Insulin Degludec (2.56mg) + Insulin Aspart (1.05mg) , 3ml Prefilled pen

OPTION CLAUSE: The Purchaser reserves the right to increase or decrease the quantity to be ordered up to 25 percent of bid quantity at the time of placement of contract. The purchaser also reserves the right to increase the ordered quantity up to 25% of the contracted quantity during the currency of the contract at the contracted rates. The delivery period of quantity shall commence from the last date of original delivery order and in cases where option clause is exercised during the extended delivery period the additional time shall commence from the last date of extended delivery period. The additional delivery time shall be (Increased quantity ÷ Original quantity) × Original delivery period (in days), subject to minimum of 30 days. If the original delivery period is less than 30 days, the additional time equals the original delivery period. The Purchaser may extend this calculated delivery duration up to the original delivery period while exercising the option clause. Bidders must comply with these terms.

Bidder shall submit the following documents along with their bid for Vendor Code Creation: a. Copy of PAN Card. b. Copy of GSTIN. c. Copy of Cancelled Cheque. d. Copy of EFT Mandate duly certified by Bank.

Data Sheet of the product(s) offered in the bid, are to be uploaded along with the bid documents. Buyers can match and verify the Data Sheet with the product specifications offered. In case of any unexplained mismatch of technical parameters, the bid is liable for rejection.

Scope of supply (Bid price to include all cost components) : Only supply of Goods

Nominated Inspection Agency: On behalf of the Buyer organization, any one of the following Inspection Agency would be conducting inspection of stores before acceptance: Pre-dispatch Inspection at Seller Premises (applicable only if pre-dispatch inspection clause has been selected in ATC): Not Required Post Receipt Inspection at consignee site before acceptance of stores: By CMO (I/C) CHD or any of her Representative

Bidder's offer is liable to be rejected if they don't upload any of the certificates / documents sought in the Bid document, ATC and Corrigendum if any.

