“Enabling Rights” means rights to Intellectual Property and Project Results that could be asserted by Awardee to block CEPI from exercising its rights under Clause 13 of this Agreement. For purposes of this Agreement, Enabling Rights also includes the contractual rights under contracts executed for the Project that control the use of such items, for example, in material transfer agreements.
“Field” means the public health vaccine response to the Outbreak and to other coronaviruses against which a Project Vaccine may be at least partially cross-protective.
“Outbreak” means the COVID-19 outbreak caused by the SARS-CoV-2 virus or any strain, mutations and related recurrences of such virus.
“Public Health License” means a grant by Awardee to CEPI of all relevant rights under Project Results, Enabling Rights and Background IP for use in the Field by CEPI as described in clause 13.
“Project Materials” means biological samples, Project Vaccines, and other tangible materials produced under the Project.
13. Project Continuity
13.2 Project Continuity Plan. Because of the exigent nature of the Outbreak, the iPDP shall include a Project Continuity Plan that, at a minimum, shall address the following items:
(a) responsibilities and level of access on the part of other collaborators, Subawardees and consortium members, if any, to Project Results and Enabling Rights;
(b) management of key Project Materials through participants in the Project and other entities such as the BioEscrow® deposit service of the American Type Culture Collection;
(c) identification of a proposed third party, for example, a Subawardee, under contract to Awardee that is capable of performing the activities in agreed Work Packages, Additional Work Packages or a Project Expansion (“Trusted Collaborator”), in the event that Awardee is unable to continue its activities under this Agreement or declines CEPI’s request to undertake additional Work Packages or a Project Expansion; and
(d) at least a preliminary identification of one or more geographically dispersed manufacturing sites, under contract with Awardee, to produce Project Vaccine for use in the Field (“Trusted Manufacturer”). Awardee shall make a final designation of one or more Trusted Manufacturers, in consultation with CEPI, and prior to the start of a Phase II clinical trial.
13.3 Alternative Designations by CEPI. If Awardee does not designate a Trusted Collaborator and/or Trusted Manufacturer, or they notify Awardee that they are no longer available, then CEPI may propose a Trusted Collaborator or Trusted Manufacturer to Awardee. Neither Party may unreasonably decline to accept the designation of a proposed Trusted Collaborator under Clause 13.2 or this Clause 13.3. Once designated and under contract to pursue Project activities, a Trusted Collaborator and Trusted Manufacturer shall be a Subawardee for the purposes of this Agreement.
13.4. Public Health License. Subject to the terms of this Agreement, Awardee hereby grants a worldwide and royalty free Public Health License to CEPI, on the condition that CEPI may only exercise the rights granted under the Public Health License in the event that:
(a) CEPI is not in material breach of its obligations under this Agreement;
(b) the Project Vaccine has achieved licensure with at least one regulatory body (including but not limited to emergency licensure); and
(c) one or more of the triggers set out in Clause 13.5 has occurred.
CEPI shall be entitled to sublicense Project Results, Enabling IP and Background IP included in the Public Health License in accordance with this Clause 13. Each sublicense shall be in writing and CEPI shall require that each sublicensee complies with the terms of the Public Health License, and if receiving a sublicense to Third Party Background IP, also complies with the terms of the Third Party Background IP license agreement. If a license to Third Party Background IP does not permit further sublicensing by CEPI, Awardee agrees to directly grant CEPI’s designee a sublicense consistent with the Public Health License, provided such third party designee agrees to comply with the terms of the Third Party Background IP license agreement, including, without limitation, any payment of sublicense fees attributable to such sublicense grant. CEPI will remain responsible and liable for the performance of sublicenses under such sublicensed rights to the same extent as if such activities were conducted by CEPI.
13.5. Public Health License Triggers. Consistent with Clause 13.4, CEPI’s right to exercise the Public Health License shall be satisfied when:
(a) Awardee declines to participate in an Additional Work Package or Project Expansion as requested by CEPI, either directly or indirectly through a Subawardee;
(b) CEPI and Awardee agree, in good faith, that Awardee shall not be able to perform the activities under an agreed Work Package, either directly or indirectly through a Sub awardee;
(c) Awardee is in material breach of this Agreement or the Equitable Access Plan and has not cured such breach within [***] days of notification of such breach by CEPI unless otherwise mutually agreed; or
(d) the Agreement is terminated by CEPI pursuant to Clause 19.2(a)-(b) (default or insolvency) or 19.3(c) – (e) (unavailability to perform Project activities, failure to satisfy payment criteria or fraud).
13.6. Agreement between CEPI and the Trusted Collaborator or Trusted Manufacturer. In the event that the Public Health License is exercised, CEPI may request assignment of the relevant Trusted Collaborator or Trusted Manufacturer contracts from Awardee or, at CEPI’s option, endeavour to reach agreement directly with the Trusted Collaborator and/or Trusted Manufacturer, as the case may be, to perform such activities as CEPI may deem necessary. At CEPI’s request, Awardee shall use [***] to facilitate the conclusion of a direct contractual relationship between the Trusted Collaborator or Trusted Manufacturer, as the case may be, and CEPI. If those negotiations do not result in an agreement in [***], then CEPI may grant rights under its Public Health License to a third party unilaterally designated by CEPI as a Trusted Collaborator or Trusted Manufacturer, without approval from Awardee.
13.7. Effects of Exercise of the Public Health License. Upon exercise of the Public Health License and written notice to Awardee, Awardee [***] shall:
(a) provide CEPI with an updated list of Enabling Rights and applicable Background IP, along with an invoice for any payments due under any license agreement for Third Party Background IP attributable to the grant of the Public Health License to CEPI or a sublicensee;
(b) provide CEPI with a good faith schedule of key technology transfer activities and estimated costs for the technology transfer in Clause 13.6;
(c) [***] transfer to the Trusted Collaborator and/or Trusted Manufacturer, as the case may be, and at CEPI’s reasonable cost, all Project Results, Project Materials described in Clause 13.2(b), all guidance, information, materials and assistance reasonably required to accomplish the Project activities identified by CEPI; and
(d) shall be deemed to have covenanted not to sue CEPI or designee for the exercise of the Public Health License.
16. Representations and Warranties
16.2.Awardee Representation. During the Term of this Agreement, Awardee shall:
(d) make no encumbrances over, dispose of, or otherwise deal with the Project Results, Intellectual Property and Enabling Rights in any way that would be reasonably deemed inconsistent with this Agreement, including the Public Health License, or that would impede the complete fulfillment of its obligations under this Agreement without the express written permission of CEPI;
16.3. Additional Awardee Representation. In the event that the Public Health License becomes exercisable, then continuing after the expiration or termination of this Agreement, Awardee shall make no encumbrances over, dispose of, or otherwise deal with the Project Results, Intellectual Property and Enabling Rights, in any way that may be inconsistent with the objectives of this Agreement, including the Public Health License, without the express written permission of CEPI.