COPYRIGHT LICENSE: for Use in Paper Or Pdf Format of the Sheehan Clinician Global Improvement

COPYRIGHT LICENSE: for use in paper or pdf format of the Sheehan – Clinician Global Improvement Scale (S-CGI) or the Sheehan – Patient Global Improvement Scale (S-PGI)

Dr. David V. Sheehan, as “copyright holder” of the “Sheehan – Clinician Global Improvement Scale” hereinafter referred to as the “S-CGI” or the “Sheehan – Patient Global Improvement Scale” hereinafter referred to as the “S-PGI”, 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 S-CGI or S-PGI 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 implementing 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 Sheehan – Clinician Global Improvement Scale or the Sheehan – Patient Global Improvement Scale and their 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 Sheehan – Clinician Global Improvement Scale or the Sheehan – Patient Global Improvement Scale,in the translations 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 Sheehan – Clinician Global Improvement Scale or the Sheehan – Patient Global Improvement Scale 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 S-CGI or S-PGIin domestic and international clinical trials / your clinical care setting.

-the right to use the S-CGI or S-PGIin rater training.

Such granting of rights to XXXXXXXX, its affiliated companies and subcontractors / your clinical care setting, to use the S-CGI or S-PGIand their final translations, as hereinabove provided for, is subject to a charge of $1 per single administration (not per patient enrolled), payable in full before study initiation to:

David V Sheehan MD

611 Warren Rd, Lutz, FL 33548

For permission contact

2 tier pricing model:

a. $1 per administration of either the S-CGI or the S-PGI (Initial purchase)

b.$2 per administration of either the S-CGI or the S-PGI(Delinquent purchases) - in line with reporting and publication of study results.

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 S-CGI or S-PGI, used within clinical trials / provision of care, defined hereinafter, a mention redacted as follows:

© Copyright 1985, 2000, 2016 Sheehan DV. All rights reserved.

Reproduced with permission of copyright holder only.

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 S-CGI or S-PGI, in Microsoft Word and/or PDF format.

-In any publication resulting from the use of the S-CGI or S-PGI, XXXXXXXX, its affiliated companies and subcontractors / your clinical care setting, SHALL NOT reproduce any part of the S-CGI or S-PGIor its translations, without the prior written consent of Dr. David V. Sheehan, copyright holder. For permission contact

The recommended citations for the S-CGI or S-PGI are:

1. Sheehan DV, and Giddens JM. Harm Research Institute. Sheehan - Global Improvement Scales (S-CGI and S-PGI). Retrieved January 7th, 2017 from: heehan-global-improvement-scales-s-cgi-and-s-pgi/
2. Sheehan DV, Raj BA, Sheehan KH, Soto S, Knapp E. The relative efficacy of high dose buspirone

and alprazolam in the treatment of panic disorder - A double-blind placebo-controlled study. ActaPsychiatricaScandinavica. 1993; 88(1): 1-11.

It is hereby agreed that, except as otherwise set forth herein, no other right or license on S-CGI or S-PGIshall 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 S-CGI or S-PGIand 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 (S-CGI or S-PGI), as designated by the terms mentioned above andsigned by Dr. David V. Sheehan as copyright holder, for the following clinical trials / clinical care settingONLY, until further request and permission has been granted for studies not listed hereinafter:

Study Identification Number

Projected number to be randomized to all study medications at baseline visit per protocol / clinical care setting

______

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 S-CGI or S-PGIfor theirownpersonalclinical and research use, but not for institutional use.

In these settings the S-CGI or S-PGImaybereproduced in paper format and in PDF format, but may not becomputerized in these settings withoutwritten permission from Dr. Sheehan. The S-CGI or S-PGImay 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 S-CGI or S-PGI in a research study with a budget above US $50,000, and which involves bringing in overhead to the participating institution, requires a license agreement signed by the copyright holder and payment of a per use licensing fee.

For Profit settings:

The use of the S-CGI or S-PGIfor 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 S-CGI or S-PGImaybereproduced 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 S-CGI or S-PGImay not becomputerizedwithoutwritten permission.

For permission contact