Goods and Related Services. A. The Supplier shall deliver the Goods and the Services, if any, described in this BOA and as specified in the applicable Annex and any resulting Order, of the type, in the quantity, at the delivery date and at the price as indicated, in accordance with the stated BOA, the applicable Annex, and Order terms and conditions. Shipment delivery, including split or partial shipments, must be approved by Chemonics in writing. The quality of the Goods and Services shall conform in all respects to the requirements of this BOA, the applicable Annex, and any resulting Order (including, but not limited to, all required testing and warranties). B. All Goods (including, but not limited to, materials, parts, components, and sub-assemblies thereof) shall, unless otherwise expressly approved by Chemonics in writing, be new, and not used, remanufactured, refurbished or Government surplus; and shall be produced entirely from goods meeting all of the foregoing requirements. C. Unless otherwise expressly approved by Chemonics in writing (based on approval by the Government's Contracting Officer) — (1) The origin of any of the Goods for which a specific "Origin" is indicated herein or any associated Order, if applicable, shall be as specified; and (2) The Goods (including the components thereof), services, sub-vendors or suppliers shall not be from Cuba, Iran, North Korea, Syria, or other countries or entities which may be subject to U.S. Government sanctions as per the OFAC list of sanctioned entities. D. For any Pharmaceuticals being procured: (1) All Pharmaceuticals supplied shall be manufactured in accordance with Good Manufacturing Practice. Unless otherwise specifically stated in this BOA, the applicable Annex, or the Order, “Good Manufacturing Practice” shall be deemed to mean the standards and guidance issued by the U.S. Food and Drug Administration (FDA), including without limitation the Current Good Manufacturing Regulations for Finished Pharmaceuticals (“GMP”) and the related regulations in 21 CFR Parts 210 and 211. If a waiver is approved and a different Stringent Drug Regulatory Authority’s standards are eligible for use in lieu of the aforementioned FDA standard/guidance, the alternative authority shall be specified in the BOA, the applicable Annex, or the Order (or as otherwise expressly agreed in writing by Chemonics). A stringent regulatory authority (SRA) is a drug regulatory authority that closely resembles FDA in the standards utilized in its operations. Currently, countries that participate in the International Conference on Harmonization (ICH) are considered as stringent regulatory authorities. (2) If the Supplier is the manufacturer of Pharmaceuticals supplied under this BOA, as part of its compliance with the current GMP (or other applicable standards and guidance), the Supplier shall collect and retain representative samples of each lot or batch of Pharmaceuticals supplied in addition to the quantity listed in the Order. If the Supplier is not the Manufacturer, the Supplier shall ensure that the Manufacturer, as part of its compliance with the aforesaid standards or guidance, collects and retains representative samples of each lot or batch of Pharmaceuticals supplied. The Supplier shall also ensure that Chemonics and its designees if any are provided with reasonable access to the samples upon request. (3) The premises used for manufacturing the Pharmaceuticals shall hold a current manufacturing license issued by the relevant Ministry of Health or other cognizant national drug regulatory authority, and shall be open to visits from inspectors appointed by Chemonics. (4) In addition, and without prejudice to the above, the Pharmaceuticals shall comply with the standards of the current edition (or the latest edition in which they are included) of the United States Pharmacopoeia (USP); or, if applicable, with another acceptable pharmacopoeia standard, e.g. the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), or the British Pharmaceutical Codex (BPC). Where the USP gives no definition of the Pharmaceuticals and no other standards are specified, the Pharmaceuticals shall be manufactured in accordance with tested “in-house” formulations so as to be suitable for human medicine. E. If the Order is for Plasters, Liquid Extracts or Ointments, Goods supplied shall be modified, where necessary, to render them suitable for use in the Cooperating Country(ies), but the specified proportion of the active ingredients must, in all cases, be maintained. F. All Goods with a shelf life (such as test kits), including all Pharmaceuticals, must be freshly manufactured, and thus have maximum possible shelf life. Unless otherwise