Buyer Added text based ATC clauses

The bidder must have to submit the following documents while submitting t he bid. A. The bid item is proprietary of Novo Nordisk India Pvt. Ltd. (Importer). Manuf actured by Novo Nordisk A/S, Denmark, hence only Novo Nordisk India Pvt. Ltd. or his authorised distributor/agent is allowed to participate in the bid. B. Import license of the item which should be valid on date of Tender opening and shall remain valid till the date of completion of supply. C. If the Importer, do not quoted directly then, their authorized sole selling age nt / authorized marketing agent / authorized dealer / authorized supplier / au thorized distributor / authorized channel partners must submit tender specifi c authorization letter from the manufacturer & valid drug license for sale of t he drug as per the provisions of Drugs & Cosmetics act 1940 and Rule made there under as amended from time to time. D. The Importer, participating in a tender should submit a non-conviction certif icate issued by concerned Licensing Authority within a period of 12 (twelve) months prior to tender opening, stating that the Company has not been conv icted under drugs and cosmetics Act. – 1940 & Rules 1945 or amended rules thereof, if any, with respect to Own Manufacture and/ or Loan Licensee (in ca se quoted products are manufactured on Loan License) or retail drug license (For Importers) during the last three years. E. The tenderer shall also submit a self-declaration, stating that the Company is not convicted under drugs and cosmetics Act. – 1940 & Rules 1945 or am ended rules thereof, if any, with respect to Own Manufacture and/ or Loan Li censee (in case quoted products are manufactured on Loan License) as on d ate of submission of bid and shall intimate the order placing authority in cas e of conviction during the currency of contractual obligation. F. WHO-GMP certificate of Importer having WHO-GMP certificate with list of pr oduct approved under WHO-GMP or Certificate of Pharmaceutical Product (C OPP) for WHO-GMP practices. G. Test Reports from Accredited laboratory of NABL authorized for conducting tests of tendered items/ medicines. H. Bidders have to submit the “Notarized Undertaking” as mentioned on Anne xure – A. (scanned copy and hard copy). Details of the same may be verified by the buyer at their end. I. The bidder/seller has to submit a bid compliance certificate on their letterh ead for complying with the all the bid terms and conditions. J. The bidder/seller/manufacturer should have not been blacklisted/debarred/de-registered/banned for the quoted product by any St ate Government / Central Government / Central or State Government’s Drug procurement agencies at the time of submission of bid. Further, quoted drug s / medicines have not been failed in house testing or testing by any State G overnment / Central Government / its Drug procurement agencies during las t two years. If any bidder/seller/manufacturer has been blacklisted / debarre d / de-registered/banned due to quality failure, such bidder/seller/manufactu rer or their Partner / Director / Owner shall not be permitted to participate in the bid. K. The bidders must have to submit a declaration that they have not been ban ned or de listed by any government or quasi-government agencies or PSU’s. L. Past experience for supply of the indented item to Govt. Undertaking/State Govt./other Govt. institutions /reputed private institutions is Required for par ticipating the techno commercial Bid. Also the bidder has to submit documen tary evidence for supplying the item at the indicated institution. However, de cision in this regard will be solely at the discretion of Management. Exemption from Experience Criteria/Performance criteria : I f b i dd e r s h a v e s u b m i tt e d d o c u m e n t s t o p r o v e t h e S t a r t - up / M S E s t a t u s f o r t h e t e n d e r e d i t e m a n d t h e i r p r o d u c t s a r e I S I m a r k e d / D G M S a pp r o v e d / P r o v e n i n C I L o r i t s S u b s i d i a r y c o m p a n i e s / P r o v e n p r o d u c t o f the ancillary unit of a Subsidiary Company of CIL, they will be required to submit the following app licable related documents, for relaxation from the criteria of prior experienc e and prior turnover: a valid BIS Marking License for the quoted items or Rate contract issued by CIL/its Subsidiary Companies for the quoted items or a valid DGMS Approval certificate for the quoted items or Proven Ancillary certificate issued by the Subsidiary Companies for the quoted items. If b i dd e r s h a v e s u b m i tt e d d o c u m e n t s t o p r o v e t h e S t a r t U p / M S E s t a t u s f o r t h e t e n d e r e d i t e m w i t h o u t certificate towards quality, assurance and capability f rom some authority like MSME, NSIC, etc, the bidder needs to submit Profor ma for Equipment and Quality Control (as per Annexure - C) duly filled along with the bid for assessing the techno-commercial capability of the vendors t o manufacture and deliver goods as per the prescribed quality and technical specification. The document(s) / certificate(s) furnished by the bidders for IS I markings or DGMS approval for any relaxation should be valid on the date o f t e n d e r o p e n i n g a nd a c o p y o f s u c h d o c u m e n t ( s ) / c e r t i f i c a t e ( s ) v a l i d o n t h e d a t e o f s u pp l y , m u s t a cc ompany their bill(s). Note 1: Performance / exemption documents for each schedule participated, n eeds to be submitted to be c o n s i d e r e d f o r p r o v e nn e ss / e x e m p t i o n . Note 2: Decision of technical evaluators (BCCL) shall be final and binding up o n bidders. M. Price Certificate : The bidder shall submit a price certificate along with the off er and bill as given below “We hereby certify that with regards to your above referred tender and our off er, the price chargeable to Central Hospital, BCCL is the lowest and is the sa me as applicable to all customers in India including other Govt. Organization / Govt. Undertakings and Coal India Limited and its subsidiaries or any other private organization”. N. The Importer shall certify on its letter head that the medicines/ drugs suppli ed are as per the formulation specified/ approved under the Drug Control Act and Food & Drug Control Administration Regulations or any similar Regulatio ns. The Pharma Company shall be held responsible for consequences, if any, of supplying spurious, adulterated or sub-standard medicines/ drugs not conf orming to such Act/ Regulations. O. The bidder must clearly state the Manufacturer, Marketer (If manufacturer a nd marketer are different)/Importer & Brand Name of the offered medicines. This fact must not be change in the later stage of the Bid. In case the manuf acturer and marketer are different then the bidder must have to submit the c ontract between the manufacturer and marketer. A bidder can quote a medi cine from a single manufacturer & marketer only. Bidders are not allowed to quote multiple manufacturer and marketer for a single medicine. The followi ng detailed table must be submitted on the letter head of the bidder. S/L no. Bid Schedule Medicine Manufacturer Markete r/Import er

If a company/firm has two or more separate manufacturing units at differe nt sites / States/region, which are not separate entities then the company will be allowed to submit only one bid for all units but necessary document r egarding separate manufacturing units will be submitted to the buyer. Howe ver, one bidder will be allowed to submit only one offer for one product.

The tenderers should ensure that the prices quoted by them should not co ntravene the provision of Drug Price Control Order, 2013 or any other contro l order enforced during the relevant period. While claiming payments, the su ccessful tenderer will be required to submit a certificate to this effect from a ny of their Internal Auditors/ Chartered Accountant.

