Subject: Test Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder-regard ing.

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1 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi To J~Alere Medical Pvt ltd., B-100,1 st Floor Naraina Industrial Area, Phase-I,New Delhi Subject: Test Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder-regard ing. With reference to your letter No.NiI dated 12/10/2011 vide diary No (FTS:70687) dated 13/10/201~,1 received by this office am to forward herewith Import Licence No. T-149/11 for the drugl drugs men~~~in your application. ('J /' :J ~\~ Kindly acknowledge receipj..oft~ 'tter and its enclosures. rr,' ~.,. v Yours faithfully VJrJ: (Dr. V.G.Somani) Drugs Controller General(lndia) Copy forwarded for information to: 2. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

2 FORM-11 (SEE RULE - 33) LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINA non, Number of Licence T-149/11 TEST OR ANAL YSIS S.No 1.MIs.Alere Medical Pvt Itd.,B-100,1st Floor Naraina Industrial Area,Phase- I,New Delhi is hereby licenced to import from MIs.ABON Biopharma(Hangzhou) Co Ltd., #198, 12 th Hangzhou Economic & Technological Development Area, Hangzhou, P.R.China the drugs specified below for purposes of examination, test or analysis at Mis. National Institute of Biologicals,A-32,Sector-62,Noida or in such other places as the licensing authority may from time to time authorize. 2.The licence is subject to the conditions prescribed in the Rules under the Drugs and Cosmetics Act, This licence shallunlesspreviq...~~ij revoked, be in force for a period of one year fl"om~~ifiedbeiow: Name of the Dru~$t irnp()"'~d: IfO( v ~. Lic~nsing Authority Seal/Stamp Conditions of Licence -;B1. 'it 1 "41.<'1 't t'ii1.oofl 1. The licensee shall use the substances imported under the licence exclusively f~~~q~'mj~; examination, test or analysis and shall carry on such examination, test or ana.li:.- iw'm~theplace specified in the licence, or in such other places as the licensing authority may Yro1t\'i:irp~;t9 time; authorise. 2. The licensee shall allow any inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used to take samples thereof. 3. The licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer. 4. The licensee shall comply with such further requirements, if any, applicable to the holders of licences for exainnation, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice. 5. The drugs imported under this licence shall not be used for clinical studies/trials unless specifically permitted so by licensing authority. 6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.

3 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi Dated: 2. MJs:Alere Medical Pvt ltd., \./B-1 00,1st Floor Naraina Industrial Phase-I,New Delhi Area, Subject: Test Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder-regard ing. With reference to your letter No.Nil dated 12/10/2011 received by this office vide diary No (FTS:70681) dated 13/1{1/2011,1am to forward herewith Import Licence No. T-150/11 for the drug/ dru~s <!""~tioned in your application.? <" 'J' Kindly acknowledge receiptaftjh'is letter and its enclosures. /.~ t' '" '> ;) Yours faithfully \},~. (Dr. V.G.Somani) Drugs Controller General{lndia) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabad/ Chennai/ Cochin/ Delhi/ Hyderabad/ Kandla /Kolkata/ Mumbai/ Nhava Sheva.

4 "Ifl<l FORM-11 (SEE RULE - 33) LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINA TlON, TEST OR ANAL YSIS Number of Licence T -150/11 1.Mls.Alere Medical Pvt ltd., S-100,1st Floor Naraina Industrial Area,Phase- I,New Delhi is hereby licenced to import from Mls.Orgenics Limited,6 Dan Street,North Industrial Zone,Yavne 70650,lsarel the drugs specified below for purposes of examination, test or analysis at Mis. National Institute of Sio/ogicals,A-32,Sector-62,Noida or in such other places as the licensing authority may from time to time authorize. ~~$\Rpe~revoked, cified below: RO.( be in force for a 1. ImmunoLisa HB 2. ImmunoLisa HB 3. ImmunoLisa HBcAg 4. ImmunoLisa HBcAb 5. New Delhi Date 2..':\""" i..iljv (,.' 9011 y~. Licensing Authority ~.e*~m~ C d Ot' f L 0 :ll1'l"rl f'\?r~ (W'ffl) on lions 0 Icence ~Q.7j inn <:,:/f, ',ill 1. The licensee shall use the substances imported under the licence exciusiveiy~j)i1zijlliirp()se'ocf,~ examination, test or analysis and shall carry on such examination, test or ana~is1.'r1~~h~,plage pc"c,3i'l. specified in the licence, or in such other places as the licensing authority may from time to time '.. authorise. 2. The licensee shall allow any inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used to take samples thereof. 3. The licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer. 4. The licensee shall comply with such further requirements, if any, applicable to the holders of licences for exainnation, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice. 5. The drugs imported under this licence shall not be used for clinical studies/trials unless specifically permitted so by licensing authority. 6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.

