“Financial Documents” means (i) the Financial Summary and Reporting Form, (ii) the most recent audited financial statement of the Partner, auditor’s report for such financial statement and management letter to the auditors for such financial statement, (iii) the Partner’s current treasury policy and (iv) an outline of the Partner’s risk management strategy for currency fluctuations.
“Financial Summary and Reporting Form” means a report by the Partner to FUNDER in the prescribed form providing up-to-date details of Work Phase costs.
“Project Inventions” means any discovery, development, Know How, invention or improvement created, devised or arising out of the undertaking and performance of any Work Phase.
“Quarterly Report” means a written report to the JMAG and FUNDER outlining Work Phase progress, key risks and risk mitigation strategies and up to date financial details relating to the Project in a form specified by FUNDER.
3. Contributions and Work Phases
3.5 Agreeing Work Phase Statements. Each Work Phase Statement shall be agreed in the following manner:
3.5.1. For the Pre-clinical Work Phase, the Work Phase Statement agreed to by the Parties is attached at Schedule 5.
3.5.2. Except where Clause 3.5.1 applies, six (6) months prior to the completion of any individual Work Phase, the Partner shall provide to FUNDER such information as the FUNDER Group may reasonably request about the next planned Work Phase and FUNDER reserves the right to conduct a formal stage-gate review that shall include a face-to-face meeting with the Partner and/or otherwise request further information prior to the exercise of FUNDER’s option to fund any subsequent Work Phase Partner agrees to participate in any face-to-face stage-gate review and to provide such requested information in a timely fashion, so as to avoid disruption between Work Phases;
3.5.3. Following FUNDER’s receipt of the information from the Partner, FUNDER shall, as soon as reasonably practicable, inform the Partner that:
i. it is willing in principle to provide funding for the next planned Work Phase; or
ii. it declines to provide funding for the next planned Work Phase.
3.5.4. If Clause 3.5.3i applies, FUNDER shall provide the Partner with the draft Work Phase Statement and the Parties shall discuss such draft in good faith. An indication in principle that FUNDER is willing to provide funding for the planned Work Phase is not an exercise of FUNDER’s option to do so, exercise only occurs when the Work Phase Statement has been agreed and both Parties have signed it. The Parties shall work together in good faith and in a timely manner to ensure smooth transition between Work Phases.
3.5.5. During the course of a given Work Phase, clinical trial results or other factors may arise, which necessitate amendment of a Work Phase Statement. If this should occur, Partner undertakes to communicate such need together with adequate written justification for same to FUNDER. The Parties agree to use reasonable endeavours to agree on any such revisions or amendments by negotiating in good faith and in a timely manner so as to ensure the continuity of the Project and the Work Phase.
3.7 Milestone Reports. The Partner shall promptly notify FUNDER when the Partner considers that a Milestone within any Work Phase has been achieved, and it shall, as soon as reasonably practicable send to FUNDER:
3.7.1. a detailed report evidencing such achievement (the “Milestone Report”); and
3.7.2. up to date, true, complete and accurate Financial Documents.
3.9 End of Work Phase Reporting. At the end of each Work Phase, within twenty (20) Business Days of the last Milestone Date in that Work Phase, the Partner shall submit to FUNDER a final Milestone Report for that Work Phase and a Final Financial Summary.
4. Records and Standards
4.9 Access to Records. Upon FUNDER’s request, the Partner shall make available (and shall procure that its collaborators and sub-contractors make available) to FUNDER all records generated in connection with any Work Phase of the Project (except for any records which at the time of the request should remain blinded to FUNDER in the interests of the integrity of the Clinical Trial).
4.11 Audit. The Partner shall procure that the control of expenditure of the FUNDER Funding and the Partner Contribution are governed by the normal standards, procedures and formal audit arrangements that exist in the Partner. FUNDER shall have the right to ask for confirmation from the Partner’s external auditors that the external auditors have signed their opinion on the Partner’s annual accounts of the Partner without qualification and the management letter from the auditors raises no matters that did or could significantly affect the administration of grants awarded by FUNDER. If the auditors have raised any such matters in their management letter, FUNDER may require the Partner to provide it with relevant extracts from the letter.
4.12. Accounting records. The Partner shall provide access to accounting and other financial records relating to the FUNDER Funding, Partner Contribution and the activities funded by the foregoing (as well as income and expenditure associated with the Project and the systems used by the Partner to administer the Project financially and otherwise) for auditors and other personnel from or appointed by FUNDER at any time if requested. Such access shall include the right to inspect any equipment or facilities acquired or funded under the FUNDER Funding or Partner Contribution. Where activities funded by the FUNDER funding or the Partner Contribution have involved a collaborator or have been sub-contracted, the Partner shall ensure that the right of access extends to the accounts and records of any such collaborator or sub- contractor.
5. Project Management and Oversight
5.10 Quarterly Reports. For any calendar quarter where there has not been a JMAG meeting and where the Partner has not submitted a Milestone Report to FUNDER, the Partner shall provide a Quarterly Technical and a Quarterly Financial Report to JMAG and FUNDER with updates on any matters relating to the Development Plan or otherwise within the JMAG’s remit.
7. Site Visit Group
7.1 Monitoring of Project. FUNDER may appoint a Site Visit Group made up of a small team of independent experts together with some FUNDER observers to consult informally with the Partner’s staff working on the Project, to evaluate progress, performance and key issues and to report back to FUNDER and the JMAG on its findings. The Partner agrees that the Site Visit Group shall have reasonable access during normal working hours and at mutually agreed times to visit the premises where any Work Phase activities are being conducted; the Partner agrees to procure that these rights of access for the Site Visit Group extend to the staff and premises of any collaborators and sub- contractors.
7.2. Site Visit Group Recommendations. The Site Visit Group may recommend that FUNDER terminates any Work Phase due to a serious failure in the progress, management or conduct of the Work Phase (including a finding that the Partner will be unable to achieve the next Milestone by the relevant Milestone Date), or due to a major external scientific, technical or commercial barrier which means that the Work Phase or the Project is unlikely to succeed in its objectives.
8. Access to and Supply of Product
8.1 Funder Policy. Partner acknowledges and understands the Funder Equitable Access Policy and agrees to comply with such policy as it applies to the Product. In accordance with that policy, Partner shall provide the following then current information to Funder in accordance with Clause 3.5.2 (Agreeing Work Phase Statement):
8.1.1 Progress report on the scale-up of the Manufacturing process to fulfil the requirement of an Approved Regulatory Authority for the grant of Marketing Approval for the Product or plans to do that same and a good faith estimate of the number of doses of Product such scaled-up Manufacturing process will be capable of producing in each year of manufacture and by when such volume will be achieved; and
8.1.2 A good faith estimate of Cost of Goods for the Product for (i) the Investigational Stockpile and (ii) additional doses of the Product together with any information that would impact the cost of the Product.
8.2 Volume. If the Partner has not developed a Manufacturing process for the Product which meets the estimated capabilities disclosed under Clause 8.1 by [date], (i) the Partner shall provide Funder with full details of the obstacles to meeting such requirement and all related Data within ten (10) Business Days after such date; (ii) Funder may at its sole discretion (i) grant an extension of time and require the Partner to consult with experts in the field approved by Funder or (b) exercise its step-in rights under Clause 9.
8.3 Cost of Goods. If the Partner has not developed a Manufacturing process for the Product which will maintain the Cost of Goods for the Product at a level Public Service Agencies agree is affordable for use in the Affected Territories by [date], (i) the Partner shall provide Funder with the Cost of Goods and supporting Data and (ii) Funder may in its sole discretion, (a) participate in the negotiations with the Public Services Agency(ies), (b) facilitate introductions for the Partner to third parties who may be of assistance in the establishment of a secondary manufacturing facility, (c) audit the Partner’s Cost of Goods (and may use a reputable accounting firm to do so in its behalf), or (d) exercise its step-in rights under Clause 9.
10. Intellectual Property – Ownership and Protection
10.1 Foreground Intellectual Property. The Partner shall procure that the Project Lead monitors the work carried out under all Work Phases for material that may be the subject of Project Inventions and shall promptly notify the JMAG of any such Project Invention. The Partner shall additionally promptly disclose all Project Inventions and Foreground Intellectual Property to FUNDER in writing.