Provision Language
Definitions
“Affected Territory” means any country, or any geographic area within a country, in which there is an Outbreak or for which there is an Increased Outbreak Preparation Need. For clarity, the Affected Territory includes any country in Awardee’s Traveler’s Market and any Non-Traveler’s Market Countries, in each case in which there is an Outbreak or for which there is an Increased Outbreak Preparation Need.
“Finished Drug Product” means the finished product formulation, containing drug substance, filled into unit packages together with a diluent, ifapplicable, and as finally labelled and packaged in a form ready for administration.
“Increased Outbreak Preparation Need” means when, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates, CEPI determines, in its sole discretion in consultation with experts (for example a sub-group or subcommittee of CEPI’s Scientific Advisory Committee that CEPI determines has appropriate expertise), that there is a heightened need for the Product to address potential Outbreaks.
“LMIC Manufacturer” means a manufacturer based in a Non-Traveler’s Market country engaged by Awardee to manufacture and/or supply the Product as outlined in the IPDP.
“Outbreak” means a Public Health Emergency of International Concern declared by WHO, or a public health emergency on a national or regional scale declared by one or more public health agencies, in each case as a result of a material increase in the number of cases of people infected with CHIK including any regional out-break, an epidemic or a pandemic.
3. Sub-Awardee Participation in the Project
3.5 the awardee will:
[…]
b. in addition to, and without in any way diminishing or otherwise altering, awardee’s obligations under this Agreement and under the IPDP with respect to use of Sub-Awardees in LMICs, cooperate with CEPI in good faith and to the extent reasonably possible to preferentially use Sub-Awardees operating in LMICs where Outbreaks are likely to occur in order to build infrastructure and develop experienced personnel in the relevant territory; and…
7. Clinical Studies
[…]
7.3 Priority for Certain Clinical Studies. Awardee acknowledges that the pool of subjects available in areas of Outbreak to participate in a clinical study to test products such as the Product may be limited. Accordingly, if CEPI reasonably determines in consultation with experts (for example a sub-group or subcommittee of CEPI’s Scientific Advisory Committee that CEPI determines has appropriate expertise) that a product other than the Awardee’s Product has substantially greater potential, as determined in accordance with WHO guidance or relevant local regulatory guidance and should be used for a particular clinical study of subjects in areas of Outbreak, the Awardee agrees that it shall abide by such decision and will not proceed with any clinical study of the Product with subjects from areas of Outbreak unless agreed with CEPI. In the event that Awardee must discontinue a clinical study of the Product in areas of Outbreak according to CEPI´s determination pursuant to this Clause 7.3 , then CEPI shall (i) cooperate with Awardee in an appropriate wind down of the study and (ii) to the extent not funded in advance by CEPI, reimburse Awardee for Awardee’s reasonably incurred non-cancellable expenses relating to such discontinued clinical study. For clarity, Awardee shall not pay back any sums already received from CEPI that have been actually spent by Awardee in connection with such discontinued clinical study. For the purposes of this Clause, CEPI agrees that nothing in this Clause 7.3 will prevent (i) Awardee from undertaking a Pivotal Study in any country or (ii) Awardee fulfilling its obligations under its risk management plan prepared by Awardee in connection with its biologics license application in any country, including but not limited to post registration efficacy trials or any other commitment with any relevant regulatory authority to conduct a clinical study that would support the development of the Product. For the purposes of this Agreement, “Pivotal Study” shall mean a clinical study designed to fulfil the requirement for the filing of an application for a marketing authorization for a Product and that is acceptable to the relevant regulatory authority as a basis for the grant of a marketing authorization.
11. Regulatory Activities
[…]
11.3 Cross Referencing. Awardee will co-operate with CEPI to allow CEPI to cross-reference specific parts of Awardee’s Project Results in order to support regulatory pandemic preparedness, to be further discussed and agreed upon between the Parties.
13. Dissemination and Publication of Project Data
[…]
13.6 Outbreak-Related Publications. Additionally, project data will be shared in accordance with WHO’s 2016 Guidance for Managing Ethical Issues in Infectious Disease Outbreaks and WHO’s 2016 Guidance on Good Participatory Practices in Trials of Interventions Against Emerging Pathogens.
17. Sharing of Commercial Benefits
17.1 Sharing of Commercial Benefits. CEPI has committed to its own funders to obtain a share of Awardee’s Commercial Benefits as a contribution to support CEPI’s programme activities.
