Earma Annual Conference 23 june 2011 - Magali Poinot (parts 2&3)

The writing and implementation of the Innovative Medicines Initiative

projectsPart II

Magali PoinotIMI Legal Manager

www.imi.europa.eu

EARMA Annual Meeting23 June 2011

How does IMI work

• IMI supports collaborative research projects following open and competitive calls with a 2-stage peer review process by independent experts

• Project funding via combined contributions from• EU funds for academia, public organizations, small

and medium sized companies (SMEs), patients associations, etc.

• Private in form of ‘in kind’ contributions from the participating EFPIA companies

1. Participation Rules

2. Funding rules

3. Intellectual Property Policy


2. Funding rules



Who can participate

• Any entity carrying out work relevant to the IMI in a Member State or Associated Country

• Anyone else with the agreement of the IMI JU

BUT

• Not all participating entities are eligible for funding


Minimum requirements

• Stage 1 – Expression of Interest• 2 legal entities

– eligible for funding

– independent from each other

– independent from an EFPIA company

• Stage 2 – Full Project Proposal• 2 legal entities as mentioned above

+ 2 research based pharmaceutical companies that are members of EFPIA


Overall structure of IMI projects

EFPIA comp

EFPIA comp

EFPIA comp

EFPIA compAcademic

Academic

Regulators SME

SME Patient Org.

IMI beneficiaries

(eligible for public funding)

EFPIA ‘in kind’contribution

EFPIA comp

EFPIA comp

“Applicants consortium” “EFPIA consortium”

(no public funding)


2. Funding Rules



Eligibility for IMI JU funding

• Eligible for funding– Academia– SMEs (EU definition)– Patient Organisations– Non-profit research organisations– Intergovernmental organisations

• Non-eligible for funding– EFPIA companies (‘in kind’ contribution)– Companies not falling within the EU definition of SMEs– Others


Eligible costs

• Actual

• Incurred by the claimant

• Incurred during the project

• Determined according to usual accounting and management principles and practices

• Incurred for work carried out in a Member State or Associated Country

• Incurred for the sole purpose of achieving the project objectives

• Recorded in the accounts of the claimant

• Indicated in the estimated overall budget

• Costs incurred for prospective research only carried out in Europe


Non-eligible costs

• Identifiable indirect taxes including value added tax

• Duties

• Interest owed

• Provisions for possible future losses or charges

• Exchange losses, cost related to return on capital

• Costs declared or incurred, or reimbursed in respect of another Union project

• Debt and debt service charges, excessive or reckless expenditure•


Costs categories

• Direct costs– Personnel– Travel and subsistence allowances– Durable equipment– Consumables– Subcontracting– Certificates (methodology / financial statement)– Conference fees

• Indirect costs = overheads

These apply equally to all participants


Indirect costs methods

• Flat-rate of 20% of direct eligible costs (minus subcontracting costs and third party resources)

• Actual indirect costs (under adoption)

For legal entities having developed an accrual accounting system

These apply to participants eligible for IMI JU funding


Upper funding limits

• Research activities-> maximum 75% of total eligible costs

• Other activities, including Management and Training activities-> maximum 100% of total eligible costs

These apply to participants eligible for IMI JU funding


‘In kind’ contribution

• Actual costs or Full Time Equivalent

• Based on the usual management principles and accounting practices

These apply to EFPIA companies


2. Funding Rules



One policy, multiple interests

Freedom of Access

Disseminationof information

Compensation forIP

Support for EUIndustry

Incentive to participate

Innovative Medicines

Research Use for project participantsFair and reasonable terms for others

Data in public domain within a year

Only necessary background includedCompensation within fair and reasonable terms

Direct exploitation rights (academia/SME)Terms known at outset (Pharma)

Terms accommodate a the needs of a spectrum of interests - large and small


Guiding principles

• Aligned with IMI objectives as a public-private partnership

• Adapted to specific research needs and challenges

• To achieve a broad participation of:- private and public entities in IMI projects (academic institutions; small biopharmaceutical companies;

large biopharmaceutical companies)- patients’ organisations and regulatory agencies


