Common use of Conditions of Supply Clause in Contracts

Conditions of Supply. General conditions GDF procures only quality assured medicines. All medicines and commodities shall be provided to patients free of charge. Standard production lead times are 4-6 months after receipt of funds. No approval from Green Light Committee, either global or regional, is needed. However, GDF may provide a copy of this document to the responsible regional or global Green Light Committee(s) for their advice; this is particularly relevant for Global Fund supported procurements. Procurement processes WHO/GDF works with procurement agent(s) (PA) to coordinate the purchasing and logistics of WHO/GDF order(s) under this MPTA (MDR-TB Procurement Request Form and Technical Agreement). The execution of this MPTA can be initiated only after signing of a commercial contract between the PA and the Client and receipt of the prepayment of funds by PA, or as agreed in writing between the PA and the Client. The Client will be responsible for payment or obtaining waiver of any applicable duties, any import requirements, as well as to facilitate product registration in cooperation with manufacturers or obtaining relevant waivers, in-country storage, distribution and monitoring of all supplies, unless otherwise agreed with the PA and/or WHO/GDF The Client understands the importance of quality medicines. Applicants submitting a MPTA for partial regimens understand that it is their direct responsibility to ensure that other medicines provided are of assured quality and they are fully accountable for the care of their patients. In the case of Global Fund supported procurements, prior written agreement of the Global Fund is required if the funds are to support partial regimens. Monitoring and technical assistance WHO/GDF reserves the right to conduct monitoring mission(s) by an independent technical agency on the use of medicines and related commodities delivered under this document. The Client agrees to interact with experts which WHO/GDF may notify and from which WHO/GDF may request assessments, such as but not limited to WHO Regional TB Advisors, regional Green Light Committee (rGLC) representatives, WHO Regional Supply Officers and Country Supply Officers. The assessment report will be shared with the Client. The Parties may also consult on and mutually agree on implementation of technical assistance on MDR-TB medicines management. Special provisions Any serious adverse effects that come to the Client’s attention and that may be related to the use of the medicines are to be reported to the national pharmacovigilance centre or, in the absence of a national pharmacovigilance centre, to the national medicines regulatory authority in a timely manner in accordance with local legislation or other applicable requirements. If the Client does not represent an established international NGO, publicly known to be active in MDR-TB patient treatment (PIH, MSF, International HIV/AIDS Alliance or similar), a UN organization or the government entity in tuberculosis related affairs of the respective country, the Client needs to provide a letter of endorsement from the National TB Program or similar entity. In case this cannot be provided, the Client needs to submit relevant explanation to allow for GDF decision on this procurement. In submitting the letter or explanation, the Client agrees that GDF may contact its Partners for additional information without further consent by the Client. In case specific off label medicines for MDR-TB treatment are requested according to WHO treatment guidelines, such as Group 5 drugs, GDF might request Client to sign specific liability waiver which needs to be submitted before the supply of these products can commence. In case of request for Bedaquiline, and according to the WHO Interim Policy Guidance on Bedaquiline1, the drug may be used as part of an MDR-TB treatment regimen provided the following five conditions are met: Treatment administered under closely monitored conditions Proper patient inclusion Patients informed consent obtained Adherence to principles of designing a WHO- recommended MDR-TB regimen Pharmacovigilance and proper management of AEs and prevention of drug-drug interactions

