Product/Instrument Safety Alert and Product/Instrument Recall. 9.1 If the Goods/On-loan Instruments do not meet the criteria in Clause 6 or Clause 8 of these T&Cs, or if there is local or overseas adverse incident, e.g. product recall, hazard alert, etc., the Seller is obligated to inform the Authority in writing via e-mail (xxxx_xxx_xx@xx.xxx.xx) within 24 hours after the Seller has known or reasonably should have known the happening of the incident, giving full details of the incident and its proposed response. 9.2 The Seller’s product safety alert notice (“Safety Alert Notice”) must be issued even if the Seller disputes legal liability for the problem or the hazard, or requires more time to establish remedial actions to be undertaken in relation to it, and the Safety Alert Notice shall not relieve the Seller from any other liability or obligation under the Contract and/or the Purchase Orders. The Safety Alert Notice must contain at least the following information: (a) the manufacturer and the type/brand/model of the Goods/On-loan Instruments in question; (b) the safety issue in question; (c) when and how the safety issue was discovered; (d) the distribution list of affected type/brand/model of the Goods/On-loan Instruments delivered to the Buyer; (e) the manufacturer’s recommendation in respect of the patients who may have used the Goods/On-loan Instruments in question and other action that needs to be taken. 9.3 The Seller’s product recall notice (“Product Recall Notice”) must contain at least the following information: (a) the manufacturer and the type/brand/model of the Goods/On-loan Instruments in question; (b) the safety issue in question; (c) when and how the safety issue was discovered; (d) the distribution list of affected type/brand/model of the Goods/On-loan Instruments delivered to the Buyer; (e) the anticipated duration of the product recall exercise; (f) whether the product recall is at hospital level or on patient level; (g) the manufacturer’s recommendation in respect of patients who may have used the type/brand/model of the Goods/On-loan Instruments in question and other action that needs to be taken; (h) whether the Department of Health has been alerted. 9.4 The Seller’s Safety Alert Notice or the Product Recall Notice (as the case may be) must comply with regulatory requirements (including as to registration requirements) and align with industry practice of goods similar to the Goods and/or the On-loan Instruments. The Seller must inform the Authority timely as and when new information emerges in respect of the Safety Alert Notice or the Product Recall Notice, in particular, with respect to safety issues or management of patients’ clinical condition. 9.5 After receipt of a Safety Alert Notice, the Authority may, without prejudice to other rights and remedies of the Authority under the Contract and/or the Purchase Order or at law, reject the Goods (or any part thereof) delivered or return the On-loan Instruments, and may: (a) suspend the performance of the Contract and/or the Purchase Order or any other contract (including cessation of any use or distribution of the Goods) until the safety issue is addressed to the satisfaction of the Authority; or (b) terminate the Contract and/or the Purchase Order whereupon Clause 19 of these T&Cs shall apply. (a) After receipt of a Product Recall Notice, without prejudice to other rights and remedies of the Authority under the Contract or at law: (i) the Seller must, on demand by the Authority, repay to the Authority the price of the Goods subject to a Product Recall Notice (“Recalled Goods”); and/or (ii) the Authority may accept products offered by the Seller to replace the Recalled Goods; and/or (iii) the Authority may purchase from other sources alternate supplies to substitute for the Recalled Goods and the Seller must, on demand by the Authority, pay to the Authority any price difference above the price of the Recalled Goods and all the related freight and delivery charges. (b) Additionally, the Authority may: (i) suspend the performance of the Contract and/or the Purchase Order and/or any other contract (including cessation of any use or distribution of the Goods) until the problem underlying the Product Recall Notice is rectified; or (ii) terminate the Contract and/or the Purchase Order and/or any other contract, whereupon Clause 19 of these T&Cs shall apply. 9.7 Where the Authority suspends the performance of this Contract and/or the Purchase Order pursuant to sub-clause 9.5 or sub-clause 9.6 of these T&Cs, or the Seller suspends supply of the Goods under this Contract and/or the Purchase Order, the Authority may purchase from other sources alternate supplies to cover Goods which the Authority may further order and the Authority shall be entitled to recover the cost of the such alternative supplies from the Seller. 