WITS REPRODUCTIVE HEALTH & HIV INSTITUTE. TENDER DOCUMENT (Non-Transferable) FOR SUPPLY OF DRUGS

Transcription

1 WITS REPRODUCTIVE HEALTH & HIV INSTITUTE TENDER DOCUMENT (Non-Transferable) FOR SUPPLY OF DRUGS Tender Reference : WRHI 060/DRUG/2016/001 Publication of tender : 29 August 2016 Period of questions : 29 August 02 September 2016; 17h00 Publication of questions and answers : 07 September 2016 Last date for submitting tender Place of Submission of Tender Date and Time of Opening of Tender Place of Opening of Tender : 16 September 2016; 16h00 : Wits Health Consortium, 8 Blackwood Avenue, Parktown, 2193 : Thursday 20 September 2016; 10h00 : Wits Health Consortium, 8 Blackwood Avenue, Parktown, 2193 i

2 Contents of Tender Document 1.0 Introduction Notice Inviting Tender Instructions to Tenderers Definitions Scope of Tender Eligibility Criteria Validity of Tender Preparation and submission of Tender Tender Prices Opening of Tenders Evaluation of Tenders Placement of Purchase Orders and Delivery Requirements Quality Testing Requirements Payment Terms Penalty Conditions Settlement of Disputes... 7 Appendix 1: List of Drugs for Tender... 9 Appendix 2: Technical Tender Form Appendix 3: Format of Price Schedule Appendix 4: Format of Contract Agreement Appendix 5: Check List ii

3 1.0 Introduction Wits Reproductive Health and HIV Institute (Wits RHI) is a research Institute of the University of the Witwatersrand and part of the Faculty of Health Sciences. The institute s portfolio embraces research, programmatic support, training, policy development, health systems strengthening and technical assistance at national and international level. Wits Health Consortium (Pty) Limited (WHC) is a wholly owned Company of the University of the Witwatersrand, Johannesburg (South Africa) under its Faculty of Health Sciences. WHC provides Wits RHI with a legal framework within which to operate the research and other activities necessary to support its objectives. The Wits Reproductive Health & HIV Institute (Wits RHI) is conducting the clinical trial titled: A 96-week Randomised, Phase 3 Non-inferiority Study of dolutegravir (DTG) / tenofovir alafenamide (TAF) / emtricitabine (FTC) Compared with dolutegravir (DTG / tenofovir disoproxil fumarate (TDF) / emtricitabine (FTC) and efavirenz (EFV) / tenofovir disoproxil fumarate (TDF) / emtricitabine (FTC) in Patients Infected with HIV-1 Starting First-line Antiretroviral Therapy. (Protocol no.: WRHI 060; also known as ADVANCE Study). To conduct the trial, the institute is required to procure the study drugs through open tender. This tender document aims to provide the necessary information for bidders, from the time of invitation for tender through to signing the contract agreement that ensures an uninterrupted supply of the awarded tender drugs. The study will be conducted over a period of three years, and is located in Johannesburg at three sites: 1). Yeoville Clinic, 35 Bedfordview and Dunbar Street; 2). Charlotte Maxeke Johannesburg Academic Hospital (CMJAH); 3) Shandukani, Hillbrow. 1 P age

4 2.0 Notice Inviting Tender i) The Wits Reproductive Health & HIV Institute (Wits RHI) hereinafter called Tender Inviting Authority, hereby invites sealed Tenders (under two envelope system from eligible manufacturers or their authorised distributors/stockist/wholesaler for supply of MCC-certified drugs. ii) The Tender Documents may be downloaded by interested bidders from the Wits RHI website or onlinetenders.ac.za. Hardcopies may be collected from Wits RHI Reception, 22 Esselen Street, Cnr Klein Street, Hillbrow 2001 on weekdays between 08h00 and 16h00. iii) Tenders must be submitted/delivered in hardcopies to: Wits Health Consortium, 8 Blackwood Avenue, Parktown 2193 on weekdays between 08h00 and 16h00. iv) Tenderers may submit questions and request for information in writing ( ) to advance@wrhi.ac.za up to Friday, 02 September h00. v) Detailed responses will be made publicly available on our website ( vi) Tenderers representatives may choose to attend the opening of tenders at address given in item iii above and the date and time given in tender document. 2 P age