Conditions of Supply. General conditions GDF procures only quality assured medicines. All medicines and commodities shall be provided to patients free of charge. Standard production lead times are 4-6 months after receipt of funds. No approval from Green Light Committee, either global or regional, is needed. However, GDF may provide a copy of this document to the responsible regional or global Green Light Committee(s) for their advice; this is particularly relevant for Global Fund supported procurements. Procurement processes WHO/GDF works with procurement agent(s) (PA) to coordinate the purchasing and logistics of WHO/GDF order(s) under this MPTA (MDR-TB Procurement Request Form and Technical Agreement). The execution of this MPTA can be initiated only after signing of a commercial contract between the PA and the Client and receipt of the prepayment of funds by PA, or as agreed in writing between the PA and the Client. The Client will be responsible for payment or obtaining waiver of any applicable duties, any import requirements, as well as to facilitate product registration in cooperation with manufacturers or obtaining relevant waivers, in-country storage, distribution and monitoring of all supplies, unless otherwise agreed with the PA and/or WHO/GDF The Client understands the importance of quality medicines. Applicants submitting a MPTA for partial regimens understand that it is their direct responsibility to ensure that other medicines provided are of assured quality and they are fully accountable for the care of their patients. In the case of Global Fund supported procurements, prior written agreement of the Global Fund is required if the funds are to support partial regimens. Monitoring and technical assistance WHO/GDF reserves the right to conduct monitoring mission(s) by an independent technical agency on the use of medicines and related commodities delivered under this document. The Client agrees to interact with experts which WHO/GDF may notify and from which WHO/GDF may request assessments, such as but not limited to WHO Regional TB Advisors, regional Green Light Committee (rGLC) representatives, WHO Regional Supply Officers and Country Supply Officers. The assessment report will be shared with the Client. The Parties may also consult on and mutually agree on implementation of technical assistance on MDR-TB medicines management. Special provisions Any serious adverse effects that come to the Client’s attention and that may be related to the use of the medicines are to be reported to the national pharmacovigilance centre or, in the absence of a national pharmacovigilance centre, to the national medicines regulatory authority in a timely manner in accordance with local legislation or other applicable requirements. If the Client does not represent an established international NGO, publicly known to be active in MDR-TB patient treatment (PIH, MSF, International HIV/AIDS Alliance or similar), a UN organization or the government entity in tuberculosis related affairs of the respective country, the Client needs to provide a letter of endorsement from the National TB Program or similar entity. In case this cannot be provided, the Client needs to submit relevant explanation to allow for GDF decision on this procurement. In submitting the letter or explanation, the Client agrees that GDF may contact its Partners for additional information without further consent by the Client. In case specific off label medicines for MDR-TB treatment are requested according to WHO treatment guidelines, such as Group 5 drugs, GDF might request Client to sign specific liability waiver which needs to be submitted before the supply of these products can commence. In case of request for BedaquilineXxxxxxxxxxx, and according to the WHO Interim Policy Guidance on Bedaquiline1, the drug may be used as part of an MDR-TB treatment regimen provided the following five conditions are met: Treatment administered under closely monitored conditions Proper patient inclusion Patients informed consent obtained Adherence to principles of designing a WHO- recommended MDR-TB regimen Pharmacovigilance and proper management of AEs and prevention of drug-drug interactions

Conditions of Supply. General conditions GDF procures only quality assured medicines. All medicines and commodities shall be provided to patients free of charge. Standard production lead times are 4-6 months after receipt of funds. No approval from Green Light Committee, either global or regional, is needed. However, GDF may provide a copy of this document to the responsible regional or global Green Light Committee(s) for their advice; this is particularly relevant for Global Fund supported procurementsinformation. Procurement processes WHO/GDF works with procurement agent(s) (PA) to coordinate the purchasing and logistics of WHO/GDF order(s) under this MPTA (MDR-TB Procurement Request Form and Technical Agreement). The execution of this MPTA can be initiated only after signing of a commercial contract an agreement between the PA and the Client and receipt of the prepayment of funds by PA, or as agreed in writing between the PA and the Client. The Client will be responsible for payment or obtaining waiver of any applicable duties, any import requirements, as well as to facilitate product registration in cooperation with manufacturers or obtaining relevant waivers, in-country storage, distribution and monitoring of all supplies, unless otherwise agreed with the PA and/or WHO/GDF The Client understands the importance of quality medicines. Applicants submitting a MPTA for partial regimens regimen deliveries understand that it is their direct responsibility to ensure that other medicines provided are of assured quality and they are fully accountable for the care of their patients. In the case of Global Fund supported procurements, prior written agreement of the Global Fund is required if the funds are to support partial regimens. Monitoring and technical assistance WHO/GDF reserves the right to conduct monitoring mission(s) by an independent technical agency on the use of medicines and related commodities delivered under this document. The Client agrees to interact with experts which WHO/GDF may notify and from which WHO/GDF may request assessments, such as but not limited to WHO Regional TB Advisors, regional Green Light Committee (rGLC) representatives, WHO Regional Supply Officers and Country national Supply Officers. The assessment report will be shared with the Client. The Parties may also consult on and mutually agree on implementation of technical assistance on MDR-TB medicines management. Special provisions Any serious adverse effects that come to the Client’s attention and that may be related to the use of the medicines are to be reported to the national pharmacovigilance centre or, in the absence of a national pharmacovigilance centre, to the national medicines regulatory authority in a timely manner in accordance with local legislation or other applicable requirements. If the Client does not represent an established international NGO, publicly known to be active in MDR-TB patient treatment (PIH, MSF, International HIV/AIDS Alliance or similar), a UN organization or the government entity in tuberculosis related affairs of the respective country, the Client needs to provide a letter of endorsement from the National TB Program or similar entity. In case this cannot be provided, the Client needs to submit relevant explanation to allow for GDF decision on this procurement. In submitting the letter or explanation, the Client agrees that GDF may contact its Partners for additional information without further consent by the Client. In case specific off label medicines for MDR-TB treatment are requested according to WHO treatment guidelines, such as Group 5 drugs, GDF might request Client to sign specific liability waiver which needs to be submitted before the supply of these products can commence. In case of request for Bedaquiline, and according to the WHO Interim Policy Guidance on Bedaquiline1, the drug may be used as part of an MDR-TB treatment regimen provided the following five conditions are met: Treatment administered under closely monitored conditions Proper patient inclusion Patients informed consent obtained Adherence to principles of designing a WHO- recommended MDR-TB regimen Pharmacovigilance and proper management of AEs and prevention of drug-drug interactions.