Common use of Quotation Subject Matter Clause in Contracts

Quotation Subject Matter. 2.1 Sellers are invited for the supply of TAA Stent Graft System under the NPS, the product types and categories required by the Authority are set out in Schedule A. Sellers are invited to offer their Goods which rightly match with the required product types and categories, by completing all details and prices in Schedule A and the Schedule of Compliance in Schedule B. Seller should note that any Goods quoted in Schedule A must have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) within 18 months immediately preceding the Closing Date. Seller must complete the consumption details for each of the Goods it proposes to supply in Schedule A. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.2 Any Goods to be supplied by the Seller must meet the following product standards and requirements: (a) the Goods offered must comply with the standard of British Standard Institution (BSI) of general requirements for TAA Stent Graft System or equivalent standard of International Organization for Standardization (ISO). Sellers must indicate the specific BSI or ISO standard applicable to each offered products in Schedule A, and confirm compliance with the applicable standards. Upon request, Sellers are required to provide to the Authority documentary evidence showing compliance with the relevant standards; (b) the Seller must, for each of the Goods quoted in Schedule A, submit with its Standing Quotation copies of 2 sets (each set in separate file) of the following: (i) certified true copy of manufacturer license issued by the Government or Health Authority of the country of origin; (ii) certified true copy of the authorized certification of compliance to ISO 13485 (latest version), Food and Drug Administration (FDA)/ Product’s compliance with European Commission legislation (CE)//BSI or other equivalent international standards in production and quality-management system; (iii) certified true copy of certifying compliance with FDA 510(K)/CE or other equivalent international standards for listing of each offered product in Schedule A. 2.3 If a Seller is not the manufacturer of the Goods offered in Schedule A, the Seller must submit with its Standing Quotation a written undertaking issued by the manufacturer of the Goods evidencing the manufacturer’s agreement to supply such Goods to the Seller should the Seller’s Standing Quotation be accepted by the Authority. The written undertaking shall be signed by a duly authorized representative of the manufacturer and dated no later than the Closing Date but not earlier than six (6) months before the Closing Date. If a Seller fails to submit the written undertaking on or before the Closing Date, or by the time specified by the Authority, its Standing Quotation may not be considered. 2.4 Sellers are to note that for each of the Goods under a Standing Quotation which has been accepted by the Authority, the Seller must, at the instruction of the Buyer, supply the Goods during the Validity Period either: (a) as a stock item pursuant to a Purchase Order placed by the Buyer; or (b) as a consignment item under the Consignment Stock Scheme. 2.5 The Buyer may at any time during the Validity Period, request the Seller to deposit certain quantities of any of the Goods which have been quoted in Schedule A at the Hospital premises as consignment stock under the Consignment Stock Scheme. The Buyer will notify the Seller when the Goods from the consignment stock are taken out for use, and will issue a Purchase Order to the Seller. The Seller may then invoice the Buyer as appropriate for the Goods consumed. The Seller must also top up from time to time during the Validity Period the quantity of Goods placed in consignment, in accordance with the quantities and time as required by the Buyer, and to replace any Goods in the consignment stock for which the expiry period has passed. 2.6 Sellers must complete and submit with their Standing Quotations Schedule C - instructions for storage and handling of the Goods under the Consignment Stock Scheme. 2.7 If during the Validity Period the Seller wishes to add new items to the list of Goods to be supplied under the NPS, the Seller must write to the Authority and propose the new items to be supplied, together with supporting written evidence that the said items have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) in the past 12 months. The Authority shall have absolute discretion whether or not to add those proposed items onto the list of Goods in Schedule A but if it does, the supply of the new items shall be subject to the terms of this Invitation to Quote. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.8 The Authority may at any time during the Validity Period, delete any items from any Standing Quotation either because (a) there has been no purchase record with the Buyer within the past 12 months; (b) bulk contract(s) has been established for such item; or (c) in the Authority’s opinion, the items should no longer remain on the Standing Quotation. The Authority will inform the Seller of the items to be deleted and the effective date of such deletion. 2.9 As part of the Invitation to Quote exercise, the Seller is also invited to offer to the Authority in their Standing Quotations on-loan instruments (“On-loan Instruments”) for the Buyer’s use with the Goods that Sellers quote in Schedule A. All On-loan Instruments offered must: (a) be fully compatible with the Goods supplied by the Seller; and (b) be provided to the Buyer free of charge. The Seller is required to provide details of the On-loan Instruments (if any), including their selling prices, in Schedule E. 2.10 The Seller must have in place appropriate and adequate product safety alert system and product recall system covering the Goods (whether or not under the Consignment Stock Scheme) and the On-loan Instruments. The Seller must in Schedule F: (a) describe the safety alert system in place in respect of the Goods and the On-loan Instruments; (b) provide the details of the product recall system in place in respect of the Goods and the On-loan Instruments, which must have been approved by the relevant regulatory authority. (c) The Seller must also provide the names, email addresses and telephone numbers of the representatives of the manufacturer and (in case the Seller is a local distributor) the Seller with whom the Authority can contact in the event of Safety Alert Notice or Product Recall Notice (both as defined in Clause 9 of Part III). 2.11 The Authority shall have the right to disclose whenever it considers appropriate, or upon request (verbal or written) by any third party (including unsuccessful Sellers) information on the Contract, such as the name and address of the successful Seller, product description/brand/model/country of origin (if applicable), description of the relevant services (if applicable) and the value of the Contract, without reference to or consent from the successful Seller. Unsuccessful Sellers may also enquire as to the reason for the rejection of their Quotation Submissions.