5 3.0 Instructions to Tenderers 3.1 Definitions The following Definitions used in this document shall have the meanings as indicated below: i. Wits RHI means Wits Reproductive & HIV Institute ii. WHC means Wits Health Consortium iii. Contract means the written agreement entered into between the Tender Inviting Authority and the Contractor, together with all the documents mentioned therein and including all attachments, appendices etc. therein. iv. Drugs means antiretroviral drugs in the form of tablets which are used for treatment of human immunodeficiency virus. v. MCC means Medicines Control Council of South Africa. vi. Services means the scope of work together with drugs, packaging materials, conditions of drugs, etc. which the contractor is required to deliver at the Wits RHI pharmacy under the contract. vii. Tender Inviting Authority OR Client or Tender Acceptance Authority or Contracting Authority or Purchaser means the Wits RHI / WHC who is inviting the tender. viii. Tender means Bids / Quotation / Tender received from a Firm / Tenderer / Bidder. ix. Tenderer means Proprietorship / Partnership / Pvt. Limited / Limited company, Societies/ Trust registered in South Africa who is participating in the bid process. 3.2 Scope of Tender The Wits RHI/ WHC, (hereinafter referred as Tender Inviting Authority and/or Tender Acceptance Authority and/or Ordering Authority unless the context otherwise requires) invites sealed tenders (under two envelope system) for the supply of drugs given in Appendix 1. Interested Tenderers may obtain further information by ing questions to advance@wrhi.ac.za up to 02 September h Eligibility Criteria The following eligibility criteria must be fulfilled by all interested tenderers: (a) The Tenderer should be either Manufacturer or Distributor/stockist/wholesaler having relevant Drug License as per Medicines and Related Substances Amendment Act, No. 101 of 1965 and such a license should be valid as on the date of Tender submission. (b) Tenderer should submit the Drug wise WHO-GMP certificate issued to the principal manufacturer. The certificate must be valid at the time and date of bid submission, and should be enclosed with the bid. Bid without above certificates shall be rejected. (c) The Tenderer (and tenderer s principal manufacturer, if tenderer is authorized 3 P age

6 distributor/stockist/wholesaler) should not be blacklisted either by the Tender Inviting Authority or by any State Government or by Government of South Africa. A declaration/undertaking by the tenderer should be submitted in this regard certifying that the tenderer or its principal manufacturer (if applicable) is eligible to participate in the bid process. 3.4 Validity of Tender (a) The Tender will be valid for a period of 30 days after the due date of submission of Tenders. A Tender valid for a shorter period shall be rejected by the Tender Inviting Authority as non-responsive. (b) In exceptional circumstances, prior to the expiration of the tender validity, the Tender Inviting Authority may request the tenderers to extend the tender validity for further period if necessary. The request and the responses thereto shall be made in writing. A tenderer, agreeing to the request will not be required or permitted to modify its Tender. 3.5 Preparation and submission of Tender (a) The Tender should be typewritten and every correction and interlineation in the bid should be attested with full signature by the Tender, failing which the bid will be treated as ineligible. Corrections done with correction fluid should also be duly attested. (b) All documents/papers should be labelled or numbered, signed and sealed by the Tenderer on each page. (c) The Tender is required to be prepared and submitted in two parts: Technical Tender and Price Tender. Each part to be prepared and submitted in duplicates. (d) The sealed envelopes which are clearly marked Technical Tender and Price Tender should be further sealed together in a common envelope addressed to: WHC 8 Blackwood Avenue Parktown 2193 (e) The Tenderer should mark the top left corner of the envelope Tender for Procurement of Drugs Not to be opened before 16 September (f) The Envelope - Technical Tender shall contain all essential documents for Technical Tender. Such documents to include the following: i) Duly completed Checklist as per format given in Appendix 5. ii) Duly completed and signed Technical Tender Form as per format given in Appendix 2. iii) Copy of relevant drug License for manufacturing/stocking, selling and distribution (whichever is appropriate) of the product quoted duly approved by the Licensing authority for the schedule of drugs quoted as per specification in the tender. iv) Copy of firm s registration certificate v) Copy of Sales tax Clearance Certificate of last financial year vi) Copy of Income Tax Clearance Certificate of last financial year. 4 P age

