Provision Language
6. Compliance with Applicable Laws and CEPI Policies and Procedures
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6.4 the awardee will:
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b. subject to clause 24.6, comply with CEPI policies and procedures;
[…]
d. notify CEPI promptly to discuss any amended CEPI policies and procedures that raise concerns about Awardee’s ability to perform its obligations under this Agreement.
16. Equitable Access
16.1 Equitable Access. CEPI is committed to achieving equitable access to the outputs of all CEPI-supported programmes, including access to all applicable Project Results in accordance with this Agreement, pursuant to CEPI’s “Equitable Access” Policy. Equitable Access to Chikungunya vaccines means the regular supply of the Product(s) to public health systems in all Non-Traveler’s Market Countries that have a demand for the vaccines at an affordable price (as outlined in Clause 16.4) and, in the context of an Outbreak or Increased Outbreak Preparation Need means that appropriate vaccines are first available to populations in the Affected Territory when and where they are needed, including to end an Outbreak or curtail an epidemic, regardless of ability to pay. Consistent with CEPI’s Equitable Access Policy, CEPI is also committed to supporting Equitable Access so that the economics are sustainable to the manufacturer.
16.2 Equitable Access Plan. The initial plan to support such Equitable Access commitment (the “Equitable Access Plan“) is set out in Annex G and sets out among other things how the Product will be suitable for Non Traveler’s Market use and made available to all populations in Affected Territories without undue delay and at an affordable but sustainable price (subject always to Clause 16.4). This Equitable Access Plan shall be reviewed by JMAG no less than every [***] and shall take into account production [***] and shall be updated throughout the Term to reflect such reviews or as otherwise agreed between the Parties. The Parties agree that a more detailed Equitable Access Plan will be agreed promptly after the Equitable Access Group is established. The Awardee will keep the JMAG and, if established, the Equitable Access Group, fully and regularly informed of its adherence to the Equitable Access Plan and its progress, or lack thereof, in meeting its objectives.
Schedule C. CEPI Policies and Procedures as of Effective Date
- Animals in Research Policy
- Anti-Corruption Policy
- Clinical Trials Policy
- Cost Guidance
- Equitable Access Policy
- Information Security Policy
- International Sanctions Policy
- Managing Conflicts Of Interest Policy
- Procurement Policy
- Scientific Integrity Policy
- Transparency & Confidentiality Policy Travel Policy
- Third Party Code
Annex C. Integrated Product Development Plan (IPDP)
1. Project description
1.1. Introduction and background. Valneva’s objective is to make the world’s first chikungunya vaccine broadly available in both developed and developing countries, to prevent the impact this disease has on communities and individuals. […]