyright holder, in collaboration with MAPI,for each trial as requested; MAPI Language Services is the exclusive coordinating center to ensure the production of consistent and conceptually equivalent translations of the M.I.N.I. 7.0.2(8/8/16 version) and to provide linguistic validation and certification of these translations and should be contacted directly for this purpose. MAPI Language Services may charge its own usual fees for this work.

Marie-SidonieEdieux

MAPI Research Trust

27 Rue de la Villette

69003 Lyon France

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. in domestic and international clinical trials / your clinical care setting.

-the right to use the M.I.N.I. 7.0.2(8/8/16 version) in rater training.

Such granting of rights to XXXXXXXX, its affiliated companies and subcontractors / your clinical care setting, to use the M.I.N.I. 7.0.2 (8/8/16 version) and its final translations, as hereinabove provided for, shall be free of charge.

In consideration of this granting of rights, XXXXXXXX, its affiliated companies and subcontractors / your clinical care setting, undertake to comply with the following conditions:

-XXXXXXXX, its affiliated companies and subcontractors / your clinical care setting, undertake to include on any reproduction of the M.I.N.I., used within Clinical Trials / provision of healthcare, defined hereinafter, a mention redacted as follows:

May be reproduced only with the permission of Dr. David V. Sheehan, copyright holder. For permission contact

-XXXXXXXX, its affiliated companies and subcontractors / your clinical care setting, undertake to transmit to Dr. David V. Sheehan a copy of ANY and ALL final translations of the M.I.N.I. 7.0.2(8/8/16 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 / your clinical care setting, SHALL NOT reproduce any part of the M.I.N.I. 7.0.2 (8/8/16 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. 7.0.2(8/8/16 version) shall be granted to XXXXXXXX, its affiliated companies and subcontractors / your clinical care setting, as a result of this license agreement, and that the rights attached to the M.I.N.I. 7.0.2(8/8/16 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 agreement by returning your completed and signed version of this agreement to David V Sheehan MD MBA at . Dr. Sheehan will countersign this agreement and return it to you directly by email. If you make any changes to this agreement, use track changes in MS Word. Any such changes will be reviewed, and if acceptable, will be countersigned signed by the copyright holder, or amended further, and returned to you.

Agreed and accepted:

______

Signature of Dr. David V. Sheehan, copyright holderDate

For XXXXXX, the sponsoring company / CRO / healthcare provider / clinical care setting, requesting permission:

______

SignatureDate

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 / a health care provider, to use the M.I.N.I. 7.0.2(8/8/16 version), as designated by the terms mentioned above and signed by Dr. David V. Sheehan as copyright holder, for the following clinical trials / clinical care setting ONLY, until further request and permission has been granted for studies not listed hereinafter:

Will the MINIs be done at the screening visit after the informed consent form is signed?

Yes / No

Product/Compound /

Study Identification Number

Projected Number to be randomized to alltreatments /study medications at baseline visit per protocol / clinical care setting

XXXXX / XXXXX / XXXX
A.
Budget for Study being conducted using the MINI at no cost*:
US $______ / Research studies only / 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 studytreatment/ medications at the baseline visit). This ratio is usually a 3:1 ratioin schizophrenia studies or 2:1 ratio in Major Depressive Disorder Studies.
This is the best estimate of the number of MINIs to be done at the screening visit.
How many MINIs will be administered, and how many MINIs are you requesting permission to use at the screening visit?
XXXXX
B. / Non-research, clinical settings only / If this is for use in a clinical setting, rather than for use in a research study, how many MINIs do you plan to administer?
XXXXX

______

Signature of Dr. David V. Sheehan, copyright holderDate

Non-Profit settings:

Individualresearchers, clinicians and students,working in nonprofit or publiclyowned settings, (includinguniversities, nonprofithospitals, and government institutions),maymakepaper copies of the M.I.N.I. instruments for theirownpersonalclinical and research use, but not for institutional use.

In these settings the M.I.N.I. instruments maybereproduced in paper format and in PDF format, but may not becomputerized in these settings withoutwritten permission from Dr. Sheehan. The M.I.N.Imay not beposted on anyinstitution’swebsite.Any use involvingfinancial gain requires a license agreement signed by the copyright holder and payment of a per use licensingfee.

* Any use of the M.I.N.I. instruments in a research study with a budget above US $50,000, 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. 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 licensingfee. In “for profit” settings no part of the M.I.N.I. instruments maybereproduced or transmitted in anyform, or by anymeans, electronic or mechanical, includingphotocopying, or by any information storage or retrieval system, withoutwritten permission from Dr. Sheehan.

The M.I.N.I. instruments may not becomputerizedwithoutwritten permission.

For permission contact

Version 8/8//16