Mis. Heart Beat Intervention Pvt. Ltd., UG-9,.Narayandarshan Apartment, Opp. Rupam Cinema, Salabatpura, Surat, Tal: Surat City (Surat),

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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 Mis. Heart Beat Intervention Pvt. Ltd., UG-9,.Narayandarshan Apartment, Opp. Rupam Cinema, Salabatpura, Surat, Tal: Surat City (Surat), SUbject-lss-ue-eof-an-EndorsemenUo_EorJn 1JLLicenseJ~~_Q.MD dated valid upto regarding Please refer to your application NIL and dated 17/06/11 received by this office vide diary no dated 17/06/2011 regarding the above cited subject. Endorsement to Form 10 License NO.MD dated valid upto for the import of devices manufactured by Mis. Mis. Minvasya, 7, rue du Fosse Blanc-92C~villiers, France is enclosed hereby. The Otheb'lf'Gf"f the license will remain same. (Dr. S. swara Reddy) Asstt. Drugs Gontroller (I) Copy forwarded for information to:../"i 1.Asstt. Drugs Controller (India), Ah~dabadl Kandla IKolkatal Mumbail Nhava Sheva. Chennail Cochinl Delhil Hyderabadl

2 FORM 10 (Endorsement 1) (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 Date:] 3 Mis. Heart Beat Intervention Pvt. Ltd., L1G-9, Narayandarshan Apartment, Opp. Rupam Cinema, Salabatpura, Surat, Tal: Surat City (Surat), is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs. Minvasya, 7, rue du Fosse Blanc Genevilliers, France is enclosed hereby. 2. This Endorsement No.1 shall be in force from [1 3 jut 19n to unless it is sooner suspended or cancelled under the said rules. ~~~~"3~ ~ ~~Name-s~~ohlrugs to"beimpurted: Drug Eluting Coronary Stents:,,. 1. Amazonia PAX (SterU~r 2. Nile PAX (Sterile)" 3. Delta PAX (Steril~) ITEM(S) THREE ONLY Place: New Delhi Date: tt ~ JUL.~ Conditions of Licence. licensing Authority Seal/Stamp 1. A photocopy of licence shall be displayed in a prominent place in a part of the premises, and the original licence shall be produced, whenever required. 2. Eacli batch of drug imported into India shall be accompan1ed with a detailed batch test report and a batch release certificate, duly signed and authenticated by the manufacturer with date of testing, date of release and the date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing authority deems fit prior to its marketing. 3. The licensee shall be responsible for the business activities of the manufacturer in India along with the registration holder and his authorised agent. 4. The licensee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the chan e takes lace unless, in the meantime, a fresh licence has been taken from the licensing authority in the name 0 t e JrmWI e c, ange v 'oj'

3 ... C'entral Drugs Standard Control Organisation Directorate Generaj of Health Services Ministry of Health & Family W.elfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi MIs Covidien Healthcare India Pvt., Ltd, No-156, Doshi Towers, 6 th Floor, Poonamallee High Road, Kilpauk, Chennai-10 Subject: Issue of an Endorsement to Form 10 License No.MD dated valid upto regarding. Date: ~1 4 JUL Please refer to your application CHIUIRNRB/F-10/MD-50(END-01)/2011 and dated 07/06/11 received by this office vide diarj no dated 08/06/2011 regarding the above cited.subject. Endorsement to Form 10 License NO.MD dated valid upto for the import of devices manufactured by MIs. Covidien lie, 15 Hampshire Street, Mansfield, MA02048, USA having manufacturing site at MIs. Covidien, 5439 State Route 40 Argy~ NY 12809, USA isenclosed hereby. The other conditions of tt~se ~\C<t:, O<{ will remain same. ~fuily (Dr. S. Eswara ~dey) Asstt. Drugs Controller (I) Copy forwarded for information to:. 1.Asstt. Drugs Controller (India), Ahmedabadl C~i1 Kandla IKolkatal Mumbail Nhava Sheva. Cochinl Delhil Hyderabadl