Quotation Subject Matter. 2.1 Sellers are invited for the supply of TAA Stent Graft System Surgical Stapler for Endoscopic Surgery under the NPS, the product types and categories required by the Authority are set out in Schedule A. Sellers are invited to offer their Goods which rightly match with the required product types and categories, by completing all details and prices in Schedule A and the Schedule of Compliance in Schedule B. Seller should note that any Goods quoted in Schedule A must have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) within 18 months immediately preceding the Closing Date. Seller must complete the consumption details for each of the Goods it proposes to supply in Schedule A. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.2 Any Goods to be supplied by the Seller must meet the following product standards and requirements: (a) the Goods offered must comply with the standard of British Standard Institution (BSI) of general requirements for TAA Stent Graft System Medical Consumables for Peripheral Endovascular Embolization Treatment or equivalent standard of International Organization for Standardization (ISO). Sellers must indicate the specific BSI or ISO standard applicable to each offered products in Schedule A, and confirm compliance with the applicable standards. Upon request, Sellers are required to provide to the Authority documentary evidence showing compliance with the relevant standards; (b) the Seller must, for each of the Goods quoted in Schedule A, submit with its Standing Quotation copies of 2 sets (each set in separate file) of the following: (i) certified true copy of manufacturer license issued by the Government or Health Authority of the country of origin; (ii) certified true copy of the authorized certification of compliance to ISO 13485 (latest version), Food and Drug Administration (FDA)/ Product’s compliance with European Commission legislation (CE)//BSI or other equivalent international standards in production and quality-management system; (iii) certified true copy of certifying compliance with FDA 510(K)/CE or other equivalent international standards for listing of each offered product in Schedule A. 2.3 If a Seller is not the manufacturer of the Goods offered in Schedule A, the Seller must submit with its Standing Quotation a written undertaking issued by the manufacturer of the Goods evidencing the manufacturer’s agreement to supply such Goods to the Seller should the Seller’s Standing Quotation be accepted by the Authority. The written undertaking shall be signed by a duly authorized representative of the manufacturer and dated no later than the Closing Date but not earlier than six (6) months before the Closing Date. If a Seller fails to submit the written undertaking on or before the Closing Date, or by the time specified by the Authority, its Standing Quotation may not be considered. 2.4 Sellers are to note that for each of the Goods under a Standing Quotation which has been accepted by the Authority, the Seller must, at the instruction of the Buyer, supply the Goods during the Validity Period either: (a) as a stock item pursuant to a Purchase Order placed by the Buyer; or (b) as a consignment item under the Consignment Stock Scheme. 2.5 The Buyer may at any time during the Validity Period, request the Seller to deposit certain quantities of any of the Goods which have been quoted in Schedule A at the Hospital premises as consignment stock under the Consignment Stock Scheme. The Buyer will notify the Seller when the Goods from the consignment stock are taken out for use, and will issue a Purchase Order to the Seller. The Seller may then invoice the Buyer as appropriate for the Goods consumed. The Seller must also top up from time to time during the Validity Period the quantity of Goods placed in consignment, in accordance with the quantities and time as required by the Buyer, and to replace any Goods in the consignment stock for which the expiry period has passed. 2.6 Sellers must complete and submit with their Standing Quotations Schedule C - instructions for storage and handling of the Goods under the Consignment Stock Scheme. 2.7 If during the Validity Period the Seller wishes to add new items to the list of Goods to be supplied under the NPS, the Seller must write to the Authority and propose the new items to be supplied, together with supporting written evidence that the said items have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) in the past 12 months. The Authority shall have absolute discretion whether or not to add those proposed items onto the list of Goods in Schedule A but if it does, the supply of the new items shall be subject to the terms of this Invitation to Quote. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.8 The Authority may at any time during the Validity Period, delete any items from any Standing Quotation either because (a) there has been no purchase record with the Buyer within the past 12 months; (b) bulk contract(s) has been established for such item; or (c) in the Authority’s opinion, the items should no longer remain on the Standing Quotation. The Authority will inform the Seller of the items to be deleted and the effective date of such deletion. 2.9 As part of the Invitation to Quote exercise, the Seller is also invited to offer to the Authority in their Standing Quotations on-loan instruments (“On-loan Instruments”) for the Buyer’s use with the Goods that Sellers quote in Schedule A. All On-loan Instruments offered must: (a) be fully compatible with the Goods supplied by the Seller; and (b) be provided to the Buyer free of charge. The Seller is required to provide details of the On-loan Instruments (if any), including their selling prices, in Schedule E. 2.10 The Seller must have in place appropriate and adequate product safety alert system and product recall system covering the Goods (whether or not under the Consignment Stock Scheme) and the On-loan Instruments. The Seller must in Schedule F: (a) describe the safety alert system in place in respect of the Goods and the On-loan Instruments; (b) provide the details of the product recall system in place in respect of the Goods and the On-loan Instruments, which must have been approved by the relevant regulatory authority. (c) The Seller must also provide the names, email addresses and telephone numbers of the representatives of the manufacturer and (in case the Seller is a local distributor) the Seller with whom the Authority can contact in the event of Safety Alert Notice or Product Recall Notice (both as defined in Clause 9 of Part III). 2.11 The Authority shall have the right to disclose whenever it considers appropriate, or upon request (verbal or written) by any third party (including unsuccessful Sellers) information on the Contract, such as the name and address of the successful Seller, product description/brand/model/country of origin (if applicable), description of the relevant services (if applicable) and the value of the Contract, without reference to or consent from the successful Seller. Unsuccessful Sellers may also enquire as to the reason for the rejection of their Quotation Submissions.

