HINDUSTAN ANTIBIOTICS LIMITED PIMPRI, PUNE-411 018 (A Govt. of India Undertaking) APPOINTMENT OF CONSULTANTS FOR KNOW-HOW & TECHNOLOGY OF LARGE VOLUME PARENTERAL PRODUCTS Hindustan Antibiotics Ltd (HAL), a pioneer in the field of antibiotics in India. HAL has facility for manufacturing Large Volume Parenteral products based on Blow-fill-Seal technology. HAL is interested to get know-how & technology for following products:Sr. No. 1 Product Strength Dose Hetastarch 350 / 500 ml 2 3 4 5 6 7 8 9 10 Hetastarch with electrolytes Hypertonic Saline Dextran – 70 / 40 Dextran – 70 with Hypertonic saline Amino Acid Infusion Hepatic Formula Amino Acid Renal formula Amino Acid Paed. Formula Oxazolidone ( Antibacterial ) Branch chain Amino acid formula 3% , 6% & 10% 6% 7.5% 6% 6% 8% 5.2% 7% & 10% 11 12 13 14 15 16 17 Total Amino acid TNP Linezolid Infusion Glycerol IV Dializer Fluid Heart Lung Perfusion Fluid Ofloxacin Ornidazole + Ofloxacin 500 ml 500 ml 100 ml / 300 ml 200ml, 500 ml, 1000 ml 500 ml 300 ml 7% 10% & 15% 500 ml 250 ml 250 / 500 ml 250 / 500 ml 500 ml 500 ml / 1000 ml 500 ml / 1000 ml 100 ml Consultant may offer his services for one product or all the above products. Consultant may also suggest additional high value IVF product which can be taken up in the HAL’s IVF plant. Product means IVF product with all its different doses or concentration for example : Hetastarch with its doses 3%, 6%, & 10% will be treated as one product The technology providers should fulfill the following conditions:a) b) c) d) should have experience of development & induction of technology for IVF products for atleast 5 years should have infrastructure & professional team for transfer of technology at plant scale. should have successfully transferred technology for manufacture of atleast 5 IVF products from above list. should be capable of providing globally competitive viable technology for manufacture of High Value IVF products as listed above at HAL’s facilities. Terms for Transfer of Technology a) b) c) d) e) f) g) Technology shall be provided without any rider for manufacture of these products by Hindustan Antibiotics Ltd for domestic as well as export market. Technology fee can be quoted on lumpsum payment product-wise linked with milestone or stages of transfer of technology i.e. Initial payment on signing the contract, giving complete information about the product to HAL, commercial production and retention till 6 months for any troubleshooting However initial payment will not be more than 10% of the total technology fee & 30% payment only after successful implementation of 3 consecutive commercial batches by achieving guaranteed parameters. 10% retention for 6 months. Other payment shall be linked to milestone on mutually agreed basis Technology provider shall arrange visit of their expert to HAL’s site to check deficiencies in the facilities and requirement for manufacture of high value IVF product. Report shall clearly state modification required in the existing facilities including utilities. Technology provider will have to demonstrate 3 Nos consecutive commercial batches for each product. Technology provider will have to provide required documentation for manufacturing as indicated above. Continue technology support for upgradation & troubleshooting for atleast 1 year post-start of manufacturing at commercial level of the product. Bid Submission Interested technology providers fulfilling above conditions are required to submit their offer in two parts i) Technical Bid ii) Commercial Bid. Technology provider shall forward technical bid as per the requirements given in Annexure-I and shall forward commercial bid as per the requirement given in Annexure – II in separately sealed envelops clearly superscribing on envelop as “Consultancy Services for IVF products - Technical Bid” & “Consultancy Services for IVF products - Commercial Bid”. The technical bid shall not bear any reference to the price. Technical Bid also shall include unprices commercial bid ( without disclosing price only indicating milestone of payments & terms) The bid documents shall be signed by the authorized person and the copy of the authorization letter be annexed with the same. Consultant can visit the site if required with prior appointment. HAL may also visit the office of the bidders and their facilities to verify information submitted. All information furnished will be kept confidential and if necessary, confidentiality agreement will be executed HAL reserves rights to accept or reject any offer without assigning