Common use of Clinical Supply Clause in Contracts

Clinical Supply. Within the JSC the Parties shall decide whether CureVac should ensure Manufacture and supply to GSK of doses of Products required for use by GSK in accordance with this Agreement for the Clinical Studies or whether GSK in lieu of CureVac should Manufacture clinical materials on its own following a transfer of the CureVac Manufacturing Technology, or whether and how the Manufacturing capability of both Parties should be combined, such decision to be based on the respective Manufacturing capacities available as declared by the respective Party, the context of the respective clinical trial material portfolios and batches across all projects, and to be aligned with the Parties’ intention to ensure the Manufacture of Drug Product conforming to the required quality standards, the agreed specifications and the estimated timelines for Development of Products defined in the R&D Plans, and that supports the competitiveness of the Products. Where the Product for use in Clinical Studies is Manufactured by CureVac, its Affiliates and/or any CMO appointed by CureVac, one or more clinical supply agreement(s) and associated clinical Quality Agreement(s) will be negotiated and agreed between GSK and either or both CureVac, the CureVac Affiliate and/or CMO supplying the Products to GSK, and in accordance with the terms and conditions set forth in Exhibit 5.3(A) PART 2 ("Clinical Supply Agreement"). To the extent CureVac or its Affiliates Manufacture clinical trial material, CureVac and its Affiliates will reserve the required capacity for the Manufacture of Products for clinical supply in its GMP Manufacturing Facilities in accordance with the forecasts given under the supply agreement(s). In the event of a transfer of the CureVac Manufacturing Technology for clinical supply under this Section 5.3 (excluding the transfer to [*****]), such transfer shall only be made to GSK, and only to one site at GSK designated by GSK and approved by CureVac (which approval is hereby already given if GSK designates its vaccines manufacturing site in Wavre / Rixensart, Belgium), and GSK shall have no right to subsequently transfer the CureVac Manufacturing Technology to another GSK site or a Third Party without the prior written consent of CureVac. Unless otherwise provided herein, Section 5.5 below shall apply mutatis mutandis. The Parties acknowledge and agree that GSK has designated and CureVac has approved [*****] as a CMO of GSK for Manufacture and supply of doses of Products for Clinical Studies at the [*****] Facility as at the Fourth Amendment Effective Date. With respect to the transfer of the CureVac Manufacturing Technology to the [*****] Facility, CureVac and GSK each undertake to comply with their obligations, including in particular completing the technical and analytical transfer, in accordance with the plans agreed by the respective technical teams of the Parties, and each Party shall use reasonable efforts to complete the list of key deliverables and activities set out in Exhibit 5.3(B) by the dates specified. For the avoidance of doubt, following the transfer of the CureVac Manufacturing Technology to the [*****] Facility, [*****] shall have no right to subsequently transfer the CureVac Manufacturing Technology to another [*****] site. Without limiting Sections 8.1.1 and 8.1.2, GSK will compensate CureVac for any costs or expenses incurred by or on behalf of CureVac with respect to the technology transfer support provided by CureVac or its Affiliates under this Section 5.3 (with any FTE costs of CureVac and its Affiliates to be calculated at the FTE Rate); provided that with respect to the technology transfer to the [*****] Facility, CureVac hereby acknowledges that no compensation will be payable by GSK to CureVac for any costs or expenses incurred by or on behalf of CureVac before the completion of the technology transfer to the [*****] Facility (which ​ ​ ​ will be deemed to occur on [*****].