Quotation Subject Matter. 2.1 Sellers are invited for the supply of TAA Stent Graft System Implants and Consumables for Peripheral Vascular Occlusive Disease under the NPS, the product types and categories required by the Authority are set out in Schedule A. Sellers are invited to offer their Goods which rightly match with the required product types and categories, by completing all details and prices in Schedule A and the Schedule of Compliance in Schedule B. Seller should note that any Goods quoted in Schedule A must have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) within 18 months immediately preceding the Closing Date. Seller must complete the consumption details for each of the Goods it proposes to supply in Schedule Schedule A. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.2 Any Goods to be supplied by the Seller must meet the following product standards and requirements: (a) the Goods offered must comply with the standard of British Standard Institution (BSI) of general requirements for TAA Stent Graft System Implants and Consumables for Peripheral Vascular Occlusive Disease or equivalent standard of International Organization for Standardization (ISO). Sellers must indicate the specific BSI or ISO standard applicable to each offered products in Schedule A, and confirm compliance with the applicable standards. Upon request, Sellers are required to provide to the Authority documentary evidence showing compliance with the relevant standards; (b) the Seller must, for each of the Goods quoted in Schedule A, submit with its Standing Quotation copies of 2 sets (each set in separate file) of the following: (i) certified true copy of manufacturer license issued by the Government or Health Authority of the country of origin; (ii) certified true copy of the authorized certification of compliance to ISO 13485 (latest version), Food and Drug Administration (FDA)/ Product’s compliance with European Commission legislation (CE)//BSI or other equivalent international standards in production and quality-management system; (iii) certified true copy of certifying compliance with FDA 510(K)/CE or other equivalent international standards for listing of each offered product in Schedule A. 2.3 If a Seller is not the manufacturer of the Goods offered in Schedule A, the Seller must submit with its Standing Quotation a written undertaking issued by the manufacturer of the Goods evidencing the manufacturer’s agreement to supply such Goods to the Seller should the Seller’s Standing Quotation be accepted by the Authority. The written undertaking shall be signed by a duly authorized representative of the manufacturer and dated no later than the Closing Date but not earlier than six (6) months before the Closing Date. If a Seller fails to submit the written undertaking on or before the Closing Date, or by the time specified by the Authority, its Standing Quotation may not be considered. 2.4 Sellers are to note that for each of the Goods under a Standing Quotation which has been accepted by the Authority, the Seller must, at the instruction of the Buyer, supply the Goods during the Validity Period either: (a) as a stock item pursuant to a Purchase Order placed by the Buyer; or (b) as a consignment item under the Consignment Stock Scheme. 2.5 The Buyer may at any time during the Validity Period, request the Seller to deposit certain quantities of any of the Goods which have been quoted in Schedule A at the Hospital premises as consignment stock under the Consignment Stock Scheme. The Buyer will notify the Seller when the Goods from the consignment stock are taken out for use, and will issue a Purchase Order to the Seller. The Seller may then invoice the Buyer as appropriate for the Goods consumed. The Seller must also top up from time to time during the Validity Period the quantity of Goods placed in consignment, in accordance with the quantities and time as required by the Buyer, and to replace any Goods in the consignment stock for which the expiry period has passed. 2.6 Sellers must complete and submit with their Standing Quotations Schedule C - instructions for storage and handling of the Goods under the Consignment Stock Scheme. 2.7 If during the Validity Period the Seller wishes to add new items to the list of Goods to be supplied under the NPS, the Seller must write to the Authority and propose the new items to be supplied, together with supporting written evidence that the said items have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) in the past 12 months. The Authority shall have absolute discretion whether or not to add those proposed items onto the list of Goods in Schedule A but if it does, the supply of the new items shall be subject to the terms of this Invitation to Quote. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.8 The Authority may at any time during the Validity Period, delete any items from any Standing Quotation either because (a) there has been no purchase record with the Buyer within the past 12 months; (b) bulk contract(s) has been established for such item; or (c) in the Authority’s opinion, the items should no longer remain on the Standing Quotation. The Authority will inform the Seller of the items to be deleted and the effective date of such deletion. 