Provision Language
Definitions
“CureVac Know-How” shall mean (i) all Know-How within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date or during the Term that is necessary or useful for the Parties to Develop, Manufacture and/or Commercialize COVID Products under this Agreement, provided that (x) with respect to Know-How within the CureVac Background Technology owned by a Third Party that is not necessary to ensure freedom to operate for the Development, Manufacture and/or Commercialization of COVID Products in the Field in the Territory and that comes under CureVac’s Control, this shall only include Know-How which is deemed CureVac Know-How pursuant to Section2.8.1; and (y) this shall not include the Know-How of any Third Party (or such Third Party’s Affiliates) that becomes anAffiliate of CureVac after the Effective Date solely as a result of a Change of Control in CureVac; and (ii) all Know–HowControlled by CureVac or its Affiliates arising or generated in connection with the performance of activities under thisAgreement; provided, however, that CureVac Know-How does not include Know-How related to (A) LNP Technology Controlled by a Third Party; and (B) [*****]. CureVac Know-How shall include (i) Know-How comprised in the CureVac Background Technology; and (ii) Know-How related to CureVac Inventions, CureVac’s share in Joint Product Inventions or Joint Other Inventions, (iii) subject to Section 7.3, Know-How related to LNP technology owned or Controlled byCureVac (other than the Licensed LNP), (iv) subject to Section 7.3, Know-How related to CVCMs; and (v) other Know-How generated by CureVac under this Agreement. Without limiting Section 9.1, the CureVac Know-How existing at theEffective Date is further described in Exhibit 1.50.
“CureVac Manufacturing Technology” shall mean CureVac Patent Rights and CureVac Know-How that are required for the Manufacture of COVID Products.
“CureVac Patent Right(s)” shall mean (i) all Patent Rights within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date or during the Term that are necessary or useful for the Development, Manufacture and/or Commercialization of COVID Products under this Agreement, provided that (x) with respect to Patent Rights within the CureVac Background Technology owned by a Third Party that are not necessary to ensure freedom to operate for the Development, Manufacture and/or Commercialization of COVID Products in the Field in the Territory and that come under CureVac’s Control after the Effective Date, this shall only include Patent Rights which are deemed CureVac Patent Rights pursuant to Section 2.8.1; and (y) this shall not include the Patent Rights of any Third Party (or such Third Party’s Affiliates) that becomes an Affiliate of CureVac solely as a result of a Change of Control in CureVac, and (ii) all CureVac Program Patent Right and CureVac’s interest in Joint Patent Rights; provided, however, that CureVac Patent Rights do not include Patent Rights within [*****]. CureVac Patent Rights shall include (i) Patent Rights comprised in the CureVac Background Technology; and (ii) CureVac’s share in Joint Patent Rights, (iii) CureVac Program Patent Rights; (iv) subject to Section 7.3, Patent Rights related to the LNP technology owned or Controlled by CureVac (other than the Licensed LNP) and CVCMs. The CureVac Patent Rights within the CureVac Background Technology Controlled by CureVac or its Affiliates as at the Effective Date are listed in Exhibit 1.55.
“Development Data” shall mean: (i) CMC Development data (including records of Manufactured batches); (ii) any non–clinical or clinical findings, results and other research data relating to the COVID Products, in any format; and (iii) the formal reports of preclinical toxicology studies and Clinical Studies, such data in each case of (i), (ii) and (iii) required for the Development, Manufacture or Commercialization of the COVID Products, including but not limited to, INDs and other regulatory filings and registration dossiers.
4. Development Collaboration
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4.6 Materials. CureVac will provide GSK with any CureVac Materials required for the Development under the COVID R&D Plan, including those which comprise, embody or incorporate CureVac Background Technology. Without limiting the foregoing, this shall be carried out in accordance with the respective COVID R&D Plan. GSK will provide CureVac with any GSK Materials required for the Development under the COVID R&D Plan, including those which comprise, embody or incorporate GSK Background Technology. Without limiting the foregoing, this shall be carried out in accordance with the COVID R&D Plan. GSK will use the CureVac Materials and CureVac will use the GSK Materials, as applicable: (i) only in accordance with the terms and conditions of this Agreement; (ii) not in human subjects, in clinical trials, or for diagnostic purposes involving human subjects, or for any animal studies, except as expressly provided for in the COVID R&D Plan; and (iii) not reverse engineer or chemically analyze the same except as expressly provided for (if at all) in the COVID R&D Plan. The Materials will remain the sole property of the Party supplying them and will be used by the recipient Party in compliance with all Applicable Laws and only to perform activities set forth in the COVID R&D Plan. The receiving Party shall not sell, transfer, disclose or otherwise provide access to the other Party’s Materials without the written consent of the providing Party, except that the receiving Party may allow access to the other Party’s Materials to its and its Affiliates’ employees, officers, consultants, subcontractors and Sublicensees who require such access to perform its activities under this Agreement and solely for purposes consistent with this Agreement; provided that such employees, officers, consultants, subcontractors and Sublicensees are bound by agreement to retain and use the Materials in a manner that is consistent with the terms of this Agreement. The Materials are provided “as is”. Except as expressly set out in this Agreement, no representations or warranties, express or implied, of any kind, are given by the providing Party with respect to any of the Materials including their condition, merchantability or fitness for a particular purpose. The receiving Party acknowledges the experimental nature of the Materials and that accordingly, not all characteristics of the Materials are necessarily known. Upon termination or expiry of this Agreement if earlier, any and all remaining Materials will, within [*****] after such event, be returned to the Party supplying them (or destroyed, if the supplying Party shall so specify, with such destruction confirmed in writing). The provision of Materials hereunder will not constitute any grant, option or license to or under such Materials, or any Patent Rights or Know–how of the supplying Party, except as expressly set forth herein.