17.2 The Awardee will: ensure any LMIC manufacturer – other than Instituto Butantan who shall remain bound by the safety stock requirements agreed under the prior funding agreement between the Parties, effective as of 1 April 2019, as amended – shall make the following contributions to CEPI:
i. Until the rolling safety stock has been established by each LMIC Manufacturer in accordance with Clause 17.2(ii), Awardee will ensure that the LMIC Manufacturer, at its own cost, maintain and make available to CEPI an Investigational Product reserve stockpile of [***] doses of drug product
ii. Awardee will ensure the LMIC Manufacturer produces, at its own cost, a one-year rolling safety stock comprised of not less than [***] doses of Finished Drug Product within [***] of receipt of marketing approval for the Product from a competent regulatory authority having jurisdiction over the relevant LMIC Manufacturer. The stock in paragraph 17.2(i) and this paragraph 17.2(ii) is referred to as (“Safety Stock“).
iii. Awardee will provide details of the Safety Stock to the global Technical Advisory Group to monitor Global Virtual Pooled Inventory (“TAG-GVPI“) once the TAG-GVPI is established.
iv. In case of an Outbreak or Increased Outbreak Preparation Need, CEPI may utilize such Safety Stock in the Affected Territory by giving notice in writing to Awardee and Awardee will ensure the LMIC Manufacturer dispatches all or some only of the Safety Stock, as instructed by CEPI and CEPI shall pay any reasonable costs incurred in connection with the utilization of the Safety Stock, including but not limited to transportation, distribution and storage in the Affected Territory. For clarity, Awardee shall ensure the LMIC Manufacturer makes no charge for the supply of the Safety Stock allocated to and used by CEPI in accordance with this paragraph 17.2(iv) and the storage costs of such Safety Stock, incurred prior to dispatch to the Affected Territory, shall be borne by the LMIC Manufacturer.
v. If the Safety Stock is used by CEPI in the case of an Outbreak or Increased Outbreak Preparation Need, CEPI or such third parties as CEPI may nominate shall be responsible for the costs of transportation of such Safety Stock from the LMIC Manufacturer’s facility. If, following the use of the Safety Stock as directed by CEPI, CEPI wishes to replenish the Safety Stock, Awardee shall, or shall obligate its LMIC Manufacturers to, produce such quantities of Product as are required to replenish the Safety Stock and CEPI shall pay Awardee for the costs of the production of such Product.
18. Preparation for Outbreaks
18.1 Outbreak. CEPI will notify awardee in writing in the event of an outbreak or if there is an increased Outbreak Preparation Need, in each case identifying the Affected Territory (“Outbreak Notice“). Once an Outbreak Notice has been provided by CEPI, CEPI shall have the right to direct how the Safety Stock referred to in Clause 17.2. or any Product manufactured pursuant to Clause 18.2 may be used and to whom it may be provided in the Affected Territory. In consultation with relevant public health authorities in the Affected Territory, CEPI may request that Awardee discuss in good faith whether and how the Project Results could be utilized in response to the Outbreak Notice. Awardee is committed to use commercially reasonable endeavours to address Outbreaks and Increased Outbreak Preparation Need wherever they occur in the world. Following receipt of an Outbreak Notice, Awardee will use its commercially reasonable endeavours to increase the supply of Product available for use by CEPI or its nominees to an amount which equals at least [***] of the production forecast for the Products prepared by Awardee immediately prior to service of the Outbreak Notice and Awardee will use its commercially reasonable endeavours to ensure that such increased capacity is available for delivery to CEPI within [***] of the date of service of the Outbreak Notice. For clarity, Awardee will use commercially reasonable endeavours to keep such deadline of [***] (including discussing with Awardee’s contract manufacturers how they can meet the proposed deadlines), however, Awardee’s ability to meet deadlines will be subject to the lead times of Awardee’s contract manufacturers and the time required for the release testing of the Product. In the event that CEPI’s request for Product to meet the increased demand during an Outbreak or Increased Outbreak Preparation Need is in excess of the quantities that Awardee is able to supply to CEPI based on Awardee’s commercially reasonable endeavours, Awardee shall not be obliged to supply Product to CEPI under this Clause 18.1 to the extent that the supply of such quantities of Product to CEPI would result in Awardee being in breach of any binding contracts in existence on the date of service of the Outbreak Notice (which for the avoidance of doubt may include the supply of Products to customers for Awardee’s Traveler’s Market or in connection with any clinical trials). In such event, provided that Awardee has supplied Product in accordance with this Clause 18.1, Awardee shall not be considered to be in default, and Clauses 18 and 19 shall not apply.
18.2 Additional Product Development. Pursuant to an outbreak notice, CEPI may request that awardee undertake additional Product development at CEPI’s expense or undertake other activities, including the pursuit of regulatory approvals and licensure to the extent not already obtained, with the aim of addressing the needs of the Affected Territory. An additional Work Package covering these activities will be negotiated expeditiously and in good faith by the Parties.
