EUROPEAN RESEARCH AND INNOVATION OFFICE

1. EUROPEAN RESEARCH AND INNOVATION OFFICE 5th FLUTCORE Progress Meeting 12th April, Pamplona (Spain) WP9 - Project Management Cristina Soriano-Carpena UCL European Research and Innovation Office c.soriano@ucl.ac.uk

2. Project Management • 2nd Periodic report (M19-36) • Finance summary • Amendment request • Pending DVs and MSs • Dissemination

3. M43 – EC 3rd Periodic Report + Final report M36 – EC 2nd Periodic Report M18 – EC 1st Periodic Report M30 - Internal Progress Report Period 2 Period 3 Period 1 ? M6 M24 M30 M12 M43 31/03/2017 M1 01/09/2013 M18 28/02/2015 M36 31/08/2016 M32 April 2016

4. 2nd Periodic report

5. 2nd Periodic Report (1st March 2015 to 31st August 2016) • Period 1 from September 2013 to February 2015: successful submission and payment of €1,032,774.02 distributed in July 2015 Pre-financing + Interim Payment 1 = approx. 65% of the project’s total EC contribution However, interim payments are limited to 85% of the maximum EC contribution. The remaining 15% will be paid at the end of the project (5% guarantee fund + 10% EC retention) All partners have to anticipate a negative cash flow at the end of the project!

6. 2nd Periodic Report (1st March 2015 to 31st August 2016) Structure of the required information for the periodic report: A. Scientific report (coordinator with the info. provided by partners) • Publishable summary (4 pages) • Description of work progress and achievements for each WP • Project management (UCL-ERIO) B. Financial report (provided by partners and revised by UCL-ERIO) • Financial Statements (Form C) for each beneficiary • An explanation of the use of resources within Form C • Audit certificates, when appropriate ( EUR 375,000) Report to be submitted on 31st October 2016

7. Finance summary

8. Finance summary (last internal report M19-M24) ?

9. Amendment

10. Amendment request It is a legal act modifying the commitments initially accepted by the parties and which may create new rights or impose new obligations on them, or modifying significant parts of the GA. To be done only in writing. WHAT? WHO? WHEN? HOW? Coordinator, BUT need to ensure that adequate proof of the consortium's agreement to such an amendment. It is signed by the legal representative of the coordinator on behalf of the Consortium. Before the end of the project, submitted sufficiently in advance in order to allow a well-timed analysis of the request. Effected through an exchange of letters: letter of request and supporting documents justifying the modifications proposed + letter of acceptance from the EC

11. Amendment request Steps to be followed: • Formal agreement by all partners to the amendment | today • Discussion of the points to be modified and the conditions for the modification | today • Preparation of a letter justifying the modifications requested | discuss deadlines • Contact informally for advice the PO in charge of the project • Once all points agreed with PO: launching of a NEF session (if required) • Once modifications are introduced in NEF: preparation of the letter of request (official model) + supporting documents (justification letter, updated Annex I, etc.) • Submission both electronically and in paper to the EC

12. Amendment request What happens next? • The EC can either accept or reject by sending a letter of acceptance or rejection • If the EC does not reply within 45 days after receipt, this is considered a rejection (‘negative silence’). If there is no reply, coordinators are advised to re-contact the EC. • If the EC agrees to the proposed changes, but not with the request as proposed by the Consortium. The EC will reject it and: • Suggest that the Consortium submits a new request • Propose in turn another amendment to the coordinator (coordinator has 45 days to confirm acceptance of the offer)

13. Amendment request • Which amendments are we requesting? • Extension of the duration of the project (months?) • Reporting periods • Modification of Annex 1 (changes in the work to be performed, e.g.: elimination of D3.4. after concerns raised by EAB) • Modification of Article 8 of GA: contact details of the coordinator

14. PM prepares the template for the justification letter and send it to WP leaders for completion WP leaders send the 1st draft to PM who collates all information and submit it to the Coordinator for revision PM to contact Project Officer and submit initial justification for consideration

15. Amendment request Please, keep in mind when asking for an extension… NEF application cannot keep open an amendment session and a cost claim session simultaneously  need to submit the amendment request asap Requests for the modification of the duration may imply the modification of the reporting periods Even in the duration of the project is extended, it will have to finalise the work with the same EC contribution

16. Pending DVs and MSs

17. Pending deliverables • D1.5. Robust method for efficient purification of recombinant VLPs suitable for transferring to a contract manufacturer – to be delivered shortly after the Tech transfer run at UCL (IQUR, due for 31/08/2014) • D4.1. Demonstration of efficacious prophylactic regimen of best candidate VLP in ferrets (IQUR, due for 31/05/2015) • D4.2. Clinical lead candidate selected (IQUR, due for 31/07/2015) • D5.1. Technical transfer documentation (3P, due for 31/08/2015) • D8.3. Exploitation plan (IQUR, due for 30/09/2015) • D5.3. material made available for (a) preclinical toxicology (b) seroconversion and (c) structural analysis (3P, due for 31/12/2015) • D5.2. MCB and WCB generated and fully characterised (3P, due for 31/01/2016) • D2.4. Long-term stability data for VLPs (UNIVLEEDS, due for 29/02/2016) • D6.1. Final version of trial protocol as submitted to Ethical committee (IQUR, due for 29/02/2016) • D6.2. Preclinical safety report (IQUR, due for 29/02/2016) • D6.3. Regulatory application (IQUR, due for 29/02/2016) • D6.4. Appointment of the Ethics Advisor (X-HUVH, due for 29/02/2016) • D5.4 GMP compliant batch release report (3P, 30/04/2016)

18. Pending milestones • MS4. Completion of immunogenicity studies (CRP Santé, due for 31/10/2015) • MS7. GMP compliance report (IQUR, due for 30/04/2015)

19. Dissemination

20. Dissemination activities • Visibility of EU funding: All publications or any other dissemination relating to foreground must • Display the EU emblem (flag): • Include the following text: The research leading to these results has received funding from the European Union Seventh Framework Programme FP7/2007-2013 under grant agreement n° 602437 • Alldissemination activities related to FLUTCORE must be listed on the participant portal

21. Dissemination activities • At least 45 days prior notice of any dissemination activity shall be given to the other beneficiaries concerned • Special clause 39: Open Access • An electronic copy of the published version or final manuscript accepted for publication shall be deposited in a (institutional or subject-based) repository at the moment of publication • Open access to the deposited publication — via the repository — must be provided: (i) immediately, if an electronic version is available free of charge via the publisher, or (ii) within six months of publication

22. Cristina Soriano-Carpena European Project Manager European Research & Innovation Office (ERIO) University College London Maple House, 149 Tottenham Court Rd, 7th Floor London W1T 7NF – United Kingdom c.soriano@ucl.ac.uk Tel: +44 (0)20 7679 9483 Thank you for your attention!