Clinical Supply. Within the JSC the Parties shall decide whether CureVac should ensure Manufacture and supply Aradigm agrees to GSK of doses of Products required provide for use by GSK the Parties such quantities of the AERx DEVICE, ACCESSORIES, DRUG PRODUCT and placebos (in AERx unit packets), required for conducting preclinical and clinical DEVELOPMENT, as the DEVELOPMENT COMMITTEE provides under the applicable DEVELOPMENT PLAN. Clinical supplies of the DRUG PRODUCT under DEVELOPMENT (and placebo if required) shall be formulated and packaged as determined by the DEVELOPMENT COMMITTEE for use with AERx DEVICE in the clinical trials to be conducted under this Agreement. The forecast of such DEVELOPMENT requirements for such PRODUCTS shall be contained within the relevant DEVELOPMENT PLAN, as updated in accordance with this Agreement Section 2.3. Aradigm shall use such forecasts and updates to prepare the manufacturing of such requirements of the PRODUCTS (and placebo) for preclinical and clinical use for the Clinical Studies or whether GSK in lieu of CureVac should Manufacture clinical materials on its own following a transfer next four (4) calendar quarters. Aradigm shall supply the quantities of the CureVac Manufacturing TechnologyAERx DEVICES, or whether ACCESSORIES, DRUG PRODUCTS and how the Manufacturing capability of both Parties should be combined, such decision to be based on the respective Manufacturing capacities available as declared by the respective Party, the context of the respective clinical trial material portfolios and batches across all projects, and to be aligned with the Parties’ intention to ensure the Manufacture of Drug Product conforming to the required quality standards, the agreed specifications and the estimated timelines for Development of Products defined in the R&D Plans, and that supports the competitiveness of the Products. Where the Product placebos for use in Clinical Studies is Manufactured by CureVacclinical trials at the delivery times outlined in the relevant DEVELOPMENT PLAN; provided, its Affiliates and/or any CMO appointed by CureVachowever, one or more clinical supply agreement(s) and associated clinical Quality Agreement(s) will be negotiated and agreed between GSK and either or both CureVac, that such delivery times are not less than [*] days after the CureVac Affiliate and/or CMO supplying most recent update of such requirements as outlined in the Products to GSK, and in accordance with the terms and conditions set forth in Exhibit 5.3(A) PART 2 ("Clinical Supply Agreement")relevant DEVELOPMENT PLAN. To the extent CureVac or possible, the DEVELOPMENT COMMITTEE shall use good faith efforts to ensure that each update of the DEVELOPMENT requirements in a particular DEVELOPMENT PLAN shall not deviate, with respect to any particular item, by more than [*] from the amount of such item forecasted to be required in the most recent previous forecast. Notwithstanding the foregoing, if unanticipated changes arise that result in an increase by more than [*] from the amount of such PRODUCT previously forecasted to be required, in the quantity requirements of AERx DEVICES, ACCESSORIES, DRUG PRODUCTS and/or placebos required for DEVELOPMENT under the applicable trial protocol, Aradigm will use DILIGENT EFFORTS to fulfill the requirements in excess of [*] of the forecasted requirements, subject to its Affiliates Manufacture clinical trial materialother business obligations. Shipment, CureVac delivery and its Affiliates will reserve the required capacity for the Manufacture acceptance of Products for clinical supply in its GMP Manufacturing Facilities AERx DEVICES, ACCESSORIES, DRUG PRODUCTS and placebos shall be in accordance with the forecasts given under the supply agreement(s)Sections 6.8 and 6.10 of this Agreement. In the event of a transfer of the CureVac Manufacturing Technology Reimbursement to Aradigm for clinical supply supplying PRODUCTS and placebos under this Section 5.3 (excluding the transfer to [*****]), such transfer 6.3 shall only be made to GSK, and only to one site at GSK designated by GSK and approved by CureVac (which approval is hereby already given if GSK designates its vaccines manufacturing site as provided in Wavre / Rixensart, Belgium), and GSK shall have no right to subsequently transfer the CureVac Manufacturing Technology to another GSK site or a Third Party without the prior written consent of CureVac. Unless otherwise provided herein, Section 5.5 below shall apply mutatis mutandis. The Parties acknowledge and agree that GSK has designated and CureVac has approved [*****] as a CMO of GSK for Manufacture and supply of doses of Products for Clinical Studies at the [*****] Facility as at the Fourth Amendment Effective Date. With respect to the transfer of the CureVac Manufacturing Technology to the [*****] Facility, CureVac and GSK each undertake to comply with their obligations, including in particular completing the technical and analytical transfer, in accordance with the plans agreed by the respective technical teams of the Parties, and each Party shall use reasonable efforts to complete the list of key deliverables and activities set out in Exhibit 5.3(B) by the dates specified. For the avoidance of doubt, following the transfer of the CureVac Manufacturing Technology to the [*****] Facility, [*****] shall have no right to subsequently transfer the CureVac Manufacturing Technology to another [*****] site. Without limiting Sections 8.1.1 and 8.1.2, GSK will compensate CureVac for any costs or expenses incurred by or on behalf of CureVac with respect to the technology transfer support provided by CureVac or its Affiliates under this Section 5.3 (with any FTE costs of CureVac and its Affiliates to be calculated at the FTE Rate); provided that with respect to the technology transfer to the [*****] Facility, CureVac hereby acknowledges that no compensation will be payable by GSK to CureVac for any costs or expenses incurred by or on behalf of CureVac before the completion of the technology transfer to the [*****] Facility (which ​ ​ ​ will be deemed to occur on [*****]7.1.

