Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke will receive an introduction to the mRNA technology training provided by Afrigen. WHO will engage with the Spoke to discuss requirements for investments and workforce development to enable readiness at the Spoke Facilities to receive the Technology Transfer. In addition, WHO will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by Spoke. The Technology Transfer will be offered as sequential packages described in Annex 3: I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released. II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing. III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”). 2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan. 2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to Spoke, as follows: (a) Training at Afrigen’s site by sending qualified Spoke personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics. (b) Training on-site as described in Section 2.3(a) will be for a period of no more than five consecutive Business Days. (c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training. (d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke Facility, additional on-site training at Afrigen) be requested by Spoke beyond Sections 2.3(a)-(c), Spoke shall bear all allowance, travel and accommodation expenses incurred. 2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke will be provided, as follows: (a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke and until Technology Transfer completion. (b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke or at Afrigen Facility) be requested by Spoke beyond Section 2.4(a), Spoke might have to bear all allowance, travel and accommodation expenses incurred. 2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
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Samples: Mrna Vaccine Technology Transfer Agreement, Mrna Vaccine Technology Transfer Agreement, Mrna Vaccine Technology Transfer Agreement
Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke [XXX] will receive an introduction to the mRNA technology training provided by Afrigen. WHO will engage with the Spoke [XXX] to discuss requirements for investments and workforce development to enable readiness at the Spoke [XXX] Facilities to receive the Technology Transfer. In addition, WHO will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by Spoke[XXX]. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke [XXX] has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to Spoke[XXX], as follows:
(a) Training at Afrigen’s site by sending qualified Spoke [XXX] personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
. (d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke [XXX] Facility, additional on-site training at Afrigen) be requested by Spoke [XXX] beyond Sections 2.3(a)-(c), Spoke [XXX] shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke [XXX] will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke [XXX] and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke [XXX] or at Afrigen Facility) be requested by Spoke [XXX] beyond Section 2.4(a), Spoke [XXX] might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke BVNL will receive an introduction to the mRNA technology training provided by Afrigen. WHO will engage with the Spoke BVNL to discuss requirements for investments and workforce development to enable readiness at the Spoke BVNL Facilities to receive the Technology Transfer. In addition, WHO will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by SpokeBVNL. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke BVNL has received confirmed reception of the Technology in writing, and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeBVNL, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke BVNL personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five consecutive Business Days.
(c) Respond Responding in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should MPP will further consider any BVNL requests for additional on-site Technical Assistance (e.g. e.g., on-site assistance of Afrigen personnel at the Spoke FacilityBVNL facility, additional on-site training at Afrigen) be ), taking into account the availability of MPP’s and Afrigen’s capacity and resources provided that if such requested by Spoke assistance is beyond Sections 2.3(a)-(c), Spoke and provided that BVNL shall bear all allowance, travel and accommodation expenses incurredincurred for such additional services.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke BVNL will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke BVNL and until Technology Transfer completion.
(b) Should MPP will further consider any BVNL requests for additional on-site Technical Assistance or training (e.g. e.g., on-site assistance of Afrigen personnel at Spoke or the BVNL facility, additional on-site training at Afrigen Facility) be Afrigen), taking into account the availability of MPP’s and Afrigen’s capacity and resources provided that if such requested by Spoke assistance is beyond Section Sections 2.4(a), Spoke might have to and provided that BVNL shall bear all allowance, travel and accommodation expenses incurredincurred for such additional services.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke TORLAK will receive an introduction to the mRNA technology training provided by AfrigenAfrigen and associated training material (Introduction to the mRNA Technology Package). WHO will engage with the Spoke TORLAK to discuss requirements for investments and workforce development to enable readiness at the Spoke TORLAK Facilities to receive the Technology Transfer. In addition, WHO and MPP will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by Spoke. The Technology Transfer will be offered as sequential packages described in Annex 3:TORLAK.
