“Approved Regulatory Authority” means the EU European Medicines Agency, the US Food and Drug Administration, SwissMedic, Japanese PMDA, Australian Therapeutic Goods Agency, South Korean Ministry of Drug Safety, Health Canada, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) or Singapore Health Sciences Authority.
“Affected Territory” means the geographic area of any country where there is an Outbreak or that is at risk of an Outbreak taking into account epidemiological data, travel and migration patterns and the lack of availability of other products or product candidates;
“Field” means the diagnosis, prevention and treatment of infections caused by:
(i) the pathogens listed in the WHO R&D blueprint priority (December 2015 or January 2017) as updated from time to time (including: Arenaviral hemorrhagic fevers (including Lassa Fever), Crimean Congo Haemorrhagic Fever (CCHF), Filoviral diseases (including Ebola and Marburg), Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (or other highly pathogenic coronaviral diseases, such as SARS), Nipah and related henipaviral diseases, Rift Valley Fever (RVF), Severe Fever with Thrombocytopenia Syndrome (SFTS) and Zika unless, at the time of CEPI’s request to work with Partner, Partner is already committed to working with Gates based on a proposal according to the Global Access Commitments Agreement dated February 13, 2015;
(iii) Lassa Fever; and
(iv) novel or previously unrecognized pathogens likely to result in an Outbreak or risk of an Outbreak unless, at the time of CEPI’s request to work with Partner, Partner is already committed to working with Gates based on a proposal according to the Global Access Commitments Agreement dated February 13, 2015 or unless products to treat such infections are already commercialized, commercialization has failed, or Partner has a commercial interest in such products. Such commercial interest of Partner is assumed for the following pathogens: [*****]. If CEPI is interested to develop a product with respect to such novel or previously unrecognized pathogen under this Agreement, it shall notify Partner hereof and Partner shall respond within [*****] business days as of the notification whether the product is within or outside the Field, and with respect to any such pathogen other than the ones listed above for which the commercial interest is assumed, Partner shall provide information on its commercial interest. With respect to pathogens which fall under this (iv), for which the Partner has previously declared commercial interest, and for which the commercial interest is not assumed, CEPI may after six (6) months as from Partner’s providing the aforementioned information reasonably request from Partner a confirmation including appropriate information, that Partner’s commercial interest continues and consequently such pathogen remains to be outside the Field.
“Outbreak” means (i) the occurrence in a community or region of cases of an illness with a frequency in excess of normal expectancy; (ii) a public health emergency of international concern declared by WHO; and/or (iii) a public health emergency on a national or regional scale declared by the relevant national or regional government.
“Project Vaccine” means vaccines targeting Lassa, to be Developed and Manufactured, pursuant to this Agreement.
7. Partner Obligations
7.6 Trusted Manufacturers. Subject to the undertakings to be defined in the Additional Work Packages and – upon Partner’s request, subject to a separate confidentiality agreement to be concluded between the Partner and the Trusted Manufacturer – the Partner will support CEPI in appointing one or more Trusted Manufacturers that are technically and operationally capable of and willing to rapidly Manufacture Product for use in the Field in the Affected Territory on an ongoing basis both during and after completion of the Project, in accordance with CEPI’s requirements, as set forth herein.
7.6.1. Subject to the undertakings in the Additional Work Packages the Partner shall:
(i) grant appointed Trusted Manufacturers all necessary rights to use (on a non-exclusive, royalty-free and license-fee free basis) the Background Technology and Project Technology to further Develop the Platform, and to Manufacture Products for use in the Field in the Affected Territory in accordance with the CEPI Production Timescale and in the quantities reasonably likely to be necessary in the event of an Outbreak or risk of Outbreak in the Field and at a cost of goods in line with the methodology to determine pricing obligations set out in the CEPI Equitable Access Policy;
(ii) provide the Technology Transfer Materials to the Trusted Manufacturers and ensure that such Technology Transfer Materials are kept up to date, in particular, at each date on which the Partner requests any payment from CEPI, on the occurrence of one or more Conditions Precedent and on termination or expiration (for whatever reason) of this Agreement;
(iii) at the request of CEPI, enable Trusted Manufacturers to establish a warm base for the further Development of the Platform, and Manufacturing of Products for use in the Field in the Affected Territory;
(iv) collaborate with public sector agencies to use the Platform to Manufacture Products for use in the Field in the Affected Territory in accordance with the CEPI Production Timeframe in the quantities reasonably likely to be necessary and at a cost of goods in line with the methodology to determine pricing obligations set out in the CEPI Equitable Access Policy, in particular before any Outbreak or when there is Risk of Outbreak; and
(v) provide all necessary commercially reasonable support to the Trusted Manufacturers to facilitate the foregoing.
7.7 Partner nominees for Trusted Manufacturers. Upon CEPI’s request, Partner will use Reasonable Efforts to notify CEPI of suitable Trusted Manufacturers for appointment by CEPI.
7.8 CEPI nominees for Trusted Manufacturers. CEPI may nominate by notice in writing to Partner Third Parties as suggested Trusted Manufacturers. The Partner shall consider any Third Parties nominated by CEPI as potential Trusted Manufacturers in good faith. Where a Third Party nominated by CEPI is not acceptable to the Partner on reasonable grounds (including commercial grounds), the Partner shall notify CEPI promptly of its decision and the reasonable grounds and CEPI shall not appoint such Third Party as a Trusted Manufacturer.