Clinical Supply. Within the JSC the Parties shall decide whether CureVac should ensure Manufacture and supply to GSK of doses of COVID Products required for use by GSK in accordance with this Agreement for the Clinical Studies or whether GSK, or a CMO appointed by GSK (and approved by CureVac), in lieu of CureVac should Manufacture clinical materials on its own following a transfer of the CureVac Manufacturing Technology, or whether and how the Manufacturing capability of both Parties should be combined, such decision to be based on the respective Manufacturing capacities available as declared by the respective Party, the context of the respective clinical trial material portfolios and batches across all projects, and to be aligned with the Parties’ ' intention to ensure the Manufacture of Drug Product conforming to the required quality standards, the agreed specifications and the estimated timelines for Development of COVID Products defined in the COVID R&D PlansPlan, and that supports the competitiveness of the COVID Products. Where the COVID Product for use in Clinical Studies is Manufactured by CureVac, its Affiliates and/or any CMO appointed by CureVac, one or more clinical supply agreement(s) and associated clinical Quality Agreement(s) will be negotiated and agreed between GSK and either or both CureVac, the CureVac Affiliate and/or CMO appointed by CureVac supplying the COVID Products to GSK, and in accordance with the terms and conditions set forth in Exhibit 5.3(A) PART 2 5.1 ("Clinical Supply Agreement"). To the extent CureVac or its Affiliates Manufacture clinical trial material, CureVac and its Affiliates will reserve the required capacity for the Manufacture of COVID Products for clinical supply in its GMP Manufacturing Facilities in accordance with the forecasts given under the supply agreement(s). In the event of a transfer of the CureVac Manufacturing Technology for clinical supply under this Section 5.3 5.1 (excluding the transfer to [*****]] in accordance with Section 5.4), such transfer shall only be made to GSK, and only to one site at GSK designated by GSK and approved by CureVac (which approval is hereby already given if GSK designates its vaccines manufacturing site in Wavre / Rixensart, Belgium)[*****], and GSK shall have no right to subsequently transfer the CureVac Manufacturing Technology to another GSK site or a Third Party without the prior written consent of CureVac. Unless otherwise provided herein, Section 5.5 5.4 below shall apply mutatis mutandis. The Parties acknowledge and agree that GSK has designated and CureVac has approved [*****] as a CMO of GSK for Manufacture and supply of doses of Products for Clinical Studies at the [*****] Facility as at the Fourth Amendment Effective Date. With respect to the transfer of the CureVac Manufacturing Technology to the [*****] Facility, CureVac and GSK each undertake to comply with their obligations, including in particular completing the technical and analytical transfer, in accordance with the plans agreed by the respective technical teams of the Parties, and each Party shall use reasonable efforts to complete the list of key deliverables and activities set out in Exhibit 5.3(B) by the dates specified. For the avoidance of doubt, following the transfer of the CureVac Manufacturing Technology to the [*****] Facility, [*****] shall have no right to subsequently transfer the CureVac Manufacturing Technology to another [*****] site. Without limiting Sections 8.1.1 and 8.1.2, GSK will compensate CureVac for any costs or expenses incurred by or on behalf of CureVac with respect to the technology transfer support provided by CureVac or its Affiliates under this Section 5.3 (with any FTE costs of CureVac and its Affiliates to be calculated at the FTE Rate); provided that with respect to the technology transfer to the [*****] Facility, CureVac hereby acknowledges that no compensation will be payable by GSK to CureVac for any costs or expenses incurred by or on behalf of CureVac before the completion of the technology transfer to the [*****] Facility (which ​ ​ ​ will be deemed to occur on [*****].