9.8 Where, as a result of a Safety Alert Notice or a Product Recall Notice, the Authority has to: (a) require its staff to work overtime in getting together the Goods and/or On-loan Instruments, which are subject to the Safety Alert Notice, or the Recalled Goods, maintaining the continuity of supplies (such as sourcing alternate supplies), stock- taking its inventory, compiling a list of patients who may be affected and contacting them, and providing follow up consultations and treatment that may be required, and has thereby incurred staff overtime cost (“Staff Overtime Cost”); and/or (b) provide the affected patients with such medication (including alternate supplies) and such medical examination (including tests, radiological examinations) as may be necessary, and has thereby incurred expenses (“Additional Expense”); and/or (c) incur other expenses (“Other Expense”); the Seller must on demand by the Authority pay to the Authority the Staff Overtime Cost, the Additional Expense, and the Other Expense. 9.9 The Seller shall indemnify and keep indemnified the Authority in full against: (a) any loss, damages, liability, cost and expense of any nature (including legal expenses) which may be incurred or suffered by the Authority; and (b) any demand, claim and action against the Authority arising out of or in connection with a Safety Alert Notice, a Product Recall Notice or the suspension in the supply of the Goods under the Contract and/or Purchase Order. 9.10 For the avoidance of doubt, the Authority may act in accordance with Clauses 9.5, 9.6, 9.7 and 9.8 of these T&Cs without incurring any liability to the Seller even if the Goods, which are subject to the Safety Alert Notice, and/or the Recalled Goods are later confirmed by any laboratory analysis, health or regulatory authority or by a court of law (whether or not in Hong Kong) to have complied fully with the relevant provisions of these T&Cs. 9.11 Notwithstanding anything herein, the Seller shall remove all Goods on consignment at Hospitals which are subject of a Safety Alert Notice or a Product Recall Notice within 48 hours of the issuance of such notice and, to the extent practicable, replace them with alternative Goods.
Appears in 8 contracts
Samples: Supply Agreement, Standing Quotation, Standing Quotation
Product/Instrument Safety Alert and Product/Instrument Recall. 9.1 8.1 If the Goods/On-loan Instruments Goods do not meet the criteria in Clause 6 or Clause 8 of these T&Cs, or if there is local or overseas adverse incident, e.g. product recall, hazard alert, etc., the Seller is obligated to inform the Authority in writing via e-mail (xxxx_xxx_xx@xx.xxx.xx) within 24 hours after the Seller has known or reasonably should have known the happening of the incident, giving full details of the incident and its proposed response.
9.2 8.2 The Seller’s product safety alert notice (“Safety Alert Notice”) must be issued even if the Seller disputes legal liability for the problem or the hazard, or requires more time to establish remedial actions to be undertaken in relation to it, and the Safety Alert Notice shall not relieve the Seller from any other liability or obligation under the Contract and/or the Purchase Orders. The Safety Alert Notice must contain at least the following information:
(a) the manufacturer and the type/brand/model of the Goods/On-loan Instruments Goods in question;
(b) the safety issue in question;
(c) when and how the safety issue was discovered;
(d) the distribution list of affected type/brand/model of the Goods/On-loan Instruments Goods delivered to the Buyer;
(e) the manufacturer’s recommendation in respect of the patients who may have used the Goods/On-loan Instruments Goods in question and other action that needs to be taken.
9.3 8.3 The Seller’s product recall notice (“Product Recall Notice”) must contain at least the following information:
(a) the manufacturer and the type/brand/model of the Goods/On-loan Instruments Goods in question;
(b) the safety issue in question;
(c) when and how the safety issue was discovered;
(d) the distribution list of affected type/brand/model of the Goods/On-loan Instruments Goods delivered to the Buyer;
(e) the anticipated duration of the product recall exercise;
(f) whether the product recall is at hospital level or on patient level;
(g) the manufacturer’s recommendation in respect of patients who may have used the type/brand/model of the Goods/On-loan Instruments Goods in question and other action that needs to be taken;
(h) whether the Department of Health has been alerted.
9.4 8.4 The Seller’s Safety Alert Notice or the Product Recall Notice (as the case may be) must comply with regulatory requirements (including as to registration requirements) and align with industry practice of goods similar to the Goods and/or the On-loan InstrumentsGoods. The Seller must inform the Authority timely as and when new information emerges in respect of the Safety Alert Notice or the Product Recall Notice, in particular, with respect to safety issues or management of patients’ clinical condition.
