Date: 5-Mar-2012

ToDr. Mahesh Chudgar,Mental Illness Treatment Rehabilitation Foundation (MITR),1, Shantinagar Society,Ashram Road, Vadaj,Ahmedabad 380013, India

Protocol Title: A Double-Blind, Placebo-Controlled Trial of Asenapine in thePrevention of Recurrence of a Mood Episode After Stabilization of an AcuteManic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phase 3B,Protocol P06384)

Subject: Ethics Committee Approval of study documents for the abovementioned study.

Dear Dr. Chudgar,

We have received from you copies of each of following study related documents

• Protocol Amendment P06384AM 3-[Dated 6 OCT 2011 - Amendment No.3] with summary of changes;

• Investigator Brochure SCH 900274Version Dated 15 Nov2010,• Investigator Brochure Memo dated 9 Nov 2011

.:. Inform Consent Form:

• Protocol P06384/ICF India model/English/Version 1.0 dated 23Jan2012based on Sample ICF version 1 dated 15 Nov 20 11<Site 3305 English ICFversion 1.0.0. dated 08 Feb 2012

• protocol P06384/ICF India model/Gujarati to English/Version 1.0 dated23 Jan 2012 based on Sample ICF version 1 dated 15 Nov 2011<Site 3305 Gujarati to English ICF version 1.0.0. dated 09 Feb 2012Back Translated from Gujarati to English on 09 Feb 2012

• Protocol P06384/ICF India model/Gujarati/Version 1.0 dated 23 Jan2012 based on Sample ICF version 1 dated 15 Nov 2011< Site 3305 Gujarati version 1.0.0. dated 09 Feb 2012Translated from English to Gujarati on 09 Feb 2012

•

ETHICS COMMITTEE MITR FOUNDATIONF0un dat ion 1, Shantinagar Society, Way to Azad Sweet, Ashram Road, Ahmedabad - 13.

• Protocol P06384/ICF India model/ Hindi/Version 1.0 dated 23 Jan 2012based on Sample ICF version 1 dated 15 Nov 2011< Site 3305 Hindi version 1.0.0. dated 09 Feb 2012Translated from English to Hindi on 09 Feb 2012

.:. PG-ICF's

• P063834_India_ Dr. Chudgar Mahesh Vrajlal , English PG ICF _Version1.0_08 Jan 2012;( Based on P06384_India Model PG ICF _English_Version 1.0_13 Oct2011)

• P063834_India_ Dr. Chudgar Mahesh Vrajlal , Gujarati PG ICF _Version1.0_09 Feb 20 12;(Based on P06384_India Model PG ICF _ Gujarati_Version 1.0_13 Oct 2011)Translated From English to Gujarati on 09 Feb 2012

• P063834_India_ Dr. Chudgar Mahesh Vrajlal_ Gujarati to English PG ICF_Version 1.0_09 Feb 20 12;(Based on P06384_India Model PG ICF_Gujarati to English_Version 1.0_13 Oct 2011)Back translated From Gujarati to English on 09 Feb 2012

• P063834_India_ Dr. Chudgar Mahesh Vrajlal_Hindi to English PG ICF_Version 1.0_09 Feb 2012;(Based on P06384_India Model PG ICF _ Hindito English_Version 1.0_13 Oct 20 l1)Back translated from Hindi toEnglish on 09 Feb 2012

• P063834_India_ Dr. Chudgar Mahesh Vrajlal_ Hindi PG ICF _Version1.0_09 Feb 2012;(Based on P06384_India Model PG ICF _HindLVersion 1.0_13 Oct 2011)Translated from English to Hindi on 09 Feb 2012

Translation Certificate:

• Certificate of Translation Hindi For Main Informed Consent Form

• Certificate of Translation Hindi For Pharmacogenetic Informed ConsentForm

• Certificate of Translation Gujarati For Main Informed Consent Form

• Certificate of Translation GujaratiConsent Form

For Pharmacogenetic Informed

• Certificate of Back Translation Hindi For Main Informed Consent Form

• Certificate of Back Translation Hindi For Pharmacogenetic InformedConsent Form

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• Certificate of Back Translation Gujarati For Main Informed Consent Form