any reason thereof. The process of this tender is subject to Indian Laws & jurisdiction shall be Pune court Technical bids will be opened after 3 weeks from the date of publication of advertisement. HAL may call for further technical details, if necessary, which may be furnished within 10 to 15 days. Financial bids of those parties who are technically suitable / qualified will be opened thereafter. The successful bidders will be called for negotiation before finalizing the agreement for technology of IVF products. If required, Consultant may visit HAL for any clarification, inspection of existing Large Volume Parenteral facilities. . HAL reserves rights to accept or reject any offer without assigning any reason thereof Technical & Commercial Bid as above shall be forwarded in separately sealed covers superscribing “Consultancy Services for IVF products - Technical Bid” & “Consultancy Services for IVF products - Commercial Bid” to the Office of Gen.Manager(Mfg. & Maint.), Hindustan Antibiotics Ltd., Pimpri, Pune 411 018, Tel. No. (020) 27303591, (020) 27425668, Fax no. (020) 27425327 within 3 weeks from the date of publication of advertisement E- mail: mts_ hapune@vsnl.net Web site: www.hindantibiotics.gov.in Annexure –I TECHNICAL BID 1.0 General Information 1.1 Name and address of Technology provider - *Registered Office *Branch offices. 1.2 Profile of the organization giving their background, current activities with supporting documents. 1.3 Name & contact details of the units where technology for IVF products required by HAL is commercialized 1.4 Contact details and CV’s of the team who would be involved in technology transfer of IVF products. 2.0 Technical 2.1 Consultant to provide following information: a. b. c. d. e. 2.2 i. Profile of Consultant indicating the consultancy services offered with special reference to Large Volume Parenteral products Facilities available with consultant. Details of work experience. List of the products from the HAL’s requirements, for which know-how / technology can be offered. Time frame for technology transfer product-wise Consultant to confirm that they shall provide following in the respect of knowhow / technology of the product after assigning the work:Raw material specification, quantitative requirements, their sources and their safety data sheets. ii. Product specification and Pharmacopial reference iii. Process details including critical steps, time cycle and process flow chart. iv. Specification of utilities, quantitative requirements and environmental conditions including classification for each stage of processing. iv. SOP, Master Formula / protocol for manufacturing the above products v. In-process control techniques & in-process control parameters. vi. Analytical testing procedure for raw material as well as finished product. vii. Details of the facilities required for manufacturing of above products giving brief specification. viii Protocol for Stability study data for the products. ix. Protocol for process validation and analytical validation x. Demonstrate at least 3 consecutive successful batches. xi. Trouble shooting strategy for deviations in raw material or any process parameter. xii. Any specific storage condition for raw material, in-process material and finished product. xiii. Conduct training of operating personnel for technology of product. Annexure-II COMMERCIAL BID 1. Technology / know-how fees for IVF products required by HAL product-wise* Sr. No. 1 Product Strength Hetastarch 350 / 500 ml 2 3 4 5 Hetastarch with electrolytes 500 ml Hypertonic Saline 250 ml Dextran – 70 / 40 250 / 500 ml Dextran – 70 with Hypertonic saline,250 / 500 ml Amino Acid Infusion Hepatic Formula,500 ml Amino Acid Renal formula, 500 ml Amino Acid Paed. Formula, 500 ml Oxazolidone ( Antibacterial ),100 ml / 300 ml Branch chain Amino acid formula, 200ml, 500 ml, 1000 ml Total Amino acid TNP, 500 ml Linezolid Infusion, 300 ml Glycerol IV Dializer Fluid, 500 ml / 1000 ml Heart Lung Perfusion Fluid, 500 ml / 1000 ml Ofloxacin, 100 ml Ornidazole + Ofloxacin 3% , 6% & 10% 6% 7.5% 6% 6% 6 7 8 9 10 11 12 13 14 15 16 17 Technology fees ( in Rs.) 8% 5.2% 7% & 10% 7% 10% & 15% 2. Payment terms including break-up / stages ( as per milestone indicated in the terms & condition) 3. Taxes / Duties applicable if any : Note : Bidder may indicate the phase wise terms of payment linked with the milestone * Product means IVF product with all its different doses or concentration for example : Hetastarch with its doses 3%, 6%, & 10% will be treated as one product