required in the Order, Goods with a maximum possible shelf life of less than twenty-four (24) months shall have at least 85% of shelf life remaining when delivered. Goods with a maximum possible shelf life of more than twenty- four (24) months shall have at least twenty-four (24) months, or 85%, of shelf life remaining whichever is longer, when delivered. No Goods will be accepted which do not comply with these requirements unless Chemonics has agreed in writing to different requirements, in which case the Goods must strictly comply with those modified requirements. G. Notwithstanding any other provision of the BOA, Chemonics may: (1) Prior to shipment of the Goods and the initiation of performance of any Related Services, by written notice to the Supplier, cancel in its entirety, or reduce the quantity(ies) of, any individual item(s) of the Goods without charge to Chemonics; and/or (2) In the event that the USAID Contract with Chemonics is terminated by the Government in whole or in pertinent part prior to shipment to its delivery destination, return to the Supplier unused items or quantities of Delivered Goods. H. If the BOA calls for performance of Related Services overseas by the Supplier’s employees or consultants (collectively, “personnel”), the Supplier shall comply with the following requirements: (1) The Supplier shall notify Chemonics (sufficiently in advance to permit Chemonics to notify USAID and obtain its concurrence if needed) of any planned travel overseas by personnel in connection with performance of Related Services. Such notice shall include the number and names of the personnel participating, the proposed itinerary and logistics arrangements, and the Services to be provided, along with the information specified in AIDAR 752.7004, EMERGENCY LOCATOR INFORMATION. (2) The Supplier shall ensure that its personnel, while in a Cooperating Country, abide by all applicable laws of the Cooperating Country and political subdivisions thereof. (3) Other than work performed under the BOA for which personnel are assigned by the Supplier, the Supplier’s personnel shall not engage, directly or indirectly, either in their own name or in the name or through the agency of another person, in any business, profession or occupation in the Cooperating Country, nor shall they make loans or investments to or in any business, profession or occupation in the Cooperating Country, without Chemonics’ approval. This provision does not apply to personnel who are citizens or legal residents of the Cooperating Country. (4) The Supplier shall obtain (a) worker’s compensation (Defense Base Act) insurance pursuant to FAR 52.228-3 and AIDAR 752.228-3, and (b) medical evacuation insurance for personnel travelling to a Cooperating Country in connection with this BOA. (5) Personnel travelling on the Supplier’s behalf for performance of Related Services shall possess appropriate language skills, if any, stated in the BOA, and shall be physically fit in accordance with AIDAR 752.7033. (6) In performing Related Services, the Supplier shall comply with USAID guidance, if any, relating to branding/marking of activities. (7) FAR 52.246-4 INSPECTION OF SERVICES – FIXED PRICE (AUG 1996) shall apply to Related Services. (8) All logistics support, visas, legal compliance matters and taxes in connection with its personnel overseas shall be the sole responsibility of the Supplier, as will all liability for the acts and omissions of the Supplier’s personnel performing the Related Services. (9) Compensation for satisfactory performance of Related Services shall be paid upon completion thereof in compliance with the terms and conditions of the BOA, and solely in the form of the firm, fixed, all-inclusive prices. (10) Notwithstanding any other provisions of the BOA no additional compensation or reimbursement will be provided to the Supplier for complying with these requirements concerning provision of Related Services.
Appears in 3 contracts
Samples: Basic Ordering Agreement, Basic Ordering Agreement, Basic Ordering Agreement
Goods and Related Services. A. The Supplier shall deliver the Goods and the Services, if any, described in this BOA and as specified in the applicable Annex and any resulting Order, of the type, in the quantity, at the delivery date and at the price as indicated, in accordance with the stated BOA, the applicable Annex, and Order terms and conditions. Shipment delivery, including split or partial shipments, must be approved by Chemonics in writing. The quality of the Goods and Services shall conform in all respects to the requirements of this BOA, the applicable Annex, and any resulting Order (including, but not limited to, all required testing and warranties).