Guiding principles

• To promote knowledge creation, together with its disclosure and exploitation

• To achieve fair allocation of rights

• To reward innovation

• To provide some scope of flexibility for participants to establish the most appropriate agreements serving the project objectives (-> Project Agreement, i.e. agreement between the participants)


References

• IP Policy set up in August 2007

• Grant Agreement adopted in March 2009

• Explanatory note of IPR Helpdesk published in 2008

• Guidance Note of 10 November 2010 (including Clarification Note of 2009)


IP Working Group

• Set up by the IMI Governing Board• Composed of representatives from EC, EFPIA and Member/Associated States• With the objectives:

─ to exchange views on the IMI IP Policy─ to coordinate a targeted dialogue between interested parties─ to consider concrete feedback and experiences


Useful definitions (1/2) Start of End of

the project the project

Implementation

Background Foreground

// Sideground // (generated under the Project but outside the Project Objectives and not needed for implementation or Research Use )

possible access rights


Useful definitions (2/2)

• Research Use– use of Foreground or Background necessary to use

Foreground for all purposes other than for completing the Project or for Direct Exploitation

• Direct Exploitation– to develop for commercialisation or to commercialise

Foreground itself• Dissemination

– disclosure by any appropriate means other than that resulting from the formalities for protection, and including the publication in any medium


Quid of Background

• Shall remain the exclusive property of each Participant

• Possibility to freely license, assign or otherwise dispose of its ownership rights in Background

• Has to be identified in the Project Agreement

• Prior legal restrictions to be specified in the Project Agreement


Quid of Foreground

• Belongs to the Participant who generated it, unless otherwise agreed• Joint ownership

– if generated by several Participants, except otherwise agreed in the Project Agreement

– each joint owner shall have the right to use such jointly owned Foreground, provided that prior notice is given to the other joint owners, and fair and reasonable compensation are provided to the other joint owners

• Possibility to freely license, assign or otherwise dispose of its ownership rights in Foreground if:

- expressly permitted in Grant Agreement and/or Project Agreement

- after obtaining the consent of all Participants


Transfer of Back/Fore-ground

• Possible transfer of ownership subject to pass on its IP obligations under the Grant Agreement and the Project Agreement regarding that Back/Fore-ground

• Transfer to affiliates, any purchaser of all or substantially all of assets, and any successor entity resulting from the merger or consolidation of such party without prior agreement


Access Rights (1/2)

• Granted on written request, unless otherwise agreed• Non-exclusive basis approach• No sub-licences, unless otherwise agreed• Not affected by the termination of participation

• Guiding framework between/for participants, affiliates and third parties

• Terms: royalty-free basis / fair and reasonable / to be negotiated


Access Rights (2/2)Access rights granted by a Participant to/on

Background

(necessary and identified)

Foreground Sideground

Participants for completion of the Project

Royalty-free Royalty-free N.A.

Participants and affiliates for Research Use

Royalty-free ORFair & reasonable termsfor Background needed for

using Foreground as determined in Project Agreement

Royalty-free ORFair & reasonable termsas determined in Project

Agreement

N.A.

Third Parties for Research Use after the Project

Fair & reasonable termsfor Background needed for

using Foreground as determined in Project Agreement

Fair & reasonable termsas determined in Project

AgreementN.A.

Participants and affiliates or Third Parties for Direct Exploitation

To be negotiated To be negotiated N.A.


Dissemination

• Obligation to disseminate the Foreground• As soon as reasonably practicable• But no later than one year after the termination or

expiry of the Project

• Description of the material to be disseminated in the Project Agreement


Further Questions ?

• Latest updates:

• Subscribe to the IMI newsletter• Helpdesk, including IP dedicated• 4th Call for proposal

• Open Info Day• Webinars

• News from the projects • Video's

www.imi.europa.eu

Thank You !www.imi.europa.eu

The writing and implementation of the Innovative Medicines Initiative

projectsPart III

www.imi.europa.eu

1. Preparing an Expression of Interest

2. Negotiating an IMI project

3. Negotiating IP provisions

Business

Earma Annual Conference 23 june 2011 - Magali Poinot (parts 2&3)