• Certificate of Back Translation Gujarati For Pharmacogenetic InformedConsent Form

• Translation validation certificate For Hindi Main Informed Consent Form

• Translation validation certificate For Hindi Pharmacogenetic InformedConsent Form

• Translation validation certificate For Gujarati Main Informed ConsentForm

• Translation validation certificate For Gujarati Pharmacogenetic InformedConsent Form

• Back Translation validation certificate For Hindi Main Informed ConsentForm

• Back Translation validation certificate For Hindi PharmacogeneticInformed Consent Form

• Back Translation validation certificate For Gujarati Main InformedConsent Form

• Back Translation validation certificate For Gujarati PharmacogeneticInformed Consent Form

.:. Patient Materials:

Patient I.D Card:

• 10033945 _Version 1.0_8 Sep 2009_ Hindi

• 10033984 Version 1.0, 1 Sep 2009 English

• 10033949 Version 1.0, 2 Sep 2009 Gujarati

• Certificate of Translation Hindi For Patient I.D Card:

• Certificate of Translation Gujarati For Patient I.D Card

• 111037 Study Tote Bag (AllLanguages) vI 030NOV11

• 111037 Dear patient Letter v1.0 India (English) 22 Nov 2011• 111037 Dear patient Letter v1.0 Source(Hindi) 22 Nov 2011• 111037 Dear patient Letter v1.0 Source(Gujarati) 22 Nov 2011

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I• 1p037 Calendar v1.0 India (Hindi) 240ct11• 111037 Calendar v1.0 India (Gujarati) 240ct11• 111037 Calendar v1.0 India (English) 240ct11

• 111037 Informed Consent Flip Chart vl.O India (English) 22Nov11• 111037 Informed Consent Flip Chart vl.O India (Hindi) 22Nov11• 111037 Informed Consent Flip Chart vl.O India Gujarati 22Novll

• 111037 _Appointment_Reminder_Card_v1.0_India (EnglishL22NOV2011• 111037 Appointment Reminder Card v1.0 India (Hindi) 22NOV2011• 111037 Appointment Reminder Card v1.0 India (Gujarati) 22NOV2011.

• 111037 _Patient Brochure_vl.O_India (EnglishL22NOV2011• 111037 Patient Brochure v1.0 India (Hindi) 22NOV20 11• 111037 Patient Brochure vl.0 India (Gujarati) 22NOV20 11

• 111037 _Table_Top_PostecTear_OfLPad_v1.0_India (EnglishL22NOV2011• 111037 _Table_Top_Poster_Tear_OfCP~d_vl.0_India (HindiL22NOV20 11• 111037 _Table_Top_Poster_Tear_OfLPad_v1.0_India

(GujaratiL22NOV20 11

• 111037 _Table_Top_Poster_v_1.0_India (EnglishL22Nov 2011• 111037 Table Top Poster v1.0 India (Gujarati) 22Nov2011• 111037 Table Top Poster v1.0 India (Hindi) 22Nov2011

• 111037 _Welcome_Booklet_v1.0_India (EnglishL9DEC2011• 111037 Welcome Booklet v2.0 India (Hindi) 9DEC2011• 111037 Welcome Booklet v2.0 India (Gujarati) 9DEC2011

• Placebo response Video -Some Information About Reasearch StudiesRXS122_A ,Hindi

• Placebo response Video -Some Information About Research StudiesRXS122_A English

• CD on Drug Administration.