7 vii) Annual turnover statement of last financial year backed by practicing chartered accountant. viii) Audited Balance sheet and Profit and Loss Statement of last financial year. ix) Copy of drug wise WHO-GMP certificate. x) Copy of MCC registration of each schedule of drugs being bided for. (g) The Envelope - Financial Bid shall contain duly filled, stamped and signed Price Schedule in the format provided in Appendix 3 (h) The sealed tenders as above should be submitted in the office of the Tender Inviting Authority up to the scheduled date and time, as stated in cover page i. (i) Late tenders will not be accepted. 3.6 Tender Prices (a) Tender has been called for in the generic names of drug products. The Tenderers should quote the rates for the drugs mentioned in Appendix 1. The composition and strength of each product should be as per details given in Appendix 1. Any variation, if found, will result in rejection of the tender. (b) The Tenderer should mention the name of manufacturer of the product being quoted. (c) Rates (inclusive of Excise Duty, Customs duty, transportation, insurance, and any incidental charges, but exclusive of State VAT should be quoted for each of the required drugs, and separately as per format of Price Schedule given in Appendix 3. (d) Quoted rates are valid up to the start and duration of the project from the date of signing of contract agreement and shall be fixed during the currency of the contract. 3.7 Opening of Tenders (a) All tenders received within the stipulated period of tendering shall be opened at the scheduled date, time and venue by the adjudication panel representing the Tender Inviting Authority. The Tenderers representative may attend the Tender opening. (b) During the tender opening as above, for each tenderer, the envelope containing Technical Tender shall be opened first. The envelope containing Price Tender shall be opened only for an eligible technical tender which has satisfied all technical requirements of the tender document. (c) In the event, the date of opening as above is declared a government holiday, the tenders shall be opened at the same time on the next working day. 3.8 Evaluation of Tenders (a) The adjudication panel of the Tender Inviting Authority, shall evaluate the tender with reference to technical requirements and various other commercial criteria given in the Tender Document. (b) The evaluation of each drug shall be carried out separately. (c) The rate per unit, exclusive of Sales Tax/VAT (landed price) for the tendered quantity, indicated in Appendix 3 shall be considered for evaluation of Price and determining successful Tenderer(s). The lowest bidder may not necessarily be the successful Tenderer. 5 P age

8 (d) No complaint shall be entertained by the Tender Inviting Authority after the opening of the bids. 3.9 Placement of Purchase Orders and Delivery Requirements (a) A representative of Wits RHI/WHC shall place Purchase Orders for supply of drugs during the period of the signed contract with successful Tenderer(s). (b) The quantity of drugs given in Appendix 1 are indicative or estimates only. The ordered quantity during the period of the contract may vary substantially subject to ceiling of 30% of the contracted quantity. (c) The supplier should complete the supply within 30 days from the date of issue of purchase order. All drugs supplied should have at least a minimum of 75% of the shelf life of the drug supplied at the time of receipt of supply at consignee end. (d) If at any time the Tenderer has, in the opinion of Wits RHI/WHC, delayed the supply of drugs due to one or more reasons related to force Majeure events such as riots, mutinies, wars, fire, storm, tempest or other exceptional events, the time for supplying the drugs may be extended by Wits RHI/WHC at its discretion for such period as may be considered reasonable, and in the interest of the project for which the drug is being supplied. However such extension shall be considered only if a specific written request/notice is made by the supplier within 7 days from the occurrence of such event. The exceptional cause does not include scarcity of raw material, power cut and labour disputes. (e) The supplier shall not be liable to pay liquidated damages/penalty for the delay in executing the contract on account of the extension of the supply period on the ground of force majeure events. For force majeure events not communicated to Wits RHI/WHC and exceptional causes, the supplier shall be liable for amount spent by Wits RHI/WHC to provide an alternative drug supply for the project during the delayed supply Quality Testing Requirements (a) The drugs including its packing (packaging), to be supplied, shall be of the best quality & WHO-GMP certified and shall comply with the specifications given in the Tender Document. (b) All drugs should be supplied with its batch wise quality certificate, complying with all the applicable tests as per relevant pharmacopeia, issued from any third party SANAS accredited test laboratory. Any drugs found without SANAS accredited test certificate shall not be accepted by the Tender Inviting Authority or its representative. (c) Wits RHI/WHC may send sample of drug for its testing or may instruct local drug inspector to take the sample. If any of the drug, supplied by the tenderer is found to be Not of Standard Quality after the delivery but before the expiry of drugs, the tenderer shall supply the whole batch quantity again irrespective of consumption of that particular batch quantity. The balance stock, if any, should be taken back within 7 days by the supplier at his/her own cost otherwise the authority will destroy it and no claim whatsoever in this regard shall be entertained by Wits RHI/WHC. 6 P age