At the time of supply, the medicine should not have crossed more than 1/6t h of the total useful life. Loss or premature deterioration due to biological an d other activities during life span of stores shall have to be made good by th e contractor free of cost.

The Pharma Company shall furnish a copy of the analytical report for each batch of medicines/ drugs based on the formulation submitted by the Pharm a Company and approved by the Drug Control Authority/ Food & Drug Contr ol Administration (FDCA), failing which the medicines/ drugs supplied may b e rejected.

CIL and its subsidiaries shall reserve the right to get the supplied medicine s/ drugs tested by NABL accredited laboratories. CIL subsidiaries may carryo ut random testing at its own cost to have a check on quality. Note: If it is decided by the Medical Office In-charge of the consign ee hospital/ store to get the sample tested through NABL, the sam e shall be sent in such a way that name of manufacturer does not c ome to the knowledge of testing laboratory. The random sample shall be given a unique code for reference. The medicines of such consignment should not be used until satisfactory test report is rec eived.

Recalls: If products are recalled because of problems with product quality o r adverse reaction to the pharmaceutical, the supplier will be obliged to notif y the buyer, providing full details about the reason leading to the recall, and shall take steps to replace the product in question at suppliers own cost at t he ultimate destination with a fresh batch of acceptable pharmaceuticals or withdraw and give a full refund of the unconsumed quantity if the product h as been taken off the market due to safety problems.

Replacement of medicines: In the event of non-liquidation of stock the firm will have to undertake the responsibility to replace the same with medicines having longer expiry period if informed before 3 months of expiry free of cos t to the purchaser which means the supplier will have to bear all the expens es up to the destination site as applicable will be borne by supplier to ensure free delivery.

Clarification of Bids/ Shortfall/ Confirmatory Documents: After evaluation of the uploaded documents, shortfall documents, if required, shall be sought fr om the bidder. Only one opportunity shall be provided for submission of suc h documents. A time period of 7 × 24 hours will be given to the bidder to upl oad the required clarifications/shortfall documents. The bidder must upload the requested documents within the specified time. No additional time shall be allowed for online submission of documents after the single opportunity of 7 × 24 hours. If the bidder fails to comply or does n ot respond within the stipulated date and time, the bid is liable to be rejecte d. Shortfall information/documents shall be sought only in respect of historic al documents, as per GeM provisions/rules.

No shortfall documents submitted during the 48-hour challenge/representa tion on period will be accepted.

B.C.C.L reserves the right to accept or reject any or the entire offer, extend tender opening, modify tender document or cancel the tender at any stage of BID/tender without assigning any reason. The offer should be submitted strictly as per the terms & conditions laid down in the tender document, faili ng which the offer may be liable for rejection.

This bid will be governed not only by the terms and conditions explicitly sta ted within the bid documents, but also by the terms and conditions found in the updated and latest Coal India Limited Purchase Manual (Available on CIL Website). Additionally, all disputes pertaining to this Bid shall be subject to Dhanbad Jurisdiction only.

Bidders have to submit EMD (@ 2% total estimated bid value) with only Onl ine Payment through RTGS / NEFT / IMPS/other digital modes in the following : Beneficiary Name: BHARAT COKING COAL LIMITED, DHANBAD Account Number: 10976596654 IFSC Code: SBIN0000066 Bank Name: State Bank of India, Branch Address: Bank More, Katras Road, Dhanbad-826001 Bidders must have to upload scanned copy/proof of the online transaction alon g with bid.