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.industrial
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Authorization Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is are made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke XXXXXX has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeTORLAK, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke TORLAK personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five ten consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke FacilityTORLAK facility, additional on-site training at Afrigen) be requested by Spoke TORLAK beyond Sections 2.3(a)-(c), Spoke TORLAK shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke TORLAK will be provided, as follows:
(a) Responding in a reasonable timeframe five (5) Business Days, unless otherwise agreed between the Parties, to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke TORLAK and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke TORLAK or at Afrigen Facility) be requested by Spoke TORLAK beyond Section 2.4(a), Spoke TORLAK might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
3.1 Work with WHO to assess TORLAK capabilities and identify actions and deliverables for the Technology Transfer to TORLAK to proceed, as well as to convene appropriate expertise to support Technology Transfer to TORLAK, as feasible and may be necessary.
3.2 Ensure TORLAK is provided with the Technology reasonably necessary to fulfil the transfer of Technology Transfer Package 1, Technology Transfer Package 2 and Technology Transfer Package 3 as contemplated in Annexes 1 and 3 herein.
3.3 Work with WHO to facilitate the strengthening of the Relevant Regulatory Authority as may be required in TORLAK territory(ies) to enable Regulatory Approval of the vaccine and facilitate WHO pre-qualification.
3.4 Provide IP analysis on the Technology, as practicable and appropriate.
3.5 Monitor the activities of TORLAK and the parties to other Programme Agreements to ensure good coordination and facilitate the sharing of data, Know-How and IP as provided for in this Agreement and other Programme Agreements within the agreed timeframes.
3.6 Provide TORLAK with the Grant (as defined below) in accordance with Section 6 of this Agreement.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke IPD will receive an introduction to the mRNA technology training provided by Afrigen. WHO will engage with the Spoke IPD to discuss requirements for investments and workforce development to enable readiness at the Spoke IPD Facilities to receive the Technology Transfer. In addition, WHO will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by SpokeIPD. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can will be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke IPD has received the Technology (and any other relevant IP) and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeIPD, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke IPD personnel to the Afrigen Facility site for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke IPD Facility, and additional on-site training at Afrigen) be requested by Spoke IPD beyond Sections 2.3(a)-(c2.3(a)-2.3(c), Spoke IPD shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke IPD will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke IPD and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke IPD or at Afrigen Facilitysite) be requested by Spoke IPD beyond Section 2.4(a), Spoke IPD might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. (e.g. assist in data analysis, non-routine investigations), be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke IPD will receive an introduction to the mRNA technology training provided by AfrigenAfrigen and associated training material (Introduction to the mRNA Technology Package). WHO will engage with the Spoke IPD to discuss requirements for investments and workforce development to enable readiness at the Spoke IPD Facilities to receive the Technology Transfer. In addition, WHO and MPP will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by SpokeIPD. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can will be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke IPD has received the Technology (and any other relevant IP) and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeIPD, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke IPD personnel to the Afrigen Facility site for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five ten consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke IPD Facility, and additional on-site training at Afrigen) be requested by Spoke IPD beyond Sections 2.3(a)-(c2.3(a)-2.3(c), Spoke IPD shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke or at Afrigen Facility) be requested by Spoke beyond Section 2.4(a), Spoke might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
Appears in 1 contract
Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke Sinergium will receive an introduction to the mRNA technology training provided by AfrigenAfrigen and associated training material (Introduction to the mRNA Technology Package). WHO and/or PAHO will engage with the Spoke Sinergium to discuss requirements for investments and workforce development to enable readiness at the Spoke Sinergium Facilities to receive the Technology Transfer. In addition, WHO and/or PAHO and MPP will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by SpokeSinergium. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is are made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke Xxxxxxxxx has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeSinergium, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke Sinergium personnel to the Afrigen Facility site for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be initially for a period of no more than five ten consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke Sinergium Facility, and additional on-site training at Afrigen) be requested by Spoke Sinergium beyond Sections 2.3(a)-(c), Spoke Sinergium shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke Sinergium will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke Sinergium and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke Sinergium or at Afrigen Facilitysite) be requested by Spoke Sinergium beyond Section 2.4(a), Spoke Sinergium might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises (i.e. assist in data analysis, non-routine investigations), be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
Appears in 1 contract
Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram roadmap as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke will receive an introduction to the mRNA technology training provided by Afrigen. WHO will engage with the Spoke to discuss requirements for investments and workforce development to enable readiness at the Spoke Facilities to receive the Technology Transfer. In addition, WHO will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by Spoke. The Technology Transfer to Biovac will be offered comprise of Technology Transfer Package 1, as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) ), which will be made accessible finalized once Phase 1 Clinical trial material is manufactured and released.