2.9 As part of the Invitation to Quote exercise, the Seller is also invited to offer to the Authority in their Standing Quotations on-loan instruments (“On-loan Instruments”) for the Buyer’s use with the Goods that Sellers quote in Schedule A. All On-loan Instruments offered must: (a) be fully compatible with the Goods supplied by the Seller; and (b) be provided to the Buyer free of charge. The Seller is required to provide details of the On-loan Instruments (if any), including their selling prices, in Schedule E. 2.10 The Seller must have in place appropriate and adequate product safety alert system and product recall system covering the Goods (whether or not under the Consignment Stock Scheme) and the On-loan Instruments. The Seller must in Schedule F: (a) describe the safety alert system in place in respect of the Goods and the On-loan Instruments; (b) provide the details of the product recall system in place in respect of the Goods and the On-loan Instruments, which must have been approved by the relevant regulatory authority. (c) The Seller must also provide the names, email addresses and telephone numbers of the representatives of the manufacturer and (in case the Seller is a local distributor) the Seller with whom the Authority can contact in the event of Safety Alert Notice or Product Recall Notice (both as defined in Clause 9 of Part III). 2.11 The Authority shall have the right to disclose whenever it considers appropriate, or upon request (verbal or written) by any third party (including unsuccessful Sellers) information on the Contract, such as the name and address of the successful Seller, product description/brand/model/country of origin (if applicable), description of the relevant services (if applicable) and the value of the Contract, without reference to or consent from the successful Seller. Unsuccessful Sellers may also enquire as to the reason for the rejection of their Standing Quotation Submissions.

Quotation Subject Matter. 2.1 Sellers are invited for the supply of TAA Stent Graft System Guidewires for Biliary Ducts under the NPS, . Sellers must comply with the mandatory requirements and specification as stipulated in Schedule H for the supply of Guidewires for Biliary Ducts. The product types and categories required by the Authority are set out in Schedule A. Sellers are invited to offer their Goods which rightly match with the required product types and categories, by completing all details and prices in Schedule A and the Schedule of Compliance in Schedule B. B, the requirements in Schedule H. Seller should note that any Goods quoted in Schedule A must have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) within 18 months immediately preceding the Closing Date. Seller must complete the consumption details for each of the Goods it proposes to supply in Schedule A. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.2 Any Goods to be supplied by the Seller must meet the following product standards and requirements: (a) the Goods offered must comply with the standard of British Standard Institution (BSI) of general requirements for TAA Stent Graft System Guidewires for Biliary Ducts or equivalent standard of International Organization for Standardization (ISO). Sellers must indicate the specific BSI or ISO standard applicable to each offered products in Schedule A, and confirm compliance with the applicable standards. Upon request, Sellers are required to provide to the Authority documentary evidence showing compliance with the relevant standards; (b) the Seller must, for each of the Goods quoted in Schedule A, submit with its Standing Quotation copies of 2 sets (each set in separate file) of the following: (i) certified true copy of manufacturer license issued by the Government or Health Authority of the country of origin; (ii) certified true copy of the authorized certification of compliance to ISO 13485 (latest version), Food and Drug Administration (FDA)/ Product’s compliance with European Commission legislation (CE)//BSI or other equivalent international standards in production and quality-management system; (iii) certified true copy of certifying compliance with FDA 510(K)/CE or other equivalent international standards for listing of each offered product in Schedule A. 2.3 If a Seller is not the manufacturer of the Goods offered in Schedule A, the Seller must submit with its Standing Quotation a written undertaking issued by the manufacturer of the Goods evidencing the manufacturer’s agreement to supply such Goods to the Seller should the Seller’s Standing Quotation be accepted by the Authority. The written undertaking shall be signed by a duly authorized representative of the manufacturer and dated no later than the Closing Date but not earlier than six (6) months before the Closing Date. If a Seller fails to submit the written undertaking on or before the Closing Date, or by the time specified by the Authority, its Standing Quotation may not be considered. 2.4 Sellers are to note that for each of the Goods under a Standing Quotation which has been accepted by the Authority, the Seller must, at the instruction of the Buyer, supply the Goods during the Validity Period either: (a) as a stock item pursuant to a Purchase Order placed by the Buyer; or (b) as a consignment item under the Consignment Stock Scheme. 2.5 The Buyer may at any time during the Validity Period, request the Seller to deposit certain quantities of any of the Goods which have been quoted in Schedule A at the Hospital premises as consignment stock under the Consignment Stock Scheme. The Buyer will notify the Seller when the Goods from the consignment stock are taken out for use, and will issue a Purchase Order to the Seller. The Seller may then invoice the Buyer as appropriate for the Goods consumed. The Seller must also top up from time to time during the Validity Period the quantity of Goods placed in consignment, in accordance with the quantities and time as required by the Buyer, and to replace any Goods in the consignment stock for which the expiry period has passed. 2.6 Sellers must complete and submit with their Standing Quotations Schedule C - instructions for storage and handling of the Goods under the Consignment Stock Scheme. 