5 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi ~. Transasia Biomedicals Limited Transasia House 8, Chandivali Studio Road, Andheri (E), Mumbai With reference to your letter No. TBMNZ-1/ADM/11-12/5'696 Dated 14/09/2011 received by this office vide diary No (FTS 62573) dated 14/09/2011 and reply received by this office vide diary No (FTS 69834) dated 11/10/2011. I am to forward herewith Import Licence No. T-141/11 for the drug! drugs mentioned in your application. 1'")'\ r',... Kindly acknowledge receipt ott~~~ter t~,... /', p~,.. ;' ~OI' ''', v and its enclosures. Drugs Controller "~ (Dr. V.G. Somani) General (I) Copy forwarded for information to: 1.Asstt. Drugs Controller (India), Ahmedabad! Chennai! Cochin/ Delhi! Hyderabad/ Kandla /Kolkata/ Mumbai/ Nhava Sheva.

6 FORM-11 (SEE RULE - 33) LICENCE TO /MPORT DRUGS FOR THE PURPOSE OF EXAM/NATION, Number of Licence T-141/11 TEST OR ANAL YS/S 1. MIs. Transasia Biomedicals Limited, Transasia House 8, Chandivali Studio Road, Andheri (E), Mumbai is hereby licenced to import from MIs. Diasis Diagnostik Sistemler Tic. Ve San. A.S. Merkez mah. Burcu sok. No. 6/4 Mart Ptaza Nurtepe/Kagithane-lstambul, Turkey the drugs specified below for purposes of examination, test or analysis at MIs. Transasia Bio-medical Limited, Khasra Nos. 542, 543, 544 & 545, Village Malpur, Disst-Solan, H.P., Baddi or in such other places as the Licensing Authority may from time to time authorize. 2. The license is subject to the conditions prescribed in the Rules under the Drugs and Cosmetics Act, 1940", 3. This license shall un'essp~~'~i~'g~;~suspended be in force for a period of one year fro,~'~d~~tespecified " Names of drugs tq>be importe c,,:>c' New Delhi 2. i".' ;J ;i Vf~r~ - - /. tj;;fcensing Authority -,, ;t:,\,,'" Seal/Stamp Cond;fiqnfi of Licen~e :.t, ',. ~. 1\'0;[''')41<''1-1;fj~~"'-I-;fj-1 1. The licensee shall use the substances'lrhpb.le'c,i r QDQ'~r.Jt~'\ license exclusively f~an;~(}ff:!t"rcr2 examination, test or analysis and shall carry on such examination, test or an~~~~ l"lyl~~' specified in the license, or in such other places as the licensing authority may 'l'roiti-:ti(l,'e.{c);iflrne :'2 authorise. 2. The licensee shall allow any inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used to take samples thereof. 3. The licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the license, together with the quantities imported, the date of importation and the name of the manufacturer. 4. The licensee shall comply with such further requirements, if any, applicable to the holders of licenses for examination, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice. 5. The drugs imported under this license shall not be used for clinical studies/trials unless specifically permitted so by licensing authority. 6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.

7 Licence Number: T-141/11 This license shall be in force from? '. ;, J)\-' ~Jl\ """ S.No Names of drugs Quantity which may be imported 1. GOT (ASAT) 10 kits 2. GPT (ALAT) 10 kits 3. Total Protein Monoreagent 10 kits 4. Creatinine 10kits 5. Triglycerides GPO 10 kits 6. Urea UV 10 kits 7. Bilirubin Total DA 10 kits 8. Bilirubin Direct DA 10 kits 9. HbA1c 10 kits 10. HbA 1c Control Level 1 10 kits 11. HbA 1c Control Level 2 10 kits 12. HbA 1c Calibrator 10 kits 13. Total Bilirubin SA 10 kits, 14. Direct Bilirubin SA t./,~.",;~ '--, ",,'.~ kits New Delhi Date 2.:) ~\CV l011 Not for Com er'c.iaf Purpose. ITEM(S) ~~RTEEN ONLY /"~ /':"";'. ~ \ij,. (( c.~ 'Y Licensing v(~ Authority ~~~~~~";lb \ft)*1lofl 'If('! #1'rfu f:''"rr~''(>-;rm) ~<1r.f:", ',<. :;1

Central Drugs Standard Control. Directorate General of Health Services / Ministry of Health & Family Welfare (Medical Device and Diagnostic

Central Drugs Standard Control L Organisation Directorate General of Health Services / Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) To ~!~. Microgene Diagnostics Systems