B. All Goods (including, but not limited to, materials, parts, components, and sub-assemblies thereof) shall, unless otherwise expressly approved by Chemonics in writing, be new, and not used, remanufactured, refurbished or Government surplus; and shall be produced entirely from goods meeting all of the foregoing requirements.
C. Unless otherwise expressly approved by Chemonics in writing (based on approval by the Government's Contracting Officer) —
(1) The origin of any of the Goods for which a specific "Origin" is indicated herein or any associated Order, if applicable, shall be as specified; and
(2) The Goods (including the components thereof), services, sub-vendors or suppliers shall not be from Cuba, Iran, North Korea, Syria, or other countries or entities which may be subject to U.S. Government sanctions as per the OFAC list of sanctioned entities.
D. For any Pharmaceuticals being procured:
(1) All Pharmaceuticals supplied shall be manufactured in accordance with Good Manufacturing Practice. Unless otherwise specifically stated in this BOA, the applicable Annex, or the Order, “Good Manufacturing Practice” shall be deemed to mean the standards and guidance issued by the U.S. Food and Drug Administration (FDA), including without limitation the Current Good Manufacturing Regulations for Finished Pharmaceuticals (“GMP”) and the related regulations in 21 CFR Parts 210 and 211. If a waiver is approved and a different Stringent Drug Regulatory Authority’s standards are standard is eligible for use in lieu of the aforementioned FDA standard/guidance, the alternative authority shall be specified in the BOA, the applicable Annex, or the Order (or as otherwise expressly agreed in writing by Chemonics). A stringent regulatory authority (SRA) is a drug regulatory authority that closely resembles FDA in the standards utilized in its operations. Currently, countries that participate in the International Conference on Harmonization (ICH) are considered as stringent regulatory authorities.
(2) If the Supplier is the manufacturer of Pharmaceuticals supplied under this BOA, as part of its compliance with the current GMP (or other applicable standards and guidance), the Supplier shall collect and retain representative samples of each lot or batch of Pharmaceuticals supplied in addition to the quantity listed in the Order. If the Supplier is not the Manufacturer, the Supplier shall ensure that the Manufacturer, as part of its compliance with the aforesaid standards or guidance, collects and retains representative samples of each lot or batch of Pharmaceuticals supplied. The Supplier shall also ensure that Chemonics and its designees if any are provided with reasonable access to the samples upon request.
(3) The premises used for manufacturing the Pharmaceuticals shall hold a current manufacturing license issued by the relevant Ministry of Health or other cognizant national drug regulatory authority, and shall be open to visits from inspectors appointed by Chemonics.
(4) In addition, and without prejudice to the above, the Pharmaceuticals shall comply with the standards of the current edition (or the latest edition in which they are included) of the United States Pharmacopoeia (USP); or, if applicable, with another acceptable pharmacopoeia standard, e.g. the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), or the British Pharmaceutical Codex (BPC). Where the USP gives no definition of the Pharmaceuticals and no other standards are specified, the Pharmaceuticals shall be manufactured in accordance with tested “in-house” formulations so as to be suitable for human medicine.
E. If the Order is for Plasters, Liquid Extracts or Ointments, Goods supplied shall be modified, where necessary, to render them suitable for use in the Cooperating Country(ies), but the specified proportion of the active ingredients must, in all cases, be maintained.
F. All Goods with a shelf life (such as test kits), including all Pharmaceuticals, must be freshly manufactured, and thus have maximum possible shelf life. Unless otherwise required in the Order, Goods with a maximum possible shelf life of less than twenty-four (24) months shall have at least 85% of shelf life remaining when delivered. Goods with a maximum possible shelf life of more than twenty- four (24) months shall have at least twenty-four (24) months, or 85%, of shelf life remaining whichever is longer, when delivered. No Goods will be accepted which do not comply with these requirements unless Chemonics has agreed in writing to different requirements, in which case the Goods must strictly comply with those modified requirements.