7.9 Additional Trusted Manufacturers. Subject to specific Additional Work Packages, CEPI has the right during the Project Term to pursue the appointment of additional Trusted Manufacturers where such additional capacity is necessary or useful to:
7.9.1. develop and/or increase Manufacturing capacity for Products for use in the Field in the Affected Territory to satisfy demand or likely demand;
7.9.2. develop and provide warm base Manufacturing capacity for emergency planning and contingency planning;
7.9.3. Manufacture emergency stockpiles of Products for use in the Field in the Affected Territory.
Partner shall consider CEPI’s requests for additional Trusted Manufacturers in good faith and shall within [*****] of receipt of such request notify CEPI in writing whether the Partner agrees or declines to support the appointment of additional Trusted Manufacturers by CEPI together with the grounds for its decision.
7.10 Disputes as to Trusted Manufacturers. In the event that the Parties are unable to reach agreement on the identity, number and/or necessary aggregate capacity of Trusted Manufacturers, the matter shall be resolved in accordance with the dispute resolution procedure set out in Clause 22.
8. Outbreak And Risk Of Outbreak In The Field
8.1 Notification of Outbreak or Outbreak risk. CEPI shall notify Partner if there is an Outbreak in the Field or risk of an Outbreak in the Field.
8.2 During or after the Project where Outbreak or risk of an Outbreak can be addressed by a Project Vaccine. On receipt of such notice, subject to the respective Work Packages, the Work Package Statements and the Work Package Budgets the Partner agrees to make Reasonable Efforts to:
8.2.1. continue the Development, and Manufacturing the Project Vaccine for use in the Field in the Affected Territory in accordance with the existing or mutually agreed upon IPDP and Work Package Statements;
8.2.2. Manufacture the Project Vaccine for use in the Field in the Affected Territory in accordance with the CEPI Production Timeframe and in the quantities reasonably likely to be necessary and at a Cost of Goods in line with the methodology to determine pricing obligations set out in the CEPI Equitable Access Policy;
8.2.3. establish directly or to enter into an agreement with CEPI, a public sector agency or another Third Party, for the supply of Project Vaccine for use in the Affected Territory;
8.2.4. at the request of CEPI, agree in good faith with CEPI how the Development, and Manufacturing of the Project Vaccine can be accelerated and the amount of any additional funding necessary for such acceleration; and
8.2.5. make the Partner Contribution in accordance with the Work Package Statements.
8.3 When an Outbreak or risk of an Outbreak Cannot be Addressed by a Project Vaccine: During the Initial Project Term and for [*****] thereafter where an Outbreak or risk of Outbreak in the Field cannot be addressed by a Project Vaccine or other Product Developed subject to an Additional Work Package, CEPI may notify Partner of its interest to develop such other Product, and CEPI and Partner may agree that Partner either develops such Product, or utilizes the RNA Optimizer Toolkit [Partner methodology and processes to provide optimized nucleotide sequences] to assist CEPI to develop a candidate vaccine against that pathogen in the Field and to produce a vaccine stockpile, in each case pursuant to an Additional Work Package to be negotiated in good faith and agreed upon.
8.3.1. If Partner declines to enter into such agreement to develop Product, and subject to Partner’s obligations under Clause 8.3.2 below, then CEPI has the right to develop and stockpile such Products for potential use in the Field and to have such Product Manufactured by a Third Party in accordance with the Public Health License under Clause 11 below.
8.3.2. Upon CEPI’s notice in accordance with this Clause 8.3.2, Partner agrees to use Reasonable Efforts to submit optimized antigen nucleotide sequences utilizing the RNA Optimizer Toolkit for up to [*****] specified pathogens (based on amino acid sequences of such antigens provided by CEPI) under Additional Work Packages within the Field and during the Initial Project Term and for [*****] thereafter in order for CEPI to start its own product development. Partner agrees to provide up to [*****] optimized antigen nucleotide sequences per specified pathogen. If Partner agrees to develop another Product, such Product shall count against such [*****] pathogens above. For the avoidance of doubt regarding the scope of these activities, the Parties shall prepare an Additional Work Package that clarifies the specifications of these activities. For clarity, Partner will not be required to undertake any further development activities with respect to a Product, and CEPI with other partners will solely be responsible to advance the candidate Product for emergency use authorization or other marketing approval, such as, for example, pre-clinical studies.
8.3.3 CEPI will give Partner a Partner Right of First Refusal to Manufacture a Product developed pursuant to the foregoing Clause 8.3.2 on the Platform, subject to an Additional Work Package to be negotiated between the Parties in good faith and agreed upon setting out the activities to be conducted, Milestone Criteria, Milestone Dates, Work Package Budget, CEPI funding and the Partner Contribution. If the Partner declines to carry out such activities:
(i) CEPI may exercise the Public Health License and the activities shall be carried out by Trusted Manufacturers; and
(ii) the Partner shall comply with the provisions of Clause 12.
If the Partner agrees to carry out the activities, but the Parties are unable to reach agreement by the deadline, or are unable to agree the Additional Work Package Statement within [*****] of CEPI’s receipt of the Partner’s written notice referred to above, the terms submitted by CEPI will apply.