2.7 If during the Validity Period the Seller wishes to add new items to the list of Goods to be supplied under the NPS, the Seller must write to the Authority and propose the new items to be supplied, together with supporting written evidence that the said items have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) in the past 12 months. The Authority shall have absolute discretion whether or not to add those proposed items onto the list of Goods in Schedule A but if it does, the supply of the new items shall be subject to the terms of this Invitation to Quote. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.8 The Authority may at any time during the Validity Period, delete any items from any Standing Quotation either because (a) there has been no purchase record with the Buyer within the past 12 months; (b) bulk contract(s) has been established for such item; or (c) in the Authority’s opinion, the items should no longer remain on the Standing Quotation. The Authority will inform the Seller of the items to be deleted and the effective date of such deletion. 2.9 As part of the Invitation to Quote exercise, the Seller is also invited to offer to the Authority in their Standing Quotations on-loan instruments (“On-loan Instruments”) for the Buyer’s use with the Goods that Sellers quote in Schedule A. All On-loan Instruments offered must: (a) be fully compatible with the Goods supplied by the Seller; and (b) be provided to the Buyer free of charge. The Seller is required to provide details of the On-loan Instruments (if any), including their selling prices, in Schedule E. 2.10 The Seller must have in place appropriate and adequate product safety alert system and product recall system covering the Goods (whether or not under the Consignment Stock Scheme) and the On-loan Instruments. The Seller must in Schedule F: (a) describe the safety alert system in place in respect of the Goods and the On-loan Instruments; (b) provide the details of the product recall system in place in respect of the Goods and the On-loan Instruments, which must have been approved by the relevant regulatory authority. (c) The Seller must also provide the names, email addresses and telephone numbers of the representatives of the manufacturer and (in case the Seller is a local distributor) the Seller with whom the Authority can contact in the event of Safety Alert Notice or Product Recall Notice (both as defined in Clause 9 of Part III). 2.11 The Authority shall have the right to disclose whenever it considers appropriate, or upon request (verbal or written) by any third party (including unsuccessful Sellers) information on the Contract, such as the name and address of the successful Seller, product description/brand/model/country of origin (if applicable), description of the relevant services (if applicable) and the value of the Contract, without reference to or consent from the successful Seller. Unsuccessful Sellers may also enquire as to the reason for the rejection of their Quotation Submissions.

Quotation Subject Matter. 2.1 Sellers are invited for the supply of TAA Stent Graft System Surgical Stapler for Endoscopic Surgery under the NPS, the product types and categories required by the Authority are set out in Schedule A. Sellers are invited to offer their Goods which rightly match with the required product types and categories, by completing all details and prices in Schedule A and the Schedule of Compliance in Schedule B. Seller should note that any Goods quoted in Schedule A must have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) within 18 months immediately preceding the Closing Date. Seller must complete the consumption details for each of the Goods it proposes to supply in Schedule A. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.2 Any Goods to be supplied by the Seller must meet the following product standards and requirements: (a) the Goods offered must comply with the standard of British Standard Institution (BSI) of general requirements for TAA Sphincterotome, Stent Graft System Introducer and Cannulation Catheter or equivalent standard of International Organization for Standardization (ISO). Sellers must indicate the specific BSI or ISO standard applicable to each offered products in Schedule A, and confirm compliance with the applicable standards. Upon request, Sellers are required to provide to the Authority documentary evidence showing compliance with the relevant standards; (b) the Seller must, for each of the Goods quoted in Schedule A, submit with its Standing Quotation copies of 2 sets (each set in separate file) of the following: (i) certified true copy of manufacturer license issued by the Government or Health Authority of the country of origin; (ii) certified true copy of the authorized certification of compliance to ISO 13485 (latest version), Food and Drug Administration (FDA)/ Product’s compliance with European Commission legislation (CE)//BSI or other equivalent international standards in production and quality-management system; (iii) certified true copy of certifying compliance with FDA 510(K)/CE or other equivalent international standards for listing of each offered product in Schedule A. 2.3 If a Seller is not the manufacturer of the Goods offered in Schedule A, the Seller must submit with its Standing Quotation a written undertaking issued by the manufacturer of the Goods evidencing the manufacturer’s agreement to supply such Goods to the Seller should the Seller’s Standing Quotation be accepted by the Authority. The written undertaking shall be signed by a duly authorized representative of the manufacturer and dated no later than the Closing Date but not earlier than six (6) months before the Closing Date. If a Seller fails to submit the written undertaking on or before the Closing Date, or by the time specified by the Authority, its Standing Quotation may not be considered. 