II. Content of Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) 1 will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible to Biovac as soon as the manufacturing process information is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submittedavailable. The Parties will meet and confer following the Effective Date to agree on a workplan Technology Transfer Plan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 31, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “WorkplanTechnology Transfer Plan”). Before Technical Transfer activities take place, Biovac will access an introduction to the mRNA technology training provided by Afrigen (timelines to be agreed upon between the Parties) and associated training material (Introduction to the mRNA Technology Package).
2.2 Each The Parties acknowledge that the timelines agreed in a Technology Transfer Plan are of paramount importance for planning purposes. In the event that the agreed timelines of any section of a Technology Transfer Plan changes after being agreed between the Parties, for any reason whatsoever including an Event of Force Majeure, the Parties agree to meet and discuss the potential changes and how it can be accommodated within any commercial obligations or other commitments which a Party may have towards a Third Party. While every reasonable effort will be made to accommodate changes to agreed timelines, the Parties agree and acknowledge that this cannot be guaranteed. If any amended timelines cannot be met by either Party, the Parties undertake to apply commercially reasonable efforts to continue the Project on amended timelines as soon as feasible.
2.3 The Technology Transfer Package 1 shall be considered complete by the Parties when Spoke Biovac has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the WorkplanTechnology Transfer Plan.
2.3 2.4 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeBiovac, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke Biovac personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(dc) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke Biovac Facility, additional on-site training at Afrigen) be requested by Spoke Biovac beyond Sections 2.3(a)-(c2.4(a)-(b), Spoke Biovac shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke or at Afrigen Facility) be requested by Spoke beyond Section 2.4(a), Spoke might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof. MPP undertakes to:
3.1 Work with WHO to assess Biovac capabilities and identify actions and deliverables for the Technology Transfer to Biovac to proceed, as well as to convene appropriate expertise to support Technology Transfer to Biovac, as feasible and may be necessary.
3.2 Ensure Biovac is provided with the Technology reasonably necessary to fulfil the transfer of Technology Transfer Package 1, as contemplated in Annexes 1 and 3 herein.
3.3 Work with WHO to facilitate the strengthening of the Relevant Regulatory Authority as may be required in the Territory to enable Regulatory Approval of the vaccine and facilitate WHO pre- qualification.
3.4 Provide IP analysis on the Technology, as practicable and appropriate and endeavour to provide better visibility on freedom to operate analyses in the Territory.
3.5 Monitor the activities of Biovac and the parties to other Programme Agreements to ensure good coordination and facilitate the sharing of data, Know-How and IP as provided for in this Agreement and other Programme Agreements.
3.6 In consultation with WHO, design and draft any further governance or technology transfer documents and provide on-going technical support as necessary and as feasible to fulfil the objectives of the Agreement within the agreed timeframes.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke IPT will receive an introduction to the mRNA technology training provided by AfrigenAfrigen and associated training material (Introduction to the mRNA Technology Package). WHO will engage with the Spoke IPT to discuss requirements for investments and workforce development to enable readiness at the Spoke IPT Facilities to receive the Technology Transfer. In addition, WHO and MPP will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by Spoke. The Technology Transfer will be offered as sequential packages described in Annex 3:IPT.