G. Notwithstanding any other provision of the BOA, Chemonics may:
(1) Prior to shipment of the Goods and the initiation of performance of any Related Services, by written notice to the Supplier, cancel in its entirety, or reduce the quantity(ies) of, any individual item(s) of the Goods without charge to Chemonics; and/or
(2) In the event that the USAID Contract with Chemonics is terminated by the Government in whole or in pertinent part prior to shipment to its delivery destination, return to the Supplier unused items or quantities of Delivered Goods.
H. If the BOA calls for performance of Related Services overseas by the Supplier’s employees or consultants (collectively, “personnel”), the Supplier shall comply with the following requirements:
(1) The Supplier shall notify Chemonics (sufficiently in advance to permit Chemonics to notify USAID and obtain its concurrence if needed) of any planned travel overseas by personnel in connection with performance of Related Services. Such notice shall include the number and names of the personnel participating, the proposed itinerary and logistics arrangements, and the Services to be provided, along with the information specified in AIDAR 752.7004, EMERGENCY LOCATOR INFORMATION.
(2) The Supplier shall ensure that its personnel, while in a Cooperating Country, abide by all applicable laws of the Cooperating Country and political subdivisions thereof.
(3) Other than work performed under the BOA for which personnel are assigned by the Supplier, the Supplier’s personnel shall not engage, directly or indirectly, either in their own name or in the name or through the agency of another person, in any business, profession or occupation in the Cooperating Country, nor shall they make loans or investments to or in any business, profession or occupation in the Cooperating Country, without Chemonics’ approval. This provision does not apply to personnel who are citizens or legal residents of the Cooperating Country.
(4) The Supplier shall obtain (a) worker’s compensation (Defense Base Act) insurance pursuant to FAR 52.228-3 and AIDAR 752.228-3, and (b) medical evacuation insurance for personnel travelling to a Cooperating Country in connection with this BOA.
(5) Personnel travelling on the Supplier’s behalf for performance of Related Services shall possess appropriate language skills, if any, stated in the BOA, and shall be physically fit in accordance with AIDAR 752.7033.
(6) In performing Related Services, the Supplier shall comply with USAID guidance, if any, relating to branding/marking of activities.
(7) FAR 52.246-4 INSPECTION OF SERVICES – FIXED PRICE (AUG 1996) shall apply to Related Services.
(8) All logistics support, visas, legal compliance matters and taxes in connection with its personnel overseas shall be the sole responsibility of the Supplier, as will all liability for the acts and omissions of the Supplier’s personnel performing the Related Services.
(9) Compensation for satisfactory performance of Related Services shall be paid upon completion thereof in compliance with the terms and conditions of the BOA, and solely in the form of the firm, fixed, all-inclusive prices.
(10) Notwithstanding any other provisions of the BOA no additional compensation or reimbursement will be provided to the Supplier for complying with these requirements concerning provision of Related Services.
Appears in 2 contracts
Goods and Related Services. A. The Supplier Vendor shall deliver the Goods (and the Services, if any, described in this BOA and as specified in the applicable Annex and any resulting Order), of the type, in the quantity, at the delivery date and at the price as indicated, in accordance with indicated on the stated BOA, the applicable Annex, and Order terms and conditions. Shipment delivery, including split or partial shipments, must be approved by Chemonics in writingPurchase Order. The quality of the Goods and Services shall conform in all respects to the requirements of this BOA, the applicable Annex, and any resulting Order Contract (including, including without limitation all required warranties). All Goods (including but not limited to, all required testing and warranties).
B. All Goods (including, but not limited to, to materials, parts, components, components and sub-assemblies thereof) shall, unless otherwise expressly approved by Chemonics in writingBuyer, be new, ; unused; non-remanufactured and non-refurbished; not used, remanufactured, refurbished or Government previously disposed as surplus; and shall be produced entirely from goods Goods meeting all of the foregoing requirements.
