Provision Language
Definitions
“Selected Manufacturer” means an LMIC-based manufacturer within CEPI’s list of preferred manufacturers and which is either (i) agreed with the Partners under the iPDP or (ii) otherwise agreed between CEPI and the relevant Partner(s).
4. FUNDING FOR FUTURE PROJECTS; TECHNOLOGY TRANSFER TO A SELECTED MANUFACTURER
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4.2 Collaboration in Event of Outbreak. Should there be an Outbreak or Increased Outbreak Preparation Need at any time during the Term:
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4.2.2 to the extent such technology transfer has not already occurred, at such time as is mutually agreed between the Parties, and on such terms as agreed between the Partner and the relevant third party, acting in good faith, each Partner shall use all reasonable endeavours to transfer or grant licenses or sublicenses to its Background IP, Project Data and Project IP (including, for the avoidance of doubt, all product data, product dossiers, and regulatory submissions submitted to a Regulatory Authority in relation to the Project Vaccine) necessary for the manufacture of the Project Vaccine to a Selected Manufacturer to manufacture such vaccines to address an Outbreak or Increased Outbreak Preparation Need, provided that the foregoing obligations shall apply only if:
(i) CEPI reasonably anticipates that the Partners cannot meet CEPI’s good faith and reasonable estimate of the anticipated demand of public-sector customers in, or purchasing on behalf of, LMICs, in the timeframe required to address an Outbreak or Increased Outbreak Preparation Need and at a price consistent with the pricing provisions contained in Clause 14.5; and
(ii) the Partners have the right to grant necessary licenses or sublicenses to a third party under agreements with Third Party Collaborators, after using reasonable endeavours to secure such rights.
4.2.3 CEPI shall be responsible for the reasonable evidenced cost related to the technology transfer (including, without limitation, capacity reservation fees and process validation engineering runs), provided that, prior to commencing the technology transfer, each Partner has provided a good faith estimate of the costs that it will incur in carrying out such technology transfer and CEPI has provided written confirmation of its acceptance of such estimate. Should CEPI not provide such written confirmation then the relevant Partner shall have no obligation under Clause 4.2.2 to undertake such technology transfer. If CEPI accepts a Partner’s costs estimate, the Parties shall negotiate and enter into a Work Package setting out which activities will be performed by such Partner and the associated Budget.
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4.4 Technology Transfer
4.4.1 If agreed in any Work Package, or otherwise agreed between CEPI and the relevant Partner(s), each such Partner shall use all reasonable endeavours to transfer or grant licenses or sublicenses to its Background IP, Project Results and Project IP (including, for the avoidance of doubt, all product data, product dossiers, and regulatory submissions submitted to a Regulatory Authority in relation to the Project Vaccine) which are necessary for the manufacture and release of the Project Vaccine to a Selected Manufacturer to manufacture and release such vaccines, subject to the relevant Partner having the right to grant necessary licenses or sublicenses to a third party under agreements with Third Party Collaborators, after using reasonable endeavours to secure such rights.
4.4.2 CEPI shall be responsible for the reasonable evidenced cost related to the technology transfer referenced in Clause 4.4.1 (including, without limitation, capacity reservation fees and process validation engineering runs), provided that, such cost has been agreed in a Work Package Budget or otherwise agreed between CEPI and the relevant Partner(s) and in no circumstance shall CEPI, the relevant Selected Manufacturer, or any third party, be required to pay any consideration for the transfer, or grant or exercise of the licences or sublicences referred to in Clause 4.4.1.
4.4.3 If any Selected Manufacturer ceases to meet the necessary requirements, to manufacture the Project Vaccine to GMP at a reasonable cost and within a reasonable timeframe, at any time, then CEPI and the Partners shall negotiate in good faith and agree on a replacement, either from other Selected Manufacturers or such other manufacturer as the Partners and CEPI may identify. The Partners may not unreasonably withhold agreement to a replacement manufacturer, and CEPI and the Partners shall use all reasonable endeavours to ensure that any replacement Selected Manufacturer shall have comparable rights to the original Selected Manufacturer considering all relevant circumstances including then- current demands for the Project Vaccine, manufacturing capacity or level of experience.
6. MANUFACTURE
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6.4 Manufacturing Process. When developing the process for manufacturing the Project Vaccine, the Partners shall endeavour to make such process as suitable as possible for technology transfer to geographically diverse locations (including LMICs) at an affordable price, consistent with Equitable Access and the Partners’ obligations under Clause 14.