2.4 Sellers are to note that for each of the Goods under a Standing Quotation which has been accepted by the Authority, the Seller must, at the instruction of the Buyer, supply the Goods during the Validity Period either: (a) as a stock item pursuant to a Purchase Order placed by the Buyer; or (b) as a consignment item under the Consignment Stock Scheme. 2.5 The Buyer may at any time during the Validity Period, request the Seller to deposit certain quantities of any of the Goods which have been quoted in Schedule A at the Hospital premises as consignment stock under the Consignment Stock Scheme. The Buyer will notify the Seller when the Goods from the consignment stock are taken out for use, and will issue a Purchase Order to the Seller. The Seller may then invoice the Buyer as appropriate for the Goods consumed. The Seller must also top up from time to time during the Validity Period the quantity of Goods placed in consignment, in accordance with the quantities and time as required by the Buyer, and to replace any Goods in the consignment stock for which the expiry period has passed. 2.6 Sellers must complete and submit with their Standing Quotations Schedule C - instructions for storage and handling of the Goods under the Consignment Stock Scheme. 2.7 If during the Validity Period the Seller wishes to add new items to the list of Goods to be supplied under the NPS, the Seller must write to the Authority and propose the new items to be supplied, together with supporting written evidence that the said items have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) in the past 12 months. The Authority shall have absolute discretion whether or not to add those proposed items onto the list of Goods in Schedule A but if it does, the supply of the new items shall be subject to the terms of this Invitation to Quote. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.8 The Authority may at any time during the Validity Period, delete any items from any Standing Quotation either because (a) there has been no purchase record with the Buyer within the past 12 months; (b) bulk contract(s) has been established for such item; or (c) in the Authority’s opinion, the items should no longer remain on the Standing Quotation. The Authority will inform the Seller of the items to be deleted and the effective date of such deletion. 2.9 As part of the Invitation to Quote exercise, the Seller is also invited to offer to the Authority in their Standing Quotations on-loan instruments (“On-loan Instruments”) for the Buyer’s use with the Goods that Sellers quote in Schedule A. All On-loan Instruments offered must: (a) be fully compatible with the Goods supplied by the Seller; and (b) be provided to the Buyer free of charge. The Seller is required to provide details of the On-loan Instruments (if any), including their selling prices, in Schedule E. 2.10 The Seller must have in place appropriate and adequate product safety alert system and product recall system covering the Goods (whether or not under the Consignment Stock Scheme) and the On-loan Instruments. The Seller must in Schedule F: (a) describe the safety alert system in place in respect of the Goods and the On-loan Instruments; (b) provide the details of the product recall system in place in respect of the Goods and the On-loan Instruments, which must have been approved by the relevant regulatory authority. (c) The Seller must also provide the names, email addresses and telephone numbers of the representatives of the manufacturer and (in case the Seller is a local distributor) the Seller with whom the Authority can contact in the event of Safety Alert Notice or Product Recall Notice (both as defined in Clause 9 of Part III). 2.11 The Authority shall have the right to disclose whenever it considers appropriate, or upon request (verbal or written) by any third party (including unsuccessful Sellers) information on the Contract, such as the name and address of the successful Seller, product description/brand/model/country of origin (if applicable), description of the relevant services (if applicable) and the value of the Contract, without reference to or consent from the successful Seller. Unsuccessful Sellers may also enquire as to the reason for the rejection of their Quotation Submissions.

Quotation Subject Matter. 2.1 Sellers are invited for the supply of TAA Stent Graft System Implants and Consumables for Peripheral Vascular Occlusive Disease under the NPS, the product types and categories required by the Authority are set out in Schedule A. Sellers are invited to offer their Goods which rightly match with the required product types and categories, by completing all details and prices in Schedule A and the Schedule of Compliance in Schedule B. Seller should note that any Goods quoted in Schedule A must have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) within 18 months immediately preceding the Closing Date. Seller must complete the consumption details for each of the Goods it proposes to supply in Schedule Schedule A. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.2 Any Goods to be supplied by the Seller must meet the following product standards and requirements: (a) the Goods offered must comply with the standard of British Standard Institution (BSI) of general requirements for TAA Stent Graft System Implants and Consumables for Peripheral Vascular Occlusive Disease or equivalent standard of International Organization for Standardization (ISO). Sellers must indicate the specific BSI or ISO standard applicable to each offered products in Schedule A, and confirm compliance with the applicable standards. Upon request, Sellers are required to provide to the Authority documentary evidence showing compliance with the relevant standards; (b) the Seller must, for each of the Goods quoted in Schedule A, submit with its Standing Quotation copies of 2 sets (each set in separate file) of the following: (i) certified true copy of manufacturer license issued by the Government or Health Authority of the country of origin; (ii) certified true copy of the authorized certification of compliance to ISO 13485 (latest version), Food and Drug Administration (FDA)/ Product’s compliance with European Commission legislation (CE)//BSI or other equivalent international standards in production and quality-management system; (iii) certified true copy of certifying compliance with FDA 510(K)/CE or other equivalent international standards for listing of each offered product in Schedule A. 2.3 If a Seller is not the manufacturer of the Goods offered in Schedule A, the Seller must submit with its Standing Quotation a written undertaking issued by the manufacturer of the Goods evidencing the manufacturer’s agreement to supply such Goods to the Seller should the Seller’s Standing Quotation be accepted by the Authority. The written undertaking shall be signed by a duly authorized representative of the manufacturer and dated no later than the Closing Date but not earlier than six (6) months before the Closing Date. If a Seller fails to submit the written undertaking on or before the Closing Date, or by the time specified by the Authority, its Standing Quotation may not be considered. 2.4 Sellers are to note that for each of the Goods under a Standing Quotation which has been accepted by the Authority, the Seller must, at the instruction of the Buyer, supply the Goods during the Validity Period either: (a) as a stock item pursuant to a Purchase Order placed by the Buyer; or (b) as a consignment item under the Consignment Stock Scheme. 2.5 The Buyer may at any time during the Validity Period, request the Seller to deposit certain quantities of any of the Goods which have been quoted in Schedule A at the Hospital premises as consignment stock under the Consignment Stock Scheme. The Buyer will notify the Seller when the Goods from the consignment stock are taken out for use, and will issue a Purchase Order to the Seller. The Seller may then invoice the Buyer as appropriate for the Goods consumed. The Seller must also top up from time to time during the Validity Period the quantity of Goods placed in consignment, in accordance with the quantities and time as required by the Buyer, and to replace any Goods in the consignment stock for which the expiry period has passed. 2.6 Sellers must complete and submit with their Standing Quotations Schedule C - instructions for storage and handling of the Goods under the Consignment Stock Scheme. 2.7 If during the Validity Period the Seller wishes to add new items to the list of Goods to be supplied under the NPS, the Seller must write to the Authority and propose the new items to be supplied, together with supporting written evidence that the said items have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) in the past 12 months. The Authority shall have absolute discretion whether or not to add those proposed items onto the list of Goods in Schedule A but if it does, the supply of the new items shall be subject to the terms of this Invitation to Quote. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.8 The Authority may at any time during the Validity Period, delete any items from any Standing Quotation either because (a) there has been no purchase record with the Buyer within the past 12 months; (b) bulk contract(s) has been established for such item; or (c) in the Authority’s opinion, the items should no longer remain on the Standing Quotation. The Authority will inform the Seller of the items to be deleted and the effective date of such deletion. 2.9 As part of the Invitation to Quote exercise, the Seller is also invited to offer to the Authority in their Standing Quotations on-loan instruments (“On-loan Instruments”) for the Buyer’s use with the Goods that Sellers quote in Schedule A. All On-loan Instruments offered must: (a) be fully compatible with the Goods supplied by the Seller; and (b) be provided to the Buyer free of charge. The Seller is required to provide details of the On-loan Instruments (if any), including their selling prices, in Schedule E. 2.10 The Seller must have in place appropriate and adequate product safety alert system and product recall system covering the Goods (whether or not under the Consignment Stock Scheme) and the On-loan Instruments. The Seller must in Schedule F: (a) describe the safety alert system in place in respect of the Goods and the On-loan Instruments; (b) provide the details of the product recall system in place in respect of the Goods and the On-loan Instruments, which must have been approved by the relevant regulatory authority. (c) The Seller must also provide the names, email addresses and telephone numbers of the representatives of the manufacturer and (in case the Seller is a local distributor) the Seller with whom the Authority can contact in the event of Safety Alert Notice or Product Recall Notice (both as defined in Clause 9 of Part III). 2.11 The Authority shall have the right to disclose whenever it considers appropriate, or upon request (verbal or written) by any third party (including unsuccessful Sellers) information on the Contract, such as the name and address of the successful Seller, product description/brand/model/country of origin (if applicable), description of the relevant services (if applicable) and the value of the Contract, without reference to or consent from the successful Seller. Unsuccessful Sellers may also enquire as to the reason for the rejection of their Quotation Submissions.