Security Deposit: I. The successful bidders will have to submit Security Deposit for the 5% valu e of the total landed value of the contract including all taxes, duties and o ther costs and charges, without considering Input Tax Credit. The format of SDBG shall be as per Annexure - B. II. The Security Deposit shall be in the form of a Bank Demand Draft/RTGS/NE FT/IMPS or in the form of a Bank Guarantee in the prescribed format from an RBI Scheduled Bank in purchaser's country (on a non-judicial stamp pa per) within 15 days from the date of award contract. III. The SDBG shall remain valid up to 3 months after completion of supplies a nd acceptance of materials by the consignee in case of supply contracts/ r ate / running contracts. IV. If the successful bidder fails to deposit the security deposit within 15 (fiftee n) days from date of award contract, another opportunity may be given to them for submission of Security Deposit within next 15 days. If the succes sful tenderer still fails to deposit the security deposit within the extended period but executes the supplies within the extended security deposit sub mission period, the submission of Security Deposit may be waived, as the purpose of submission of SD is fulfilled. V. In cases where the successful tenderer did not submit the security deposit even within the extended period for SD submission but has supplied the materials either in full or in part after the extended period for SD submissi on, the SD may be deducted from the first bill or in case of insufficient am ount from subsequent bill(s) of the supplier till the full SD amount is dedu cted. Further, a penalty equivalent to 0.5% (half percent) of SD amount fo r delay of each week or part thereof (period of delay is to be calculated fr om the 31st day from the date of notification of award/placement of order to the date of receipt of full SD/deduction of full SD) shall be levied subject to a maximum of 10% of the contract value. VI. Security Deposit will be released with the approval of HOD of MM Departm ent/ Area GM within 30 days after completion of supplies and acceptance of material by the consignee. VII. All Central/State Government Organization/PSUs shall be exempted from s ubmission of Security Deposit. OEM/OES shall also be exempted from sub mission of Security Deposit in case of procurement of Spare Parts for equi pment against Single Tender Enquiry/Open/Limited Tenders. VIII. Submission of Security Deposit is exempted for the contracts having value up to Rs.2 lakhs. IX. Bidders can also submit the SD amount in the form of Demand Draft In Fa vour of Bharat Coking Coal Limited, CHD, and Payable at Dhanbad. X. The SDBG will be submitted Through Structured Financial Management Sys tem (SFMS). XI. Bidders can also submit the Security Deposit Amount with Online Payment through RTGS / NEFT / IMPS / other digital modes in Beneficiary name with in 15 days from the date of placement of Contract: Beneficiary Name: BHARAT COKING COAL LIMITED, DHANBAD Account Number: 10976596654 IFSC Code: SBIN0000066 Bank Name: State Bank of India, Branch Address: .Bank More, Katras Road, Dhanbad-826001 XII. Bidder to indicate bid number and name of bidding entity in the transaction details field at the time of on-line transfer along with Invoice / bills. Annexure – A UNDERTAKING (to be on non-judicial stamp paper of Rs 10 and notarized) I, , s/o / d/o / w/o _, aged about resident of , do hereby declare and undertake that;

I am the partner / proprietor / director of (name of entity) and d uly authorized to sign this undertaking on behalf of _. (Name of e ntity)

We are the manufacturers of the drug/medicine _(“Product”) and inte nd to offer the same for sale through the GeM portal.

We state that the license for the Product has been granted/obtained b y us as per the provisions of the Drug & Cosmetics Act, 1940 and rules framed there under as amended till date.

We further state that the details regarding the Product/licenses have been uploaded by us on the online ‘SUGAM’ portal of CDSCO as per rul e 84AB of the Drugs and Cosmetics Rules, 1945 as amended till date. R eference no. for SUGAM portal is _.