4.7 Know-How Transfer. As and when required in relation to a COVID R&D Plan (and from time to time during the Term if new Know-How within the CureVac Know-How comes to be Controlled by CureVac) or as soon as reasonably practicable upon GSK’s request, CureVac shall disclose and/or deliver to GSK copies of all Development Data and the CureVac Know-How that is reasonably required for GSK’s Development activities in accordance with the COVID R&D Plan (including for regulatory purposes) (“Development Transfer Materials”), with the exception, however, of all Know-How comprised in the CureVac Manufacturing Technology which shall be made available to GSK or its designee as set forth in Section 5.2.1. The technology transfer to be undertaken under this Section 4.7 shall be overseen by the Joint Steering Committee. Any transfer of Know-How pursuant to this Section 4.7 shall be carried out on the basis of a specific technology transfer plan determined in good faith by the Parties and reflected in a technology transfer addendum to this Agreement, detailing at least the following activities together with appropriate timelines: (i) the provision by CureVac of soft copies and, to the extent reasonably required by GSK, hard copies of all Development Transfer Materials; (ii) the procurement by CureVac of the services of such qualified and experienced scientists and technicians, production and quality assurance personnel, engineers, and quality checking personnel as may be reasonably necessary to support the transfer of the Development Transfer Materials. Until completion of the transfer of the Development Transfer Materials, CureVac shall build and maintain a secure, readable, accessible and complete repository of the Development Transfer Materials.
5. Manufacturing and commercialization
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5.4 Manufacture by GSK. Upon the request of GSK [*****], CureVac shall transfer all Know-How comprised in the CureVac Manufacturing Technology (“Manufacturing Technology Transfer Materials”) to GSK, an Affiliate of GSK or a Third Party CMO designated by GSK and approved by CureVac (such approval not to be unreasonably withheld, conditioned or delayed), as applicable, so that GSK itself, the Affiliate of GSK or the appointed Third Party CMO (approved by CureVac), as applicable, can take over the Manufacture of COVID Products for GSK (of Finished Product, Filled Containers or Drug Product and Drug Substance, or a combination thereof); provided, however, that any such request must not jeopardize the Parties’ obligations under the [*****] Agreement unless otherwise agreed with the relevant government, if and to the extent any [*****] Agreement requires that the Manufacture of COVID Products is performed in a specific territory or by specific CMO, and (ii) [*****]. In the event of a technology transfer, the JSC shall establish a Manufacturing tech–transfer sub–committee, which shall agree, manage and oversee the Manufacturing technology transfer. Any transfer of Know-How pursuant to this Section 5.4 shall be carried on the basis of a specific technology transfer plan determined in good faith by the Parties and reflected in a technology transfer addendum to this Agreement, detailing at least the following activities together with appropriate timelines: (i) the provision by CureVac of soft copies and, to the extent reasonably required by GSK, hard copies of all Manufacturing Technology Transfer Materials; (ii) if and to the extent reasonably required, the procurement by CureVac of the services of such qualified and experienced scientists, production and quality assurance personnel, engineers, and quality checking personnel as may be reasonably necessary to support the transfer of the Manufacturing Technology Transfer Materials; and (iii) if and to the extent reasonably required by GSK, the provision by CureVac to the personnel of GSK or its Affiliate with reasonable access to its facilities to observe the Manufacture at such times as the Parties may agree; provided such access shall be coordinated in a manner to minimize the disruption of CureVac’s activities and considering CureVac’s limited personnel resources, and CureVac may require any personnel of a Third Party with access to its facilities to sign a confidentiality agreement and to abide by the rules and guidelines applicable to the CureVac facility. Until the completion of the transfer of the Manufacturing Technology Transfer Materials, CureVac shall build and maintain a secure, readable, accessible and complete repository of the Manufacturing Technology Transfer Materials. [*****].
GSK will bear all costs and expenses for the technology transfer contemplated under this Section 5.4 (including any work of the FTEs at the FTE Rate), any payments due under a CMO agreement as a result of the technology transfer to GSK (including reservation fees, cancellation costs or any kind of termination costs resulting from the fact that the COVID Product in question is no longer Manufactured at the site in question) and any increase in COGS (if any), i.e. such costs will not be split as part of the profit split, other than in the case GSK terminates this Agreement on the basis of CureVac’s material breach or otherwise for cause and GSK exercises the GSK Continue Option.
CureVac may also request that GSK Manufactures Finished Product, Filled Containers and/or Drug Product and Drug Substance, whether for Development or for Commercial supply. The Parties shall discuss such matter in good faith, but the final decision shall be with GSK.
Any relevant Clinical Supply Agreement, Commercial Supply Agreement or Quality shall be adapted (or terminated) as appropriate in light of the in–transfer by GSK (or a GSK–designated) CMO of the Manufacturing of COVID Products.
For the avoidance of doubt, GSK may only use the Manufacturing Technology Transfer Materials for the Manufacture of COVID Products under this Agreement. In case GSK manufactures an mRNA–Based product, GSK shall, at the request of CureVac, provide evidence to an independent expert agreed by the Parties in good faith proving that GSK is not using the Manufacturing Technology Transfer Materials for the manufacture of such mRNA–Based product. Unless the expert finds that GSK has used the Manufacturing Technology Transfer Materials for a purpose not permitted under this Agreement, CureVac shall be responsible for the expense of retaining the independent expert. This obligation shall survive the expiration or termination of this Agreement.