4 FORM 10 (Endorsement 1) (See Rules 23 and 27) Licence to import drugs (excluding those specified in Scheduie X) to the Drugs and Cosmetics Rules, 1945 Date: T1 4 JUL 2011 Mis Covidien Healthcare India Pvt., Ltd, No-156, Doshi Towers, 6 th Floor, Poonamallee High Road, Kilpauk, Chennai-10 is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by Mis. Covidien lie, 15 Hampshire Street, Mansfield,MA 02048, USA having manufacturing site at Mis. Covidien, 5439 State Route 40 Argyle, NY 12809, USA is enclosed hereby. ~his Endorsement NO.1 shall be in force from L1 4 JUL 2011 to unless it is sooner suspended or cancelled under the said rules. Names of drugs to be imported: 1. Palindrome TM H ChronicCatbeter kit 2. Palindrome TM SI Chror:fi~::Catheter kit 3. Palindrome TM HSI Ct:lronic Catheter kit Place: New Delhi a 4 JUL Date: ITEM(SrtHREE ONLY.... ~. vo~ ~\C<.:, O~ Li~ensl"g AuthoritY IX 5 ESWA~~' Ph.D ~ O~g~controiier"(titdlal ConcJltions oflicence.... D.G.H.S", EO.A. a=n 1. A photocopy of licence shall bedis.plclyedin a prominent pla~,~oat~f the premises, and the original licence shall beproduced,wh~fl~v~rj~quin9d. 2. Each batch of drug lmpoiiecl into India shalfbe accompanied with a detailed batch test report and a batch release certificate, duly signed and authenticated by the manufacturer with date of testing, date of release and the date of forwarding such reports. The imported batch of each drug shall be subjected to _~2C?min9ti9nJmd. testingasthe-lite-nsliigaijfhoritycleems fifpnor to itsmarkeitng The licensee shall be responsible for the business activities of the manufacturer in India along with the registration holder and his authorised agent. 4. The licensee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing allthor~-gf-tae firm with the changed collstitutiotl.

5 Central Drugs Standard Control Organ,isatlon Directorate Gen'eral of Health Services Ministry of Health & Family Welfare (Medical Device. and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi Dated: (1 4 JUL ZOll MIs. Becton Dickinson India Pvt. Ltd., No.34, Assisi Nagar, West Thottam, Madhavaram, Chennai-51 SUbject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. With reference to your application for import lice'nce forwarded to this office with your letter NO.BDIURA-100/11/01 dated 02/06/2011 received by this office vide c;iiaryno dated 02/06/2011 and additional documents received by this office,.vi e diary NO dated 16/06/11. I enclose Iicence(s) NO. MD dated Il, s 1 these licence(s) has 1 have been granted under the Drugs and Cosmetics c 40 and Rules1945 thereunder. 2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules1945 are in addition to and not derogation of any other law for the time being in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to and distinct from any Iicence(s) which may be necessary under the Import Trade Control Regulations made of the Government of India, Ministry of Commerce. ~ 3. The import licence(s) mentioned in pa!]l~al>ove will not accordingly to itself 1 themselves be sufficient auth~rit J.pr~ort of Drugs covered by that 1 those licence(s) if under the Import,~ontrol Regulations of the Commerce Ministry separate Iicense(s) are re~ for import of such drug(s). A. I am therefore, to advise ~u to obtain, where necessary Iicence(s) for import of drugs in question under the Import Trade Control Regulations. 5. Any literature or packing accompanying the drugs or any mc!tterstated on the label should not contravene the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act. 6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs Control Organisation at the ports will be Officers authorized to inspect the premises of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rules thereunder. 7. Please acknowledge receipt of this letter and its enclosures "'1>--. (Dr. S. Eswara Reddy) Asstt. Drugs Controller (I) Copy forwarded for information to:. / ~A.. ss-tt...j. Drugs ControHer--(trldiat.-Ahmedabadl Ch'eflA-ail CochiAt---Qelhil Hyderabad/ Kandla IKolkatal Mumbail Nhava Sheva

6 FORM 10 (See Rules 23 and ~7) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 Date: ~ MIs. Becton Dickinson India Pvt. Ltd.,No.34, Assisi Nagar, West Thottam, Madhavaram, Chennai-51 is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs. Becton Dickinson and company, 1 Becton Drive, Franklin lakes, NJ 07417, USA having factory premises at MIs. BD Caribe Ltd., Road 31, KM 24.3, PO Box 4010, Juncos, Puerto Rico USA and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence. (1 4 JUL ZOll 2. This licence shall be in force from unless it is sooner suspended or cancelled under the said rules. 3. Names of drugs to be imported: 1. Kit VECSE 27G Whitacre/18GWeiss 2. Kit Perisafe 18Gx3/12",Weiss ITEM(S) TWO ONLY ~~ (jo ~\~<c, O~ JUL Lan Date.:~A ~ 'Ltcensing Authority or.s. ESWAlAt~Ph. ~.D Asstt. DrugsControUer (1ncha) D.G.H.S., F.D.A. Bhawan 1. A photocopy of licence shall be dispr~y~~'~i~'.i~,,~~6minentpl~te fwtw _~t~hf premises, and the original licence shall be,:prodtjce(j~whenever required. 2. Each batch of drug imported into,lndia shall be accompanied>with a detailed batch test report and a batch release certiijc;:ite,. duly.si.gne(:jand authenticated by the manufacturer with date of testing, date of releas'eand the date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing authority deems fit prior to its marketing. 3. The licensee shall be responsible for the business activities of the manufacturer in India along with the registration holder and his authorised agent. 4. The licensee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution