Provision Language
4. Development
4.1 Development. As between the Parties, AstraZeneca shall have the sole right and responsibility for all aspects relating to the research and development of the Vaccine with the goal of establishing a Vaccine that is safe and efficacious for manufacture and sale as contemplated by this Agreement.
4.2 Reporting
(a) Along with its offer, AstraZeneca has provided to the Commission reports of the interim and final results of the Oxford University–sponsored Phase I/II clinical study of the Vaccine (the “Phase l/II Trial Results”) from Oxford University. AstraZeneca shall provide to the Commission (i) key updates on development of the Vaccine project, including regulatory matters relevant to the Vaccine; and (ii) updates on progress, challenges and opportunities on establishment of the supply chain for the Vaccine. Notwithstanding the foregoing, in no event shall AstraZeneca be obligated to disclose Vaccine development project results or other information concerning development of the Vaccine that AstraZeneca is not legally or contractually permitted to share, including such information which AstraZeneca may be required to first disclose to Oxford University. In the event that AstraZeneca is not legally or contractually permitted to share such information, AstraZeneca shall explain the basis upon which it is not permitted to share such information and provide relevant evidence to the extent legally or contractually permissible.
(b) On reasonable notice and as reasonably requested, AstraZeneca shall enable the Commission (or an independent expert appointed by the Commission as set forth below) to access all clinical trial data (including communications and correspondence with Regulatory Authorities and bodies to include all audit observations, inspection reports, meeting minutes, and all AstraZeneca commitments and responses) and all data relevant to the manufacturing of the Vaccine; provided, that AstraZeneca is permitted to share such information with the Commission; and provided further, that if AstraZeneca is not permitted to share such information with the Commission, it shall use its Best Reasonable Efforts to obtain permission to share such information. If the Commission chooses to access such information through a third party, such third party must be an independent expert in the applicable field the Commission shall notify AstraZeneca of such expert in advance, and such expert shall be subject to Section 15 of this Agreement. The Commission shall choose another expert if AstraZeneca provides reasonable justification upon which such expert should not be permitted access to such information.
10. Regulatory Matters
10.1 Compliance; Assistance. AstraZeneca shall be responsible for timely complying with all legal requirements of approval processes of the clinical trials and the market authorization of the Vaccine in the Member States. Notwithstanding the foregoing, the Commission and the Participating Member States shall use Best Reasonable Efforts, within the framework of their competencies, to support AstraZeneca in providing accelerated quality and current Good Manufacturing Practices facility approvals and OMCL testing if the requirements of safety, quality and efficacy of the Vaccine allows it to do so and are fully met. The Commission and the Participating Member States shall use their Best Reasonable Efforts to support, within the framework of their competencies, AstraZeneca in its Best Reasonable Efforts to achieve for the Vaccine fast access to the European population through pan–European access mechanisms, including accelerated regulatory approval processes.
10.2 Reporting. AstraZeneca shall promptly inform the Commission if, in the process of reviewing the results or progress of AstraZeneca’s clinical trials, AstraZeneca reasonably determines that the ongoing or planned clinical trials by AstraZeneca and its partners are not likely to be sufficient for approval of the Vaccine by the Commission.
10.3 Post–Launch Safety and Risk Management Studies. In the event that post-launch safety or risk management studies for the Vaccine are (i) required by the EMA, (ii) required by another Regulatory Authority and relied upon by EMA for approval, or (iii) otherwise required or advisable to be conducted for the benefit of any Participating Member States in AstraZeneca’s reasonable discretion, AstraZeneca will introduce all such costs and expenses incurred for, or fairly allocable to, such post–launch safety and risk management study activities to the Costs of Goods and include it in the payments to be made by the Participating Member States.