• Certificate of Translation Hindi For Dear Patient Letter

• Certificate of Validation Hindi For Dear Patient Letter

• Certificate of Translation Gujarati For Dear Patient Letter

• Certificate of validation Gujarati For Dear Patient Letter

• Certificate of Translation Hindi For Calendar

• Certificate of Validation Hindi For Calendar

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• Certificate of Translation Gujarati For Calendar

• Certificate of validation Gujarati For Calendar

• Certificate of Translation Hindi For Informed Consent Flip Chart

• Certificate of Validation Hindi For Informed Consent Flip Chart

• Certificate of Translation Gujarati For Informed Consent Flip Chart

• Certificate of validation Gujarati For Informed Consent Flip Chart

• Certificate of Translation Hindi For Appointment Reminder Card

• Certificate of Validation Hindi For Appointment_ReminderCard

• Certificate of Translation Gujarati For Appointment Reminder Card

• Certificate of validation Gujarati For Appointment Reminder..Card

• Certificate of Translation Hindi For Patient Brochure

• Certificate of Validation Hindi For Patient Brochure

• Certificate of Translation Gujarati For Patient Brochure

• Certificate of validation Gujarati For Patient Brochure

• Certificate of Translation Hindi For Table_Top_PostecTear_OfLPad

• Certificate of Validation Hindi For Table_Top_Poster_Tear_OfLPad

• Certificate of Translation Gujarati For Table_Top_Poster_Tear_OfLPad

• Certificate of validation Gujarati For Table_Top_Poster_Tear_Off_Pad

• Certificate of Translation Hindi For Table_Top_Poster

• Certificate of Validation Hindi For Table_Top_Poster

• Certificate of Translation Gujarati For Table_Top_Poster

• Certificate of validation Gujarati For Table_Top_Poster

• Certificate of Translation Hindi For Welcome_Booklet

• Certificate of Validation Hindi For Welcome_Booklet

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• Certificate of Translation Gujarati For Welcome_Booklet

• Certificate of validation Gujarati For Welcome_Booklet

Rater Scale:

• AIMS Instructions

• AIMS_Final

• BARS

• CGI-BP-C DoubleBlind

CGI-BP-CP06384 _OpenLabel_Final_20 II_Au~22

• CGI-BP-S_P06384_DoubleBlind

• CGI-BP-S_P06384_0penLabel_Final

• C-SSRS 1-14-09 Version - Baseline

• C-SSRS 1-14-09 Version - Since Last Visit

• MINI _6.0_Final_l0 Oct 2010

• PANSS QuikScore

• PANSS Rating Criteria

• SAS

• SCI-PANSS

• SIGMA

• YMRS QuikScore

• YMRS_Manual

• eCRFjCRF version dated 27 Jan 2012

• Certificate of liability Insurance Policy No: OG-12-1901-3306-00000004 &PolicyPeriod: 1 Sep 2011 to 30 June 2015

• DCGI Acknowledgement letter for Clinical Trial Application dated 3 Jan2012

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• Investigator Undertaking dated 20 Dee 2011

• Draft CSA verion 1.0 dated16 Dee 2011,111037_P06384_IND_ 3305_CSA_Dr.Mahesh Chudgar_English_20111216_1.0(Draft 0.1)

• CVdated 20 Dee 2011

• Merek EC Letter for using the patient material.

At the Ethics Committee meeting held on 29th Feb 2012 your referencedletter and the above documents were examined and discussed. Afterconsideration, the Committee has decided to approve the aforementionedstudy-related documents as well as the study to be conducted under yourdirection at Mental Illness Treatment And Rehabilitation Foundation(MITR) 1, Shantinagar Society, Way of Azad Sweet, Juna Wadaj,Ahmedabad-13, India.

Please inform us, in case if any serious adverse event is observed during theconduct of the study

The members who attended this meeting held on 29th Feb 2012 at whichyour proposal was discussed, are listed below:

Names of members Role in the EC

1. Dr. Harshad shah2. Dr. Manoj Shah3. Dr. Rohit Modi4. Dr.4>Jyotindra Bhatt5. Ms. Mobina Tinwala6. Dr. Usha Shah7. Mr. Dinesh Dalal8. Mr. Ashok Bhatt

ChairpersonSecretarymembermembermembermembermembermember

It is to be noted that neither you nor any of my proposed study teammembers were present during the decision-making procedures of the EthicsCommittee.

Yours truly,

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