Clinical Supply. ​ Within the JSC the Parties shall decide whether CureVac should ensure Manufacture and supply to GSK of doses of COVID Products required for use by GSK in accordance with this Agreement for the Clinical Studies or whether GSK in lieu of CureVac should Manufacture clinical materials on its own following a transfer of the CureVac Manufacturing Technology, or whether and how the Manufacturing capability of both Parties should be combined, such decision to be based on the respective Manufacturing capacities available as declared by the respective Party, the context of the respective clinical trial material portfolios and batches across all projects, and to be aligned with the Parties’ intention to ensure the Manufacture of Drug Product conforming to the required quality standards, the agreed specifications and the estimated timelines for Development of COVID Products defined in the COVID R&D PlansPlan, and that supports the competitiveness of the COVID Products. Where the COVID Product for use in Clinical Studies is Manufactured by CureVac, its Affiliates and/or any CMO appointed by CureVacCMO, one or more clinical supply agreement(s) and associated clinical Quality Agreement(s) will be negotiated and agreed between GSK and either or both CureVac, the CureVac Affiliate and/or CMO supplying the COVID Products to GSK, and in accordance with the terms and conditions set forth in Exhibit 5.3(A) PART 2 5.1 ("“Clinical Supply Agreement"”). To the extent CureVac or its Affiliates Manufacture clinical trial material, CureVac and its Affiliates will reserve the required capacity for the Manufacture of COVID Products for clinical supply in its GMP Manufacturing Facilities in accordance with the forecasts given under the supply agreement(s). In the event of a transfer of the CureVac Manufacturing Technology for clinical supply under this Section 5.3 (excluding the transfer to [*****])5.1, such transfer shall only be made to GSK, and only to one site at GSK designated by GSK and approved by CureVac (which approval is hereby already given if GSK designates its vaccines manufacturing site in Wavre / Rixensart, Belgium[*****]), and GSK shall have no right to subsequently transfer the CureVac Manufacturing Technology to another GSK site or a Third Party without the prior written consent of CureVac. Unless otherwise provided herein, Section 5.5 5.4 below shall apply mutatis mutandis. The Parties acknowledge and agree that GSK has designated and CureVac has approved [*****] as a CMO of GSK for Manufacture and supply of doses of Products for Clinical Studies at the [*****] Facility as at the Fourth Amendment Effective Date. With respect to the transfer of the CureVac Manufacturing Technology to the [*****] Facility, CureVac and GSK each undertake to comply with their obligations, including in particular completing the technical and analytical transfer, in accordance with the plans agreed by the respective technical teams of the Parties, and each Party shall use reasonable efforts to complete the list of key deliverables and activities set out in Exhibit 5.3(B) by the dates specified. For the avoidance of doubt, following the transfer of the CureVac Manufacturing Technology to the [*****] Facility, [*****] shall have no right to subsequently transfer the CureVac Manufacturing Technology to another [*****] site. Without limiting Sections 8.1.1 and 8.1.2, GSK will compensate CureVac for any costs or expenses incurred by or on behalf of CureVac with respect to the technology transfer support provided by CureVac or its Affiliates under this Section 5.3 (with any FTE costs of CureVac and its Affiliates to be calculated at the FTE Rate); provided that with respect to the technology transfer to the [*****] Facility, CureVac hereby acknowledges that no compensation will be payable by GSK to CureVac for any costs or expenses incurred by or on behalf of CureVac before the completion of the technology transfer to the [*****] Facility (which ​ ​ ​ will be deemed to occur on [*****].​