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Date: 07 Dec 2010SH/RM/RND/178-1 0-1881-201 0

To,

Dr. Raj Mdndot,Sterling HospitalSterling Hospital Road,Memnagar,Ahmedabad-380052Gujarat, India.

Subject: Ethics Committee (EC) Approval for Clinical Study No. 178-10

Dear Dr. Mandot,

Ethics Committee of Sterling Hospital, Ahmedabad reviewed and discussed yourapplication to conduct the clinical trial entitled "An Open Label Study To Evaluate TheSafety And Efficacy Of Amphotericin B Lipid Suspension For Injection (Amfy®) inImmunocompromised patients with Invasive Fungal Infections (IFI)"

The following documents were reviewed:

Sr. Document (along with controlled copy no., if Version No. & No. OfNo. applicable) Date Copies

01 Study Protocol (Controlled copy no 16 to 27 ) Version no. 01, 12Dated 07 Sep 10

02 Patient Information Sheet and Informed Consent Version no. 01, 12Form in English Dated 07 Sep 10

03 Patient Information Sheet and Informed Consent Version no. 01, 12Form in Hindi translated on - 09 Sep 10 Dated 0'1 Sep 10

Patient Information Sheet and Informed Consent Version no. 01,04 Form back translated from Hindi to English on 09 12Sep 10 Dated 07 Sep 10

05 Patient Information Sheet and Informed Consent Version no. 01, 12Form in Gujarati translated on 09 Sep 10 Dated 07 Sep 10

Patient Information Sheet and informed Consent Version no. 01,06 Form back translated from Gujarati to English on 12

09 Sep 10 Dated 07 Sep 10

Translation certificate and Back Translation07 certificate for English to Hindi, Hindi to English, ._--- 12

English to Gujarati and Gujarati to EnQlishVersion draft dated

08 CRF 02 Jul10 12

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Sterling Hospitals, Sterling Hospital Road, Ahmedabad 380 052. PhOM & Fax: +91-79-40011622.

09 Product Monograph (Control COpyno. 16 to 27) ---- 12

10 Investigator Undertaking ----- 12

11 CV & Medical Registration Certificate of ----- 12Investigator

12 DCGI Acknowledgement letter Dated : 28 Sep 10 12

OG -11-2202-

13 Insurance certificate effective from: 01 Oct 10; 3306-00000009; 12expired on 30 Sep 11. Policy issued on 16

Sep 10

14 Clinical Trial Agreement Draft 13 Sep 10 12

The following members of the Ethics Committee were present at the meeting held on04 Dec 2010 at 9:00 a.m. at 8th floor, Conference hall Sterling Hospital, sterling HospitalRoad, Memnagar, Ahmedabad-380052, Gujarat, India.

Sr. No. Name of EC member Position

1 Dr. Gaurang Shah Chairman2 Dr. Lubna Mansuri Member Secretary3 Dr. M.D.Shukla Member, Non medical Scientist4 Mr. Pranav Bhatt Member, Legal Expert5 MrViiav Patel Member, Legal Expert6 Mr. Shardul Radadiva Member, Lav Person7 Dr. Harsh Desai Member, Clinician8 Dr. Sanjav Patel Member, Clinician9 Dr. Shrenik Shah Member, Clinician10 Bhoomee Thakrar Member, Social Worker

This is to confirm that neither you nor any study team members were present / participated duringdecision-making process for approval of the study proposal.

We approve the trial to be conducted in its presented form for the above mentioned study.

The Institutional Ethics Committee expects to be informed about the progress of the study, anySAE occurring in the course of the study, and any changes in the protocol and patientinformation/informed consent and asks to be provided a copy of the final report.

This is to declare that this Ethics Committee (Sterling Hospital Ethics Committee), is orqanized andoperating in accordance with the Schedule Y, ICH-GCP and applicable local laws & regulations

Yours sincerely,

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