I. (a) Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. (b) Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. (c) Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke IPT has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeIPT, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke IPT personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five ten consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke IPT Facility, additional on-site training at Afrigen) be requested by Spoke IPT beyond Sections 2.3(a)-(c), Spoke IPT shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke IPT will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke IPT and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke IPT or at Afrigen Facility) be requested by Spoke IPT beyond Section 2.4(a), Spoke IPT might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke IPT will receive an introduction to the mRNA technology training provided by Afrigen. WHO will engage with the Spoke IPT to discuss requirements for investments and workforce development to enable readiness at the Spoke IPT Facilities to receive the Technology Transfer. In addition, WHO will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by SpokeIPT. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke IPT has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeIPT, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke IPT personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke IPT Facility, additional on-site training at Afrigen) be requested by Spoke IPT beyond Sections 2.3(a)-(c), Spoke IPT shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke IPT will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke IPT and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke IPT or at Afrigen Facility) be requested by Spoke IPT beyond Section 2.4(a), Spoke IPT might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke BGP will receive an introduction to the mRNA technology training provided by AfrigenAfrigen and associated training material (Introduction to the mRNA Technology Package). WHO will engage with the Spoke BGP to discuss requirements for investments and workforce development to enable readiness at the Spoke BGP Facilities to receive the Technology Transfer. In addition, WHO and MPP will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by SpokeBGP. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke BGP has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeBGP, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke BGP personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five ten consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke BGP Facility, additional on-site training at Afrigen) be requested by Spoke BGP beyond Sections 2.3(a)-(c), Spoke BGP shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke BGP will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke BGP and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke BGP or at Afrigen Facility) be requested by Spoke BGP beyond Section 2.4(a), Spoke BGP might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof. MPP undertakes to:
3.1 Work with WHO to assess BGP capabilities and identify actions and deliverables for the Technology Transfer to BGP to proceed, as well as to convene appropriate expertise to support Technology Transfer to BGP, as feasible and may be necessary.
3.2 Ensure BGP is provided with the Technology reasonably necessary to fulfil the transfer of Technology Transfer Package 1, Technology Transfer Package 2 and Technology Transfer Package 3 as contemplated in Annexes 1 and 3 herein.
3.3 Work with WHO to facilitate the strengthening of the Relevant Regulatory Authority as may be required in BGP territory(ies) to enable Regulatory Approval of the vaccine and facilitate WHO pre-qualification.
3.4 Provide IP analysis on the Technology, as practicable and appropriate.
3.5 Monitor the activities of BGP and the parties to other Programme Agreements to ensure good coordination and facilitate the sharing of data, Know-How and IP as provided for in this Agreement and other Programme Agreements within the agreed timeframes.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke will receive an introduction to the mRNA technology training provided by Afrigen. WHO will engage with the Spoke to discuss requirements for investments and workforce development to enable readiness at the Spoke Facilities to receive the Technology Transfer. In addition, WHO will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by Spoke. The Technology Transfer to Biovac will be offered comprise of Technology Transfer Package 1, as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) ), which will be made accessible finalized once Phase 1 Clinical trial material is manufactured and released.
II. Content of Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) 1 will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible to Biovac as soon as the manufacturing process is scaled up at industrial scale and analytical methods information are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submittedavailable. The Parties will meet and confer following the Effective Date to agree on a workplan Technology Transfer Plan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 31, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “WorkplanTechnology Transfer Plan”). Before Technical Transfer activities take place, Biovac will access an introduction to the mRNA technology training provided by Afrigen (timelines to be agreed upon between the Parties).
2.2 Each The Parties acknowledge that the timelines agreed in a Technology Transfer Plan are of paramount importance for planning purposes. In the event that the agreed timelines of any section of a Technology Transfer Plan changes after being agreed between the Parties, for any reason whatsoever including an Event of Force Majeure, the Parties agree to meet and discuss the potential changes and how it can be accommodated within any commercial obligations or other commitments which a Party may have towards a Third Party. While every reasonable effort will be made to accommodate changes to agreed timelines, the Parties agree and acknowledge that this cannot be guaranteed. If any amended timelines cannot be met by either Party, the Parties undertake to apply commercially reasonable efforts to continue the Project on amended timelines as soon as feasible.
2.3 The Technology Transfer Package 1 shall be considered complete by the Parties when Spoke Biovac has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the WorkplanTechnology Transfer Plan.