18.3 Multidose presentation. Awardee shall assist and support each LMIC manufacturer in the potential development of a multi-dose presentation of the Product.
18.4 Additional Investigational Product or Product Stockpiles. In addition to the safety stock referred to in Clause 17.2ii., CEPI may request that Awardee undertake, at CEPI’s expense, the manufacturing and maintenance of an additional stockpile of Investigational Product or Product for use in or for the Affected Territory. Such Product may be used for further clinical trials in Outbreak conditions to advance vaccine development, or pursuant to an emergency use authorization, in each case in emergency situations based on national or international guidance (such as WHO), or in such other manner within an Affected Territory as CEPI may reasonably determine. An additional Work Package covering this activity will be negotiated expeditiously and in good faith by the Parties.
18.5 Trusted Collaborator. Promptly after receipt of a written request from (or at any earlier time), Awardee will propose a third party, for example, a Sub-Awardee, as a preferred alternative to itself (“Trusted Collaborator“), that is capable of performing the work and would be prepared to undertake activities pursuant to Clause 18.2 or 18.4 in the event that Awardee declines CEPI’s request to do so, or if Awardee and CEPI do not reach agreement on a new Work Package. CEPI may also propose a Trusted Collaborator to Awardee. Neither Party may unreasonably decline to accept the designation of a proposed Trusted Collaborator.
18.6 Technology Transfer. As described in the IPDP, awardee will be transferring technology to LMIC Manufacturers. Awardee will promptly and diligently provide all necessary guidance, information, materials and assistance reasonably required to transfer Awardee’s technology to each such LMIC Manufacturer as outlined in the IPDP. Pursuant to an Outbreak Notice, CEPI may request to accelerate the timelines for transfer of Awardee’s technology to one or both of such Sub-Awardees and/or CEPI may request an expansion of the transfer to another Trusted Collaborator (other than such LMIC Manufacturers) if that would achieve the transfer more quickly. If CEPI requests transfer of Awardee’s technology to another Trusted Collaborator, Awardee will promptly and diligently provide all necessary guidance, information, materials and assistance reasonably required by such Trusted Collaborator to accomplish the activities that may be requested by CEPI under Clause 18.2 or 18.4 (“Technology Transfer”) at CEPI’s cost. Awardee shall carry out the Technology Transfer to such other Trusted Collaborator pursuant to the terms and conditions of a to-be-agreed-upon confidentiality agreement in accordance with this Agreement to be entered into between Awardee and the Trusted Collaborator governing the Trusted Collaborator’s use and non-disclosure of information and materials provided in connection with the Technology Transfer, provided that Awardee and the Trusted Collaborator shall not delay the execution of such agreement.
18.7 The Awardee will: use commercially reasonable endeavours to cooperate with CEPI in developing a response to an Outbreak or Increased Outbreak Preparation Need which may include opportunities for Awardee and its Sub-Awardees to receive additional Work Packages and funding from CEPI. CEPI is engaging with global stakeholders and in the future, it is likely that Outbreak response will be coordinated by a global entity. In such event, Awardee shall use all reasonable endeavours to collaborate with such entity and to comply with its requirements concerning the Outbreak.
18.8 Outbreak in Awardee’s Traveler’s Market. Notwithstanding anything to the contrary herein, in the event any country in the Awardee’s Traveler’s Market is included in the Affected Territory, Clauses 18 and 19 shall not apply to such country in the Awardee’s Traveler’s Market on the condition that Awardee shall, at the request of public health agencies in such country in the Awardee’s Traveler’s Market, supply the Product to all such public health agencies that request the Product in a quantity and at a price as agreed with the relevant public health agencies. The price agreed with the relevant public health agency shall not exceed the lowest supply price of the Product for similar volumes of Product agreed by Awardee with any customer in the Affected Territory in the [***] preceding the receipt of the Outbreak Notice by Awardee. For purposes of this Clause 18.8, “similar volume” shall mean a volume within the range of [***]. For clarity, if Awardee fails to comply with the foregoing supply obligation with respect to any country in the Awardee’s Traveler’s Market that is included in the Affected Territory, the terms of Clauses 18 and 19 shall apply to such country in the Awardee’s Traveler’s Market that is included in the Affected Territory. However, if the reason why Awardee cannot comply with the supply obligation is that (i) the quantity of Product requested by the relevant public health agency is impossible to fulfil due to Awardee’s capacities or (ii) the price proposed by the public health agency would be unsustainable to Awardee, Clauses 18 and 19 shall not apply in such case. In any case, “sustainable price” shall never be below Awardee’s manufacturing costs.