9 3.11 Payment Terms (a) Upon submission of claim for payment supported by invoice, 100% payment shall be effected within 30 days from the receipt of the accepted drug supply. If supplied drugs are found to be not of standard quality, then whole payment will be withheld and shall be released only after receipt of replacement of the not-of-standard drugs. (b) At the time of release of payment, any deduction towards delayed deliveries as per instruction 3.12 below shall be made from the claim amount Penalty Conditions a) Pursuant to instruction 3.9 above and subject to instruction 3.9 (d) and (e), in case the delivery period is extended with liquidated damages, Wits RHI/WHC shall impose liquidated damages at 0.5% per day of the delivered price of the delayed items or part thereof until the actual delivery is made up to a maximum deduction of 10% of the contract price. b) Once the maximum is reached the Wits RHI/WHC may consider termination of the order in part or full. In such case, the client may consider terminating the contract and seek an alternative source of drug supply to save the project Settlement of Disputes (a) The purchaser and the supplier shall make every effort to resolve, amicably by direct informal negotiation any disagreement or dispute arising between them under or in connection with the contract. (b) Any Tenderer aggrieved by the decision of the Tender Inviting Authority may represent to the project director of Wits RHI/WHC within 15 days from the date of receipt of order and the director shall dispose the appeal expeditiously. (c) No Appeal shall be entertained while the tender is in process and until tender is finalized and Notification of Award is issued by Wits RHI/WHC. (d) In the event of any dispute arising out of the tender or orders, and which could not be settled by the project Director of Wits RHI/WHC, the same shall be settled in accordance with the Arbitration Act 42 of 1965, as amended by Justice Laws Rationalisation Act 18 of The venue of arbitration shall be the place of Wits RHI/WHC. (e) In the event of any dispute arising out of the tender or orders, and which could not be settled by the project director of Wits RHI/WHC, the same shall be settled subject to the jurisdiction of Courts of South Africa nearest to the place of Wits RHI/WHC. (f) In no event will Wits RHI/WHC be liable for any loss, be it savings, or incidental, indirect, special or consequential damages arising out of or in relation to the present tender. (g) Neither Wits RHI/WHC shall be liable for any claims, losses, costs, damages of any nature whatsoever nor the tenderer shall claim expenses for any cause or causes, including any legal liability arising out of or in relation to the present tender. (h) The tenderer shall be solely responsible for any deficiency in services and supplies given by him/her including the quality and specification of drugs and the tenderer shall 7 P age

10 be liable to make good the losses suffered by Wits RHI/WHC due to the fault on the part of the tenderer. (i) The maximum liability of Wits RHI/WHC shall be limited to the extent of payment of goods delivered as per terms of this tender document. Wits RHI/WHC shall not bear any other financial liability such as cost of alternative drugs due to delayed supplies or supplies not simply completed for some reasons including efficient service delivery by the tenderer. 8 P age

11 Appendix 1: List of Drugs for Tender S/no. Generic name of drug Tablet/Capsule strength Unit Pack 1. TDF/FTC* 300mg/200mg 30 tablets/bottle 2. TDF/FTC/EFV** 300mg/200mg/600mg tablets/bottle Abbreviations: TDF, tenofovir disoproxil fumarate; EFV, efavirenz; FTC, emtricitabine. * TDF/FTC combined as a single tablet ** TDF/FTC/EFV combined as a single tablet Estimated no. of bottles required P age

12 Appendix 2: Technical Tender Form Date completed: Tender Reference No.: WRHI 060/DRUG/2016/001 Dated_29 August 2016 To, Wits RHI/WHC 8 Blackwood Avenue Parktown We, the undersigned have examined the above mentioned Tender document. We now offer to supply and deliver drugs in conformity with your above referred document and as per table below: S/no. Generic name of drug Tablet/Capsule strength Unit Pack Name of Manufacturer 2. If our tender is accepted, we undertake to supply the drugs in accordance with the delivery requirements given in the Tender Document. 3. We agree to keep our tender valid for acceptance as required in item 3.4 under instructions, or for subsequently extended period, if any, agreed to by us. We also accordingly confirm to abide by this tender up to the aforesaid period and this tender may be accepted any time before the expiry of the aforesaid period. We further confirm that, until a formal contract is executed, this tender read with your written acceptance thereof within the aforesaid period shall constitute a binding contract between us. 4. We further understand that you are not bound to accept the lowest or any tender you may receive against your above referred tender enquiry. 5. We confirm that we do not stand deregistered/banned/blacklisted/debarred by any Government. Authorities. 6. We confirm that we fully agree to the terms and conditions specified in above mentioned Tender Document, including amendment/corrigendum if any. (Signature with date) (Name and designation) Duly authorised to sign tender for and on behalf of (Name of Tenderer) 10 P age