2.3 2.4 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeBiovac, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke Biovac personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(dc) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke Biovac Facility, additional on-site training at Afrigen) be requested by Spoke Biovac beyond Sections 2.3(a)-(c2.4(a)-(b), Spoke Biovac shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke or at Afrigen Facility) be requested by Spoke beyond Section 2.4(a), Spoke might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
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Technology Transfer. 2.1 MPP will cause the Technology Transfer to be conducted in accordance with the chronogram as described in Annex 1. Prior to Technology Transfer activities taking place, the Spoke INCEPTA will receive an introduction to the mRNA technology training provided by AfrigenAfrigen and associated training material (Introduction to the mRNA Technology Package). WHO will engage with the Spoke INCEPTA to discuss requirements for investments and workforce development to enable readiness at the Spoke INCEPTA Facilities to receive the Technology Transfer. In addition, WHO and MPP will facilitate access to dedicated biomanufacturing trainings (manufacturing/good manufacturing practice base training) and appropriate tools to allow informed decisions to be taken by SpokeINCEPTA. The Technology Transfer will be offered as sequential packages described in Annex 3:
I. Technology Transfer Package 1, called “mRNA technology for R&D” (hands-on and mandatory) will be made accessible once Phase 1 Clinical trial material is manufactured and released.
II. Technology Transfer Package 2, called “mRNA technology industrial scale process” – industrial implementation (including analytics validated) will be made accessible once the manufacturing process is validated. An Interim Technology Transfer Package 2a, called “mRNA technology scaled-up process (including analytics) – non-validated” can be made accessible as soon as the manufacturing process is scaled up at industrial scale and analytical methods are assessed for industrial testing.
III. Technology Transfer Package 3, called “mRNA technology industrial scale process” – Marketing Authorisation Application (“MAA”) dossier (including MAA submission package and Clinical trial Phase III results) will be made accessible once the Phase III clinical trial results is made available and the complete MAA dossier submitted. The Parties will meet and confer following the Effective Date to agree on a workplan setting out the timeline for the delivery of the Technical Transfer Packages and specific access to Technology Transfer Package 2 (and Interim Technology Transfer Package 2a) and Technology Transfer Package 3, as well as detailing actions, reporting, deliverables, and success criteria linked to the Technology Transfer (the “Workplan”).
2.2 Each Technology Transfer Package shall be considered complete by the Parties when Spoke INCEPTA has received the Technology and the Parties are satisfied that the production of the selected mRNA vaccine candidate meets the requirements outlined in the Workplan.
2.3 As part of Technology Transfer Package 1, MPP will, on dates to be agreed to by the Parties, cause Afrigen to provide Technical Assistance to SpokeINCEPTA, as follows:
(a) Training at Afrigen’s site by sending qualified Spoke INCEPTA personnel to the Afrigen Facility for training on documentation and Phase I manufacturing process and analytics.
(b) Training on-site as described in Section 2.3(a) will be for a period of no more than five ten consecutive Business Days.
(c) Respond in a reasonable timeframe to any query concerning the Technology Transfer Package 1 that might arise during and after the on-site training.
(d) Should any additional on-site Technical Assistance (e.g. on-site assistance of Afrigen personnel at the Spoke INCEPTA Facility, additional on-site training at Afrigen) be requested by Spoke INCEPTA beyond Sections 2.3(a)-(c), Spoke INCEPTA shall bear all allowance, travel and accommodation expenses incurred.
2.4 As part of the Technology Transfer Package 2, Technical Assistance to Spoke INCEPTA will be provided, as follows:
(a) Responding in a reasonable timeframe to any query concerning the Technology Transfer Package that might arise after the relevant Technical Information is shared with Spoke INCEPTA and until Technology Transfer completion.
(b) Should any additional Technical Assistance or training (e.g. on-site assistance at Spoke INCEPTA or at Afrigen Facility) be requested by Spoke INCEPTA beyond Section 2.4(a), Spoke INCEPTA might have to bear all allowance, travel and accommodation expenses incurred.
2.5 Any additional services associated therewith and the means of delivery thereof not provided for in this Agreement shall, as the need for same arises i.e. assist in data analysis, non-routine investigations, be negotiated for and agreed to by the Parties in writing, prior to implementation thereof.
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