9.5 8.5 After receipt of a Safety Alert Notice, the Authority may, without prejudice to other rights and remedies of the Authority under the Contract and/or the Purchase Order or at law, reject the Goods (or any part thereof) delivered or return the On-loan Instrumentsdelivered, and may:
(a) suspend the performance of the Contract and/or the Purchase Order or any other contract (including cessation of any use or distribution of the Goods) until the safety issue is addressed to the satisfaction of the Authority; or
(b) terminate the Contract and/or the Purchase Order whereupon Clause 19 18 of these T&Cs shall apply.
(a) After receipt of a Product Recall Notice, without prejudice to other rights and remedies of the Authority under the Contract or at law:
(i) the Seller must, on demand by the Authority, repay to the Authority the price of the Goods subject to a Product Recall Notice (“Recalled Goods”); and/or
(ii) the Authority may accept products offered by the Seller to replace the Recalled Goods; and/or
(iii) the Authority may purchase from other sources alternate supplies to substitute for the Recalled Goods and the Seller must, on demand by the Authority, pay to the Authority any price difference above the price of the Recalled Goods and all the related freight and delivery charges.
(b) Additionally, the Authority may:
(i) suspend the performance of the Contract and/or the Purchase Order and/or any other contract (including cessation of any use or distribution of the Goods) until the problem underlying the Product Recall Notice is rectified; or
(ii) terminate the Contract and/or the Purchase Order and/or any other contract, whereupon Clause 19 of these T&Cs shall apply.
9.7 8.7 Where the Authority suspends the performance of this Contract and/or the Purchase Order pursuant to sub-clause 9.5 8.5 or sub-clause 9.6 8.6 of these T&Cs, or the Seller suspends supply of the Goods under this Contract and/or the Purchase Order, the Authority may purchase from other sources alternate supplies to cover Goods which the Authority may further order and the Authority shall be entitled to recover the cost of the such alternative supplies from the Seller.
9.8 8.8 Where, as a result of a Safety Alert Notice or a Product Recall Notice, the Authority has to:
(a) require its staff to work overtime in getting together the Goods and/or On-loan InstrumentsGoods, which are subject to the Safety Alert Notice, or the Recalled Goods, maintaining the continuity of supplies (such as sourcing alternate supplies), stock- stock-taking its inventory, compiling a list of patients who may be affected and contacting them, and providing follow up consultations and treatment that may be required, and has thereby incurred staff overtime cost (“Staff Overtime Cost”); and/or
(b) provide the affected patients with such medication (including alternate supplies) and such medical examination (including tests, radiological examinations) as may be necessary, and has thereby incurred expenses (“Additional Expense”); and/or
(c) incur other expenses (“Other Expense”); the Seller must on demand by the Authority pay to the Authority the Staff Overtime Cost, the Additional Expense, and the Other Expense.
9.9 8.9 The Seller shall indemnify and keep indemnified the Authority in full against:
(a) any loss, damages, liability, cost and expense of any nature (including legal expenses) which may be incurred or suffered by the Authority; and
(b) any demand, claim and action against the Authority arising out of or in connection with a Safety Alert Notice, a Product Recall Notice or the suspension in the supply of the Goods under the Contract and/or Purchase Order.
9.10 8.10 For the avoidance of doubt, the Authority may act in accordance with Clauses 9.58.5, 9.68.6, 9.7 8.7 and 9.8 8.8 of these T&Cs without incurring any liability to the Seller even if the Goods, which are subject to the Safety Alert Notice, and/or the Recalled Goods are later confirmed by any laboratory analysis, health or regulatory authority or by a court of law (whether or not in Hong Kong) to have complied fully with the relevant provisions of these T&Cs.
9.11 8.11 Notwithstanding anything herein, the Seller shall remove all Goods on consignment at Hospitals which are subject of a Safety Alert Notice or a Product Recall Notice within 48 hours of the issuance of such notice and, to the extent practicable, replace them with alternative Goods.
Appears in 1 contract
Samples: Standing Quotation