Quotation Subject Matter. 2.1 Sellers are invited for the supply of TAA Stent Graft System Surgical Stapler for Endoscopic Surgery under the NPS, . Sellers must comply with the mandatory requirements and specification as stipulated in Schedule H for the supply of Surgical Stapler for Endoscopic Surgery. The product types and categories required by the Authority are set out in Schedule A. Sellers are invited to offer their Goods which rightly match with the required product types and categories, by completing all details and prices in Schedule A and A, the Schedule of Compliance in Schedule B. B and the requirements in Schedule H. Seller should note that any Goods quoted in Schedule A must have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) within 18 months immediately preceding the Closing Date. Seller must complete the consumption details for each of the Goods it proposes to supply in Schedule A. D. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.2 Any Goods to be supplied by the Seller must meet the following product standards and requirements: (a) the Goods offered must comply with the standard of British Standard Institution (BSI) of general requirements for TAA Stent Graft System Surgical Stapler for Endoscopic Surgery or equivalent standard of International Organization for Standardization (ISO). Sellers must indicate the specific BSI or ISO standard applicable to each offered products in Schedule A, and confirm compliance with the applicable standards. Upon request, Sellers are required to provide to the Authority documentary evidence showing compliance with the relevant standards; (b) the Seller must, for each of the Goods quoted in Schedule A, submit with its Standing Quotation copies of 2 sets (each set in separate file) of the following: (i) certified true copy of manufacturer license issued by the Government or Health Authority of the country of origin; (ii) certified true copy of the authorized certification of compliance to ISO 13485 (latest version), Food and Drug Administration (FDA)/ Product’s compliance with European Commission legislation (CE)//BSI or other equivalent international standards in production and quality-management system; (iii) certified true copy of certifying compliance with FDA 510(K)/CE or other equivalent international standards for listing of each offered product in Schedule A. 2.3 If a Seller is not the manufacturer of the Goods offered in Schedule A, the Seller must submit with its Standing Quotation a written undertaking issued by the manufacturer of the Goods evidencing the manufacturer’s agreement to supply such Goods to the Seller should the Seller’s Standing Quotation be accepted by the Authority. The written undertaking shall be signed by a duly authorized representative of the manufacturer and dated no later than the Closing Date but not earlier than six (6) months before the Closing Date. If a Seller fails to submit the written undertaking on or before the Closing Date, or by the time specified by the Authority, its Standing Quotation may not be considered. 2.4 Sellers are to note that for each of the Goods under a Standing Quotation which has been accepted by the Authority, the Seller must, at the instruction of the Buyer, supply the Goods during the Validity Period either: (a) as a stock item pursuant to a Purchase Order placed by the Buyer; or (b) as a consignment item under the Consignment Stock Scheme. 2.5 The Buyer may at any time during the Validity Period, request the Seller to deposit certain quantities of any of the Goods which have been quoted in Schedule A at the Hospital premises as consignment stock under the Consignment Stock Scheme. The Buyer will notify the Seller when the Goods from the consignment stock are taken out for use, and will issue a Purchase Order to the Seller. The Seller may then invoice the Buyer as appropriate for the Goods consumed. The Seller must also top up from time to time during the Validity Period the quantity of Goods placed in consignment, in accordance with the quantities and time as required by the Buyer, and to replace any Goods in the consignment stock for which the expiry period has passed. 2.6 Sellers must complete and submit with their Standing Quotations Schedule C - instructions for storage and handling of the Goods under the Consignment Stock Scheme. 2.7 If during the Validity Period the Seller wishes to add new items to the list of Goods to be supplied under the NPS, the Seller must write to the Authority and propose the new items to be supplied, together with supporting written evidence that the said items have been consumed by HA/Hospital(s) (or equivalent in Hong Kong or elsewhere) in the past 12 months. The Authority shall have absolute discretion whether or not to add those proposed items onto the list of Goods in Schedule A but if it does, the supply of the new items shall be subject to the terms of this Invitation to Quote. The Authority shall have absolute discretion to determine what experience or consumption is “equivalent” in the circumstances. 2.8 The Authority may at any time during the Validity Period, delete any items from any Standing Quotation either because (a) there has been no purchase record with the Buyer within the past 12 months; (b) bulk contract(s) has been established for such item; or (c) in the Authority’s opinion, the items should no longer remain on the Standing Quotation. The Authority will inform the Seller of the items to be deleted and the effective date of such deletion. 2.9 As part of the Invitation to Quote exercise, the Seller is also invited to offer to the Authority in their Standing Quotations on-loan instruments (“On-loan Instruments”) for the Buyer’s use with the Goods that Sellers quote in Schedule A. All On-loan Instruments offered must: (a) be fully compatible with the Goods supplied by the Seller; and (b) be provided to the Buyer free of charge. The Seller is required to provide details of the On-loan Instruments (if any), including their selling prices, in Schedule E. 2.10 The Seller must have in place appropriate and adequate product safety alert system and product recall system covering the Goods (whether or not under the Consignment Stock Scheme) and the On-loan Instruments. The Seller must in Schedule F: (a) describe the safety alert system in place in respect of the Goods and the On-loan Instruments; (b) provide the details of the product recall system in place in respect of the Goods and the On-loan Instruments, which must have been approved by the relevant regulatory authority. (c) The Seller must also provide the names, email addresses and telephone numbers of the representatives of the manufacturer and (in case the Seller is a local distributor) the Seller with whom the Authority can contact in the event of Safety Alert Notice or Product Recall Notice (both as defined in Clause 9 of Part III). 2.11 The Authority shall have the right to disclose whenever it considers appropriate, or upon request (verbal or written) by any third party (including unsuccessful Sellers) information on the Contract, such as the name and address of the successful Seller, product description/brand/model/country of origin (if applicable), description of the relevant services (if applicable) and the value of the Contract, without reference to or consent from the successful Seller. Unsuccessful Sellers may also enquire as to the reason for the rejection of their Standing Quotation Submissions.