13 Appendix 3: Format of Price Schedule S/no Generic Name of Drug and Strength Name of Manufacturer Unit Quantity (in Units) Total Unit Price (Inclusive of all Incidental Charges In figure In words Rand Cent VAT (Signature & seal of Tenderer) 11 P age

14 Appendix 4: Format of Contract Agreement THIS AGREEMENT made on the... day of..., 20 Between Wits RHI/WHC (hereinafter "the Purchaser") of the one part and name of supplier her (hereinafter called "the Supplier") of the other part : WHEREAS the Purchaser is desirous that certain Goods and ancillary services viz. Supply of Drugs in the tender reference no. WRHI 060/DRUG/2016/001 Dated 29 August 2016 and has accepted a bid by the Supplier for the supply of those goods and services for the sum of R ( Rand only) (hereinafter called "the Contract Price"). NOW THIS AGREEMENT WITNESSETH AS FOLLOWS: 1. In this Agreement words and expressions shall have the same meanings as they are respectively assigned to them in the Conditions of Contract referred to, and they shall be deemed to form and be read and construed as part of this agreement. 2. The following documents shall be deemed to form and be read and construed as part of this Agreement, viz.: a) The Letter of Acceptance issued by the purchaser. b) The Notice Inviting Tender c) The supplier s bid including enclosures, appendices, etc. d) The Terms and Conditions of the Contract e) The Schedule of Requirement f) The Technical Specification g) Any other document listed in the supplier s bid and replies to queries, clarifications issued by the Purchaser, such confirmations given by the bidder which are acceptable to the purchaser and the entire Addendum issued as forming part of the contract. 3. This is estimated-quantity, periodic-order contract. In this, the Purchaser will order (quantity lower than the total estimated in appendix 1) periodically from the Supplier at the contract price throughout the contract term. The supplier takes the risk that the actual quantities will differ from those estimated in the tender. The periodic order may be quarterly, six monthly or as needed. 4. Each order shall be supplied to the address designated in the purchase order form. In consideration of the payments to be made by the Purchaser to the Supplier as hereinafter mentioned, the Supplier hereby covenants with the Purchaser to provide, the goods and services and to remedy defects therein in conformity in all respects with the provisions of the Contract. 12 P age

15 5. The purchaser hereby covenants to pay the Supplier in consideration of the provision of the goods and services and the remedying of defects therein, the Contract Price or such other sum as may become payable under the provisions of the Contract at the times and in the manner prescribed by the Contract. Brief particulars of the goods and services which shall be supplied / provided by the Supplier are as under. S/ n o Brief Description of Drugs Name of manufact urer Unit pack Tender Qty. in Nos. Unit Price (Rs.) Sales tax in % Total value inclusive of sales tax DELIVERY SCHEDULE: Supply shall complete within 30 days from the date of purchase order and as per item 2.9 of the Tender Document. IN WITNESS where of the parties here to have caused this Agreement to be executed in accordance with their respective laws the day and year first above written. Signed, Sealed and Delivered by the Said (For the Purchaser) in the presence of... Signature: Name: Address: Witness Signed, Sealed and Delivered by the Said (For the Supplier) in the presence of... Signature: Name: Address: Witness P age

16 Appendix 5: Check List S/no Tender Item No of copy Enclosed? Yes No 1 Checklist Appendix Technical Tender Pack 3 Financial bid Pack 4 Copy of drug License for 5 Copy of drug License for Manufacturing/stocking, selling and distribution of the product quoted duly approved by the Licensing authority for each schedule of product quoted as per specification in the tender. 6 Drug wise WHO-GMP certificate 7 Proof of drug testing Certificate of Analysis 8 Copy of firm registration certificate 9 Declaration for not having been debarred/blacklisted either by the Tender Inviting Authority or by any State Government or by Government of South Africa 10 Copy of Sales tax Clearance Certificate of last financial year Copy of Income Tax Clearance Certificate of last financial year Annual turnover statement of last financial year backed by practicing chartered accountant Audited Balance sheet and Profit and Loss Statement of last financial year. 14 P age