We undertake that all the information provided above is true and com plete in all respect. We understand that in the event any false informat ion/declaration is provided by us, suitable legal action/action as per Dr ugs and Cosmetics Act, 1940 as amended till date and rules made ther e under will be initiated. Place: Date: …………………………………….. Signature, Name, Designation & Seal on behalf of the Manufacturer Annexure – B Security Deposit Bank Guarantee Format …………………………….……. (Name & address of the Purchaser ………………… …………….… Company) Re: Bank Guarantee in respect of Notification of Award / Purchase Order vide no. … …. Dated .......... between …… (Name of Purchaser Company) and ….. (Name of Supplier Company) Messers ..................................................................... ..a Company / Firm having its office at No. ................................................... .................... (here in after called ‘the Contractor’) has received the Notific ation of Award / Purchase Order vide no. ….dated……… (herein after called ‘the said Agreement’) with .……………………………(Name of the Purc haser Company) (hereinafter called ‘the Company’) to supply……………… …… stores/ materials amounting to Rs. ………………on the terms and cond itions contained in the said Notification of Award / Purchase Order. The……….................. (Name of the Bank) (herein after called ‘the Bank’) having its office at................................. has at the request of the Contract or agreed to give the guarantee as hereinafter contained. We..........................................(Name of the Bank) do hereby unconditionally agree with the Company that if the Contractor shall in any way fail to obse rve or perform the terms and conditions of the said Agreement or shall co mmit any breach of its obligations there under, the Bank shall on demand and without any objection or demur pay to the Company, the said sum of Rs………………. or any portion thereof without requiring the Company to h ave recourse to any legal remedy that may be available to it to compel th e Bank to pay the same or calling on the Company to compel such payme nt by the Contractor. Any such demand shall be conclusive as regards the liability of the Contracto r to the Company and as regards the amount payable by the Bank under t his guarantee. The Bank shall not be entitled to withhold payment on the ground that the C ontractor has disputed its liability to pay or has disputed the quantum of t he amount or that any arbitration proceeding or legal proceeding is pending between the Company and the Contractor regarding the claim. We, the Bank, further agree that the guarantee shall come into force from th e date hereof and shall remain in full force and effect till the period that wi ll be taken for the performance of the said Agreement which is likely to be the …….. day of………… but if the period of Agreement is extended either pursuant to the provisions in the said Agreement or by mutual agreement between the Contractor and the Company, the Bank shall renew the perio d of the guarantee failing which it shall pay to the Company the said sum of Rs…………, or such lesser amount out of the said sum of Rs……………..a s may be due to the Company and as the Company may demand. This guarantee shall remain in force until the dues of the Company in respec t of the said sum of Rs……… are fully satisfied and the Company certifies t hat the Agreement has been fully carried out by the contractor and discha rges the guarantee. The Bank further agrees with the Company that the Company shall have the fullest liberty without the consent of the Bank and without affecting in any way the obligations hereunder to vary any of the terms and conditions of t he said Agreement or to extend the time for performance of the said Agre ement from time to time or to postpone for any time or from time to time any of the powers exercisable by the Company against the contractor and to forbear to enforce any of the terms and conditions relating to the said A greement and the Bank shall not be relieved from its liability by reason of such failure or extension being granted to the contractor or thro ugh any forbearance, act or omission on the part of the Company or any in dulgence by the Company to the contractor or any other matter or thing w hatsoever which under the law relating to sureties would but for this provi sions have the effect of relieving or discharging the Guarantor. The Bank further agrees that in case this guarantee is required for a longer period and it is not extended by the Bank beyond the period specified abo ve, the Bank shall pay to the Company the said sum of Rs………………… or such lesser sum as may then be due to the Company and as the Company may require. Notwithstanding anything herein contained the liability of the Bank under thi s guarantee is restricted to Rs……… only. The guarantee shall remain in fo rce till the……day of …… 20... and unless the guarantee is renewed or a cl aim is preferred against the Bank within the validity period and/or the clai m period from the said date, all rights of the Company under this guarante e shall cease and the Bank shall be released and discharged from all liabili ty hereunder except as provided in the preceding clause. The Bank has under its constitution power to give this guarantee and……… ………….. [(Name of the person(s)] who have signed it on behalf of the Ban k has authority to do so. Dated this…………………day of ………….20…… Place………………………………… Signature of the author ized person(s) For and on behalf of the Bank. Submission of SDBG: Beneficiary bank details : The bank details of BCCL is given below 1 Name of Bank STATE BANK OF INDIA 2 Branch name & Co de BANK MORE, DHANBAD, SBIN0000066 3 Account Number 10976596654 4 Branch address BANK MORE, KATRAS ROAD, DHANBAD Original Bank guarantee issued by the issuing bank shall be sent by the Is suing bank to concerned Department/Area by Registered Post (AD). ANNEXURE - C PROFORMA FOR EQUIPMENT AND QUALITY CONTROL Reference: Tender No. ………………………………………_ Date ………………….. for supply of ………………………………………………….. _

Name and Address of the Firm

(a) Telephone No. office/factory/works (b) Fax No. I E-mail ID

Location of manufacturing works / factories owned by the firm (docum entary evidence of owner ship must be produced).

Brief description of the factory (i.e. area covered accommodation, Dep artment into which it is divided, laboratory etc.)

Details of plant and machinery erected and functioning in each depart ment (monographs and description pamphlets) be supplied if available.

Whether the process of manufacture in the factory is carried out with t he aid of power or without it.

Details and stocks of raw materials held.

Production capacity of items quoted for with the existing plants and m achinery (a) Normal (b) Maximum

Details of arrangements for quality control products such as laboratori es etc.

(a) Details of technical supervisory staff in-charge of production and quality control. (b) Skilled labor employed. (c) Unskilled labor employed (d) Maximum number of workers (skilled and unskilled) employed on an y day during 18 months preceding the date of application.

Whether stores were tested to any standard specification, if so, copie s of original test Certificate should be submitted in duplicate. ……………………………………………………………………………………… Date……………… Place……………… (Signature of Tenderer) NB: Details against sl. nos. 5 to 11 inclusive need be restricted to the ext ent they pertain to the items under reference. . अ'वीकरण अ'वीकरण /Disclaimer