C. Unless otherwise expressly approved by Chemonics in writing (based on approval by the Government's Contracting Officer) —
(1) The origin of any of the Goods for which a specific "Origin" is indicated herein or any associated OrderB. Except as Buyer may specifically notify Vendor, if applicable, shall be as specified; and
(2) The no Goods (including the components thereof), services, sub-vendors or suppliers subcontractors shall be from countries under an UN embargo. Notwithstanding any of the foregoing, the origin of any of the Goods for which a specific “Origin” is indicated on the Purchase Order shall be as specified.
C. Outside of product compliance disclosure (if any) expressly stated in the Warranty, Buyer is solely responsible for ensuring that the purchase and resale of them comply with applicable laws, regulations, or requirements, including, without limitation, any emergency mandates enacted in response to COVID-19 and Buyer shall indemnify and hold harmless Vendor from any claims, damages, losses, or costs arising out of or relating to Buyer’s violation of or failure to follow such applicable laws, regulations, or requirement. Xxxxx agrees to comply with all applicable laws and regulations relating to the export controls of the United States, the People's Republic of China and other applicable governments as required. Buyer shall not be engage in activities involving restricted items, sanctioned parties or countries and illegal use unless first obtain all required authorizations and necessary export licenses from Cuba, Iran, North Korea, Syria, or other countries or entities which may be subject to the U.S. Government sanctions and/or other applicable governments as per the OFAC list of sanctioned entitiesrequired.
D. For any Pharmaceuticals being procured:
(1) All Pharmaceuticals supplied shall be manufactured in accordance with Good Manufacturing Practice. Unless otherwise specifically stated in this BOA, the applicable Annex, or the Order, “Good Manufacturing Practice” shall be deemed to mean the standards manufacturing premises and guidance issued by the U.S. Food and Drug Administration (FDA), including without limitation the Current Good Manufacturing Regulations for Finished Pharmaceuticals (“GMP”) and the related regulations in 21 CFR Parts 210 and 211. If a waiver is approved and a different Stringent Drug Regulatory Authority’s standards are eligible for use in lieu of the aforementioned FDA standard/guidance, the alternative authority shall be specified in the BOA, the applicable Annex, or the Order (or as otherwise expressly agreed in writing by Chemonics). A stringent regulatory authority (SRA) is a drug regulatory authority that closely resembles FDA in the standards utilized in its operations. Currently, countries that participate in the International Conference on Harmonization (ICH) are considered as stringent regulatory authorities.
(2) If the Supplier is the manufacturer of Pharmaceuticals supplied under this BOA, as part of its compliance with the current GMP (or other applicable standards and guidance), the Supplier shall collect and retain representative samples of each lot or batch of Pharmaceuticals supplied in addition to the quantity listed in the Order. If the Supplier is not the Manufacturer, the Supplier shall ensure that the Manufacturer, as part of its compliance with the aforesaid standards or guidance, collects and retains representative samples of each lot or batch of Pharmaceuticals supplied. The Supplier shall also ensure that Chemonics and its designees if any are provided with reasonable access to the samples upon request.
(3) The premises storage locations used for manufacturing the Pharmaceuticals shall hold a all required current manufacturing license issued by the relevant Ministry of Health or other cognizant national drug regulatory authority, operating licenses and shall be open to visits from inspectors appointed by Chemonics.
(4) In addition, and without prejudice to the above, the Pharmaceuticals shall comply with the standards of the current edition (or the latest edition in which they are included) of the United States Pharmacopoeia (USP); or, if applicable, with another acceptable pharmacopoeia standard, e.g. the European Pharmacopoeia (EP), the British Pharmacopoeia (BP), or the British Pharmaceutical Codex (BPC). Where the USP gives no definition of the Pharmaceuticals and no other standards are specified, the Pharmaceuticals shall be manufactured in accordance with tested “in-house” formulations so as to be suitable for human medicineBuyer.
E. If the Order is for Plasters, Liquid Extracts or Ointments, Goods supplied shall be modified, where necessary, to render them suitable for use in the Cooperating Country(ies), but the specified proportion of the active ingredients must, in all cases, be maintained.
F. All Goods with a shelf life (such as test kits), including all Pharmaceuticals, must be freshly manufactured, and thus have maximum possible shelf life. Unless otherwise required in the Order, Goods with a maximum possible shelf life Shelf Life of less than twenty-four (24) or equal 24 months shall have at least 85% of shelf life Shelf Life remaining when deliveredthe packing has been completed, and goods are ready for inspection. Goods with a maximum possible shelf life Shelf Life of more than twenty- four (24) 24 months shall have at least twenty-four (24) 24 months, or 85%, of shelf life Shelf Life remaining whichever is longerwhen the packing has been completed, when deliveredand the goods are ready for inspection. No Goods will be accepted which do not comply with these the requirements unless Chemonics has agreed in writing to different requirements, in which case the Goods must strictly comply with those modified requirementsmentioned under this paragraph.
G. Notwithstanding any other provision of the BOA, Chemonics may:
(1) Prior to shipment of the Goods and the initiation of performance of any Related Services, by written notice to the Supplier, cancel in its entirety, or reduce the quantity(ies) of, any individual item(s) of the Goods without charge to Chemonics; and/or
(2) In the event that the USAID Contract with Chemonics is terminated by the Government in whole or in pertinent part prior to shipment to its delivery destination, return to the Supplier unused items or quantities of Delivered Goods.
H. If the BOA calls for performance of Related Services overseas by the Supplier’s employees or consultants (collectively, “personnel”), the Supplier shall comply with the following requirements:
(1) The Supplier shall notify Chemonics (sufficiently in advance to permit Chemonics to notify USAID and obtain its concurrence if needed) of any planned travel overseas by personnel in connection with performance of Related Services. Such notice shall include the number and names of the personnel participating, the proposed itinerary and logistics arrangements, and the Services to be provided, along with the information specified in AIDAR 752.7004, EMERGENCY LOCATOR INFORMATION.
(2) The Supplier shall ensure that its personnel, while in a Cooperating Country, abide by all applicable laws of the Cooperating Country and political subdivisions thereof.
(3) Other than work performed under the BOA for which personnel are assigned by the Supplier, the Supplier’s personnel shall not engage, directly or indirectly, either in their own name or in the name or through the agency of another person, in any business, profession or occupation in the Cooperating Country, nor shall they make loans or investments to or in any business, profession or occupation in the Cooperating Country, without Chemonics’ approval. This provision does not apply to personnel who are citizens or legal residents of the Cooperating Country.
(4) The Supplier shall obtain (a) worker’s compensation (Defense Base Act) insurance pursuant to FAR 52.228-3 and AIDAR 752.228-3, and (b) medical evacuation insurance for personnel travelling to a Cooperating Country in connection with this BOA.
(5) Personnel travelling on the Supplier’s behalf for performance of Related Services shall possess appropriate language skills, if any, stated in the BOA, and shall be physically fit in accordance with AIDAR 752.7033.
(6) In performing Related Services, the Supplier shall comply with USAID guidance, if any, relating to branding/marking of activities.
(7) FAR 52.246-4 INSPECTION OF SERVICES – FIXED PRICE (AUG 1996) shall apply to Related Services.
(8) All logistics support, visas, legal compliance matters and taxes in connection with its personnel overseas shall be the sole responsibility of the Supplier, as will all liability for the acts and omissions of the Supplier’s personnel performing the Related Services.
(9) Compensation for satisfactory performance of Related Services shall be paid upon completion thereof in compliance with the terms and conditions of the BOA, and solely in the form of the firm, fixed, all-inclusive prices.
(10) Notwithstanding any other provisions of the BOA no additional compensation or reimbursement will be provided to the Supplier for complying with these requirements concerning provision of Related Services.
Appears in 1 contract
Samples: Flexible Price Indefinite Delivery, Indefinite Quantity Agreement